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This ICSI Technology Assessment Report is designed to assist clinicians by providing a scientificassessment, through review and analysis of medical literature, of the safety and efficacy of medicaltechnologies and is not intended either to replace a clinician’s judgment or to suggest that a par-ticular technology is or should be a standard of medical care in any particular case. Standards ofmedical care are determined on the basis of all the facts and circumstances involved in a particularcase and are subject to change as scientific knowledge and technology advance and practice pat-terns evolve.

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Technology Assessment ReportICSII NSTITUTE FOR C LINICAL

S YSTEMS I MPROVEMENT

Approved January, 2005 TA # 87Copyright © 2005 by ICSI (www.icsi.org)This document is a scientific statement of safety and efficacy only. It is not intended to replace a clinician's judgement or to suggest that aparticular technology is or should be a standard of medical care in any particular case.

Institute for Clinical Systems ImprovementTechnology Assessment Abstract

Behavioral Therapy Programs for Weight Loss inAdults

Prepared under the direction of theTechnology Assessment Committee

(TAC Sponsor, James Smith, M.D.)by Nancy L. Greer, Ph.D., Staff

Description of Treatment/ProcedureRecent guidelines from the National Heart, Lung, and Blood Institute (NHLBI) have defined overweight as a body massindex (BMI) of 25 kg/m2 to 29 kg/m2 and obesity as a BMI of 30 kg/m2 or higher. It is estimated that the overallprevalence of obesity is greater than 30% in adults. Obesity has been found to be associated with a number of diseaseconditions including type 2 diabetes mellitus, coronary heart disease, high blood pressure, osteoarthritis, andgallbladder disease. A poor diet and physical inactivity is the second leading cause of death in the United States. A10% reduction in body weight has been found to decrease risk factors for diabetes and cardiovascular disease.

Potential UsesBehavioral therapy programs may be suitable for patients that are either overweight or obese.

ContraindicationsBehavioral therapy programs are inappropriate for patients who are pregnant or lactating; have serious uncontrolledpsychiatric illness; have a serious illness that might be impacted by caloric restriction; are abusing controlled substances;have a history of anorexia nervosa or bulimia nervosa; or are at or under healthy weight.

Efficacy of Treatment/ProcedureGroup behavioral therapy programs attempt to alter an individual's eating and activity levels. Successful programsinclude cognitive and behavioral skills training, goals for total caloric intake and fat intake, and goals for physicalactivity. A focus on making healthier choices rather than weight loss may be important for maintaining weight loss. Inrandomized trials of behavioral therapy programs, weight losses of up to 10% of baseline weight have been reportedaccompanied by reductions in depression and anxiety, and decreases in systolic and diastolic blood pressure. Telephone-or Internet-based counseling may provide an alternative to face-to-face programs. Individuals who successfully maintainweight loss monitor dietary intake, engage in physical activity, and weigh themselves at least once per week.

Committee SummaryWith regard to behavioral therapy programs for weight loss in adults, the ICSI Technology Assessment Committee finds:1. Behavioral therapy programs are generally safe unless the patient has an underlying psychological condition.2. Successful behavioral therapy programs have typically been conducted in academic settings and generally include thefollowing components: a) an active phase (typically 6 months) during which modest weight loss can be expected, b) an on-going maintenance phase, and c) cognitive behavioral therapy (with sufficient time for individuals to learn theseapproaches).3. Behavioral therapy programs in a community setting are largely unregulated with no specific credentialing forprogram leaders.4. Individuals enrolled in behavioral therapy programs without incentives or food provision typically experiencedweight losses of 2.5% to 10% of baseline weight following an active treatment phase of from 8 weeks to 6 months.(Conclusion Grade II) There are limited post-treatment follow-up data but the available evidence suggests that weightloss may be maintained or furthered at 6 to 12 months following treatment. (Conclusion Grade III)5. In programs involving incentives or food provision in addition to behavioral therapy, individuals typicallyexperienced weight losses of 6.6% to 13.7% after 6 months. In programs that actively continued treatment for 18 months,further weight losses were not observed. At 12 months post-treatment, weight losses had been reduced to 1.7% to 8.6% oforiginal body weight. (Conclusion Grade II)6. Many of the behavioral therapy programs did not choose to assess health outcomes. The available evidence indicatesthat blood pressure and lipid levels are improved following treatment. State anxiety, trait anxiety, and depressionscores have typically improved but differences between treatment groups or between treatment and control groups havegenerally not been significant.

Work Group MembershipJames Smith, MD, Leader

HealthPartners Medical GroupSusan Deno, RD

Park Nicollet Health ServicesNico Pronk, PhD

HealthPartnersLinda Reinhardt, MSW, LICSW

HealthPartners Medical Group

Technology Assessment 1 Behavioral Therapy for Weight Loss

Institute for Clinical Systems Improvement

Technology Assessment Report

Behavioral Therapy Programs for Weight Loss in Adults

Work Group Members*Leader:James Smith, MD Susan Deno, RDInternal Medicine DietitianHealthPartners Medical Group Park Nicollet Health Services

Nico Pronk, PhD Linda Reinhardt, MSW, LICSWCenter for Health Promotion Behavioral HealthHealthPartners HealthPartners Medical Group

ICSI technology assessment reports are designed to assistclinicians by providing a scientific assessment, throughreview and analysis of medical literature, of the safetyand efficacy of medical technologies and are not intendedto replace a clinician's judgement or to suggest that aparticular technology is or should be a standard ofmedical care in any particular case. Standards ofmedical care are determined on the basis of all the factsand circumstances involved in a particular case and aresubject to change as scientific knowledge and technologyadvance and practice patterns evolve.

Prepared under the direction of theTechnology Assessment Committee(TAC Sponsor: James Smith, M.D.)

by Nancy L. Greer, Ph.D., Staff

TA#87Approved: January, 2005Copyright © 2005 by ICSI

www.icsi.org

*See Potential Conflict of Interest Disclosure at the end of the report


Technology Assessment CommitteeJames Smith, M.D., ChairHealthPartners Medical Group

Merrill Biel, M.D.ENT Specialty Care

Richard Kopher, M.D.HealthPartners Medical Group

Lorre Ochs, M.D.HealthPartners Medical Group

Bruce Burnett, M.D.Park Nicollet Health Services

Thomas Kottke, M.D.HealthPartners Medical Group

Del Ohrt, M.D.Medica

Craig Christianson, M.D.Ucare Minnesota

George Logan, M.D.Park Nicollet Health Services

Jamie Peters, M.D.Fairview Ridges

Thomas Elliott, M.D.St. Mary's/Duluth ClinicHealth System

Kirsten Hall Long, Ph.D.Mayo Clinic

Arthur Puff, M.D.Metropolitan Health Plan

Keith Folkert, M.D.BlueCross BlueShield MN

Thomas Marr, M.D.HealthPartners

Howard Stang, M.D.HealthPartners Medical Group

John Frederick, M.D.PreferredOne

James Mickman, M.D.HealthPartners Medical Group

Rick Wehseler, M.D.Affiliated Community MedicalCenters

George Klee, M.D., Ph.D.Mayo Clinic

ICSI Technology Assessment Report Process

� A topic is selected by the Technology Assessment Committee based on expression of interest in that topic from theICSI medical groups or ICSI sponsoring health plans.

� A work group of 4 to 6 physicians and other health care professionals who are experts in the topic area isassembled (with a formally designated leader).

� The literature search is completed using MEDLINE and PREMEDLINE; in addition, bibliographies of articlesobtained from the literature search are examined to identify articles that may have been missed and work groupmembers are asked to provide key references. The evidence is graded according to the system described in thereference section of the report.

� The ICSI staff person prepares a draft report.� The work group meets to review the draft report and directs the ICSI staff person in revising the report.� The work group leader presents the report to the ICSI Technology Assessment Committee. Committee members

review the report to determine whether the conclusions are supported by the evidence cited. The Committee oftenrequests revisions prior to approving the report for review and comment.

� The report is distributed to the ICSI Medical Groups for review and comment. Comments received are shared withthe work group members and revisions to the report are made, if necessary.

� The Technology Assessment Committee reviews the comments and the work group response and makes the finaldecision regarding approval of the report for distribution.

� Reports are reviewed bi-annually and revised, if warranted.


Description of Technology/Procedure

Recent clinical guidelines from the National Heart, Lung, and Blood Institute (NHLBI) definedoverweight as a body mass index [BMI] of 25 kg/m2 to 29.9 kg/m2 and obesity as a BMI of 30 kg/m2

or higher (NHLBI, 1998). Based on height and weight measurements obtained from 4,115 adultmen and women in 1999-2000 as part of the National Health and Nutrition Examination Survey(NHANES), the age-adjusted prevalence of obesity was 30.5% (Flegal, Carroll, Ogden, & Johnson,2002). This was significantly higher (p<0.001) than the 22.9% reported in NHANES III (from1988-1994). The prevalence of overweight increased from 55.9% to 64.5% (p<0.001) during thissame time period. The prevalence of extreme obesity (BMI>40 kg/m2) increased from 2.9% to 4.7%(p=0.002). Hedley, Ogden, Johnson, Carroll, Curtin, and Flegal (2004) reported NHANES dataobtained from 4,390 adults in 2001-2002. The prevalence of obesity was 30.6%, the prevalence ofoverweight was 65.7%, and the prevalence of extreme obesity was 5.1%. These results were notsignificantly different from the 1999-2000 findings. When the data from 1999-2000 and 2001-2002surveys were combined, the corresponding values were 30.4%, 65.1%, and 4.9%.

Further evidence that the prevalence of obesity in the United States (U.S.) is increasing rapidlywas presented by Mokdad, Serdula, Dietz, Bowman, Marks, and Koplan (1999). A multi-statesurvey (the Behavioral Risk Factors Surveillance System [BRFSS]) of non-institutionalizedadults, 18 years of age or older, was conducted between 1991 and 1998. There were over 100,000respondents each year. The self-reported prevalence of obesity in 1991 was 12%; in 1998, theprevalence was 17.9% with similar increases for both men (11.7% in 1991, 17.7% in 1998) andwomen (12.2% in 1991, 18.1% in 1998). The 2000 BRFSS data indicated a continued increase inobesity with an overall prevalence of 19.8% (Mokdad, Bowman, Ford, Vinicor, Marks, & Koplan,2001).

The disease burden associated with individuals being overweight or obese has been described(Must, Spadano, Coakley, Field, Colditz, & Dietz, 1999). Data from NHANES III indicated anassociation between increasing BMI status and the prevalence of type 2 diabetes mellitus, coronaryheart disease, high blood pressure, osteoarthritis, and gallbladder disease. Other conditionsassociated with obesity include dyslipidemia, sleep apnea, stroke, cancer (including colon, breast,endometrial, and gallbladder cancer), menstrual irregularity, and infertility (NHLBI, 1998).

There is also a strong association between obesity and mortality. Mokdad, Marks, Stroup, andGerberding (2004) identified poor diet and physical inactivity as the second leading cause ofdeath in the U.S. in the year 2000. The leading cause of death was tobacco use. Calle, Rodriguez,Walker-Thurmond, and Thun (2003), based on data from more than 900,000 U.S. adults observedover a period of 16 years, reported relative risks of death from all cancers of 1.52 (95%CI1.13=2.05) for men and 1.62 (95%CI 1.40-1.87) for women with BMI values of 40 kg/m2 or higher.For BMI values of 30 kg/m2 or higher, the corresponding relative risk values were 1.09 (95%CI1.05-1.14) and 1.23 (95%CI 1.18-1.29). A BMI of 30 kg/m2 or higher was associated with increasedrisk of death from colorectal, liver, gallbladder, pancreatic, prostate, and kidney cancer alongwith non-Hodgkin's lymphoma, multiple myeloma, and leukemia in men and colorectal,gallbladder, pancreatic, breast, uterine, and kidney cancer along with multiple myeloma inwomen.

Direct and indirect costs associated with obesity have also been reported. A higher BMI valuehas been associated with a greater rate of outpatient visits and a greater number of inpatient days(Quesenberry, Caan, & Jacobson, 1998) and more sick days absent from work (Burton, Chen, Schultz,& Edington, 1998). Several studies have also reported higher health care costs associated withobesity (Burton et al., 1998; Quesenberry et al., 1998; Pronk, Goodman, O'Connor, & Martinson,1999). Wolf and Colditz (1998) estimated that the direct (personal health care, hospital care,physician services, allied health services, and medications) and indirect (the value of lost outputdue to a reduction or cessation of productivity as a result of morbidity and mortality) costsassociated with obesity were $99.2 billion in 1995. The direct cost portion of the total ($51.6


billion) represents 5.7% of the total U.S. Health Expenditure for 1995. Their analysis was basedon 8 diseases that are linked to obesity (type 2 diabetes mellitus; coronary heart disease;hypertension; gallbladder disease; breast, endometrial, and colon cancer; and osteoarthritis).Subsequent analyses have estimated the 2000 total cost of obesity at $117 billion (U.S. Departmentof Health and Human Services, 2001). The RAND corporation estimated that the total healthcare costs associated with obesity are greater than any other health condition, including smoking(Sturm, 2002).

The goal of any weight loss program is to achieve not only a sustainable reduction in weight butalso to improve the comorbid conditions associated with excess weight. The NHLBI guidelines(NHLBI, 1998) recommend an initial target weight loss of 10% of body weight over 6 months. A10% reduction in body weight has been found to decrease risk factors for diabetes andcardiovascular disease (Colditz, Willett, Rotnitzky, & Manson, 1995; Huang, Willett, Manson etal., 1998). Goldstein (1992) reviewed the evidence on health benefits associated with modestweight loss. Studies of overweight and obese patients with type 2 diabetes indicated improvedglycemic control after weight losses of 5% to 10% of baseline weight. Decreased blood pressure wasobserved following similar weight loss in overweight and obese individuals with elevated bloodpressure. Overweight and obese patients with hyperlipidemia typically experienced decreasedlevels of serum triglycerides, total serum cholesterol, and low density lipoprotein cholesterol andincreased levels of high density lipoprotein cholesterol following modest weight loss.

Several recent studies have observed that patients at high-risk for type 2 diabetes can reduce thelikelihood of developing the disease with life-style modifications including weight loss, dietarychanges, and increased levels of physical activity. In the study presented by Wing, Venditti,Jakicic, Polley, and Lang (1998) 154 patients, ages 40-55 years, with a family history of type 2diabetes mellitus, and who were 30% to 100% over ideal body weight were randomly assigned toeither a control group, a diet group, an exercise group, or a diet plus exercise group. The treatmentprograms continued for 2 years. At the completion of the treatment phase, there were nodifferences between groups in weight loss, fat intake, or fitness measures and fasting glucose levelswere significantly above baseline in all groups. The authors concluded that the interventions usedin this study were not effective in producing long-term changes in behavior, weight, or physiologicparameters. Twenty-one of the participants (17%) developed diabetes (including 7% of the controlgroup, 30.3% of the diet group, 14% of the exercise group, and 15.6% of the diet plus exercise group).The strongest predictor of developing diabetes was impaired glucose tolerance at baseline.However, a weight loss of 4.5 kg (approximately 4.5% of initial weight) was associated with a31% decrease in risk of developing type 2 diabetes.

Tuomilehto et al. (2001) studied 523 patients from 5 centers. All were 40 to 65 years of age, hadBMI values of 25 kg/m2 or higher, and impaired glucose tolerance (both fasting and following aglucose challenge). The patients were randomly assigned to either an intervention group that wasgiven detailed, individual advice (multiple sessions) on losing weight (at least 5% of initialweight was the goal), decreasing fat intake, increasing fiber intake, and increasing physicalactivity (30 minutes or more per day was the goal) or a control group that was given generalinformation at baseline about diet and exercise with annual visits thereafter. With a follow-upextending to 6 years (mean of 3.2 years), diabetes had been diagnosed in 27 intervention patientsand 59 controls. Based on all person-years accumulated, the cumulative incidence of diabetes was58% lower in the intervention group than in the control group (p<0.001). To prevent one case ofdiabetes, the number of patients with impaired glucose tolerance needed to treat (with lifestylechanges) was 22 for one year or 5 for five years.

The Diabetes Prevention Program Research Group (2002) presented data from 3,234 patients (27centers) with elevated fasting and post-load glucose levels, ages 25 years and older, and BMIvalues of 24 kg/m2 or higher (22 kg/m2 for Asian participants). The study was designed to enrollapproximately 50% of participants from racial and ethnic groups at higher risk for developingdiabetes. Participants were randomly assigned to one of three interventions: standard lifestylerecommendations (written information on diet and activity) plus metformin, standard lifestyle


recommendations plus placebo, or intensive lifestyle modification (including decreasing weight by7% using a low calorie/low fat diet, and exercising for 150 minutes/week) delivered in individuallearning sessions. Assignment to a fourth intervention, treatment with troglitazone, wasdiscontinued early because of safety concerns. The overall study was terminated early (atapproximately 65% of the planned person-years of observation) because of evidence of efficacy.The mean follow-up was 2.8 years (range 1.8-4.6). Per 100 person-years of follow-up, there were 11cases of type 2 diabetes in the placebo group, 7.8 cases in the metformin group, and 4.8 cases in thelifestyle modification group. The incidence of diabetes in the lifestyle modification group was58% lower than the placebo group and 39% lower than the metformin group. The number needed totreat (with lifestyle modification) for three years to prevent one case of diabetes was 6.9 patients.

Similarly, Stevens et al. (2001) reported reductions in blood pressure and lowered risk forhypertension associated with weight loss. Overweight adults (ages 30 to 54 years with BMI of 26to 37 kg/m2 for men and 24 to 37 kg/m2 for women) with non-medicated systolic blood pressure ofless than 140 mmHg and diastolic blood pressure of 83 to 89 mmHg were included. Patients wererandomized to one of four intervention groups; this study focused on the weight loss group (n=595)and the usual care (control) group (n=596). The goal of the weight loss group was to lose at least 4.5kg during the first 6 months of the program and to maintain that loss. Patients attended an initialindividual counseling session followed by 14 weekly group sessions. Over the course of the study,the frequency of the group meetings changed from weekly to biweekly to monthly. At 18 months,patients were given the option of continuing with group or individual sessions. The focus of thesessions was on self-directed behavior change, nutrition education, physical activity, and socialsupport. For the weight loss group, the average weight change from baseline was -4.4 kg at 6months, -2.0 kg at 18 months, and -0.2 kg at 36 months. The corresponding changes for the controlgroup were 0.1, 0.7, and 1.8 kg. The differences were significant at all 3 time points (all p<0.001).There were also significant differences (all p<0.05) between groups in systolic and diastolic bloodpressure at each time point with lower blood pressure readings in the intervention group. Diastolicpressures differed by 2.7 mmHg, 1.3 mm Hg, and 0.9 mm Hg at 6, 18, and 36 months, respectively.The corresponding values for systolic pressure were 3.7 mmHg, 1.8 mmHg, and 1.3 mmHg. Changesin blood pressure were greatest for individuals who lost the most weight. Those who lost 4.5 kg ormore at 6 months and who maintained the loss through 36 months (n=73) also maintained asubstantial reduction in blood pressure. The risk of developing hypertension (defined as systolicpressure of 140 mmHg or higher, diastolic pressure of at least 90 mmHg, or need forantihypertensive medication) was lower in the weight loss group. At the end of the study, therisk ratio for hypertension in the intervention group was 0.79 (95%CI 0.65-0.96). For individuals inthe intervention group who successfully maintained a weight loss of 4.5 kg or more, the relativerisk for hypertension (compared with the control group) was 0.35 (95%CI 0.20-0.59). In thesubgroup who failed to lose weight, the relative risk was 1.10 (95%CI 0.85-1.42).

A variety of approaches to weight loss have been studied. These include dietary restriction,increase in activity level, behavioral modification, pharmacological intervention, and surgicalintervention (ICSI, 2000; ICSI 2003; ICSI 2004).

The purpose of this report is to evaluate the safety and efficacy of behavioral therapy programsfor weight loss in adults. The intent is to assess whether these programs can have an impact on thephysical and psychological health of adults who are overweight or obese, and, as a result, reducethe financial burden associated with overweight and obesity.

It is difficult to make comparisons between and generalizations about the various behavioraltherapy approaches. The programs have varied in length and content emphasis. Although manyof the studies are randomized, controlled trials, the number of patients per treatment group isgenerally low and the number of patients who discontinue participation in the treatment programsmust be considered. There are also limited follow-up data at one year or beyond.


Potential Uses

Behavioral therapy programs may be suitable for patients that are considered either overweightor obese. According to the National Institutes of Health guidelines (NHLBI, 1998), individualswith a BMI of 25 kg/m2 to 29.9 kg/m2 are considered overweight and those with a BMI of 30 kg/m2

or higher are considered obese.

The U.S. Preventive Services Task Force (USPSTF) (2003) developed the followingrecommendations/conclusions:

1. The USPSTF recommends that clinicians screen all adult patients for obesity and offer intensivecounseling and behavioral interventions to promote sustained weight loss for obese adults.2. The USPSTF concludes that the evidence is insufficient to recommend for or against the use ofmoderate- or low-intensity counseling together with behavioral interventions to promotesustained weight loss in obese adults.3. The USPSTF concludes that the evidence is insufficient to recommend for or against the use ofcounseling of any intensity and behavioral interventions to promote sustained weight loss inoverweight adults.

The intensity of counseling was defined as high (more than 1 face-to-face session per month for atleast the first 3 months of the program; sessions may be either individual or group), medium(monthly intervention), or low (less than 1 session per month). It was further noted that the mosteffective interventions combine nutrition education and diet and exercise counseling withbehavioral strategies to help patients acquire the skills and supports needed to change eatingpatterns and to become physically active. Initial interventions paired with maintenanceinterventions were recommended to achieve sustained weight loss (USPSTF, 2003).

Many individuals entering behavioral therapy programs have a long history of "dieting" only.These individuals should understand that to be successful in losing weight and maintaining theweight loss with a behavioral therapy approach requires a life-long commitment.

Contraindications

Behavioral therapy programs for weight loss would be inappropriate in (NHLBI, 1998):

a . pregnant or lactating women,b. patients with serious uncontrolled psychiatric illness*,c. patients with serious illnesses that might be exacerbated by caloric restriction,d. patients with active substance abuse,e. patients with a history of anorexia nervosa or bulimia nervosa,f . patients who are at or under healthy weight.

*In patients experiencing a major depressive episode, a recent manic episode, or an active thoughtdisorder, the psychiatric difficulty should be addressed first and participation in behaviortherapy postponed until the patient is psychiatrically stable (Abrams, King, Clark, Forsyth,Pera, & Goldstein, 2000).

Efficacy of Treatment or Procedure

Readiness to Change

Transtheoretical models of readiness to change (and specific assessment scales) have beendeveloped for weight control. These models incorporate stages of change, processes of change,decisional balance (the pros and cons of change), and self-efficacy (confidence in ability to change)(Rossi, Rossi, Velicer, & Prochaska, 1994). Sutton, Logue, Jarjoura, Baughman, Smucker, andCapers (2003) developed and tested a multi-item stages of change questionnaire. The purpose was


to more accurately capture stage of change by asking about readiness to change specific behaviors(e.g., readiness to drink skim milk vs. readiness to eat a low-fat diet).

Prochaska, Norcross, Fowler, Follick, and Abrams (1992) studied 184 hospital staff members whowere enrolled in a behavioral weight loss program. Thirty of the participants completed TheStages of Change Questionnaire at baseline, 5 weeks, and 10 weeks of the treatment program.Contemplation scores decreased and action scores increased significantly (p<0.05) during the first 5weeks and the changes were maintained at week 10. Better attendance at the therapy sessions andgreater weight loss were observed in patients who moved into the action stage by the fifth week ofthe program.

Macqueen, Byrnes, and Frost (2002) found that use of a stages of change questionnaire, sent before anappointment was scheduled to adult outpatients referred for weight-reducing advice, reduced thenumber of patients who failed to attend the first appointment relative to a time period wherepatients were scheduled for a first appointment upon referral. An earlier study (Macqueen, Brynes,& Frost; 1999) found no correlation between the initial scores on the stages of change questionnaireand amount of weight lost. In addition, the initial stages of change score did not differentiatethose patients who would and those who would not attend the second of two planned visits (4 to 6weeks after the first appointment).

Group Behavioral Therapy Programs

Group behavioral therapy programs have been found to be effective for patients coping withcancer, diagnosed with depression, and attempting to change an addictive behavior (such asalcoholism). In general, the success rate is approximately 85%. Given this success, groupbehavioral therapy would appear to be an appropriate approach for achieving weight loss.

The goal of a behavioral therapy program for weight loss is to alter the obese patient's eating andactivity levels. Specific strategies might include self-monitoring of eating habits, stressmanagement, stimulus control, problem solving (to self-correct problem areas), contingencymanagement, cognitive restructuring, and social support. These strategies can be used by thepatient to overcome barriers to compliance with diet and activity level changes. The assumptionsare that with a change in dietary and activity behaviors, body weight can change; that patternsof diet and activity are learned and can be modified; and that to change these patterns over thelong-term, the environment must change (NHLBI, 1998).

There have been several studies of group behavioral therapy programs (summarized below). Insome cases, the study protocols have included other components such as cognitive therapy,nutritional education, a personalized system of skill acquisition, and behavioral choice therapy.This report does not include trials that involved pharmacological agents as part of the treatmentprogram.

In general, no one behavioral therapy program has been found to be superior. However, multi-modal strategies (including cognitive, exercise, and emotional regulation components), programswith greater frequency and duration of contacts between program leaders and patients (a long-termactive phase), and continued intervention (an on-going maintenance phase with a problem solvingapproach) appear to result in the greatest weight loss and the greatest ability to prevent a returnto baseline weight (NHLBI, 1998).

In the studies cited below, programs that resulted in at least a 5% weight loss following an activetreatment phase of from 6 to 13 weeks involved:

a . Cognitive and behavioral skills training including coping skills, cognitive restructuring,behavior modification, relapse prevention, stimulus control, self-monitoring, problem-solving, andshort-term goal setting

b. Goals for total caloric intake and fat intake

c. Goals for physical activity.


Two programs that resulted in at least a 5% weight loss at 6 months follow-up to the active phaseboth were focused on teaching individuals to make healthier choices in eating and exercise habitsrather than on weight loss.

Behavioral and Cognitive Therapy Programs without Incentives or Food Provision

Clifford, Tan, and Gorsuch (1991) studied 48 overweight, healthy members of a family YMCAfacility. Thirty-six members paid to join a year-long (6 months treatment and 6 months follow-up)program, the remaining 12 were part of an assessment-only control group. Three treatmentprograms were available, each on a different night. The 36 participants selected a meeting nightand thus a specific treatment program. Group 1 (n=11) received a wellness program that used aself-directed change approach to exercise adherence, nutrition, weight control, human relations,stress management, and values clarification and development skills. Over the 12 months of thestudy, there were 19 group sessions. Group 2 (n=11) received the same self-directed change programplus 5 individual sessions with a therapist. Group 3 (n=14) received the self-directed changeprogram plus 5 individual peer problem-solving support sessions. All treatment groups and thecontrol group underwent 4 assessments (baseline, 3 month mid-treatment, 6 month post-treatment,and 6 month follow-up) including body weight, body composition, cardiovascular fitness, and bloodpressure. Thirty-four of the initial 48 participants completed the study leaving 10 in group 1, 7 ingroup 2, 8 in group 3, and 9 in the control group. The mean age of the 34 who completed the studywas 48.9 years. At baseline, there were no differences between the groups (including the group thatdropped out of the study). Of the 25 individuals that completed the treatment program, 4 (16%)had baseline BMI values that were in the desirable (absence of medical risk) category, 13 (52%)were classified as overweight, and 8 (32%) were classified as obese. Attendance at the treatmentsessions (the first 6 months of the study) ranged from 65% to 85%; attendance at the post-treatmentsessions ranged from 31% to 60%. Group 2 participants attended approximately 70% of theindividual professional support systems; group 3 participants attended approximately 10% of thepeer-support sessions. To assess the effect of the self-directed change approach, results from all 3treatment groups were compared to those from the control group. The treatment groups improvedsignificantly more (all p≤0.05) than the control group in weight (decreases of 3.8% post-treatmentand 3.4% at 6 month follow-up vs. a decrease of 0.1% and an increase of 0.2%, respectively),exercise adherence (increases of 23% post-treatment and 21% at 6 months vs. decreases of 3.6% bothpost-treatment and at 6 months), chronic tension (decreases of 8.6% post-treatment and 17.7% at 6months vs. increases of 9.6% and 7.1%, respectively), and blood pressure (decreases of 9.9% post-treatment and 8.2% at 6 months vs. an increase of 0.4% and a decrease of 0.9%, respectively).There were no significant differences between the 3 treatment groups.

In the study presented by Kalodner and DeLucia (1991), 69 subjects (60 female and 9 male)weighing at least 15% more than the highest weight in the range for their height and body framesize were randomly assigned to 1 of 4 treatment groups. The mean age of the participants was 40.7years. A $50 deposit, refundable upon completion of the program, was required of eachparticipant. The four interventions were (a) behavior therapy (BT) plus cognitive therapy (CT),(b) BT plus nutrition education (NE), (c) BT plus CT plus NE, or (d) BT only. Twelve of the 69 (17%)failed to attend at least 6 sessions and were considered drop-outs. The program consisted of 10weekly, 2-hour group sessions. Follow-up testing was done at 3 and 6 months. Based on data from44 participants (64%), weight decreased 3.8% post-treatment and 4.5% at 6 months (p<0.01) withno differences between treatment groups.

Meyers, Graves, Whelan, and Barclay (1996) randomly assigned 71 individuals at least 20%overweight based on height and weight tables to either a live-contact group, a live-contact groupthat would be videotaped, a group that would view the videotaped group from their homes, or acontrol group (waiting list). Eligible participants were between 18 and 60 years of age (the meanage was 39.1 years) and were free of medical conditions that contraindicated participation in anexercise program. A $55 refundable deposit was required. Of the 56 in a treatment group, 49completed the program. The post-treatment analysis was based in 45 treatment group participants(80% of the 56 enrolled) and 11 of 15 control group members (73%). The analysis was not by


intention-to-treat. The program consisted of one individual orientation session, one pre-treatmentgroup session, and eight weekly cognitive-behavorial treatment sessions. Three- and fifteen-month follow-up assessments were done. All of the treatment groups lost more weight anddecreased their percentage of overweight to a greater degree at the post-treatment assessmentthan the control group (both p≤0.05) with no differences between the three treatment groups. Theweight of the videotaped group decreased by 5.0%, the weight of the home viewing groupdecreased by 4.8%, and the weight of the live-contact group decreased by 5.2%. The weight of thecontrol group decreased by 0.9%. Data from 34 of the participants were available at 3- and 15-months post-treatment. The weight losses were maintained by all three treatment groups at 3months; at 15 months, the videotaped group had gained weight such that the 15 month follow-upweight did not differ significantly from the pre-treatment weight while the other two groupscontinued to maintain their weight loss. Actual weights at 15 months were not given in the reportso the percentage of weight lost could not be determined.

The purpose of the study presented by Fuller, Perri, Leermakers, and Guyer (1998) was to determinewhether a personalized system of skill acquisition (PSA) would improve the efficacy ofbehavioral treatment of obesity. The participants included 80 women and 28 men all of whomwere 20% to 100% over ideal weight. The age and health status of the participants were notreported. There were three treatment conditions (randomly assigned): weight loss education (6monthly lectures plus readings on proper nutrition and diet, behavioral strategies for changingeating and exercise habits, and guidelines for increasing physical activity), standard behavioraltreatment (25 weekly sessions with training in self-monitoring, goal setting, stimulus control, andcognitive restructuring; participant were paid for attendance and for completing eating andexercise records), and behavioral treatment plus PSA (similar to the behavioral treatmentprogram with monetary reinforcement based on mastery of behavioral skills). There were nodifferences in age, education, or body weight between groups at baseline. Twenty-two patients(20%) dropped out of the study; the data analysis was not by intention-to-treat. At 6 months, thebehavioral treatment (decrease of 9.8%) and the behavioral treatment with PSA (decrease of8.4%) groups achieved significantly greater (p<0.05) changes in weight than the weight losseducation group (decrease of 1.7%). The number of minutes spent exercising increased significantlyfrom baseline for both treatment groups (76% for the behavioral treatment plus PSA group and 51%for the behavioral treatment only group). The consumption of kilocalories from fat decreased 43%in the behavioral treatment plus PSA group and 31% in the behavioral treatment only group withan increase of 7.7% in the weight loss education group. The behavioral therapy group received82% of the number of dollars possible while the behavioral therapy plus PSA group received 70%(p<0.05).

Obese women (BMI ≥30 kg/m2) with at least three prior unsuccessful attempts at weightloss/maintenance were the subjects of the study by Tanco, Linden, and Earle (1998). Theparticipants were 19 years of age or older and were free of any medical condition that wouldprevent them from taking part in an exercise program. They were also free of anypsychopathology that would preclude participation. The women were randomly assigned toeither standard behavioral weight management (focused on fat reduced diets and exerciseadoption), a cognitive treatment program (focused on maladaptive behaviors, enhanced emotionalwell-being, physical activity, and non-disordered eating and not weight reduction), or a controlgroup (wait list). Sixty-two women were randomized; 12 dropped out leaving 18 in the cognitivetreatment program, 19 in the behavorial therapy program, and 13 in the control group. Anadditional two participants (1 from the behavioral therapy group and 1 from the control group)failed to attend the post-treatment weight assessment so the analysis of weight changes included77% of those initially enrolled. The analysis was not by intention-to-treat. At baseline, therewere no differences between the treatment groups in age; BMI; depression, anxiety, and self-control; the Eating Disorders Inventory; or proportion exercising regularly. The mean weight lossafter 8 weeks of treatment was 1.76 kg (1.6% of baseline) for the cognitive therapy group and 2.6 kg(2.5% of baseline) for the behavioral therapy group (both p<0.05). The control group gained amean of 0.75 kg (0.7% of baseline). At 6 months post-treatment, data were available for 12 of the


cognitive therapy group and 9 of the behavioral therapy group members. The cognitive therapygroup had lost a mean of 4.9 kg (4.4% of baseline weight) and the behavioral therapy group hadlost a mean of 8.9 kg (8.4% of baseline). Post-treatment BMI decreased in the cognitive therapyand behavior therapy groups (both p<0.025) but increased in the control group. Measures ofdepression (decreased by 44%), state anxiety (decreased by 20%), and trait anxiety (decreased by15%) were significantly improved post-treatment for the cognitive therapy group only (allp<0.05).

The study presented by Rippe et al. (1998) included 80 women who weighed 20% to 50% more thanthe desirable weight for height. Eligible women were between 20 and 49 years (the mean age was36.8 years), were free of cardiovascular or orthopedic problems that would preclude participationin an exercise program, were not undergoing psychological counseling or taking psychotropicmedications, and were not taking any other medication known to effect heart rate response. Thewomen were randomly assigned to either an intervention program (Weight WatchersInternational) that involved a self-selected low-calorie diet; self-selected exercise; behaviormodification and problem solving and coping skills; and weekly group support meetings or a controlgroup that was asked to maintain current dietary and activity patterns. The study lasted 12weeks. During that time, 10 subjects withdrew from the intervention group and 26 withdrew fromthe control group (14 of whom were unhappy with their group assignment). The 36 who withdrewrepresent 45% of the total enrollment in the study; the analyses were not by intention-to-treat.The remaining 30 intervention group and 14 control group participants were similar at baseline inage, weight, percent body fat, maximal oxygen consumption, resting heart rate, and blood pressure.The control group was significantly taller and had a significantly higher activity level (bothp<0.05). At the end of 12 weeks, the intervention group lost an average of 6.07 kg (7.5% ofbaseline) and the control group gained an average of 1.31 kg (1.6% of baseline) (p<0.001). TheBody Cathexis Scale score (self-esteem related to satisfaction with body) decreased by 17.6% inthe treatment group and by 0.7% in the control group indicating an improved satisfaction(p<0.001). Trait anxiety also improved significantly in the treatment group (17%) but not thecontrol group (0.6%) (p<0.01). Heart rate was 7.8% lower than baseline for the treatment groupand 3% higher for the control group (both p<0.05). Both systolic (5.5%) and diastolic (5.3%) bloodpressure decreased significantly for the treatment group (both p<0.02) but not the control group(decreases of 2.5% and 2.6%, respectively). Physical activity and quality of life scores alsoimproved significantly in the intervention group compared to the control group.

Sbrocco, Nedegaard, Stone, and Lewis (1999) randomly assigned 24 obese women (30% to 60% aboveideal body weight for a medium frame) to either behavioral choice treatment (BCT) ortraditional behavior treatment (TBT). The program enrolled women ages 18 to 55 years (mean ageof 41.4 years) who were non-smokers and in good health. A $150 refundable deposit was required.The BCT intervention used a decision-making model of women's food choice that related situation-specific eating behavior to outcomes and goals. The intent was a slower weight loss withpermanent changes in eating behavior. The TBT program was designed to promote substantialweight loss and development of habits and strategies to maintain weight loss (including self-monitoring, stimulus control, and behavioral substitution). Both programs involved 13 weeklygroup sessions of 1.5 hours each. Follow-up group meetings were conducted at 3 and 6 months aftertreatment and follow-up weights were assessed at 3, 6, and 12 months. For the first 2 weeks of theprogram, the TBT group was prescribed a 1,200 kcal/day diet and the BCT group a 1,800 kcal/daydiet. Participants were asked to adhere to the diet for 2 weeks to model new behavior. The TBTgroup was subsequently encouraged to keep their calorie intake at 1,200 kcal/day. The compositionof the diets was similar. At baseline, the groups were similar in age, weight, BMI, and caloricintake. One BCT group member withdrew during the treatment phase. During follow-up, 1 BCTgroup member and 2 TBT group members withdrew from the study. The analyses were not byintention-to-treat. The TBT participants achieved greater weight loss than the BCT group (6.3%vs. 2.8%, p<0.01) at the end of the treatment phase. At 6 month follow-up, a greater percentage ofbaseline weight was lost by the BCT group than the TBT group (7.8% vs. 5.0%, p<0.05). Thispattern continued at 12 months followup (11.2% vs. 4.8%, p<0.01). A body dissatisfaction subscale


indicated that neither group was dissatisfied at either post-treatment or 6 month follow-up.Similarly, scores for both groups improved on a depression scale.

A modified cognitive-behavioral treatment program (M-CBT), designed to focus on psychologicaland psychosocial aspects of weight management rather than weight loss, was studied byRapoport, Clark, and Wardle (2000). The study included women, ages 18 to 65 years, with a BMIof 28 kg/m2 or higher, identified by their physician as being suitable for group treatment ofobesity, and not currently involved in any other weight management activities. Women who hadserious medical or psychiatric conditions (including eating disorders) or insulin dependentdiabetes, or who were pregnant or lactating were excluded from the study. Of 84 womenrandomized, 75 started a treatment program and 63 attended at least 7 of the 10 weekly treatmentsessions as well as the end of treatment assessment. Patients in the M-CBT group focused onpermanent lifestyle change. Regular physical activity and healthy eating were promoted asways to reduce medical and psychosocial risks associated with obesity. In keeping with theemphasis on lifestyle change to achieve weight management rather than weight loss, individualsin the M-CBT group were weighed only at baseline and at the end of treatment. Patients in thestandard cognitive-behavioral treatment group (S-CBT) were directed to achieve a healthyweight loss (1 to 2 pounds per week) with a moderate energy-deficit diet (approximately 1,200kcal/day). Daily food intake and physical activity were recorded. Weights were measuredweekly. Biological measures (weight, body fat, lipid and glucose levels, and blood pressure),psychological measures (depression, self-esteem, and stress), eating behavior and body image(binge eating, eating style, body dissatisfaction, and body image avoidance); diet and activity;and acceptability of the treatment program were assessed at baseline, at the end of treatment, andat 6 and 12 months post-treatment. The analyses included only those who completed the program(31 in the M-CBT group and 32 in the S-CBT group). At the end of treatment (10 weeks), weightlosses of 3.9 kg and 1.3 kg were reported in the S-CBT group and M-CBT groups, respectively. At 1year, the losses were 3.6 kg in the S-CBT group and 2.0 kg in the M-CBT group. The differencebetween groups at 1 year was not significant. Changes in other biological measures, psychologicalfactors, dietary intake, and physical activity and fitness were generally comparable for the 2treatment groups.

Renjilian, Perri, Nezu, McKelvey, Shermer, and Anton (2001) compared group therapy withindividual therapy. The study included individuals who were 21 to 59 years old and had a BMI of28 to 45 kg/m2. All of the subjects received physician approval to participate in a study involvingdiet and exercise. Individuals who were in another weight loss program, had lost 5 or more poundsin the previous 6 months, or were pregnant or planning to become pregnant were excluded from thestudy. Eligible patients were asked to express their preference for individual or group therapy. A6 point scale was used with responses ranging from strongly prefer group therapy to strongly preferindividual therapy. Only those who expressed strong or moderate preference for eitherindividual (n=40) or group (n=35) therapy were included. Individuals were randomly assigned toreceive either their preferred or non-preferred treatment. Treatment consisted of 26 weeklysessions of cognitive-behavioral weight management training including self-monitoring, goalsetting, and stimulus control). A diet of 1,200 to 1,500 kcal/day was recommended along with 30minutes of brisk walking 6 days per week. Group sessions were 90 minutes long and included 8 to 12individuals. During the session, individuals were weighed, self-monitoring records werereviewed, progress was reported, and new eating and/or exercise strategies were introduced.Individual sessions were 45 minutes long. The content was similar to that of the group session. Thefour treatment groups (group therapy/preferred [PG; n=20], group therapy/non-preferred [NG;n=20], individual therapy/preferred [PI, n=19], and individual therapy/non-preferred [NI; n=16])were similar at baseline with respect to age, weight, height, and BMI. The 26 week treatmentprogram was completed by 58 of the 75 participants (77%) with no differences in completion ratesamong the 4 groups. There was greater weight loss for completers of the group therapy programcompared with completers of the individual therapy program (11.0 kg vs. 9.1 kg; p=0.02) with nodifference between groups based on whether the therapy modality was preferred or non-preferred.Weight losses for program completers ranged from 8.6% of initial body weight in the PI group to


11.9% of initial weight in the NG group. A weight loss of at least 10% of initial weight wasachieved by 45% of the group therapy participants and 29% of the individual therapyparticipants. Two measures of psychological functioning, the General Severity Index (GSI) ofSymptoms Checklist�90�Revised and the Beck Depression Inventory, improved significantly(p<0.0001) from pre-to post-treatment with no differences between groups based on type of therapyor treatment preference. Adherence to treatment strategies was similar across the groups .Participants in the individual therapy program rated therapist effectiveness higher than didparticipants in the group therapy programs (p<0.01). Each therapist in the study was involvedwith both group and individual therapy sessions.

A lifestyle change program that included motivation-support, nutritional behavior, eatinghabits, physical activity, social skills, and body image components was described by Munsch,Biedert, and Keller (2003). Patients with a BMI of 30 kg/m2 or greater were included in the study.Patients with severe mental disorder, insulin-dependent diabetes, hypothyroidism, or terminaldisease were excluded. Seventy patients were identified from general practices. Those patientswere randomly assigned to either a treatment (GP Tx) or a control group (GP control). Anadditional 52 patients from a clinical center comprised another treatment group (Clinic Tx). The 3groups were similar at baseline with the exception of a higher BMI in the clinic treatment groupcompared with the control group (p<0.01). The treatment program consisted of 16 sessions and wasdesigned to promote long-term change in lifestyle. The control group was given only non-specificcomments about weight loss. BMI, eating behavior, psychopathological symptoms, body image,and quality of life were assessed at baseline, after treatment, and 12 months after completion oftreatment. Through the end of the treatment phase, the dropout rates were 23%, 29%, and 37% forthe GP Tx, GP control, and Clinic Tx groups, respectively. During the 1 year follow-up, the drop-out rates were 0%, 33%, and 52%, respectively. At the end of the treatment phase, the GP Tx grouphad lost 4.0% of initial weight, the GP control group had lost 0.7%, and the Clinic Tx group hadlost 1.6%. Change in weight, from baseline, was significant only for the GP Tx group (p<0.001). Atone year, the weight losses were 4.7%, 0.5%, and 2.9%, respectively. Again, the only significantweight loss, from baseline, was for the GP Tx group. The GP Tx group had lost significantly moreweight than the GP control group. The analysis was not by intention-to-treat.

Behavioral and Cognitive Therapy Programs with Incentives or Food Provision

A number of studies have looked at using incentives for weight loss, providing specific foods orstructured meal plans, or both. Studies of this type are an attempt to modify eating and exercisebehaviors by changing the environmental factors that control these behaviors. Control of bothenvironmental antecedents (such as restricting the locations in which eating may occur andchanging the types of foods available in the home) and the environmental consequences (such asrewards contingent on changes in behaviors or body weight) has been attempted.

These programs have found that provision of meal plans (either in the form of menus or actual pre-packaged food) is effective in achieving a weight loss of at least 5% from baseline following 18months of active treatment. These programs also included calorie and fat intake goals. Otherincentives, including personal trainers and cash payments, were no more effective than a standardbehavioral therapy program.

Jeffery et al. (1993) studied 101 men and 101 women who were between 14 and 32 kg overweightaccording to insurance industry standards, who were between the ages of 25 and 45 years, and whohad no current serious disease. The participants, whose mean age was 37.5 years, were randomizedto one of 5 treatment groups for the 18 month program:a . control (no intervention, evaluated at 6, 12, and 18 months)b. standard behavioral treatment (SBT) (group behavioral counseling held weekly for the first 20weeks and monthly thereafter, emphasis on caloric goals and exercise via stimulus control,problem-solving storages, social assertion, short-term goal setting and reinforcement techniques,cognitive strategies, relapse prevention, and social support)


c. SBT plus food provision (FP) (packaged meals for 5 breakfasts and 5 dinners each week for 18months, provided at no cost to participants)d. SBT plus incentives (I) (cash payments each week based on amount of weight lost relative toweight-loss goal with a maximum of $25 per week)e. SBT plus FP plus IThere were no significant differences between groups at baseline with respect to age, education,race, participation in prior weight loss programs, weight, BMI, dietary intake, and exercise. The6-month evaluation was completed by 89% of the participants; 87% completed the 12-monthevaluation and 85% completed the 18-month evaluation. Overall, 79% completed all evaluationsand the data analyses are based on that group. Results were compared to an analysis based on the85% who completed the 18-month evaluation (using extrapolation for missing values) and nodifferences were found between the analyses. There were differences in the percentage ofparticipants in each group that completed all follow-up assessments. The values were 70% for thecontrol group, 65% for the SBT group, 90% for the SBT+FP group, 85% for the SBT+I group, and 83%for the SBT+FP+I group (p=0.03). The two FP groups had the greatest weight loss (a mean of 10.1kg [11.3% of baseline weight] at 6 months, 9.1 kg [10.1%] at 12 months, and 6.4 kg [7.1%] at 18months). The SBT and SBT+I groups experienced mean weight losses of 7.7 kg [8.4%], 4.5 kg [5.0%],and 4.1 kg [4.5%] at 6, 12, and 18 months, respectively). The control group experienced no change inweight over the 18 months. Food provision, and not financial incentives, enhanced completion offood records, quality of diet, and nutrition knowledge.

A subsequent report by French, Jeffery, and Wing (1994) explored sex differences between the whitemen (n=98 ) and women (n=88) enrolled in the study. Although men lost significantly more absoluteweight then women at each of the follow-up periods (all p<0.05), when the values were adjustedfor baseline weight, treatment group, age, education, and marital status, the men lost significantlymore weight only at the 6 month follow-up (p<0.03). Few of the behavioral and psychologicalvariables assessed were related to weight loss suggesting that different emphases in weight-lossprograms for men and women may not be necessary.

In another follow-up report, data obtained at 12 months after the completion of the 18 month studyperiod were provided (Jeffery & Wing, 1995). Study staff did not contact the participants duringthis time period. Data were available for 177 of the 202 initially enrolled (88%). The analysiswas based on those 177 participants. Over the entire 30 month period, control group participantsgained an average of 0.6 kg (0.7%), the SBT group lost 1.4 kg (1.6%), the SBT+FP group lost 2.2 kg(2.5%), the SBT+I group lost 1.6 kg (1.7%), and those in the SBT+FP+I group lost 1.6 kg (1.8%).Average weight loss did not differ between the treatment groups at 30 months.

To further clarify the impact of food provision, Wing et al. (1996) randomly assigned 163overweight women (30 to 70 pounds based on insurance industry norms) to either a standardbehavioral treatment program (SBT) with weekly meetings, SBT plus structured meal plans andgrocery lists, SBT plus meal plans plus food provision with subjects sharing the cost ($25 per week),or SBT plus meal plans plus free food provision. Eligible women ranged in age from 15 to 55 yearsand were free of illness that would preclude participation in a diet and exercise program. Themean age of the participants was 41.2 years. he program lasted 26 weeks with a 1 year follow-up.Of the 163 randomized, 148 (91%) completed the 6 month assessment. The SBT group experiencedsignificantly less weight loss (9.3% from baseline) than each of the treatment groups (p<0.003)with no differences in weight loss between the 3 treatment groups (13.7% from baseline for thegroup that received meal plans, 13.4% for the group that had to purchase food, and 13.5% for thegroup that received free food). The groups that received meal plans with or without food reportedreductions in perceived barriers to weight loss, more favorable changes in the types of food storedin their homes, and more regular meal patterns than those receiving only behavioral treatment.Attendance at the treatment meetings was higher in the groups that had to purchase food (86.2%of meetings attended) or who were given food (83.1%) compared to those given meal plans (68.4%)or behavioral treatment only (60.8%). One year follow-up data were available for 144 (88%)


subjects (evenly distributed among the treatment groups). Weight losses were 3.3 kg (3.8% frombaseline) for the SBT only group, 6.9 kg (7.9%) for the meal plan group, 7.5 kg (8.6%) for the sharedfood costs group, and 6.6 kg (7.8%) for the free food group. Weight loss at one-year of follow-upwas significantly lower in the SBT group (p<0.02) with no differences between the three treatmentgroups. It should be noted that the post-treatment and follow-up analyses were not by intention-to-treat.

The use of personal trainers to direct exercise sessions and/or financial incentives for completingexercise sessions was reported by Jeffery, Wing, Thorson, and Burton (1998). The study included 29men and 167 women all between 14 and 32 kg overweight according to insurance industry standards.The age of the participants could range from 25 to 55 years (the mean age was 41.2 years) and allwere free of serious disease and able to walk for exercise. Participants were randomized to:a . standard behavior therapy (SBT) or control (weekly group sessions for 24 weeks followed bymonthly sessions; included caloric goals, structured meal plans, exercise recommendations)b. supervised exercise (same information as SBT group with supervised walking sessions threetimes per week)c. SBT+supervised walks+personal trainer (trainer walked with participants, made remindertelephone calls, scheduled make-up sessions)d. SBT+supervised walks+incentive (financial reward based on number of walks attended eachmonth; reward increased with cumulative attendance)e. SBT+supervised walks+trainer+incentiveEvaluations were done at baseline, 6, and 18 months. At baseline, the participants in the differenttreatment groups did not differ significantly. Six-month data were available for 87% of thoseenrolled; the 18-month evaluation was complete for 78%. The data analyses were based on thenumber of participants who completed each evaluation. The 44 individuals who did not attendthe 18 months follow-up were contacted and asked for their weights. Fifteen of the 44 providedweights but an analysis that included their weights did not differ from an analysis without thoseindividuals and was therefore not presented. The presence of a personal trainer increasedattendance at the walking sessions and there were significant differences between groups(p<0.001). In the supervised walk group, the average number of walks completed was 35. In thepersonal trainer group, the average was 80 and in the trainer plus incentive group, the average was103. In the incentive group, the average was 65. All groups demonstrated a decrease in number ofwalk sessions attended between the first 26 weeks of the study and weeks 27 to 78 of the study(p<0.001). All of the treatment groups experienced similar weight losses from baseline to 6 months(9.7% in the SBT only group, 6.9% in the supervised exercise group, 6.6% in the personal trainergroup, 7.6% in the incentive group, and 9.2% in the trainer plus incentives group). From baseline to18 months, there was greater weight loss in the SBT only group (8.9%; p<0.03) than in thesupervised exercise group (4.4%), the personal trainer group (3.4%), the incentives group (5.1%),and the trainer plus incentive group (6.0%).

Jeffery, Wing, Sherwood, and Tate (2003) presented results from a randomized trial designed tocompare 2 levels of physical activity. The study was conducted at 2 sites. Eligible participantswere 25 to 50 years old, 14 to 32 kg overweight (compared with actuarial norms), and had noserious medical or psychological problems that were likely to limit their participation in thetreatment program. The 202 study participants were randomly assigned to either standardbehavioral therapy (SBT; n=93) or high physical activity (HPA; n=109). SBT was conducted in agroup (less than 20 people) setting. Meetings were held weekly for the first 6 months, every otherweek during months 6 to 12, and monthly during months 12 to 18. The program emphasized diet(reducing energy intake to 1,000-1,500 kcal with less than 20% of energy from fat), physicalactivity (increasing activity to 1,000 kcal/week), stimulus control, problem solving, goal setting,social support, motivation, and relapse prevention. Diet and exercise were to be recorded daily forthe first 6 months and then during 1 week each month after that. The HPA group completed thesame program except that the physical activity goal was 2,500 kcal/week (to be achieved within6 months of starting the program). To increase the likelihood of achieving this goal, participantsin the HPA group were encouraged to recruit family or friends to take part in the program, exercise


coaches were provided, and participants were awarded $3 each week that they achieved the2,500 kcal/wk goal during months 12 to 18 of the study. The study groups were comparable atbaseline. Overall, the mean age was 42.2 years, 58% were women, 80% were of white ethnicity,and the mean BMI was 31.7 kg/m2. Follow-up visits at 12 and 18 months were recorded for 82% and87%, respectively, of the SBT group and 79% and 80%, respectively, of the HPA group. The SBTgroup experienced mean weight losses of 8.1 kg, 6.1kg, and 4.1 kg at 6, 12, and 18 months. Thecorresponding weight losses in the HPA group were 9.0 kg, 8.5 kg, and 6.7 kg. The differencebetween groups was significant at 18 months (p=0.04). Energy expenditure was significantlyhigher (p=0.01) for the HPA group at 6, 12, and 18 months. The physical activity goal of 2,500kcal/week was achieved by 49% of the HPA group at 6 months and maintained by 39% at 18months. The goal was also achieved by 28% of the SBT group at 6 months and maintained by 20%at 18 months. Energy intake and percentage of intake from fat decreased significantly (p<0.001)for both groups although the mean values remained above the intake goals. The HPA groupreported more exercise-related injuries or illnesses with a significant difference between groups at18 months. The overall number of injuries or illnesses at 18 months was 2.0 for the SBT group and2.6 for the HPA group.

Telephone- or Internet-based Counseling

Telephone-based counseling offers an alternative to face-to-face programs. Hellerstedt andJeffery (1997) studied 64 men and women, 25 to 55 years old, who were 20 to 80 pounds overweightand who did not want to attend regular weight loss sessions. All of the participants attended twogroup education sessions prior to being randomized to either (a) minimal contact (no contact fromstudy organizers), (b) a weight-focused phone group (participants were phoned once per week andasked to report their weight), or (c) a behavior-based phone group (participants were phoned onceper week and asked to report their weight and their caloric intake and expenditure during thepast week). All groups were allowed to contact the study nutritionist at any time during the 24week program. The program was completed by 86%; 2 subjects became pregnant and 7 dropped out.Ninety percent of the scheduled telephone calls were completed. The nutritionist received 18 callsfrom 10 participants. There were no differences between the three groups in mean change in weightor BMI. Overall, 29% lost no weight or gained weight, 27% lost 0.5 to 9.9 pounds, 15% lost 10 to19.9 pounds, and 29% lost 20 pounds or more. Telephone counseling was found to be feasible but itwas concluded that further work was need to identify the optimal content.

Boucher, Schaumann, Print, Priest, Ett, and Gray (1999) reported the results of a 6 monthtelephone-based weight management program targeted for individuals from 2 clinic sites whowere at least 50 pounds overweight or had a BMI above 29 kg/m2. The program focused onnormalizing eating behavior, increasing activity levels, decreasing fat intake, social support, andrelapse prevention training. Of 138 referred to the program, 68 completed 6 months. Separateanalyses were done for those prescribed medications for weight loss. The mean weight loss was 6.1kg in the group not taking weight loss medications and 11.3 kg in those who were (p<0.05). Themean change in BMI was 2.2 kg/m2 in those not taking weight loss medications and 4.2 kg/m2 inthose who were (p<0.05). A satisfaction survey, completed by 46 participants, indicated that 96%were very satisfied with the quality of the program and 91% were very satisfied with theconvenience. Of 21 providers at the 2 clinic sites, 13 (12 of whom had referred patients to theprogram) completed a satisfaction questionnaire. Of the 13 who completed the survey, 92%believe that it helped patients. Of the 12 who referred patients, 92% were very satisfied withthe quality of the program.

Mail and telephone interventions were evaluated in the randomized trial presented by Jeffery,Sherwood, Brelje, et al. (2003). Data from the first 12 months of a planned 24 month interventionwere reported. The 1,801 patients were members of a managed-care organization who attended oneof 4 staff-model clinics. To be eligible for the study, individuals needed to be at least 18 years oldand have a BMI above 27 kg/m2. Patients were randomized into mail intervention, phoneintervention, and usual care groups. Both the mail and the phone interventions consisted of 10lessons with feedback from a health counselor between lessons. The lessons focused on nutrition,


physical activity, and behavior management. Food and exercise logs were maintained. Althoughthe lessons were designed to be done as quickly as one per week, participants were asked to go attheir own pace allowing time to practice new lifestyle behaviors. Phone counseling sessionsaveraged 19 minutes in length. Both groups were given options for follow-up intervention aftercompleting the 10 lesson program. The usual care group had access to weight management servicesavailable to all members of the managed-care organization. This group received informationabout those services as well as about community resources. Baseline weight was recorded in theclinic; follow-up weights at 6-and 12-months were self-reported. The study groups were similar atbaseline with one exception. Compared with the other treatment groups, a higher percentage ofindividuals in the phone group reported taking medication for depression (p<0.002).Approximately 80% of participants had attempted to diet in the past with approximately 30%having been part of a formal weight-loss program in the past 2 years. The average BMI wasapproximately 34 kg/m2. Weight changes at 6 months were -1.93 kg for the mail group, -2.38 kgfor the phone group, and -1.47 kg for the usual care group (overall p=0.003 with the control groupsignificantly different [p<0.001] from the phone group). A loss of at least 5% of initial weight wasreported by 19% to 24% of the participants while a loss of at least 10% was reported by 5% to 7%(no differences between groups). At 12 months, weight losses were -2.28 kg for the mail group, -2.29kg for the phone group, and -1.92 for the usual care group (no differences between groups). A weightloss of at least 5% of initial weight was reported by 23% to 28%; a loss of at least 10% of initialweight was reported by 6% to 9% (no differences between groups). At the 12 month mark, 87% ofthe mail group and 69% of the phone group had activated treatment. The mail group hadcompleted a mean of 2 sessions while the phone group had completed a mean of 7 sessions. Sevenpercent of the mail group and thirty-six percent of the phone group had completed all 10 sessions.In both groups, individuals who had activated treatment had lost significantly more weight (bothp<0.05) than those who had not activated treatment. Similarly, those who had completed 10sessions had lost more weight than those who had completed fewer than 10 sessions (bothp<0.001).

An Internet-based program was studied by Tate, Jackvony, and Wing (2003). The 92 participantshad BMI values of 27-40 kg/m2 and at least one other risk factor for type 2 diabetes. The studyexcluded individuals who were pregnant, had major health or psychiatric diseases, or a recentweight loss of at least 4.5 kg. Patients were randomized to either a basic Internet weight lossprogram or the Internet program with additional behavioral counseling. At baseline and at the3rd, 6th, and 12th month of the program, patients were seen in-person for measurements of weight,waist circumference, and fasting blood glucose. The patients were paid for attending these session.The Internet program was explained at a 1-hour group session. At the session, patients were alsogiven information about diet (1,200 to 1,500 kcal/day with ≤20% of calories from fat), physicalactivity (≥1,000 kcal/week), and behavior change. The Internet program included learningsessions on weight loss, weekly weight loss tips and Internet resources, and a directory of relatedweight loss links. There were message boards for each group and participants received remindersto submit their weight each week. The additional behavioral counseling group communicated bye-mail with an assigned weight loss counselor. The patients in this group submitted data on dietand activity daily for the first month and then either daily or weekly for the remainder of theyear. Counselors sent responses 5 times per week for the first month and then weekly. In additionto feedback on the individual's diet and physical activity program, the counselors providedreinforcement, recommendations for change, answers to questions, and overall support. The twogroups of patients (46 per group) did not differ at baseline. The 12-month assessment wascompleted by 77 patients (84%) including 39 in the basic Internet group and 38 in the Internet pluscounseling group. Of 15 patients lost to follow-up, 2 were lost for medical reasons and 13 were lostfor unknown reasons or for lack of interest. Using an intention-to-treat analysis (with baselinevalues in place of missing data), there was greater weight loss in the Internet with counselinggroup (-4.4 kg vs. -2.0 kg, p=0.04). The Internet with counseling group also lost a greater percentageof initial weight (-4.8% vs. -2.2%, p=0.03) and had a greater reduction in BMI (-1.6 vs. -0.8,p=0.03) and waist circumference (-7.2 cm vs -4.4 cm, p=0.05). Fasting plasma glucose levels were


significantly lower (p=0.01) in the Internet with counseling group at 3 months but no differencesbetween groups were observed at 12 months. The Internet with counseling group logged-in to thestudy Web site more frequently than the Internet only group (p<0.05). In both groups, participantswho lost more weight logged-in more often (r=-0.47 [p=0.003] for the Internet with counselinggroup; r=-0.61 [p<0.001] for the Internet only group).

Commercial Weight Loss Programs

In the study presented by Heshka et al. (2003), participants were randomly assigned to either aself-help weight loss program (n=212) or a commercial weight loss program (n=211). The studywas conducted at 6 sites. Eligible participants were ages 18 to 65 years with BMI values of 27 to 40kg/m2. Approximately 85% of the participants were women. The study excluded patients withfasting glucose above 140 mg/dL, triglycerides above 1,000 mg/dL, liver function tests more thantwice the upper normal level, or serum creatinine above 1.4 mg/dL. Other exclusion criteriaincluded use of systemic or inhaled corticosteroids or lithium, a history of alcohol abuse in thepast year, a history of or current psychiatric disorder likely to interfere with participation in thestudy, initiation of new drug therapy within 30 days of randomization, current participation in aweight loss study, or use of prescription weight loss or investigational medications within 90 daysof randomization. The self-help group received 20-minute dietitian consultations at baseline and12 weeks. They were also given publicly available printed materials addressing dietary andphysical activity principles and alerted to other resources offering free weight controlinformation. The commercial program group attended weekly Weight Watchers meetings at nocost. The weekly, 1-hour meetings consisted of weigh-ins, distribution of educational materials,and social support. As part of the program, participants received a food plan, an activity plan,and a behavior modification plan. The two groups were comparable at baseline. It was noted thatduring the 2-year study, 14 of the self-help group participants reported using weight lossmedications, 6 used herbal supplements, 10 enrolled in a commercial weight loss program, and 9followed one of several popular diet plans. These patients were retained in the statisticalanalyses. Using an intention-to-treat analysis, mean weight losses of 4.3 kg (4.5% of initialweight) (commercial group) and 1.3 kg (1.4%) (self-help group) were observed at one year; at 2years, the mean losses were 2.9 kg (3.1%) and 0.2 kg (0.2%), respectively (p<0.001 between groupsat year 1 and year 2). Overall, 61 members (29%) of the commercial diet group and 53 members(25%) of the self-help group were lost to follow-up or withdrew consent. Regardless of treatmentgroup, those who did not complete the study were younger, had a higher baseline BMI, had ahigher baseline percentage of body fat, were more likely smokers, and had slightly lower incomesthan those who completed the study (all p<0.05). An analysis of weight lost by completers of the2-year study indicated losses at 1 year of 5.0 kg by the commercial diet group and 1.4 kg by the self-help group with losses of 3.0 kg and 0.1 kg, respectively, at 2 years (p<0.001 between groups at year1 and year 2). A weight loss (at 2 years) of at least 10% of initial weight was reported by 16% ofthe commercial diet group and 6% of the self-help group (p=0.005). A weight gain of 10% or morewas reported by 1% of the commercial diet group and 9% of the self-help group (p=0.003). Severalbiological parameters were analyzed. The analyses of blood pressure, lipid, and glucose changeswere done after excluding patients taking medication for those conditions. The analyses alsoexcluded patients with values more than 3 standard deviations from the mean. Overall, therewere few differences between groups. At one year, diastolic blood pressure was significantlydifferent between groups (p=0.02) due to a significant increase (p<0.05) from baseline in the self-help group. Insulin was significantly different between groups (p=0.01) due to a significantdecrease from baseline in the commercial diet group (p<0.05). At 2 years, only insulin levelsdiffered between groups (p=0.04). Overall, fasting glucose levels were increased in both groups,total cholesterol levels were decreased in both groups, and the HDL/total cholesterol ratioincreased in both groups (all p<0.05 relative to baseline).

Maintenance Programs

The National Weight Control Registry (2004) is a database of adults who have maintained aweight loss of at least 30 pounds for at least one year. Over 4,000 people are registered. Based on


data from 784 Registry participants, Klem, Wing, McGuire, Seagle, and Hill (1997) identifiedthat individuals who have successfully maintained a weight loss often restrict intake of certaintypes or classes of foods, count calories, eat the majority of meals at home, and limit intake fromfats; eat an average of 4.9 times per day; engage in physical activity (for many, the equivalent of28 miles per week); and weigh themselves at least once per week. Gorin, Phelan, Wing, and Hill(2004) reported that individuals who maintained a consistent diet throughout the week and acrossthe year (compared with individuals who were less strict about their diet on weekends, duringholiday periods, and when on vacation) were more likely to maintain their weight within 5pounds over a 1 year period (OR=1.58; 95%CI 1.2-2.2). The analysis included 1,429 participants inthe National Weight Control Registry.

Actual success rates for individuals attempting to maintain weight loss are unknown. Jeffery et al.(2000) reviewed studies that attempted to improve long-term maintenance of weight loss by eitherincreasing the intensity of the initial treatment (e.g., lowering caloric intake), extending thelength of the behavioral support component, modifying behavioral recommendations (e.g.,focusing on fat intake rather than caloric intake, increasing the attention on exercise), enhancingmotivation (e.g., through the use of tangible incentives or social support incentives), and teachingmaintenance-specific skills (as compared with skills for weight loss). Overall, extending thelength of treatment and increasing the emphasis on exercise were beneficial in at least delayingweight regain. Following specific menus (with or without food provision) was beneficial for short-term but not long-term weight loss.

Several studies have looked at the effects of extended maintenance programs. Perri, McAllister,Gange, Jordan, McAdoo, and Nezu (1988) enrolled 123 participants between the ages of 22 and 59years who were 20% to 100% of ideal body weight. Participants were randomly assigned to (a)control - behavior therapy treatment phase consisting of 20 weekly, 2 hour sessions with no contactafter 20 weeks except for assessments at 6, 12, and 18 months post-treatment, (b) behavior therapyplus contact - a post-treatment maintenance program consisting of 26 biweekly therapist contacts(weigh-in, review of self-monitoring data, problem solving), (c) same as (b) with program of socialinfluence strategies to enhance motivation and provide incentives for continued weight loss, (d)same as (b) with aerobic exercise maintenance program (increased from 80 min/wk to 180 min/wk),or (e) all of the components. There were no differences between the groups at baseline. During theinitial 5 months treatment phase, 23.6% of the participants withdrew from the study (equallydistributed across the treatment groups). Overall, there were follow-up data from 74% of the 123who enrolled. Following the treatment phase, all groups lost weight with no differences betweengroups. The mean weight losses across the 5 groups ranged from 10.8 to 13.67 kg. At 6 months post-treatment, the 4 groups with post-treatment contact had greater weight loss progress than the nocontact group (a); only the group with all components (e) experienced significant further weightloss. At 12 months, the contact group had significant relapse in weight loss and the contact groupswere significantly different from the no contact group. The pattern continued at 18 months post-treatment. Overall, participants in the 4 contact conditions maintained 82.7% of the mean post-treatment weight loss while those in the no-contact group maintained 33.3% of the originalweight loss. There was a negative correlation between adherence to treatment and maintenanceprogram strategies and weight gain (across groups r=-0.27 to r=-0.48, all p<0.05).

A similar study compared two extended therapy programs with a no-contact condition following a5 month initial treatment phase (Perri, McKelvey, Renjilian, Nezu, Shermer, & Viegener, 2001).Participants were 103 individuals (93 women, 10 men) between the ages of 21 and 60 years withBMI values of 27 to 40 kg/m2. Assignment to one of the three conditions was random. All groupsunderwent an initial treatment phase consisting of 5 months of cognitive-behavior interventiondelivered in 20 weekly 2 hour sessions. The focus was on self-monitoring, goal setting, and stimuluscontrol. A low calorie, low fat diet was also recommended along with increased physical activity.Following the initial treatment phase, one group (BT) had no further contact except forassessments at 6 and 12 months , one group received relapse prevention training (RPT) consisting ofbi-weekly sessions designed to assist participants in anticipating, avoiding, and coping with


lapses in diet and exercise behaviors, and one group received problem solving therapy(PST)consisting of group problem solving following a 5-step model: orientation, definition,generation of alternatives, decision making, implementation and evaluation. There were nodifferences between groups at baseline. The initial treatment phase was completed by 88% of theenrollees. However, the 8 males who completed the program were unevenly distributed across thegroups so their data were not included in subsequent analyses. For the 80 females who completedthe initial treatment, mean weight losses were 9.5% for the BT group, 9.6% for the RPT group, 8.7%for the PST group. During the year-long maintenance phase, 29% of the RPT group and 34% of thePST group either withdrew or failed to attend sufficient sessions. Based on those who completedthe program (69% of those who started the extended maintenance phase), the BT group had lostapproximately 4.4% of initial weight, the RPT group had lost approximately 6.0%, and the PSTgroup had lost approximately 11.0% at the 12 months post-treatment evaluation. An intention-to-treat analysis was done assuming no change from baseline for those who withdrew or failed tocomplete the final assessment. With that assumption, 35% of the PST group achieved at least a10% weight loss from baseline compared to 21% of the RPT group and 6% of the BT group. It wasalso noted that the PST group had significantly better adherence than the BT group and that partof the effect of treatment condition on weight loss could be attributed to adherence to behavioralstrategies.

Latner, Wilson, Stunkard, and Jackson (2002) described long-term (5 year) results from participantsin satellite groups modeled after the Trevose (Pennsylvania) Behavior Modification Program.The program is run by volunteers (who are also members of the Program) and is offered at no cost.For the purposes of this study, 3 satellite sites were randomly chosen from among all sites thatexisted in 1994 and had kept participant records. All individuals who had joined the program atthe 3 sites prior to 1995 (5 years before the time of data collection) were included. To be eligible tojoin the program, participants had to be between 20 and 80 pounds above normal weight, had nohistory of diabetes, and have never been a member of the Trevose program. Weekly meetings(groups of 10) focused on behavior modification principles including self-monitoring of intake,increasing physical activity, and changing eating habits. Continuation in the program wascontingent on meeting preset goals. During the first 5 weeks of the program, a screening phase, foodrecords must be submitted, the weekly meetings must be attended, and participants must lose 15%of the total weight loss goal (or, if the weight loss goal is 80 pounds or more, the participant mustlose 12 pounds). If the screening phase goals are met, participants are accepted as members andmay continue in the program; if not, they are permanently dismissed from the group. Continuedmembership requires consistent attendance at meetings, self-monitoring of caloric intake, andmonthly weight loss (and eventually weight maintenance) goals. When the weight loss goal ismaintained for 12 months, members are no longer required to attend meetings but are still requiredto mail in weight records. A total of 128 individuals entered the 3 satellite programs between 1986and 1994. Most (96.9%) were women; the mean age at time of entry was 47.1 years and mean BMIwas 31.8 kg/m2. Of the 128 participants, 89.8% continued past the 5 month screening phase. At oneyear, 69.5% were still in the program; at 2 years and 5 years, the percentages of initialparticipants still involved were 43.8% and 23.4%, respectively. Using an intention-to-treatanalysis, mean weight loss for the entire group at the last meeting attended was 13.7% of initialweight (or 11.8 kg). Of those remaining in the program at 1, 2, and 5 years, mean weight losseswere 18.0% (15.4 kg), 19.0% (16.2 kg), and 18.4% (15.6 kg), respectively. For those who continued inthe program, 90% or more achieved weight losses of more than 5% or more than 10% of initial bodyweight at all points during the 5 year follow-up. The average length of treatment was 2.3 years.

Safety of Treatment or Procedure

The evidence (or lack thereof), as cited in the literature, pertaining to:

a . morbidity rate (side effects) - there have been no reports of adverse side effects due tobehavioral weight loss programs


b. mortality rate - there have been no reports of deaths due to behavioral weight loss programs

c. training and experience required to perform the procedure safely - most of the research has beendone in academic settings; behavioral therapy programs in a community setting are largelyunregulated and there is wide variation

d. where the procedure should be performed (e.g., volume of procedures, skilled support team,location/need for follow-up visits, etc.) - there are no established standards for behavioraltherapy programs and no specific credentialing for program leaders; consumers should ask for thebackground and experience of the person leading the program, the mission of the program, and themedical supervision of the program

e. co-morbidities that increase the risk associated with the procedure - underlying psychologicalconditions that are undetected and/or untreated

f . potential for inappropriate use of the technology - commercial programs run by unqualifiedindividuals

Alternative Forms of Treatment

Alternative forms of treatment include both prescription and non-prescription diet products as wellas diet and/or exercise programs. In a 1998 survey, 14,679 non-institutionalized adults in 5 stateswere asked about their use of over-the-counter weight loss products in the past 2 years (Blanck,Kahn, & Serdula, 2001). Overall, seven percent reported having used non-prescription weight lossproducts with a greater likelihood among women, those age 18 to 34 years (vs. those 35-54 years),those with some college or a college degree or more (vs. those with less than a high schooldiploma), those who were overweight or obese (vs. those of normal weight), those who had used aprescription weight loss pill in the past 2 years, and those who were either somewhat active orwho achieved 30 minutes or more of physical activity at least 5 times per week.

Short-term diet programs have received a great deal of attention in the press but there is littleevidence of their long-term effectiveness with regard to weight loss. Short-term weight loss (aone-week program) may facilitate normalization of blood glucose levels in diabetic patients.

Gastric surgery (involving either gastric restriction or gastric bypass) is an option for adults with aBMI of 40 kg/m2 or higher, or a BMI of 35 kg/m2 or higher with comorbid conditions, and who havefailed maximal medical therapy. Although there is evidence that weight loss may be sustainedfor seven years or longer and that glucose tolerance, forms of hyperlipidemia, hypertension, andarthritis may be improved following the surgery, long-term trials are needed to demonstrate long-term survival benefits and long-term maintenance of weight loss and reversal of comorbidities.Patients who undergo gastric surgery need lifelong medical surveillance for nutrient deficienciesand medical complications (ICSI, 2000).

Epidemiology and Costs

It is estimated that in 1999, 61% of adults in the United States were either overweight or obese.The prevalence of overweight or obesity has risen considerably over the past 25 years (U.S.Department of Health and Human Services, 1999). The increased prevalence has been observed inall age groups, all racial and ethnic groups, and for both men and women (Mokdad et al., 2000).The risk of premature death and the risk of developing serious health conditions (such as type 2diabetes, heart disease, stroke, hypertension, osteoarthritis, asthma, cancer, and depression) bothincrease with increased degrees of weight gain and higher BMI values (NHLBI, 1998).Overweight and obesity is a leading health indicator (i.e., a major health issue) in the HealthyPeople 2010 initiative. A modest weight loss of 5% to 10% of initial body weight has been found tobe effective in decreasing blood pressure, improving lipid profiles, improving glycemic control inpatients with type 2 diabetes mellitus, and preventing the development of type 2 diabetes


mellitus in patients at high risk for developing the disease (Goldstein, 1992; Tuomilehto et al.,2001; Diabetes Prevention Program Research Group, 2002).

The total cost of health care in the United States that is associated with obesity has beenestimated at $117 billion for the year 2000 (U.S. Department of Health and Human Services,2001). It is estimated that consumers spend more than $30 billion per year on diet foods andbeverages, diet books, weight loss programs, and other products while attempting to lose weight orprevent weight gain (AOA, undated).

Summary

With regard to behavioral therapy programs for weight loss in adults, the ICSI TechnologyAssessment Committee finds the following:

1. Behavioral therapy programs are generally safe unless the patient has an underlyingpsychological condition.

2. Successful behavioral therapy programs have typically been conducted in academic settingsand generally include the following components:a. an active phase (typically 6 months) during which modest weight loss can be expected,b. an on-going maintenance phase, andc. cognitive behavioral therapy (with sufficient time for individuals to learn these approaches).

3. Providing meal plans and grocery lists to participants is as effective as providing food. The useof personal trainers and cash incentives may improve attendance at program sessions but did notenhance long-term weight loss.

4. Behavioral therapy programs in a community setting are largely unregulated with no specificcredentialing for program leaders.

5. Individuals enrolled in behavioral therapy programs without incentives or food provisiontypically experienced weight losses of 2.5% to 10% of baseline weight following an activetreatment phase of from 8 weeks to 6 months. (Conclusion Grade II based on Class A and Cevidence, see Appendix A) There are limited post-treatment follow-up data but the availableevidence suggests that weight loss may be maintained or furthered at 6 to 12 months followingtreatment. (Conclusion Grade III based on Class A evidence, see Appendix A)

6. In programs involving incentives or food provision in addition to behavioral therapy,individuals typically experienced weight losses of 6.6% to 13.7% after 6 months. In programs thatactively continued treatment for 18 months, further weight losses were not observed. At 12 monthspost-treatment, weight losses had been reduced to 1.7% to 8.6% of original body weight.(Conclusion Grade II based on Class A evidence, see Appendix B)

7. Many of the behavioral therapy programs did not choose to assess health outcomes. Theavailable evidence indicates that blood pressure and lipid levels are improved followingtreatment. State anxiety, trait anxiety, and depression scores have typically improved butdifferences between treatment groups or between treatment and control groups have generally notbeen significant.

Potential Conflict of Interest Disclosure

In the interest of full disclosure, ICSI has adopted the policy of revealing relationships workgroup members have with companies that sell products or services that are relevant to thistechnology assessment report topic. The reader should not assume that these financial interestswill have an adverse impact on the content of the technology assessment report, but they are notedhere to fully inform readers. Readers of the technology assessment report may assume that onlywork group members listed below have potential conflicts of interest to disclose.


No work group members have potential conflicts of interest to disclose.

ICSI's conflict of interest policy and procedures are available for review on ICSI's Web site atwww.icsi.org.

ReferencesEvidence is classed and graded as described below.

I . CLASSES OF RESEARCH REPORTS

A. Primary Reports of New Data Collection:

Class A: Randomized, controlled trial

Class B: Cohort study

Class C: Non-randomized trial with concurrent or historical controlsCase-control studyStudy of sensitivity and specificity of a diagnostic testPopulation-based descriptive study

Class D: Cross-sectional studyCase seriesCase report

B. Reports that Synthesize or Reflect upon Collections of Primary Reports:

Class M: Meta-analysisSystematic reviewDecision analysisCost-effectiveness analysis

Class R: Consensus statementConsensus reportNarrative review

Class X: Medical opinion

II. CONCLUSION GRADES

Key conclusions (as determined by the work group) are supported by a conclusion gradingworksheet that summarizes the important studies pertaining to the conclusion. Individualstudies are classed according to the system defined in Section I, above, and are assigned adesignator of +, -, or ø to reflect the study quality. Conclusion grades are determined by thework group based on the following definitions:

Grade I: The evidence consists of results from studies of strong design for answering thequestion addressed. The results are both clinically important and consistent with minorexceptions at most. The results are free of any significant doubts about generalizability, bias,and flaws in research design. Studies with negative results have sufficiently large samples tohave adequate statistical power.

Grade II: The evidence consists of results from studies of strong design for answering thequestion addressed, but there is some uncertainty attached to the conclusion because ofinconsistencies among the results from the studies or because of minor doubts aboutgeneralizability, bias, research design flaws, or adequacy of sample size. Alternatively, theevidence consists solely of results from weaker designs for the question addressed, but theresults have been confirmed in separate studies and are consistent with minor exceptions atmost.

Grade III: The evidence consists of results from studies of strong design for answering thequestion addressed, but there is substantial uncertainty attached to the conclusion because of


inconsistencies among the results from different studies or because of serious doubts aboutgeneralizability, bias, research design flaws, or adequacy of sample size. Alternatively, theevidence consists solely of results from a limited number of studies of weak design for answeringthe question addressed.

Grade Not Assignable: There is no evidence available that directly supports or refutesthe conclusion.

The symbols +, �, ø, and N/A found on the conclusion grading worksheets are used to designatethe quality of the primary research reports and systematic reviews:+ indicates that the report or review has clearly addressed issues of inclusion/exclusion, bias,generalizability, and data collection and analysis;� indicates that these issues have not been adequately addressed;ø indicates that the report or review is neither exceptionally strong or exceptionally weak;N/A indicates that the report is not a primary reference or a systematic review and thereforethe quality has not been assessed.

Abrams DB, King TK, Clark MM, Forsyth LH, Pera Jr V, Goldstein MG. Behavioral medicinestrategies: management of nicotine dependence, obesity, and cardiopulmonary rehabilitationexercise. In: A Stoudemire, BS Fogel, DB Greenberg (Eds). Psychiatric Care of the MedicalPatient (2nd ed.), 519-544. New York: Oxford University Press, 2000. (Class R)

American Obesity Association (AOA). Consumer protection: weight management products andservices. AOA Fact Sheet (undated). (Accessed June 2, 2004, athttp://www.obesity.org/subs/fastfacts/Obesity_Consumer_Protect.shtml.) (Class not assignable)

Blanck HM, Khan LK, Serdula MK. Use of nonprescription weight loss products. Results from amultistate survey. JAMA 2001;286:930-935. (Class C)

Boucher JL, Schaumann JD, Pronk NP, Priest B, Ett T, Gray CM. The effectiveness of telephone-based counseling for weight management. Diabetes Spectrum 1999;12:121-123. (Class D)

Burton WN, Chen C-Y, Schultz AB, Edington DW. The economic costs associated with body massindex in a workplace. J Occup Environ Med 1998;40:786-792. (Class D)

Calle EE, Rodriguez C, Walker-Thurmond K, Thun MJ. Overweight, obesity, and mortality fromcancer in a prospectively studied cohort of U.S. adults. N Engl J Med 2003;348:1625-1638. (Class B)

Clifford PA, Tan SY, Gorsuch RL. Efficacy of a self-directed behavioral health change program:weight, body composition, cardiovascular fitness, blood pressure, health risk, and psychosocialmediating variables. J Behav Med 1991;14:303-23. (Class C)

Colditz GA, Willett WC, Rotnitzky A, Manson JE. Weight gain as a risk factor for clinicaldiabetes mellitus in women. Ann Intern Med 1995;122:481-486. (Class B)

Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes withlifestyle intervention or metformin. N Engl J Med 2002;346:393-403. (Class A)

Flegal KM, Carroll MD, Ogden CL, Johnson CL. Prevalence and trends in obesity among US adults,1999-2000. JAMA 2002;288:1723-1727. (Class D)

French SA, Jeffery RW, Wing RR. Sex differences among participants in a weight-control program.Addict Behav 1994;19:147-58. (Class C)

Fuller PR, Perri MG, Leermakers EA, Guyer LK. Effects of a personalized system of skillacquisition and an educational program in the treatment of obesity. Addict Behav 1998;23:97-100.(Class A)

Goldstein DJ. Beneficial health effects of modest weight loss. Int J Obes Relat Metab Disord1992;16:397-415. (Class R)


Gorin AA, Phelan S, Wing RR, Hill JO. Promoting long-term weight control: does dietingconsistency matter? Int J Obes Relat Metab Disord 2004;28:278-281. (Class D)

Hedley AA, Ogden CL, Johnson CL, Carroll MD, Curtin LR, Flegal KM. Prevalence of overweightand obesity among US children, adolescents, and adults, 1999-2002. JAMA 2004;291:2847-2850.(Class D)

Hellerstedt WL, Jeffery RW. The effects of a telephone-based intervention on weight loss. Am JHealth Promot 1997;11:177-182. (Class A)

Heshka S, Anderson JW, Atkinson FL, Greenway FL, HIll JO, Phinney SD, et al. Weight loss withself-help compared with a structured commercial program. A randomized trial. JAMA2003;289:1792-1798. (Class A)

Huang Z, Willett WC, Manson JE, et al. Body weight, weight change, and risk for hypertension inwomen. Ann Intern Med 1998;128:81-88. (Class B)

Institute for Clinical Systems Improvement (ICSI). Diet programs for weight loss in adults.Technology Assessment #83, 2004. (Class R)

Institute for Clinical Systems Improvement (ICSI). Gastric restrictive surgery for morbid obesity.Technology Assessment #14 (Second Update), 2000. (Class R)

Institute for Clinical Systems Improvement (ICSI). Pharmacological approaches to weight loss inadults. Technology Assessment #71, 2003. (Class R)

Jeffery RW, Drewnowski A, Epstein LH, et al. Long-term maintenance of weight loss: currentstatus. Health Psychol 2000;19(1 Suppl):5-16. (Class R)

Jeffery RW, Sherwood NE, Brelje K, et al. Mail and phone interventions for weight loss in amanaged care setting: Weigh-To-Be one-year outcomes. Int J Obes 2003;27:1584-1592. (Class A)

Jeffery RW, Wing RR. Long-term effects of interventions for weight loss using food provision andmonetary incentives. J Consult Clin Psychol 1995;63:793-6. (Class A)

Jeffery RW, Wing RR, Sherwood NE, Tate DF. Physical activity and weight loss: doesprescribing higher physical activity goals improve outcome? Am J Clin Nutr 2003;78:684-689.(Class A)

Jeffery RW, Wing RR, Thorson C, et al. Strengthening behavioral interventions for weight loss: arandomized trial of food provision and monetary incentives. J Consult Clin Psychol 1993;61:1038-45. (Class A)

Jeffery RW, Wing RR, Thorson C, Burton LR. Use of personal trainers and financial incentives toincrease exercise in a behavioral weight-loss program. J Consult Clin Psychol 1998;66:777-83.(Class A)

Kalodner CR, DeLucia JL. The individual and combined effects of cognitive therapy and nutritioneducation as additions to a behavior modification program for weight loss. Addict Behav1991;16:255-63. (Class A)

Klem ML, Wing RR, McGuire MT, Seagle HM, & Hill JO. A descriptive study of individualssuccessful at long-term maintenance of substantial weight loss. Am J Clin Nutr 1997;66:239-246.(Class D)

Latner JD, Wilson GT, Stunkard AJ, Jackson ML. Self-help and long-term behavior therapy forobesity. Behav Res Ther 2002;40:805-812. (Class D)

Macqueen CE, Brynes AE, Frost GS. Treating obesity: can the stages of change model help predictoutcome measures? J Hum Nutr Dietet 1999;12:229-236. (Class C)

Macqueen CE, Brynes AE, Frost GS. Treating obesity: a follow-up study. Can the stages of changemodel be used as a postal screening tool? J Hum Nutr Dietet 2002;15:3-7. (Class C)


Meyers AW, Graves TJ, Whelan JP, Barclay DR. An evaluation of a television-deliveredbehavioral weight loss program: are the ratings acceptable? J Consult Clin Psychol 1996;64:172-8.(Class A)

Mokdad AH, Bowman BA, Ford ES, Vinicor F, Marks JS, Koplan JP. The continuing epidemics ofobesity and diabetes in the United States. JAMA 2001;286:1195-1200. (Class D)

Mokdad AH, Marks JS, Stroup DF, Gerberding JL. Actual causes of death in the United States,2000. JAMA 2004;291:1238-1245. (Class M)

Mokdad AH, Serdula MK, Dietz WH, Bowman BA, Marks JS, Koplan JP. The spread of theobesity epidemic in the United States, 1991-1998. JAMA 1999;282:1519-1522. (Class D)

Munsch S, Biedert E, Keller U. Evaluation of a lifestyle change programme for the treatment ofobesity in general practice. Swiss Med Wkly 2003;133:148-154. (Class A)

Must A, Spadano J, Coakley EH, Field AE, Colditz G, Dietz WH. The disease burden associatedwith overweight and obesity. JAMA 1999;282:1523-1529. (Class D)

National Heart, Lung, and Blood Institute (NHLBI) Obesity Education Initiative Expert Panel onthe Identification, Evaluation, and Treatment of Overweight and Obesity in Adults. Clinicalguidelines on the identification, evaluation, and treatment of overweight and obesity in adults:the evidence report. Washington DC: National Institutes of Health Publication Number 98-4083,1998. (Class R)

National Weight Control Registry. (Accessed July, 2004 athttp://www.lifespan.org/services/bmed/wt_loss/nwcr.) (Class not assignable)

Perri MG, McAllister DA, Gange JJ, Jordan RC, McAdoo WG, Nezu AM. Effects of four maintenanceprograms on the long-term management of obesity. J Consult Clin Psychol 1988;56:529-534. (ClassA)

Perri MG, McKelvey WF, Renjilian DA, Nezu AM, Shermer RL, Viegener BJ. Relapse preventiontraining and problem-solving therapy in the long-term management of obesity. J Consult ClinPsychol 2001;69:722-726. (Class A)

Prochaska JO, Norcross JC, Fowler JL, Follick MJ, Abrams DB. Attendance and outcome in a worksite weight control program: processes and stages of changes as process and predictor variables.Addict Behav 1992;17:35-45. (Class C)

Pronk NP, Goodman MJ, O'Connor PJ, Martinson BC. Relationship between modifiable healthrisks and short-term health care charges. JAMA 1999;282:2235-2239. (Class B)

Quesenberry CP, Caan B, Jacobson A. Obesity, health services use, and health care costs amongmembers of a health maintenance organization. Arch Intern Med 1998;158:466-472. (Class D)

Rapoport L, Clark M, Wardle J. Evaluation of a modified cognitive-behavioural programme forweight management. Int J Obes 2000;24:1726-1737. (Class A)

Renjilian DA, Perri MG, Nezu AM, McKelvey WF, Shermer RL, Anton SD. Individual versus grouptherapy for obesity: effects of matching participants to their treatment preferences. J Consult ClinPsychol 2001;69:717-721. (Class A)

Rippe JM, Price JM, Hess SA, et al. Improved psychological well-being, quality of life, andhealth practices in moderately overweight women participating in a 12-week structured weightloss program. Obes Res 1998;6:208-18. (Class A)

Rossi JS, Rossi SR, Velicer WF, Prochaska JO. Motivational readiness to control weight. InAllison DB (ed). Handbook of Assessment Methods for Eating Behaviors and Weight-RelatedProblems: Measure, Theory, and Research. Thousand Oaks, CA: SAGE Publications, 1995. (ClassR)


Sbrocco T, Nedegaard RC, Stone JM, Lewis EL. Behavioral choice treatment promotes continuingweight loss: preliminary results of a cognitive-behavioral decision-based treatment for obesity. JConsult Clin Psychol 1999;67:260-6. (Class A)

Stevens VJ, Obarzanek E, Cook NR, et al. Long-term weight loss and changes in blood pressure:results of the Trials of Hypertension Prevention, Phase II. Ann Intern Med 2001;134:1-11. (Class A)

Sturm R. The effects of obesity, smoking, and drinking on medical problems and costs. Obesityoutranks both smoking and drinking in its deleterious effects on health and health costs. HealthAff (Millwood) 2002;21:245-253. (Class D)

Sutton K, Logue E, Jarjoura D, Baughman K, Smucker W, Capers C. Assessing dietary and exercisestage of change to optimize weight loss interventions. Obes Res 2003;11:641-652. (Class C)

Tanco S, Linden W, Earle T. Well-being and morbid obesity in women: a controlled therapyevaluation. Int J Eat Disord 1998;23:325-39. (Class A)

Tate DF, Jackvony EH, Wing RR. Effects of Internet behavioral counseling on weight loss in adultsat risk for type 2 diabetes. A randomized trial. JAMA 2003;289;1833-1836. (Class A)

Tuomilehto J, Lindström J, Eriksson JG, et al. for the Finnish Diabetes Prevention Study Group.Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucosetolerance. N Engl J Med 2001;344:1343-1350. (Class A)

U.S. Department of Health and Human Services. The Surgeon General's call to action to preventand decrease overweight and obesity. Rockville, MD: U.S. Department of Health and HumanServices, Public Health Office, Office of the Surgeon General, 2001. Available atwww.surgeongeneral.gov/library. Accessed February, 2002. (Class R)

U.S. Preventive Services Task Force. Screening for obesity in adults: recommendations andrationale. Rockville, MD: Agency for Healthcare Research and Quality, 2003. Available atwww.ahrq.gov/clinic/3rduspstf/obesity/obesrr.htm. Accessed December, 2003. (Class M)

Wing RR, Jeffery RW, Burton LR, Thorson C, Nissinoff KS, Baxter JE. Food provision vs structuredmeal plans in the behavioral treatment of obesity. Int J Obes Relat Metab Disord 1996;20:56-62.(Class A)

Wing RR, Venditti E, Jakicic JM, Polley BA, Lang W. Lifestyle intervention in overweightindividuals with a family history of diabetes. Diabetes Care 1998;21:350-359. (Class A)

Wolf AM, Colditz GA. Current estimates of the economic cost of obesity in the United States. ObesRes 1998;6:97-106. (Class D)

AppendicesSee next pages


Ap

pen

dix

A:

Con

clu

sion

Gra

din

g W

ork

shee

t

Wor

k G

rou

p's

Con

clu

sion

:In

div

idua

ls e

nrol

led

in b

ehav

iora

l the

rapy

pro

gram

s w

itho

ut in

cent

ives

or

food

pro

visi

on ty

pica

llyex

peri

ence

d w

eigh

t los

ses

of 2

.5%

to 1

0% o

f bas

elin

e w

eigh

t fol

low

ing

an a

ctiv

e tr

eatm

ent p

hase

of f

rom

8 w

eeks

to 6

mon

ths.

Con

clu

sion

Gra

de:

II

Wor

k G

rou

p's

Con

clu

sion

:T

here

are

lim

ited

pos

t-tr

eatm

ent f

ollo

w-u

p d

ata

but t

he a

vaila

ble

evid

ence

sug

gest

s th

at w

eigh

t los

sm

ay b

e m

aint

aine

d o

r fu

rthe

red

at 6

to 1

2 m

onth

s fo

llow

ing

trea

tmen

t.

Con

clu

sion

Gra

de:

III

Au

thor

/Y

ear

Des

ign

Typ

eC

las

sQ

ual

-it

y+

,–,ø

Pop

ula

tion

Stu

die

d/

Sam

ple

Size

Pri

mar

y O

utco

me

Mea

sure

(s)/

Res

ults

(e.g

., p-

valu

e, c

onfi

den

ce i

nter

val,

rela

tive

ris

k, o

dd

sra

tio,

lik

elih

ood

rat

io, n

um

ber

need

ed t

otr

eat)

Aut

hors

' Con

clus

ions

/W

ork

Gro

up's

Com

men

ts (

ital

iciz

ed)

Clif

ford

, Tan

, &G

orsu

ch, 1

991

Non

-R

an-

dom

C–

-48

heal

thy

over

wei

ght f

amily

YM

CA

mem

bers

; sel

f-se

lect

edtr

eatm

ent g

roup

-6 m

onth

s tr

eatm

ent;

6 m

onth

mai

nten

ance

; mon

thly

mee

tings

duri

ng m

aint

enan

ce p

hase

-Gro

up 1

: gro

up w

elln

ess

pro-

gram

(sel

f-di

rect

ed c

hang

e ap

-p

roac

h)-G

roup

2: s

ame

as G

roup

1 p

lus

ind

ivid

ual

ses

sion

s-G

roup

3: s

ame

as G

roup

1 p

lus

peer

pro

blem

-sol

ving

sup

port

sess

ions

-Con

trol

gro

up: a

sses

smen

t onl

y

-34

of 4

8 co

mpl

eted

the

stud

y (1

0 in

gro

up 1

, 7 in

grou

p 2,

8 in

gro

up 3

, 9 c

ontr

ol);

17 m

ale,

17

fem

ale;

mea

n ag

e 48

.9 y

ears

-Tre

atm

ent g

roup

s co

mbi

ned

(no

diff

eren

ces

betw

een

grou

ps) a

nd c

ompa

red

to c

ontr

ol (a

ll p<

0.05

for

trea

tmen

t vs.

con

trol

):Tr

eatm

ent

Con

trol

% W

t L

oss

(Pos

t-tx

)-3

.8%

-0.1

%%

Wt L

oss

(6 m

o Po

st-t

x)-3

.4%

+0.

2%Sy

st B

P (P

ost-

tx)

-9.9

%+

0.4%

Syst

BP

(6 m

o Po

st-t

x)-8

.2%

-0.9

%D

iast

BP

(P

ost-

tx)

-12.

7%+

2.4%

Dia

st B

P (6

mo

Post

-tx)

-11.

8%-2

.4%

-No

chan

ge in

sta

te o

r tr

ait a

nxie

ty o

ver

tim

e fo

rtr

eatm

ent o

r co

ntro

l gro

ups

-A s

elf-

dire

cted

cha

nge

inte

rven

tion

that

in-

clud

ed s

ever

al c

ogni

tive

-beh

avio

ral t

ech-

niqu

es a

s ap

plie

d to

exe

rcis

e ad

here

nce,

wei

ght r

educ

tion/

mai

nten

ance

, and

str

ess

man

agem

ent p

rodu

ced

sign

ifica

ntly

gre

ater

impr

ovem

ent r

elat

ive

to a

con

trol

gro

up in

wei

ght a

nd b

lood

pre

ssur

e bo

th p

ost-

trea

tmen

t and

6 m

onth

s af

ter

trea

tmen

t.

Wor

k G

roup

's C

omm

ents

: 29

% d

ropp

ed o

ut o

fpr

ogra

m

Kal

odne

r &

DeL

uci

a, 1

991

RC

TA

–-6

9 su

bjec

ts; ≥

15%

mor

e th

anhi

ghes

t wei

ght f

or h

eigh

t and

fram

e si

ze-1

0 w

eek

trea

tmen

t pha

se (2

hou

rgr

oup

sess

ions

); no

mai

nten

ance

phas

e-4

gro

ups:

a) b

ehav

ior

ther

apy

(BT

) plu

s co

gnit

ive

ther

apy

(CT

),b)

BT

plu

s nu

trit

ion

educ

atio

n(N

E), c

) BT

plu

s C

T p

lus

NE,

d)

BT

onl

y

-9 m

ales

, 60

fem

ales

; 12

of 6

9 (1

7%) f

aile

d to

com

plet

eat

leas

t 6 s

essi

ons

(dro

p-ou

ts)

-Mea

n ag

e 40

.7 y

ears

-No

diff

eren

ces

betw

een

trea

tmen

t gro

ups;

ove

rall

wt

loss

-3.8

% o

f bas

elin

e w

eigh

t pos

t-tx

; -4.

5% o

f bas

e-lin

e w

eigh

t aft

er 6

mon

ths

-Phy

siol

ogic

al m

easu

res

of o

besi

ty c

hang

edsi

gnif

ican

tly o

ver

time

but n

ot b

etw

een

trea

t-m

ent c

ondi

tions

.

Wor

k G

roup

's C

omm

ents

: aut

hors

sta

te t

hat

17%

dro

pped

out

of

prog

ram

but

wei

ght

loss

anal

ysis

was

bas

ed o

n 44

par

tici

pant

s (6

4% o

fth

e 69

enr

olle

d);

anal

ysis

was

not

int

enti

on-t

o-tr

eat


Ap

pen

dix

A:

Con

clu

sion

Gra

din

g W

ork

shee

t (c

ont)

Au

thor

/Y

ear

Des

ign

Typ

eC

las

sQ

ual

-it

y+

,–,ø

Pop

ula

tion

Stu

die

d/

Sam

ple

Size

Pri

mar

y O

utc

ome

Mea

sure

(s)/

Res

ult

s (e

.g.,

p-va

lue,

con

fid

ence

int

erva

l, re

lati

ve r

isk,

od

ds

rati

o, l

ikel

ihoo

d r

atio

, nu

mbe

r ne

eded

to

trea

t)

Aut

hors

' Con

clus

ions

/W

ork

Gro

up's

Com

men

ts (

ital

iciz

ed)

Mey

ers,

Gra

ves,

Whe

-la

n, &

Bar

clay

,19

96

RC

TA

–-7

1 in

div

idu

als

at l

east

20%

over

wei

ght b

ased

on

ht/w

t; ag

es18

-60

yrs

-3 g

roup

s: a

) liv

e co

ntac

t b)

live

cont

act t

hat w

as v

ideo

tape

d, c

)vi

ewed

(at

hom

e) v

ideo

tape

grou

p, d

) con

trol

-8-w

eek

prog

ram

(cog

nitiv

e-be

havi

oral

trea

tmen

t)

-Ini

tial

71

incl

uded

6 m

ales

, 65

fem

ales

-Of 5

6 in

a tr

eatm

ent a

rm, 4

9 (8

8%) c

ompl

eted

pro

-gr

am; 3

4 co

mpl

eted

15

mon

th fo

llow

-up

-Pos

t-tr

eatm

ent %

bas

elin

e w

eigh

t cha

nge:

Liv

e co

ntac

t (n=

18):

-5.2

%*

Liv

e co

ntac

t vid

eota

ped

(n=1

3):

-5.0

%*

Hom

e vi

ewed

vid

eo (n

=14)

:-4

.8%

*C

ontr

ol (

n=11

)-0

.9%

*All

p≤0.

05 v

s. c

ontr

ol; n

o d

iffe

renc

es b

etw

een

trea

t-m

ent g

roup

s-A

t 15

mon

th fo

llow

-up,

vid

eota

ped

grou

p di

d no

tm

aint

ain

wei

ght l

oss;

oth

er tr

eatm

ent g

roup

s di

d

-Par

tici

pant

s in

all

thre

e tr

eatm

ent g

roup

slo

st s

igni

fica

ntly

mor

e w

eigh

t dur

ing

the

8-w

eek

trea

tmen

t pro

gram

than

thos

e in

the

con-

trol

gro

up.

Wor

k G

roup

's C

omm

ents

: po

st-t

reat

men

tan

alys

is b

ased

on

45 o

f 56

enr

olle

d in

tre

at-

men

t gr

oup

(80%

) an

d 11

of

15 c

ontr

ols

(73%

);an

alys

is w

as n

ot i

nten

tion

-to-

trea

t

Fulle

r, P

erri

,Le

erm

aker

s, &

Gu

yer,

199

8

RC

TA

–-1

08 i

ndiv

idu

als

20%

-100

%ov

er id

eal w

eigh

t-3

gro

ups:

a) w

eigh

t los

s ed

uca-

tion

(6 m

onth

ly le

ctur

es),

b)st

and

ard

beh

avio

ral t

reat

men

t(2

5 w

eekl

y se

ssio

ns),

c) b

ehav

-io

ral t

reat

men

t plu

s "p

erso

nal-

ized

sys

tem

of s

kill

acqu

isit

ion"

(PSA

) inc

ludi

ng m

onet

ary

rein

-fo

rcem

ent

-6 m

onth

trea

tmen

t pha

se

-Ini

tial

108

incl

uded

28

mal

es, 8

0 fe

mal

es; 2

2 (2

0%)

drop

ped

out

-Pos

t-tr

eatm

ent %

bas

elin

e w

eigh

t cha

nge:

Beh

avio

ral

tx (

n=36

)-9

.8%

*B

ehav

iora

l tx

+ P

SA (

n=33

)-8

.4%

*W

t. lo

ss e

duc

atio

n (n

=17

)-1

.7%

*Bot

h p<

0.05

vs.

wt.

loss

ed

ucat

ion

grou

p

-The

ad

dit

ion

of a

per

sona

lized

sys

tem

of

skill

acq

uisi

tion

may

no

prod

uce

bett

er o

ut-

com

e th

an s

tand

ard

beha

vior

al tr

eatm

ent.

Ed

ucat

ion

alon

e is

not

suf

fici

ent t

o pr

oduc

ew

eigh

t los

s.

Wor

k G

roup

's C

omm

ents

: 20%

dro

pped

out

;an

alys

is w

as n

ot b

y in

tent

ion-

to-t

reat

Tan

co, L

ind

on,

& E

arle

, 19

98R

CT

A–

-Wom

en w

ith B

MI≥

30kg

/m2

wit

h ≥3

pri

or u

nsuc

cess

ful a

t-te

mpt

s at

wei

ght

loss

/mai

nten

ance

; age

19+

yrs

-3 g

roup

s: a

) sta

ndar

d b

ehav

-io

ral w

t man

agem

ent (

focu

s on

die

t/ex

erci

se),

b) c

ogni

tive

trea

tmen

t (fo

cus

on b

ehav

ior,

emot

iona

l wel

l-be

ing,

act

ivit

y),

c) c

ontr

ol-8

wee

k tr

eatm

ent p

hase

; no

mai

nten

ance

pha

se

-62

enro

lled,

12

drop

ped

out d

urin

g tr

eatm

ent p

hase

and

2 fa

iled

to a

tten

d fi

nal w

eigh

t ass

essm

ent (

tota

lof

23%

did

not

com

plet

e st

udy)

-Pos

t-tr

eatm

ent %

bas

elin

e w

eigh

t cha

nge:

Beh

avio

ral g

rou

p (n

=18

)-2

.5%

*C

ogni

tive

grou

p (n

=18)

-1.6

%*

Con

trol

(n=

12)

+0.

7%*B

oth

p<0.

05 fr

om b

asel

ine

-6-m

onth

follo

w u

p w

eigh

t cha

nge:

Beh

avio

ral g

roup

(n=

9)-8

.4%

Cog

nitiv

e gr

oup

(n=1

2)-4

.4%

-Onl

y th

e co

gniti

ve g

roup

impr

oved

on

mea

sure

s of

dep

ress

ion

(by

44%

from

bas

elin

e), s

tate

anx

iety

(20%

), an

d t

rait

anx

iety

(15

%)

(all

p<

0.05

)

-Sub

ject

s in

bot

h th

e co

gniti

ve th

erap

y an

dbe

havi

oral

ther

apy

grou

ps s

how

ed m

odes

tw

eigh

t los

ses,

and

for

thos

e w

ho r

espo

nded

to r

eque

sts

for

follo

w-u

p d

ata,

the

wei

ght

loss

es w

ere

mai

ntai

ned.

Cog

nitiv

e th

erap

ygr

oup

mem

bers

sho

wed

impr

ovem

ents

in d

e-pr

essi

on a

nd a

nxie

ty w

hile

ind

ivid

uals

in th

ebe

havi

oral

ther

apy

and

con

trol

gro

ups

did

not.

Wor

k G

roup

's C

omm

ents

: 23%

dro

pped

out

;an

alys

is w

as n

ot b

y in

tent

ion-

to-t

reat


Ap

pen

dix

A:

Con

clu

sion

Gra

din

g W

ork

shee

t (c

ont)

Au

thor

/Y

ear

Des

ign

Typ

eC

las

sQ

ual

-it

y+

,–,ø

Pop

ula

tion

Stu

die

d/

Sam

ple

Size

Pri

mar

y O

utc

ome

Mea

sure

(s)/

Res

ult

s (e

.g.,

p-va

lue,

con

fid

ence

int

erva

l, re

lati

ve r

isk,

od

ds

rati

o, l

ikel

ihoo

d r

atio

, nu

mbe

r ne

eded

to

trea

t)

Aut

hors

' Con

clus

ions

/W

ork

Gro

up's

Com

men

ts (

ital

iciz

ed)

Rip

pe, P

rice

,H

ess,

et a

l.,19

98

RC

TA

–-W

omen

20%

to 5

0% a

bove

de-

sira

ble

wei

ght f

or h

eigh

t; ag

es20

-49

year

s-2

gro

ups:

a) i

nter

vent

ion

(Wei

ght W

atch

ers

Inte

rnat

iona

lpr

ogra

m o

f die

t, ex

erci

se, b

ehav

-io

r m

odifi

catio

n, p

robl

em s

olvi

ng&

cop

ing

skill

s), b

) con

trol

-12

wee

k tr

eatm

ent p

hase

-80

enro

lled

, 36

(45%

) wit

hdre

w fr

om s

tud

y-M

ean

age

36.8

yrs

-Pos

t-tr

eatm

ent %

wei

ght l

ost (

p<0.

001)

:In

terv

enti

on (n

=30)

-7.5

%C

ontr

ol (

n=14

)+

1.6%

-Tra

it a

nxie

ty im

prov

ed b

y 17

% fr

om b

asel

ine

in in

-te

rven

tion

gro

up (0

.6%

for

cont

rol g

roup

, p<0

.01)

-Blo

od p

ress

ure

chan

ges

(bot

h p<

0.02

):Sy

stol

icD

iast

olic

Inte

rven

tion

(n=3

0)-5

.5%

-5.3

%C

ontr

ol (

n=14

)-2

.5%

-2.6

%

-Pra

ctic

al w

eigh

t los

s pr

acti

ces

such

as

in-

crea

sed

act

ivit

y, s

elf-

sele

cted

hyp

erca

lori

cdi

et, a

nd g

roup

sup

port

are

eff

ectiv

e fo

rw

eigh

t los

s an

d y

ield

sig

nifi

cant

hea

lth

and

psyc

holo

gica

l ben

efits

in m

oder

atel

y ob

ese

fem

ales

.

Wor

k G

roup

's C

omm

ents

: 45%

dro

pped

out

;an

alys

is w

as n

ot b

y in

tent

ion-

to-t

reat

Sbro

cco,

Ned

e-ga

ard,

Sto

ne, &

Lew

is,

1999

RC

TA

–-W

omen

30%

to 6

0% a

bove

idea

lw

eigh

t for

med

ium

fram

e; a

ges

18to

55

year

s-2

gro

ups:

a) b

ehav

iora

l cho

ice

(dec

isio

n-m

akin

g m

odel

of f

ood

choi

ce),

b) t

rad

itio

nal b

ehav

ior

trea

tmen

t (se

lf-m

onito

ring

, stim

u-lu

s co

ntro

l, su

bsti

tuti

on)

-13

wee

k tr

eatm

ent p

hase

wit

hfo

llow

-up

mee

tings

at 3

and

6m

onth

s po

st-t

reat

men

t

-24

enro

lled

; 1 w

ithd

rew

dur

ing

tx (4

%) a

nd 2

ad

di-

tion

al p

arti

cipa

nts

wit

hdre

w d

uri

ng f

ollo

w-u

p (t

otal

of 1

3%)

-Mea

n ag

e 41

.4 y

rs-%

wei

ght l

ost (

post

-tx

and

follo

w-u

p):

Pos

t-tx

6 m

os12

mos

Beh

av. c

hoic

e-2

.8%

-7.8

%-1

1.2%

(n=

11)

Tra

dit

ion

al-6

.2%

-5.0

%-4

.8%

(n=

12)

(p<

0.01

)(p

<0.

05)

(p<

0.01

)

-The

trad

itio

nal b

ehav

iora

l the

rapy

gro

up

evid

ence

d gr

eate

r w

eigh

t los

s at

pos

t-tr

eatm

ent b

ut a

lso

evid

ence

d a

tren

d to

reg

ain

wei

ght w

here

as th

e be

havi

oral

cho

ice

grou

pco

ntin

ued

a s

low

wei

ght l

oss

dur

ing

follo

w-

up.

Wor

k G

roup

's C

omm

ents

: 4%

dro

pped

out

dur

-in

g tr

eatm

ent

phas

e, t

otal

of

13%

dur

ing

trea

tmen

t an

d fo

llow

-up

phas

es;

anal

ysis

was

not

by i

nten

tion

-to-

trea

t


Ap

pen

dix

A:

Con

clu

sion

Gra

din

g W

ork

shee

t (c

ont)

Au

thor

/Y

ear

Des

ign

Typ

eC

las

sQ

ual

-it

y+

,–,ø

Pop

ula

tion

Stu

die

d/

Sam

ple

Size

Pri

mar

y O

utc

ome

Mea

sure

(s)/

Res

ult

s (e

.g.,

p-va

lue,

con

fid

ence

int

erva

l, re

lati

ve r

isk,

od

ds

rati

o, l

ikel

ihoo

d r

atio

, nu

mbe

r ne

eded

to

trea

t)

Aut

hors

' Con

clus

ions

/W

ork

Gro

up's

Com

men

ts (

ital

iciz

ed)

Rap

opor

t,C

lark

, &W

ard

le,

2000

RC

TA

–-W

omen

; BM

I ≥28

kg/m

2 ; age

s 18

to 6

5-2

gro

ups:

a) m

odifi

ed c

ogni

tive-

beha

vior

al tr

eatm

ent f

ocus

ed o

nlif

esty

le c

hang

e (M

-CB

T),

b)st

and

ard

cog

niti

ve-b

ehav

iora

ltr

eatm

ent f

ocus

ed o

n w

eigh

t los

s(S

-CB

T)

-10

wee

k tr

eatm

ent p

hase

wit

h 1

year

fol

low

-up

-84

wom

en r

ando

miz

ed; 7

5 st

arte

d a

trea

tmen

t pro

-gr

am; 6

3 (3

1 in

M-C

BT

gro

up; 3

2 in

S-C

BT

gro

up) a

t-te

nded

at l

east

7 (o

f 10)

wee

kly

sess

ions

-Mea

n ag

e 49

yrs

in M

-CB

T g

roup

; 46

year

s in

S-C

BT

grou

p-W

eigh

t los

s10

wee

ks*

1 ye

arS-

CB

T3.

9 kg

3.6

kgM

-CB

T1.

3 kg

2.0

kg*p

=0.

001

-Bot

h M

-CB

T a

nd S

-CB

T p

rogr

ams

wer

e su

c-ce

ssfu

l at i

nduc

ing

mod

est w

eigh

t los

s as

wel

las

impr

ovin

g em

otio

nal w

ell-b

eing

, red

ucin

gd

istr

ess,

incr

easi

ng a

ctiv

ity,

impr

ovin

g d

ie-

tary

qu

alit

y, a

nd r

edu

cing

car

dio

vasc

ula

rd

isea

se r

isk

fact

ors.

Wor

k G

roup

's C

omm

ents

: 25

% w

ithd

rew

be-

fore

or

duri

ng t

reat

men

t; a

naly

sis

was

not

by

inte

ntio

n-to

-tre

at

Mun

sch,

Bie

d-

ert,

& K

elle

r,20

03

RC

TA

–-M

en a

nd w

omen

; BM

I ≥30

kg/m

2 ;-7

0 pa

tien

ts fr

om g

ener

al p

rac-

tices

ran

dom

ized

to a

) tre

atm

ent

(GP

Tx;

BA

SEL

pro

gram

), b)

con

-tr

ol (G

P c

ontr

ol) n

on-s

peci

fic

com

men

ts a

bout

wei

ght l

oss

met

hods

)-5

2 pa

tien

ts fr

om c

linic

al c

ente

rre

ceiv

ed B

ASE

L p

rogr

am (C

linic

Tx)

-16

trea

tmen

t ses

sion

s w

ith

1ye

ar f

ollo

wu

p

-Mea

n ag

e 49

in G

P T

x an

d G

P co

ntro

l gro

ups,

. 46

inC

linic

Tx

grou

p-W

eigh

t los

s:Po

st-t

reat

men

t1

year

GP

Tx

4.0%

4.7%

*G

P C

ontr

ol0.

7%0.

5%C

linic

Tx

1.6%

2.9%

*sig

nifi

cant

loss

from

bas

elin

e an

d s

igni

fica

ntly

grea

ter

loss

then

GP

Con

trol

(p<

0.00

1)

-The

pro

gram

BA

SEL

(tre

atm

ent p

rogr

am fo

rob

esity

with

mai

n em

phas

is o

n ea

ting

beha

v-io

r an

d li

fe s

tyle

cha

nges

) is

an e

ffec

tive

trea

tmen

t pro

ced

ure

for

clin

ical

pra

ctic

e.

Wor

k G

roup

's C

omm

ents

: dro

p-ou

t ra

tes

at e

ndof

tre

atm

ent

wer

e 23

%, 2

9%, a

nd 3

7% f

or G

PT

x, G

P c

ontr

ol,

and

Clin

ic T

x gr

oups

, re

spec

-ti

vely

; du

ring

1 y

ear

follo

w-u

p, d

rop-

out

rate

sw

ere

0%,

33%

, an

d 52

%,

resp

ecti

vely

; an

aly-

sis

was

not

by

inte

ntio

n-to

-tre

at


Ap

pen

dix

B:

Con

clu

sion

Gra

din

g W

ork

shee

t

Wor

k G

rou

p's

Con

clu

sion

: In

pro

gram

s in

volv

ing

ince

ntiv

es o

r fo

od p

rovi

sion

in a

dd

itio

n to

beh

avio

ral t

hera

py, i

ndiv

idua

ls ty

pica

llyex

peri

ence

d w

eigh

t los

ses

of 6

.6%

to 1

3.7%

aft

er 6

mon

ths.

In

prog

ram

s th

at a

ctiv

ely

cont

inue

d tr

eatm

ent f

or 1

8 m

onth

s, fu

rthe

rw

eigh

t los

ses

wer

e no

t obs

erve

d.

At 1

2 m

onth

s po

st-t

reat

men

t, w

eigh

t los

ses

had

bee

n re

duc

ed to

1.7

% to

8.6

% o

f ori

gina

l bod

yw

eigh

t.

Con

clu

sion

Gra

de:

II

Au

thor

/Y

ear

Des

ign

Typ

eC

las

sQ

ual

-it

y+

,–,ø

Pop

ula

tion

Stu

die

d/

Sam

ple

Size

Pri

mar

y O

utco

me

Mea

sure

(s)/

Res

ults

(e.g

., p-

valu

e, c

onfi

den

ce i

nter

val,

rela

tive

ris

k, o

dd

sra

tio,

lik

elih

ood

rat

io, n

um

ber

need

ed t

otr

eat)

Aut

hors

' Con

clus

ions

/W

ork

Gro

up's

Com

men

ts (

ital

iciz

ed)

Jeff

ery,

Win

g,T

hors

on e

t al.,

1993

Jeff

ery

& W

ing,

1995

(12

mon

thfo

llow

-up

dat

a)

RC

TA

–-M

en a

nd w

omen

14

to 3

2 kg

over

wei

ght;

ages

20-

49 y

ears

-5 g

roup

s: a

) con

trol

, b) s

tan-

dar

d b

ehav

iora

l tre

atm

ent (

SBT

),c)

SB

T p

lus

food

pro

visi

on (F

P),

d) S

BT

plu

s ca

sh in

cent

ives

(I),

e)SB

T p

lus

FP p

lus

I-1

8 m

onth

trea

tmen

t pha

se; n

om

aint

enan

ce p

hase

-101

men

and

101

wom

en e

nrol

led;

ass

essm

ents

com

-pl

eted

by

89%

at 6

mon

ths,

87%

at 1

2 m

onth

s, 8

5% a

t18

mon

ths;

79%

com

plet

ed a

ll as

sess

men

ts; 8

8% o

for

igin

al 2

02 c

ompl

eted

12

mon

th p

ost-

tx a

sses

smen

t-M

ean

age

37.5

yea

rs-C

ompa

red

grou

ps w

ith F

P to

thos

e w

ithou

t FP

(all

had

SB

T):

6 m

os12

mos

18 m

os12

mos

pos

tFP

-11.

3%-1

0.1%

-7.1

%-2

.2%

No

FP-8

.4%

-5.0

%-4

.5%

-1.7

%C

ontr

ol g

roup

- no

cha

nges

ove

r tim

e

-Pro

visi

on o

f foo

d to

wei

ght-

loss

pat

ient

s is

apr

omis

ing

met

hodo

logy

.-O

besi

ty tr

eatm

ent r

esea

rch

shou

ld fo

cus

onde

velo

ping

bet

ter

way

s to

mai

ntai

n ch

ange

sin

the

diet

and

exe

rcis

e be

havi

ors

need

ed fo

rsu

stai

ned

wei

ght l

oss.

NO

TE

: by

gro

up 7

0% o

f con

trol

gro

up, 6

5%of

SB

T g

roup

, 90%

of S

BT

+FP

grou

p, 8

5% o

fSB

T+I g

roup

, 83%

of S

BT+F

P+I g

roup

com

-pl

eted

all

asse

ssm

ents

dur

ing

trea

tmen

t pha

se;

anal

ysis

to 1

8 m

onth

s ba

sed

on

ind

ivid

uals

who

com

plet

ed a

ll as

sess

men

ts (r

esul

ts n

otfo

und

to b

e di

ffer

ent f

rom

ext

rapo

latin

g m

iss-

ing

data

for

all w

ho c

ompl

eted

18

mon

th a

s-se

ssm

ent)

Wor

k G

roup

's C

omm

ents

: A

naly

sis

was

not

inte

ntio

n-to

-tre

atW

ing,

Jeff

ery,

Bur

ton

et a

l.,19

96

RC

TA

ø-W

omen

30

to 7

0 po

unds

ove

r-w

eigh

t; ag

es 1

5 to

55

year

s-4

gro

ups:

a) s

tand

ard

beh

av-

iora

l tre

atm

ent (

SBT

), b)

SB

Tpl

us m

eal p

lans

and

gro

cery

list

s,c)

SBT

plu

s m

eal p

lans

plu

s fo

odpr

ovis

ion

(FP)

wit

h co

st s

hare

d,

d) S

BT p

lus

mea

l pla

ns p

lus

free

FP -6 m

onth

trea

tmen

t pha

se; m

ain-

tena

nce

phas

e of

fere

d to

par

tici

-pa

nts

-163

ran

dom

ized

; 148

(91%

) com

plet

ed 6

mon

th a

s-se

ssm

ent;

144

(88%

) inc

lude

d in

12

mon

th fo

llow

-up

-Mea

n ag

e 41

.2 y

ears

-% w

eigh

t los

t:Po

st tx

12 m

os p

ost

SBT

-9.3

%-3

.8%

SBT

+FP

-13.

7%-7

.9%

SBT

+sh

ared

FP

-13.

4%-8

.6%

SBT

+fr

ee F

P-1

3.5%

-7.8

%W

eigh

t los

ses

wer

e si

gnif

ican

tly

low

er fo

r SB

T g

roup

com

pare

d to

oth

er g

roup

s (p

<0.0

03 p

ost t

reat

men

t and

p<0.

02 a

t 12

mon

ths)

-Pro

vidi

ng s

truc

ture

d m

eal p

lans

and

gro

cery

lists

impr

oves

out

com

e in

a b

ehav

iora

l wei

ght

cont

rol p

rogr

am; n

o fu

rthe

r be

nefi

t is

seen

by

actu

ally

giv

ing

food

to p

atie

nts.

Wor

k G

roup

's C

omm

ents

: A

naly

sis

was

not

inte

ntio

n-to

-tre

at


Ap

pen

dix

B:

Con

clu

sion

Gra

din

g W

ork

shee

t (c

ont)

Au

thor

/Y

ear

Des

ign

Typ

eC

las

sQ

ual

-it

y+

,–,ø

Pop

ula

tion

Stu

die

d/

Sam

ple

Size

Pri

mar

y O

utco

me

Mea

sure

(s)/

Res

ults

(e.g

., p-

valu

e, c

onfi

den

ce i

nter

val,

rela

tive

ris

k, o

dd

sra

tio,

lik

elih

ood

rat

io, n

um

ber

need

ed t

otr

eat)

Aut

hors

' Con

clus

ions

/W

ork

Gro

up's

Com

men

ts (

ital

iciz

ed)

Jeff

ery,

Win

g,T

hors

on, &

Bu

rton

, 19

98

RC

TA

–-M

en a

nd w

omen

14

to 3

2 kg

over

wei

ght ,

age

s 25

to 5

5 ye

ars

-5 g

roup

s: a

) sta

ndar

d b

ehav

-io

ral t

reat

men

t (SB

T),

b) S

BT

plus

sup

ervi

sed

exe

rcis

e (S

E),

c)SB

T p

lus

SE p

lus

pers

onal

trai

ner

(PT

), d

) SB

T p

lus

SE p

lus

cash

ince

ntiv

es (I

), e)

SBT

+SE

+P

T+

I-1

8 m

onth

trea

tmen

t pha

se

-29

men

and

167

wom

en e

nrol

led;

ass

essm

ents

com

-pl

eted

by

87%

at 6

mon

ths,

78%

at 1

8 m

onth

s-M

ean

age

41.2

yea

rs-%

wei

ght l

ost:

to 6

mos

to 1

8 m

osSB

T-9

.7%

-8.9

%SB

T+

SE-6

.9%

-4.4

%SB

T+

PT

-6.6

%-3

.4%

SBT

+I

-7.6

%-5

.1%

SBT

+P

T+

I-9

.2%

-6.0

%

-The

use

of p

erso

nal t

rain

ers

and

cas

h in

cen-

tive

s in

crea

sed

att

end

ance

at s

uper

vise

dw

alki

ng s

essi

ons

but d

id n

ot e

nhan

ce lo

ng-

term

wei

ght l

oss.

It i

s lik

ely

that

the

leve

l of

exer

cise

nee

ded

for

succ

essf

ul lo

ng-t

erm

wei

ght l

oss

is m

uch

high

er th

an th

at u

sual

lyre

com

men

ded

in b

ehav

iora

l tre

atm

ent p

ro-

gram

s.

NO

TE

S: d

rop-

outs

wer

e as

ked

to r

epor

tw

eigh

t at 1

8 m

onth

s

Wor

k G

roup

's C

omm

ents

: A

naly

sis

was

not

inte

ntio

n-to

-tre

at; 1

5 of

44

gave

wei

ght

at 1

8m

onth

s bu

t an

alys

is d

id n

ot y

ield

diff

eren

t re

-su

lts

so o

nly

thos

e w

ith

mea

sure

d w

eigh

tsw

ere

incl

uded

Jeff

rey

, Win

g,Sh

erw

ood

, &T

ate,

200

3

RC

TA

–-M

en a

nd w

omen

14

to 3

2 kg

over

wei

ght;

ages

25

to 5

0 ye

ars

-2 g

roup

s: a

)sta

ndar

d b

ehav

ior

ther

apy

(SB

T),

b) h

igh

phys

ical

acti

vity

(H

PA

) as

par

t of

SB

T-1

8 m

onth

trea

tmen

t pha

se; n

om

aint

enan

ce p

hase

-202

ran

dom

ized

; 87%

of S

BT

gro

up a

nd 8

0% o

f HPA

grou

p co

mpl

eted

18

mon

th fo

llow

-up

visi

t-M

ean

age

42.2

yea

rs-W

eigh

t los

s:6

mos

12 m

os18

mos

*SB

T8.

1 kg

6.1

kg4.

1 kg

HPA

9.0

kg8.

5 kg

6.7

kg*p

=0.

04-E

nerg

y ex

pend

iture

sig

nific

antly

hig

her

in H

PAgr

oup

at 6

, 12,

and

18

mon

ths

(all

p=0.

01)

-Rec

omm

enda

tions

of h

ighe

r le

vels

of p

hysi

cal

acti

vity

(ene

rgy

expe

ndit

ure

of 2

,500

kcal

/wee

k) p

rom

ote

long

-ter

m w

eigh

t los

sbe

tter

than

do

conv

entio

nal r

ecom

men

datio

ns.

Wor

k G

roup

's C

omm

ents

: A

naly

sis

was

not

inte

ntio

n-to

-tre

at;

base

line

wei

ghts

and

per

-ce

ntag

es o

f in

itia

l w

eigh

t lo

st w

ere

not

re-

port

ed

Date post:	28-Jan-2020
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Technology Assessment Report #087 · The information contained in this ICSI Technology Assessment...

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