Rationale and design of Faith-based Approaches in theTreatment of Hypertension (FAITH), a lifestyleintervention targeting blood pressure control amongblack church membersKristie J. Lancaster, PhD, RD, a Antoinette M. Schoenthaler, EdD, b Sara A. Midberry, MPH, b
Sheldon O. Watts, PhD, MPH, c Matthew R. Nulty, MPH, RD, a Helen V. Cole, MPH, b Elizabeth Ige, BS, b
William Chaplin, PhD, d and Gbenga Ogedegbe, MD, MPHb New York, and Queens, NY; and Philadelphia, PA
Background Uncontrolled hypertension (HTN) is a significant public health problem among blacks in the United States.Despite the proven efficacy of therapeutic lifestyle change (TLC) on blood pressure (BP) reduction in clinical trials, few studieshave examined their effectiveness in church-based settings—an influential institution for health promotion in black communities.
Methods Using a cluster-randomized, 2-arm trial design, this study evaluates the effectiveness of a faith-based TLCintervention vs health education (HE) control on BP reduction among hypertensive black adults. The intervention is delivered bytrained lay health advisors through group TLC sessions plus motivational interviewing in 32 black churches. Participants in theintervention group receive 11 weekly TLC sessions targeting weight loss, increasing physical activity, fruit, vegetable and low-fat dairy intake, and decreasing fat and sodium intake, plus 3 monthly individual motivational interviewing sessions.Participants in the control group attend 11 weekly classes on HTN and other health topics delivered by health care experts. Theprimary outcome is change in BP from baseline to 6 months. Secondary outcomes include level of physical activity, percentchange in weight, and fruit and vegetable consumption at 6 months, and BP control at 9 months.
Conclusion If successful, this trial will provide an alternative and culturally appropriate model for HTN control throughevidence-based lifestyle modification delivered in churches by lay health advisors. (Am Heart J 2014;167:301-7.)
Blacks experience disproportionately higher burden ofhypertension (HTN) and cardiovascular mortality com-pared with whites.1-4 Blacks also experience greaterHTN-related complications including kidney disease andstroke.5 Hypertension explains most of the racial gap inmortality between blacks and whites.6 Fortunately,adequate blood pressure (BP) control can improvecardiovascular outcomes.7
The efficacy of lifestyle modification such as medicationadherence, increasing fruit, vegetable, and dairy intake,1,8
rom the aDepartment of Nutrition, Food Studies and Public Health, Steinhardt School ofulture, Education, and Human Development, New York University, New York, NY,Division of Health & Behavior, Department of Population Health, Center for Healthfulehavior Change, New York University School of Medicine, New York, NY, cDepartmentf Public Health, College of Health Professions and Social Work, Temple University,hiladelphia, PA, and dDepartment of Psychology, Saint John's University, Queens, NY.rial registration: www.clinicaltrials.gov no. NCT01065831.ubmitted January 22, 2013; accepted October 28, 2013.eprint requests: Kristie J. Lancaster, PhD, RD, Department of Nutrition, Food Studies andublic Health, Steinhardt School of Culture, Education, and Human Development, Nework University, 411 Lafayette St, 5th Floor, New York, NY 10003.002-8703/$ - see front matter2014, Published by Mosby, Inc.
decreasing fat and sodium consumption,8-12 increasingphysical activity,13-15 and weight loss in prevention andtreatment of HTN is well established.8,11,16-18 For exam-ple, the reduction in systolic (SBP) and diastolic (DBP) BPthat was achieved in the lifestyle intervention, DietaryApproaches to Stop Hypertension (DASH) trial,17 iscomparable with those observed in drug trials. Similarly,PREMIER demonstrated that DASH-related lifestylechanges were more effective in BP reduction than adviceonly.16 This evidence led to the recommendation oflifestyle modification as standard treatment of HTN inclinical guidelines.7,17,19 However, the proven efficacyand benefits of therapeutic lifestyle change (TLC) on BPreduction8,11,16-18,20-24 were obtained in clinical settingsunder controlled conditions.25 To have a significantpublic health impact, benefits of proven lifestyle in-terventions must be translated to community settings in aculturally sensitive and sustainable manner.The FAITH trial, which was designed for implementa-
tion in black churches, addresses this gap in the literatureby evaluating the effectiveness of an evidence-basedlifestyle intervention (delivered by lay health advisors[LHAs]) on BP reduction. Black churches are a valuable
channel for delivery of health promotion programs giventheir history of volunteerism and belief in the connectionbetween mind, body, and spirit26; their influence onhealth promotion far exceeds those of other types ofsocial organizations. In urban black communities, 65% to80% of adults attend church regularly and 55% areinvolved in church-related activities.27
Lay health advisors are especially valuable in theimplementation of church-based health programs throughtheir social networks and familiarity with key churchpersonnel, procedures, and membership.28,29 Indeed, theInstitute of Medicine regards LHAs as an importantcommunity-based resource and an influential link betweenthe health care system and the community.28 Extendingthe role of LHAs to deliver evidence-based lifestyleinterventions in high-risk populations may improve healthoutcomes among those with poor access or have amistrustof the health care system.
Study aimsThe primary goal of the FAITH trial is to evaluate the
effectiveness of a group-counseling therapeutic lifestyleintervention and motivational interviewing (MINT-TLC)delivered by LHAs vs health education (HE) on BPreduction among hypertensive black adults who attendchurches in New York City. Secondary aims includeevaluation of the effect of the intervention on changes inphysical activity, weight, and number of daily servings offruits and vegetables from baseline to 6 months, and BPcontrol at 9 months. We hypothesize that participants inchurches randomized to the MINT-TLC group will havegreater BP reduction from baseline to 6 months; greaterlevels of physical activity, weight loss, and increasedintake of fruits and vegetables from baseline to 6 months;and higher BP control at 9 months, compared withparticipants in the HE group.
MethodsStudy designFAITH is a cluster-randomized controlled trial with 2 arms:
MINT-TLC vs HE control. Thirty-two black churchesare randomly assigned equally to either the MINT-TLC or HEcontrol with data collection at baseline and at 3, 6, and9 months (Figure).
Study sites and populationThe targeted enrollment is 32 churches with 300 adults who
meet the study eligibility criteria, as follows: self-identification asblack, age ≥18 years, and having a diagnosis of HTN withuncontrolled BP (BP ≥140/90 mm Hg, or BP ≥ 130/80 mm Hgfor participants with diabetes or chronic kidney disease), asmeasured by a validated automated BP monitor (BpTRU, ModelBPM-300; VSM Medtech, Coquitlam, BC, Canada). Exclusioncriteria included non–English speaking, participation in anotherstudy, arm circumference N52 cm, cognitive impairment based on
the Comprehensive Assessment and Referral Evaluation DementiaDiagnostic Scale if age 60 years or older,30,31 unwillingness/inability to complywith study protocol, and pregnancy or plans tobecome pregnant within the next 9 months. All participantsprovide informed consent; the study was approved by theinstitutional review boards of New York University and registeredat www.clinicaltrials.gov: NCT01065831.Church recruitment. Churches are recruited in 8 co-horts of 4 churches each. Churches are identified byreferral from other churches, the FAITH staff's informalnetworks, neighborhood outreach, and health-related com-munity organizations. A Community Advisory Committee of6 leaders from participating churches provides input onrecruitment strategies.Lay health advisor recruitment. Each church leadershiprecruits 3 LHAs who have a high school degree, are activemembers of the church, able to deliver the program, andcommitted to the trial requirements.Participant recruitment. For both arms of the study, eachcohort begins with a 3-week recruitment period, during whichparticipants are recruited, consented, and screened by study staffafter church services and events. Church members are notifiedof the study through flyers, posters, announcements from thepulpit, and church bulletins. Lay health advisors also participatein recruitment.Randomization. The study statistician randomly assignseach church to either MINT-TLC or HE control based on a 2:2ratio using an online random number generator. The random-ization group for each church is kept in opaque envelopes in alocked safe away from the study sites. At the end of eachcohort's 3-week recruitment period, study staff opens theenvelopes to reveal the church assignments. Given the nature ofthe intervention, participants and study staff are not blinded tothe intervention.
Description of the MINT-TLC interventionThis intervention is based on recommended guidelines for
HTN treatment: weight loss (if overweight), regular physicalactivity, reduced sodium intake, and a low-fat diet rich in fruits,vegetables, and low-fat dairy foods.7 Participants attend eleven90-minute weekly group TLC sessions (intensive phase),followed by 3 monthly individual MINT sessions (maintenancephase), delivered by LHAs, who are trained in adult learningprinciples, behavioral counseling approaches, and the programcurriculum.32 The methodology, structure, and the content ofthe group classes incorporate elements from PREMIER16 andthe Healthy Eating and Lifestyle Program trial,33 whichwas culturally tailored for blacks. The FAITH curriculumincludes prayer, scripture, and faith-based discussion pointsrelated to health.Intensive phase. The 11 weekly group TLC sessions focus onlifestyle change including following a DASH-like eating plan,increasing physical activity, and stress reduction. The format ofthe sessions is group discussion focused on skill building andweekly goal setting, and they include activities that fosterproblem solving, social support, and program ownership. Inaddition, a “Taste It” at the beginning of each session allowsparticipants to taste a food or beverage that fits the FAITHGuidelines. Participants are encouraged to keep a daily food andactivity diary (see Table I).
Lancaster et al 303American Heart JournalVolume 167, Number 3
Maintenance phase. After the intensive phase, the LHAsconduct 3 monthly one-on-one MINT sessions with participantsto help them focus on problem solving and maintain lifestylechanges adopted in the intensive phase. Each session involvesstandard MINT techniques and lasts approximately 30 minutes.To maintain treatment fidelity, the LHAs use a standardized
counseling script patterned after our recently completed studyin the same population.34,35
Motivational interviewing training of LHAs. Layhealthadvisors participate in a 2-day training with a member of theMotivational Interviewing Network of Trainers (A.S.), to learnbasic MINT skills during which, the LHAs practice their
Table I. FAITH intervention topics
Session Content
Every session Check-inTaste ItGoal Setting
Session 1 Overview of the Program and High BPThe DASH Eating Plan and PAUsing a Food and Fitness DiarySetting Goals
Session 2 Fat and CaloriesLowering SaltLabel Reading
Session 3 Increasing Fruits, Vegetables, and Low-Fat DairyPortion ControlManaging Your Meals: Breakfast
Session 9 Recipe ModificationStaying on Track With PA
Session 10 Stocking Your KitchenMaking PA Routine and Fun!
Session 11 S.M.A.R.T. Goal SettingFinding Time for PASocial Support
Session 12 Closing Potluck
Abbreviation: PA, Physical activity.
304 Lancaster et alAmerican Heart Journal
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skills in a group setting and in individual role plays withfeedback. Lay health advisors are encouraged to use theMINT sessions to address specific barriers they encounteredduring the group sessions with study participants. The roleplays are audiotaped, and the tapes are coded to determineif the LHAs meet the minimum level of proficiency (spiritscore of 3 on the Motivational Interviewing TreatmentIntegrity scale36).
Description of the HE controlThe HE control is an attention control, designed to provide
participants with the same amount of contact as the MINT-TLCgroup. Participants in churches randomized to the HE controlgroup receive the NHLBI booklet “Your Guide to LoweringBlood Pressure” and attend eleven 90-minute group sessions ledby health experts recruited from nonprofit health organizations,the department of health, and the investigators' academicinstitutions. In the first session, participants receive patienteducation on lifestyle management of HTN, whereas theremaining sessions cover health topics unrelated to thetreatment of HTN, including lead poisoning, fire safety, healthinsurance, and Alzheimer's disease. The investigators schedulesimilar presentation topics for all cohorts.
Outcomes assessmentsThe primary outcome is change in SBP and DBP from baseline
to 6 months. Secondary outcomes include the following: intakeof fruits and vegetables, level of physical activity and weight lossat 6 months, and BP control at 9 months. Study assessments areperformed by trained research assistants) at baseline and at 3, 6,and 9 months, as shown in Table II.
Primary outcomeBlood pressure. Blood pressure is assessed with a validatedautomated digital BP monitor (BpTRU) based on American HeartAssociation guidelines.37 Six BP readings are taken with theparticipant seated comfortably for 5 minutes before measure-ment. The average of the last 5 readings is recorded.
Secondary outcomesDietary intake of fruits and vegetables is assessed using the
National Cancer Institute (NCI) Fruit and Vegetable IntakeScreener.38 It contains 14 items about fruit and vegetableconsumption that include portion size. The screener has beenvalidated with estimated intakes from the NCI Diet HistoryQuestionnaire and 24-hour recalls39 and is validated in blacks.40
Physical activity is assessed with the 7-item InternationalPhysical Activity Questionnaire,41 which measures the amountof health-related vigorous- and moderate-intensity physicalactivity, sedentary behaviors, and physical activity limitationsin adults for 7 days. The number of hours and minutes per dayparticipants spent in various types of physical activity ismultiplied by the average metabolic equivalent of each categoryand summed to calculate energy expenditure as kilocalories perkilogram per minute per week.Height and weight are measured using a stadiometer (Seca
214, Chino, CA) and a validated digital scale (WB-800S DigitalMedical Weight Scale; Tanita Corporation of America, Inc,Arlington Hts, IL) and then used to calculate participants' bodymass index.
Other assessmentsParticipant characteristics include sex, age, ethnicity, place of
birth, language spoken at home, marital status, education,employment, insurance, religious affiliation, smoking, andalcohol use. Other data collected include the NCI PercentEnergy from Fat Screener, self-efficacy and intrinsic motivationfor physical activity and fruits and vegetables, CharlsonComorbidity Index, Spiritual Locus of Control, Perceived Stress,Quality of Life (12-item Short-Form Health Survey), PatientHealth Questionnaire 8-item Depression Scale, Medical Out-comes Study Social Support Survey, Hope Scale, and MoriskyMedication Adherence Questionnaire. We also measure waistcircumference (Gulick II Tape Measure; Country Technology,Inc, Gays Mills, WI).
AnalysisSample size and power analysis. Because FAITH is acluster-randomized trial with the church as the unit ofrandomization, there are 2 important sample size estimates: N,the number of participants, and K, the number of churches. TheN participants are nested within K churches. This nestingcreates dependency in the data; the degree of which is indicated
Table II. Study measures by modality
ES BL 3M 6M 9M
Physiological measuresBP measurements X X X XHeight and weight X X X XWaist circumference X X X X
Self-report measuresDemographic characteristics XNCI percentage energy from fat screener X X XNCI fruit and vegetable intake screener X X XInternational Physical Activity Questionnaire X X XMedication adherence(Morisky Questionnaire)
X X
Diet/Physical ActivitySelf-Efficacy Questionnaire
X X X
Intrinsic motivation for fruit/vegetableintake and physical activity
X X X
Medical comorbidity (CharlsonComorbidity Index)
X X
Spiritual locus of control X XPerceived Stress Scale X X XMedical Outcomes Study SocialSupport Survey
X X X
Quality of Life (12-item Short-FormHealth Survey)
X X
Patient Health Questionnaire8-Item Depression Scale
X X
The Hope Scale X X
Abbreviations: BL, Baseline; ES, eligibility screen; M, months.
Lancaster et al 305American Heart JournalVolume 167, Number 3
by the intraclass correlation (ICC) and requires an increase inthe sample size to maintain the same level of power as would beavailable if the unit of randomization was individual participants.Estimates from the literature and our previous studies suggest amoderate to large (d = 0.50-0.80) effect size for this intervention,an average of between 15 and 20 participants/church (clustersize, or CS), and an ICC of between 0.02 and 0.05. Thehypothesized moderate effect size reflects a difference in thechange (pre-post) in BP of half an SD in SBP between the 2groups. Assuming an SD of SBP change of 12 mm Hg, this wouldmean a change in SBP in the control group, that is, 6 mm Hg lessthan the change in the treatment group. For DBP with an SD of8 mm Hg, the difference in change would be 4 mm Hg. Ourprimary analysis will be on a linear combination of SBP and DBP,which should have greater power owing to the increasedreliability of the linear combination. If we set our α level at .05 (2tailed), our desired power at 0.90, we obtain the estimates of thetotal number of churches (K) needed for the study (see TableIII). The total N is obtained by multiplying CS × K.Based on these assumptions and calculations, we established
recruitment goals of 20 churches (10 per arm)with 15participantsper church. This yields a sample size of 15 × 20 = 300 participants(150/group). After recruitment began, it became clear that wewould likely not recruit an average CS of 15/church; thus, weincreased the target church enrollment to 32, with 10 to 11participants per church. This change increases our statisticalpower substantially to near 0.99 because increasing clusters has asubstantial beneficial effect on power in cluster-randomizeddesigns that offsets the reduced sample size per church.42
Analysis of the primary aimA multilevel analysis with an unstructured covariance matrix
will test the primary hypothesis that those assigned to MINT-TLCwill, on average, exhibit greater reduction in SBP and DBP thanthose assigned to the HE group. This analysis will have 1 within-person factor (time; coded continuously across the 6 months)and 1 dummy-coded between-person factor (treatment group).The primary outcome measure in this analysis will be a linearcombination of SBP and DBP, specifically mean arterial pressure.A significant effect of treatment on change in mean arterialpressure will be followed by separate evaluations of the effect oftreatment on SBP and DBP. In addition, participants will benested within churches creating a 3-level analytic model(observations nested within participants nested withinchurches). Multilevel modeling software (SAS, version 9,PROC MIXED; Cary, NC)43 will be used to compute full-information maximum likelihood estimates of the modelparameters. The PROC MIXED procedure will use an errorstructure that allows for the possibility of group differences in(a) the error variances at follow-up and (b) the serialcorrelations of baseline BP with 3- and 6-month BP. TheKenward-Rogers method will be used to calculate the errordegrees of freedom. The primary test concerns the group × timeinteraction, and the resulting F test will provide the primary“intent-to-treat” test of the hypothesis. Because our primaryanalysis is intent to treat, all randomized participants will beanalyzed, including those lost to follow-up. If this is statisticallysignificant at the 2-tailed α = .05 level, the magnitude of thetreatment effect will be estimated and reported, with 95% CI,separately for SBP and DBP. Randomization of churches totreatment arm and the absence of significant selection and/or
attrition biases should obviate the need for any covariates in theanalysis. However, in the event that probit analyses indicateeither selection bias or attrition bias, the predicted values ofthose analyses will be included as covariates in the multivariateanalysis of variance (including their interactions with the within-person factors).
This trial is supported by National Institutes of Health GrantR01 HL092860. The authors are solely responsible for the designand conduct of this study, all analyses, the drafting and editing ofthe manuscript, and its final contents.
DiscussionThe FAITH trial offers a unique opportunity to assess
the effect of a church-based lifestyle intervention,delivered by trained LHAs on BP reduction in a high-riskpopulation. The concept of evaluating the effectivenessof well-proven efficacious lifestyle interventions incommunity-based settings using a collaborative partner-ship approach is innovative and can facilitate thetranslation of research into public health practice. Moreimportantly, FAITH is the first study, to our knowledge, totrain LHAs to promote lifestyle modification for BPreduction through group and individual MINT sessions.Training LHAs to incorporate MINT skills into both thegroup and individual sessions enables participants toexplore their perceived barriers toward behavior change,develop the motivation and confidence to change, and
Table III. Number of churches for different combinations of effectsizes (ES; 0.50 or 0.80), CSs (15 or 20 participants/church), andICCs (0.02 or 0.05) for a power of 0.90 and a 2-tailed α of .05
ES ICC
CS
15 20
0.50 0.02 16 120.05 20 18
0.80 0.02 6 60.05 8 8
306 Lancaster et alAmerican Heart Journal
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make a commitment to such change.44 If successful, thefindings from this study will provide much-neededinformation on the translation and sustainability ofthese approaches in church-based settings with potentialfor dissemination to other black churches. Findings fromour study will be generalizable to only black churcheswith similar demographic characteristics.
Lessons learnedIn implementing FAITH, we have learned a number of
positive and challenging lessons. Lay health advisorsreport that the Leader's Guide greatly facilitates theirability to lead the classes. Previous studies have foundsome churches hesitant to participate when there is nointervention in the control group. For this reason, wedesigned an attention control HE group, which is wellreceived by participants. Incorporating basic MINTprinciples into the training for the group curriculumand reinforcing them during weekly calls increases theLHAs' comfort with the skills before the intensive MINTtraining for the individual sessions. In addition, processevaluations showed that participants enjoy the sessions.We experienced major challenges in recruitment of
churches and participants. Although many churches areinterested in health promotion, identifying and reachingthe decision makers in churches proves difficult. Evenafter making connections, timely recruitment does notalways happen. Barriers to timely church recruitmentinclude competing priorities of church contacts and acrowded church schedule that result in delayed or missedmeetings, misunderstandings about the program and itsrequirements, and changes in church leadership. For thisreason, we have had to recruit some churches withsmaller congregations, resulting in smaller group sizes. Inaddition, once church commitment is obtained, it is oftendifficult to identify members who possess the requiredlevel of commitment to serve as an LHA. Finally, buy-infrom church leadership and LHAs is critical for partici-pant recruitment. For successful recruitment, LHAs and/or church leaders must actively promote the programbefore and during the recruitment period, which did notconsistently occur across churches. In addition, somepotential participants were not willing or able to devotethe time required for the group sessions.
Trial statusThe FAITH trial began in November 2010. As of
September 2013, we have randomized a total of 32churches with 373 participants, of which 172 are in theMINT-TLC group and 201 in the HE control group.Participant recruitment was completed in September2013, with final follow-up planned for April 2014.
AcknowledgementsThe authors would like to thank the FAITH staff Jessica
Forsyth, PhD; Amanda Hoyte, BS; Lindsey Smith, MPH;Meher Singh, BS; Adetutu Adekoya, BA; and Jamillah Hoy-Rosas, MPH, RD, for their work on the project. They alsoacknowledge Mark Butler and Mary Jane Ojie at SaintJohn's University for their biostatistical support of thisproject, as well as several other support staff.
DisclosuresThis work was supported by Grant R01HL092860 from
the National Institutes of Health (principal investigators:Ogedegbe and Lancaster). The funding organizationplayed no role in the study conception, design andwriting of the manuscript, or decision to submit themanuscript for publication.
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