Healthy Living Partnerships to Prevent Diabetes: A Community Translation …€¦ · ·...

Healthy Living Partnerships to

Prevent Diabetes: A Community

Translation of the Diabetes

Prevention Program.

David C. Goff, Jr., MD, PhD

Dean and Professor

Colorado School of Public Health

Credits and Disclosures

Co-Investigators: Jeffrey Katula, Jorge Calles, Mark Espeland, Michael Lawlor, Tim Morgan, Carolyn Pedley, Mara Vitolins

Staff: Caroline Blackwell, Kara Foster, Scott Isom, Alexander Lucas, Eileen Searson, Wesley Roberson, Erica Rosenberger, Terry Tembreull.

Wake Forest University & Wake Forest University School of Medicine

NIDDK R18 DK069901

Goff CME presentation at a symposium in Sweden funded by Merck

DSMB member for trial funded by Takeda

Objectives

Review the evidence base regarding

diabetes prevention

Present the HELP PD study as an example

of implementation research moving into

dissemination research

Save time for discussion of D&I research

and DIRH study section

Diabetes: The American Population

Prevalence of diagnosed and undiagnosed diabetes in the United States, all ages, 2007

Total: 23.6 million people or 7.8% of the population have diabetes.

Diagnosed: 17.9 million people

Undiagnosed: 5.7 million people

2007 National Diabetes Fact Sheet.

http://www.cdc.gov/diabetes/pubs/estimates07.htm#1

Consequences of Diabetes Damage to nerves and blood vessels, which

leads to:

heart disease heart attacks

chronic heart failure

stroke

blindness

kidney disease, including dialysis

nerve problems

amputation

gum infections

What is Pre-Diabetes?

Blood glucose levels higher than normal but not high enough to be diagnosed as diabetes

Fasting plasma glucose between 100-125 mg/dL

High risk for type 2 diabetes within 10 years (~10% per year).

~57 million people in the US

http://www.diabetes.org/diabetes-basics/prevention/pre-diabetes/

CDC’s Division of Diabetes Translation. National Diabetes Surveillance System

available at http://www.cdc.gov/diabetes/statistics

Obesity (BMI≥30) Diabetes

<4.5% Missing data

4.5 - 5.9% 6.0 - 7.4%

7.5 - 8.9% ≥9.0% 18.0 -21.9%

<14.0% Missing Data

14.0 - 17.9%

22.0 - 25.9% ≥26.0%

Age-adjusted Percentage of U.S. Adults Who Were Obese or

Who Had Diagnosed Diabetes

1994




<4.5% Missing data

4.5 - 5.9% 6.0 - 7.4%

7.5 - 8.9% ≥9.0% 18.0 -21.9%

<14.0% Missing Data

14.0 - 17.9%

22.0 - 25.9% ≥26.0%



1995




<4.5% Missing data

4.5 - 5.9% 6.0 - 7.4%

7.5 - 8.9% ≥9.0% 18.0 -21.9%

<14.0% Missing Data

14.0 - 17.9%

22.0 - 25.9% ≥26.0%



1996




<4.5% Missing data

4.5 - 5.9% 6.0 - 7.4%

7.5 - 8.9% ≥9.0% 18.0 -21.9%

<14.0% Missing Data

14.0 - 17.9%

22.0 - 25.9% ≥26.0%



1997




<4.5% Missing data

4.5 - 5.9% 6.0 - 7.4%

7.5 - 8.9% ≥9.0% 18.0 -21.9%

<14.0% Missing Data

14.0 - 17.9%

22.0 - 25.9% ≥26.0%



1998




<4.5% Missing data

4.5 - 5.9% 6.0 - 7.4%

7.5 - 8.9% ≥9.0% 18.0 -21.9%

<14.0% Missing Data

14.0 - 17.9%

22.0 - 25.9% ≥26.0%



1999




<4.5% Missing data

4.5 - 5.9% 6.0 - 7.4%

7.5 - 8.9% ≥9.0% 18.0 -21.9%

<14.0% Missing Data

14.0 - 17.9%

22.0 - 25.9% ≥26.0%



2000




<4.5% Missing data

4.5 - 5.9% 6.0 - 7.4%

7.5 - 8.9% ≥9.0% 18.0 -21.9%

<14.0% Missing Data

14.0 - 17.9%

22.0 - 25.9% ≥26.0%



2001




<4.5% Missing data

4.5 - 5.9% 6.0 - 7.4%

7.5 - 8.9% ≥9.0% 18.0 -21.9%

<14.0% Missing Data

14.0 - 17.9%

22.0 - 25.9% ≥26.0%



2002




<4.5% Missing data

4.5 - 5.9% 6.0 - 7.4%

7.5 - 8.9% ≥9.0% 18.0 -21.9%

<14.0% Missing Data

14.0 - 17.9%

22.0 - 25.9% ≥26.0%



2003




<4.5% Missing data

4.5 - 5.9% 6.0 - 7.4%

7.5 - 8.9% ≥9.0% 18.0 -21.9%

<14.0% Missing Data

14.0 - 17.9%

22.0 - 25.9% ≥26.0%



2004




<4.5% Missing data

4.5 - 5.9% 6.0 - 7.4%

7.5 - 8.9% ≥9.0% 18.0 -21.9%

<14.0% Missing Data

14.0 - 17.9%

22.0 - 25.9% ≥26.0%



2005




<4.5% Missing data

4.5 - 5.9% 6.0 - 7.4%

7.5 - 8.9% ≥9.0% 18.0 -21.9%

<14.0% Missing Data

14.0 - 17.9%

22.0 - 25.9% ≥26.0%



2006




<4.5% Missing data

4.5 - 5.9% 6.0 - 7.4%

7.5 - 8.9% ≥9.0% 18.0 -21.9%

<14.0% Missing Data

14.0 - 17.9%

22.0 - 25.9% ≥26.0%



2007




<4.5% Missing data

4.5 - 5.9% 6.0 - 7.4%

7.5 - 8.9% ≥9.0% 18.0 -21.9%

<14.0% Missing Data

14.0 - 17.9%

22.0 - 25.9% ≥26.0%



2008



Obesity (BMI≥30 kg/m2) Diabetes

<4.5% Missing data

4.5 - 5.9% 6.0 - 7.4%

7.5 - 8.9% ≥9.0% 18.0 -21.9%

<14.0% Missing Data

14.0 - 17.9%

22.0 - 25.9% ≥26.0%



2009

23

What has lead to diabetes epidemic?

Overweight

Obesity

Physical Inactivity

Poor eating habits

Diabetes Prevention

Current research shows that these lifestyle

changes can help prevent or delay

diabetes:

• Physical activity (30 minutes a day,

at least 5 days per week)

• Nutrition (low fat, low calorie)

• PA + healthy diet = weight loss

Evidence Base on Diabetes

Prevention for HELP PD

Finnish Diabetes Prevention Study

Diabetes Prevention Program


522 overweight people with IGT

Interventions Diet and exercise (reduce weight 5%)

○ Low fat (< 30%kcal)

○ High fiber diet (>/= 15 g/ 1000 kcal)

○ 30 minutes moderate physical activity/day

Usual Care ○ Brochure

Tuomilehto J, et al. NEJM 2001;344:1343-1350.


Diet and exercise Nutritionist

○ 7 sessions in first year

○ Quarterly thereafter

Individual guidance on activity: walking, jogging, swimming, skiing, etc.

Supervised, progressive, individually tailored, circuit type resistance training ○ (50-85% across clinics)


Finnish Diabetes Prevention Study: Success in

Achieving the Goals of the Intervention by One

Year.

Goal Intervention Group (%)

Control Group (%)

P value

Weight reduction > 5%

43 13 0.001

Fat intake < 30% energy

47 26 0.001

SFA intake < 10% energy

26 11 0.001

Fiber inatke > 15 g/1000 kcal

25 12 0.001

Exercise > 4 hr/wk

86 71 0.001




RR = 0.4, P < 0.001

0

20

40

60

80

Control (n=250) Diet intervention (n=256)

Inc

ide

nc

e o

f d

iab

ete

s

(ca

se

s/1

00

0 p

ers

on

-ye

ars

)

Tuomilehto et al. N Engl J Med. 2001;344:1343.

58%

The Finnish Diabetes Prevention

Study: Lifestyle Modifications

US Diabetes Prevention Program

3,234 people with IGT

Interventions Diet and exercise (reduce weight 7%, via low fat

diet and 150 minutes of exercise/week)

Metformin (850 mg bid)

Usual Care plus placebo, 10% developed DM per year

Troglitazone arm stopped due to liver toxicity

DPP. NEJM 2002;346:393-403.

US Diabetes Prevention Program

Diet and exercise 16 lesson curriculum: diet, exercise, behavior

modification

Case managers ○ One-on-one for 24 weeks

○ Subsequent monthly sessions (group and individual)

DPP. NEJM 2002;346:393-403.

Diabetes Prevention Program:

Achievement of Study Goals

Average follow-up of 2.8 years

Goal % Achieving Goal

Lifestyle modifications Week 24 Last visit

Weight loss 7% 50% 38%

Physical activity 150 74% 58%

(min/wk)

Pharmacologic intervention Placebo Metformin

Compliance 80% 77% 72%

Full dose 2 tablets/d 97% 84%

DPP. NEJM 2002;346:393-403.

DPP: Weight Change

DPP. NEJM 2002;346:393-403.

DPP: Activity Change

DPP. NEJM 2002;346:393-403.

DPP: Incidence of DM

DPP. NEJM 2002;346:393-403.

Diabetes Prevention Program:

Progression to Type 2 Diabetes

0

2

4

6

8

10

12

Placebo Metformin Intensive

lifestyle

Ca

se

s/1

00

pe

rso

n-y

ea

rs

Average follow-up of 2.8 years

31%*

58%*

*All pairwise comparisons significantly different by

group; sequential log-rank test.

DPP. NEJM 2002;346:393-403.

Conclusions

Physical inactivity, poor diet and obesity increase the risk of DM.

Interventions to reduce adiposity via increased physical activity and dietary changes reduce risk of DM.

Translation into the community a major challenge.

Diabetes Prevention & Translation Studies

Author Year Study N

Treatment condition and

setting

Comparison

Condition Follow-up

Weight loss

Effect

Glucose

Effect

Tuomilehto 2001 FDPS 522 Individualized counseling

Dietary

Information 3.2 years -4.2 kg (4.7%) -5 mg/dl

Knowler 2002 DPP 3234

Individual lifestyle

modification program,

metformin Placebo 2.8 years -4.5 kg (4.9%) -4 mg/dl

Boltri 2008

Diabetes

Prevention in a

Faith-based

setting 26 Group-based, churches NA 6, 12 months -5.6 lb, -1.0 lb -6.4 mg/dl

Ackerman 2008 DEPLOY 92 Group-based, YMCA

Brief

counseling 6, 12 months -6%, -2%

-0.1%

HbA1c,

NS

McBride 2008 ALL 37

Group-based, cardiac

rehabilitation NA 3, 12 months

-5.0 kg, -4.3

kg NR

Kramer 2009

Group Lifestyle

Balance 93

Group-based, primary

care NA 3, 12 months -4.9%, -4.5%

-1.5 mg/dl

NS

Whittemore 2009 DPP NP 58

Group-based, nurse

practitioners

Enhanced

standard

care 9.3 months

25% lost 5%

weight vs

11% NR

McTigue 2009 WiLLoW 166


care NA 10-14 months -5.19 kg NR

Amundson 2009

MT Diabetes

Control

Program 355

Group-based, health-care

facilities NA 4 months -6.7 kg (6.7%) NR

HELP PD Design Randomized trial of a community based translation of DPP

Testing a group-based behavioral lifestyle change strategy for weight loss and diabetes prevention versus usual care

Fasting glucose is the primary outcome

Delivered via local DCC with RD’s and Community Health Workers (CHWs)

301 overweight or obese persons (BMI 25-40) with pre-diabetes (glucose 95-125)

Participants receive health evaluations every 6 months at the GCRC

Initial participation in the study lasts for two years

Extended follow-up has been funded

Katula J. et al. Contemp Clin Trials. 2009 Sep 13. PMID: 19758580.

HELP PD Interventions Participants randomized into two groups:

Lifestyle Weight loss (LWL)

3 sessions with a registered dietitian during the first 6 months

Group meetings led by lay CHWs focused on weight loss, physical activity, and nutrition

○ One per week for 6 month intensive phase

○ Monthly thereafter for 18 month maintenance phase

Enhanced Usual Care (EUC)

2 sessions with a registered dietitian during the first 3 months

Monthly newsletters about community resources for weight loss


Lifestyle Weight Loss Intervention Located in ADA-recognized DM education program

Managed by RD/CDEs trained by the research team

Delivered by lay CHWs, trained by the RD/CDEs and

further supported by DVDs

Patients with DM who had completed DM education, made lifestyle

change and judged to have personality/competency to lead groups

Supported by the research team that includes dietitians,

exercise physiologist, behavioral specialist, physicians

Intervention goals (intensive phase)

Deficit of 500-1000 calories per day

Increase to at least 180 minutes per week (usually brisk walking)

1-2 pounds lost per week

7% weight loss

42


Participant Characteristics

Variable N (%) or Mean +/- SD

Number 301

Gender

Male 128 (42.5%)

Female 173 (57.5%)

Race

African American 74 (24.6%)

White 222 (73.8%)

Other 5 (1.6%)

Age (yrs) 57.8 +/- 9.5

Weight (kg) 94.1 +/- 15.6

BMI (kg/m2) 32.8 +/- 4.0

Glucose (mg/dl) 105.5 +/- 11.3

Insulin (μU/ml) 16.7 +/- 9.8

HOMA IR 4.4 +/- 2.9

Clinical Follow-up

Visit Usual Care Lifestyle

Baseline 150 151

Month 6 141 (94%) 139 (92%)

Month 12 138 (92%) 135 (89%)

Month 18 132 (88%) 125 (83%)

Month 24 134 (89%) 127 (84%)

Intervention Adherence

Interval # visits

planned

Attended

session

N (%)

Made up

session

N (%)

Missed

session

N (%)

Phase 1

(Months 1-6)

3624 2615 (72.2) 561 (15.5) 448 (12.4)

Phase 2

(Months 7-24)

2718 1098 (40.4) 622 (22.9) 998 (36.7)

Total 6342 3713 (58.6) 1183 (18.7) 1446 (22.8)

45

Katula JA, at al. Am J Prev Med. 2013 Apr;44(4 Suppl

4):S324-32. doi: 10.1016/j. PubMed PMID: 23498294.

Body Weight: 24 months

46

Baseline to 12

month change:

LWL: -7.1 kg

EUC: -1.5 kg

p<0.001

Baseline to 24

month change:

LWL: -5.34 kg

EUC: -1.16 kg

p<0.001



Percent Weight Loss: 24 months

47

Baseline to 12

month change:

LWL: -7.3%

EUC: -1.4%

p<0.001

Baseline to 24

month change:

LWL: -5.1%

EUC: -0.6%

p<0.001



Fasting Blood Glucose: 24 months

48

Baseline to 12

month change:

LWL: -4.2 mg/dl

EUC: -0.3 mg/dl

p = 0.002

Baseline to 24

month change:

LWL: -2.2 mg/dl

EUC: 2.1 mg/dl

p = 0.002



Adverse Events and Incident Diabetes

Lifestyle Weight

Loss

Usual Care P value

Adverse Events

Month 6 7 13 0.21

Month 12 11 15 0.46

Serious Adverse

Events

Month 6 3 5 0.51

Month 12 5 5 0.98

Diabetes*

Month 6 2 5 0.29

Month 12 2 7 0.12

*Fasting glucose > 126 or using diabetes medications at visit

P-values are based on a Poisson regression model using the #

of events as the outcome and testing the difference between

randomization groups at months 6 and 12 independently.

HELP Prevent Diabetes Excellent weight loss, greater than 7% during first year

and 5% at 2 years, with decrease in waist size, ~5cm.

Meaningful net reduction in glucose (4 mg/dl).

Low frequency of AEs, SAEs, and incident DM.

All achieved with lay community health workers and

community based systems with high potential for

dissemination.

Dissemination Aspects:

Community Health Workers (CHWs),

Diabetes Care Centers (DCCs), and

NC HELP PD

Community Health Workers

11 originally recruited • 1 did not complete training

• 2 completed training but did not complete 24 month intervention

• 8 remaining after 24 months

Of remaining 8: • 3 led one group each

• 5 led two groups each

CHWs were willing to fill in for each other when necessary

Community Health Workers

Demographics (of 10 who completed training)

All had DM and had completed diabetes education

Sex: 2 male, 8 female

Age: mean 57.2 yrs (47-74, at time of enrollment)

Education: 8 beyond HS, 3 more than college

Marital Status: 7 married, 2 divorced, 1 widow

Race: 7 Black, 3 White

7 currently employed (other than as a CHW)

CHW Time and Compensation

CHWs contributed approximately 10

hours per week during Intensive Phase,

and between 10 and 20 hours per month

during Maintenance Phase

CHWs compensated $100/week during

Intensive Phase and $200/month during

Maintenance Phase

Diabetes Care Centers (DCCs)

We surveyed all ADA recognized DCCs

in NC and a sample nationally (n = 87).

Over 95% reported they had the

personnel, space, and technology

needed to implement this program.

Also had significant capacity and

interest.

NC HELP PD Goals

56

Overarching Goal: Reduce incidence, burden, and health disparities associated

with diabetes by implementing diabetes prevention programs throughout NC

Phase 1 Establish collaborative partnership

Identify and recruit patients at-risk for diabetes (prediabetes)

Implement Diabetes Prevention Program ○ 12-months

○ Increase physical activity, reduce caloric intake

○ Induce 7% weight loss at 12 months

○ Reduce fasting blood glucose (-3 mg/dl) at 12 months

○ Collect data

Prepare for Phase 2 (Expand reach and access through CHWs)

Organizational Structure

57

NCHELP PD: Phase 1

Train staff (RDs, CDEs)

Conduct 12-month demonstration

project

Weight loss intervention delivered by center

staff

Participants with prediabetes

Evaluation: changes in weight, CVD risk

Earn CDC Diabetes Prevention Program

Recognition for each center

58

NCHELP PD: Phase 2

Include Community Health Workers

Center staff train CHWs

CHWs lead weight loss groups

Program evaluation

59

Role of County Health Departments

Dedicate staff time to project

Receive training

Recruit participants

Conduct weight loss groups

Manage participants/monitor program

Collect data

Communicate with Coordinating Center

(WFSM)/Monthly conference calls

60

Role of Coordinating Center

Funding

Provide technical assistance and training

On-going support

Facilitate communication between health

departments

Monitor program

Program evaluation

61

Staff Training

Recruiting participants

Intervention materials

Group Facilitation

Managing participants

Individual visits

Data collection

Approximately 16 hours

CE offered

Held in March 2012, Winston-Salem, NC

62

Participant Recruitment

Target Prediabetes

○ Risk assessment questionnaire (from CDC)

○ Blood-based diagnostic test within the last year for at least 50% of participants enrolled:

Fasting plasma glucose 100-125 mg/dL

OGTT 140-199 mg/dL

HbA1c of 5.7-6.4%

Self-reported history of GDM (no time limit)

No contraindications for weight loss or exercise

• Simplification of criteria used in HELP PD study for program implementation

63

Monitoring the Intervention

Body weight

Attendance

Data entered into web-based system

Reviewed by Coordinating Center

Reviewed with sites monthly

Problem-solving approach

64

Program evaluation

Baseline, 6-months, 12-months

Key Measures

Taken at clinic

Body Weight

Fasting glucose

BMI

Blood pressure

65

Progress to Date

82 participants enrolled at 5 sites 84% female

28% minority

Mean age: 45 years

Mean BMI: 36.3 kg/m2

Groups began in June-July 2012

Mean weight loss across all participants at all sites is currently 13 lbs (-5.9%) at 9 months (6-month intensive phase completed, 3 months maintenance)

Lifestyle Management of Pre-Diabetes Obesity epidemic fueling epidemics of diabetes,

metabolic syndrome and pre-diabetes. Threatening progress to prevent heart disease, stroke

and other conditions.

Diabetes preventable through lifestyle change to promote weight loss.

Professional and CHW approaches effective.

A Diabetes Prevention Training Center could disseminate strategy widely and rapidly to DM education programs.

We really need food and activity policy and environmental change.

D&I critique of HELP PD initiative

Demonstration project aspects, but

theoretical frameworks for D&I

incorporated.

Absence of testing potential alternative

models for implementation or

dissemination.

Process evaluation key for generating

more generalizable knowledge

regarding D&I science.

Diabetes Prevention & Translation Studies

Author Year Study N

Treatment condition and

setting

Comparison

Condition Follow-up

Weight loss

Effect

Glucose

Effect

Tuomilehto 2001 FDPS 522 Individualized counseling

Dietary

Information 3.2 years -4.2 kg (4.7%) -5 mg/dl

Knowler 2002 DPP 3234

Individual lifestyle

modification program,

metformin Placebo 2.8 years -4.5 kg (4.9%) -4 mg/dl

Boltri 2008

Diabetes

Prevention in a

Faith-based

setting 26 Group-based, churches NA 6, 12 months -5.6 lb, -1.0 lb -6.4 mg/dl

Ackerman 2008 DEPLOY 92 Group-based, YMCA

Brief

counseling 6, 12 months -6%, -2%

-0.1%

HbA1c,

NS

McBride 2008 ALL 37

Group-based, cardiac

rehabilitation NA 3, 12 months

-5.0 kg, -4.3

kg NR

Kramer 2009

Group Lifestyle

Balance 93


care NA 3, 12 months -4.9%, -4.5%

-1.5 mg/dl

NS

Whittemore 2009 DPP NP 58

Group-based, nurse

practitioners

Enhanced

standard

care 9.3 months

25% lost 5%

weight vs

11% NR

McTigue 2009 WiLLoW 166


care NA 10-14 months -5.19 kg NR

Amundson 2009

MT Diabetes

Control

Program 355

Group-based, health-care

facilities NA 4 months -6.7 kg (6.7%) NR

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