1. Prevention of Diabetes in African American Communities: Project PROUD Community Trevor Hart, Betty Kennedy, Susan Peterson, Guido Urizar, Ben Van Voorhees, and Ken Ward

2. Background  African Americans (AA’s) have a greater incidence of diabetes compared to Whites  AA’s suffer diabetes complications disproportionately relative to Whites:  CV disease (heart attacks, stroke)  Diabetic retinopathy (blindness)  Diabetic nephropathy (kidney failure)  Peripheral vascular disease (amputations)  Lifestyle interventions delay diabetes onset

3. Limitations of the DPP Study  Suggested efficacy in AA’s based on exploratory post-hoc analyses  DPP lifestyle intervention was an intensive high-cost medical model delivered by professional staff  Design not specifically targeted for AA’s at high risk for diabetes  In current form, may not be feasible in many AA communities

4. Primary Study Question We hypothesize that a culturally- appropriate community implementation model (Project PROUD) will reduce the incidence of Type II Diabetes Mellitus (DM) relative to standard care

5. Secondary Study Question We hypothesize that Project PROUD is cost effective when savings in long term medical costs are included ($50,000/quality adjusted life year)

6. Recruitment  Community-based recruitment conducted  Six study centers  Detroit  New Orleans  Memphis  Oakland  Houston  Chicago

7. Study Population Inclusion criteria:  African American adults  Age > 25 years  Plasma glucose  2 hour glucose 140-199 mg/dl (7.8 – 11.1 mmol/L) and  Fasting glucose 95-125 mg/dl (5.3 – 7.0 mmol/L)  Body Mass Index (BMI) > 24 kg/m 2

8. Study Population Exclusion criteria:  Other member in household enrolled  Type I or II diabetes  Taking medications that alter glucose tolerance  Illness that could seriously reduce life expectancy

9. Sample Size Assumptions  Effect sizes  Based on our pilot data, we predict a 30% reduction in diabetes incidence in AA’s randomized in Project PROUD relative to standard care  Incidence of 12.1% in standard care group

10. Screening and Recruitment Step 1 screening Step 2 OGTT Step 3 start run-in Step 5 randomization Number of participants 160,000 30,000 4,800 4,00 0 3,260* Step 4 end run-in

11. Randomization  Stratified randomization by study center  Sample size 1630 in each arm of the study = 3260  Project PROUD (community implementation of DPP)  Control (standard care)

12. Design and Protocol Project PROUD (n=1630) Standard Care (n=1630) Baseline Year 1 Year 3 Year 5 Year 4 Year 2 Year 6

13. Outcome Measures  Primary Outcome  Diabetes diagnosis (assessed annually)  Secondary Outcome  Physical Activity Level  Usual caloric intake  Body Mass Index (BMI)  HbA1c  All measures will be administered on the same schedules to both groups

14. Key Aspects of Project PROUD  Weight loss and physical activity goals  Lifestyle coaches  Intensive, ongoing intervention  Core curriculum  Supervised exercise sessions  Maintenance program

15. ComponentDPPPROUD Intervention Case Managers University-Trained Health Interventionists Trained Community Health Educators – African American INTERVENTION COMPONENTS

16. Community Members as Peer Health Educators Project PROUD Community

17. ComponentDPPPROUD Intervention Case Managers University-Trained Health Interventionists Trained Community Health Educators – African American Setting Health Clinic Churches

18. ComponentDPPPROUD Intervention Case Managers University-Trained Health Interventionists Trained Community Health Educators – African American Setting Health Clinic Churches Diet Non-ethnic specific foods Soul food pyramid, cooking demonstrations

19. Project PROUD Community  Nutrition Education  Introduction to the Lifestyle Balance Program  Record Keeping of Food and Exercise Diary  Getting Started Losing Weight  Healthy Eating  Tip the Calorie Balance  Four Keys to Healthy Eating Out  You Can Manage Stress  Ways to Stay Motivated  Diet and Physical Activity Self Monitoring

20. ComponentDPPPROUD Intervention Case Managers University-Trained Health Interventionists Trained Community Health Educators – African American Setting Health Clinic Churches Diet Non-ethnic specific foods Soul food pyramid, cooking demonstrations Exercise Brisk Walking Dancing Dancing Gospel Aerobics

21. ComponentDPPPROUD Intervention Case Managers University-Trained Health Interventionists Trained Community Health Educators – African American Setting Health Clinic Churches Diet Non-ethnic specific foods Soul food pyramid, cooking demonstrations Exercise Brisk Walking Dancing Gospel Aerobics Adherence Strategies Problem-solvingReinforcements Healthy neighborhood options, ethnic-specific recipes/cookbooks

22. ComponentDPPPROUD Intervention Case Managers University-Trained Health Interventionists Trained Community Health Educators – African American Setting Health Clinic Churches Diet Non-ethnic specific foods Soul food pyramid, cooking demonstrations Exercise Brisk Walking Brisk walking Dancing Gospel Aerobics Adherence Strategies Problem-solvingReinforcements Healthy neighborhood options, ethnic-specific recipes/cookbooks Ethnically targeted materials Materials not targeted for African-Americans African-American specific materials (e.g., testimonials, illustrations, stories)

23. Time point StrategyPROUD Standard Care Week 1-24 16-week intensive lifestyle curriculum - Lifestyle workbook Self-monitoring 6 months + (maintenance) Monthly face-to-face consultations - Monthly phone contact - Group courses - Self-monitoring Annual reminders Intervention Schedule

24. Treatment Fidelity  Treatment Delivery  1-week initial training for lifestyle counselors  Weekly rounds to discuss cases  Review 3 audiotapes of sessions  Treatment Receipt  Follow-up adherence checklist covering goals of session (coach and participant)  Treatment Enactment  Weight assessment each meeting  Assessment of activity level and caloric intake

25. Ascertainment of Response Variables  Training of Assessors  Major assessments (6 mo and 1 year) conducted by independent study staff at local clinics  Assessors blinded to condition  Trained to assess behavior and biological variables

26. Adverse Events  Based on the DPP we will monitor for adverse events in both study arms  Musculoskeletal symptoms  Hospitalizations  Length of stay and diagnosis  Deaths  Cause of death

28. Data Analysis  Interim Monitoring  After 2 years of the study and every year following until end of study  Primary Analysis  Comparison of Diabetes Incidence between Project PROUD and Standard Care conditions  Time to outcome assessed using life-table methods  Secondary Analysis  Pair-wise comparisons of secondary outcomes

29. Secondary Outcome: Cost Effectiveness  Purpose: to determine if Project PROUD is cost effective when savings in long term medical costs are included ($50,000/quality adjusted life year)  Decision analysis model projecting results of Project PROUD into the general population  We will examine the cost effectiveness of this project under different assumptions

30. Model Assumptions  Efficacy: Study results relative to standard care  Costs (Project PROUD & standard care): all costs not related to research implementation  Costs (Medical): medical costs of diabetes and or complications treatment  Costs (Non-Medical): We will include estimates of productivity gained for those not diagnosed with DM

31. Cost Effectiveness Analysis  Outcome: costs/quality adjusted life year gained by intervention compared to standard care  First analysis: based on efficacy and costs in intervention  Second analysis: sensitivity analysis based on reasonable range of values for efficacy and costs anticipated in actual implementation conditions.

32. Methodologic Issues  Unit of randomization  Procedures designed to limit cross-arm contamination  Selection of diabetes incidence as primary endpoint  Use of African American churches as intervention sites

33. Other designs considered: 2-arm Eligible participants Randomized DPP Project PROUD Pros – Replicate DPP in African Americans Cons– Small expected effect – sample size approaches infinity

34. Other designs considered: 3-arm Eligible participants Randomized Standard careDPPProject PROUD Pros – Replicate DPP in African Americans Cons– Resource intensive

35. Proposed Design: 2-arm Eligible participants Randomized Standard Care Project PROUD

36. ACKNOWLEDGEMENTS  Group 1 would like to thank the following faculty for assisting us in designing project PROUD Community:  Dr. Ron Abeles  Dr. Jim Blumenthal  Dr. Lynda Powell  Dr. Michael Proschan