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

Prevention of Diabetes in African Prevention of Diabetes in African American Communities:American Communities:

Project PROUD CommunityProject PROUD Community

Trevor Hart, Betty Kennedy, Susan Trevor Hart, Betty Kennedy, Susan Peterson, Guido Urizar, Ben Van Voorhees, Peterson, Guido Urizar, Ben Van Voorhees,

and Ken Wardand Ken Ward

BackgroundBackground African Americans (AA’s) have a greater African Americans (AA’s) have a greater

incidence of diabetes compared to Whitesincidence of diabetes compared to Whites

AA’s suffer diabetes complications AA’s suffer diabetes complications disproportionately relative to Whites:disproportionately relative to Whites: CV disease (heart attacks, stroke)CV disease (heart attacks, stroke) Diabetic retinopathy (blindness)Diabetic retinopathy (blindness) Diabetic nephropathy (kidney failure)Diabetic nephropathy (kidney failure) Peripheral vascular disease (amputations)Peripheral vascular disease (amputations)

Lifestyle interventions delay diabetes onsetLifestyle interventions delay diabetes onset

Limitations of the DPP StudyLimitations of the DPP Study Suggested efficacy in AA’s based on Suggested efficacy in AA’s based on

exploratory post-hoc analysesexploratory post-hoc analyses

DPP lifestyle intervention was an intensive DPP lifestyle intervention was an intensive high-cost medical model delivered by high-cost medical model delivered by professional staffprofessional staff

Design not specifically targeted for AA’s at Design not specifically targeted for AA’s at high risk for diabeteshigh risk for diabetes

In current form, may not be feasible in In current form, may not be feasible in many AA communitiesmany AA communities

Primary Study QuestionPrimary Study Question

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

Secondary Study QuestionSecondary Study Question

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

RecruitmentRecruitment Community-based recruitment conductedCommunity-based recruitment conducted

Six study centers Six study centers DetroitDetroit New OrleansNew Orleans MemphisMemphis OaklandOakland HoustonHouston ChicagoChicago

Study PopulationStudy Population

Inclusion criteria:Inclusion criteria: African American adultsAfrican American adults Age Age >> 25 years 25 years Plasma glucosePlasma glucose

2 hour glucose 140-199 mg/dl (7.8 – 11.1 mmol/L) 2 hour glucose 140-199 mg/dl (7.8 – 11.1 mmol/L)

andand Fasting glucose 95-125 mg/dl (5.3 – 7.0 mmol/L)Fasting glucose 95-125 mg/dl (5.3 – 7.0 mmol/L)

Body Mass Index (BMI) Body Mass Index (BMI) >> 24 kg/m 24 kg/m22

Study PopulationStudy Population

Exclusion criteria:Exclusion criteria: Other member in household enrolledOther member in household enrolled Type I or II diabetesType I or II diabetes Taking medications that alter glucose Taking medications that alter glucose

tolerancetolerance Illness that could seriously reduce life

expectancy

Sample Size AssumptionsSample Size Assumptions

Effect sizesEffect sizes Based on our pilot data, we predict a 30% Based on our pilot data, we predict a 30%

reduction in diabetes incidence in AA’s reduction in diabetes incidence in AA’s randomized in Project PROUD relative to randomized in Project PROUD relative to standard carestandard care

Incidence of 12.1% in standard care groupIncidence of 12.1% in standard care group

Screening and Screening and RecruitmentRecruitment

Step 1 screeningStep 1 screening

Step 2 OGTTStep 2 OGTT

Step 3 start run-inStep 3 start run-in

Step 5 randomizationStep 5 randomization

Number of participantsNumber of participants

160,000160,000

30,00030,000

4,8004,800

4,0004,000

3,260*3,260*

Step 4 end run-inStep 4 end run-in

RandomizationRandomization

Stratified randomization by study centerStratified randomization by study center

Sample size 1630 in each arm of the study = 3260Sample size 1630 in each arm of the study = 3260 Project PROUD (community implementation of DPP)Project PROUD (community implementation of DPP) Control (standard care)Control (standard care)

Design and ProtocolDesign and Protocol

Project PROUD (n=1630)

Standard Care Standard Care (n=1630)(n=1630)

BaselineBaseline Year 1Year 1 Year 3Year 3 Year 5Year 5

Year 4Year 4Year 2Year 2 Year 6Year 6

Outcome MeasuresOutcome Measures Primary OutcomePrimary Outcome

Diabetes diagnosis (assessed annually)Diabetes diagnosis (assessed annually)

Secondary OutcomeSecondary Outcome Physical Activity LevelPhysical Activity Level Usual caloric intakeUsual caloric intake Body Mass Index (BMI)Body Mass Index (BMI) HbA1cHbA1c

All measures will be administered on the same All measures will be administered on the same schedules to both groupsschedules to both groups

Key Aspects of Project PROUDKey Aspects of Project PROUD

Weight loss and physical activity goalsWeight loss and physical activity goals

Lifestyle coachesLifestyle coaches

Intensive, ongoing interventionIntensive, ongoing intervention Core curriculumCore curriculum Supervised exercise sessionsSupervised exercise sessions Maintenance programMaintenance program

ComponentComponent DPPDPP PROUDPROUDIntervention Case Intervention Case ManagersManagers

University-Trained Health University-Trained Health InterventionistsInterventionists

Trained Community Health Trained Community Health Educators – African Educators – African

AmericanAmerican

INTERVENTION COMPONENTSINTERVENTION COMPONENTS

Community Members as Peer Health EducatorsCommunity Members as Peer Health Educators

Project PROUD CommunityProject PROUD Community

ComponentComponent DPPDPP PROUDPROUDIntervention Case Intervention Case ManagersManagers

University-Trained Health University-Trained Health InterventionistsInterventionists

Trained Community Health Trained Community Health Educators – African Educators – African

AmericanAmerican

SettingSetting Health ClinicHealth Clinic ChurchesChurches

ComponentComponent DPPDPP PROUDPROUDIntervention Case Intervention Case ManagersManagers

University-Trained Health University-Trained Health InterventionistsInterventionists

Trained Community Health Trained Community Health Educators – African Educators – African

AmericanAmerican

SettingSetting Health ClinicHealth Clinic ChurchesChurches

DietDiet Non-ethnic specific foodsNon-ethnic specific foods Soul food pyramid, Soul food pyramid, cooking demonstrationscooking demonstrations

Project PROUD CommunityProject PROUD Community Nutrition EducationNutrition Education

Introduction to the Lifestyle Balance ProgramIntroduction to the Lifestyle Balance Program Record Keeping of Food and Exercise DiaryRecord Keeping of Food and Exercise Diary Getting Started Losing WeightGetting Started Losing Weight

Healthy EatingHealthy Eating

Tip the Calorie BalanceTip the Calorie Balance

Four Keys to Healthy Eating OutFour Keys to Healthy Eating Out

You Can Manage StressYou Can Manage Stress

Ways to Stay MotivatedWays to Stay Motivated

Diet and Physical Activity Self MonitoringDiet and Physical Activity Self Monitoring

ComponentComponent DPPDPP PROUDPROUDIntervention Case Intervention Case ManagersManagers

University-Trained Health University-Trained Health InterventionistsInterventionists

Trained Community Health Trained Community Health Educators – African Educators – African

AmericanAmerican

SettingSetting Health ClinicHealth Clinic ChurchesChurches

DietDiet Non-ethnic specific foodsNon-ethnic specific foods Soul food pyramid, Soul food pyramid, cooking demonstrationscooking demonstrations

ExerciseExercise Brisk WalkingBrisk Walking Brisk WalkingBrisk Walking

DancingDancing

Gospel AerobicsGospel Aerobics

ComponentComponent DPPDPP PROUDPROUDIntervention Case Intervention Case ManagersManagers

University-Trained Health University-Trained Health InterventionistsInterventionists

Trained Community Health Trained Community Health Educators – African Educators – African

AmericanAmerican

SettingSetting Health ClinicHealth Clinic ChurchesChurches

DietDiet Non-ethnic specific foodsNon-ethnic specific foods Soul food pyramid, Soul food pyramid, cooking demonstrationscooking demonstrations

ExerciseExercise Brisk WalkingBrisk Walking Brisk WalkingBrisk Walking

DancingDancing

Gospel AerobicsGospel Aerobics

Adherence StrategiesAdherence Strategies Problem-solvingProblem-solving

ReinforcementsReinforcements

Healthy neighborhood Healthy neighborhood options, ethnic-specific options, ethnic-specific

recipes/cookbooksrecipes/cookbooks

ComponentComponent DPPDPP PROUDPROUDIntervention Case Intervention Case ManagersManagers

University-Trained Health University-Trained Health InterventionistsInterventionists

Trained Community Health Trained Community Health Educators – African Educators – African

AmericanAmerican

SettingSetting Health ClinicHealth Clinic ChurchesChurches

DietDiet Non-ethnic specific foodsNon-ethnic specific foods Soul food pyramid, Soul food pyramid, cooking demonstrationscooking demonstrations

ExerciseExercise Brisk WalkingBrisk Walking Brisk walkingBrisk walking

DancingDancing

Gospel AerobicsGospel Aerobics

Adherence StrategiesAdherence Strategies Problem-solvingProblem-solving

ReinforcementsReinforcements

Healthy neighborhood Healthy neighborhood options, ethnic-specific options, ethnic-specific

recipes/cookbooksrecipes/cookbooks

Ethnically targeted Ethnically targeted materialsmaterials

Materials not targeted for Materials not targeted for African-AmericansAfrican-Americans

African-American specific African-American specific materials (e.g., materials (e.g.,

testimonials, illustrations, testimonials, illustrations, stories)stories)

Time pointTime point StrategyStrategy PROUDPROUD Standard Standard CareCare

Week 1-24Week 1-24 16-week intensive 16-week intensive lifestyle curriculumlifestyle curriculum

--

Lifestyle workbookLifestyle workbook

Self-monitoringSelf-monitoring

6 months + 6 months + (maintenance)(maintenance)

Monthly face-to-face Monthly face-to-face consultationsconsultations

--

Monthly phone Monthly phone contactcontact

--

Group coursesGroup courses --

Self-monitoringSelf-monitoring

Annual remindersAnnual reminders

Intervention Schedule

Treatment FidelityTreatment Fidelity Treatment DeliveryTreatment Delivery

1-week initial training for lifestyle counselors1-week initial training for lifestyle counselors Weekly rounds to discuss casesWeekly rounds to discuss cases Review 3 audiotapes of sessionsReview 3 audiotapes of sessions

Treatment ReceiptTreatment Receipt Follow-up adherence checklist covering goals of Follow-up adherence checklist covering goals of

session (coach session (coach andand participant) participant)

Treatment EnactmentTreatment Enactment Weight assessment each meeting Weight assessment each meeting Assessment of activity level and caloric intakeAssessment of activity level and caloric intake

Ascertainment of Response Ascertainment of Response VariablesVariables

Training of AssessorsTraining of Assessors Major assessments (6 mo and 1 year) Major assessments (6 mo and 1 year)

conducted by independent study staff at local conducted by independent study staff at local clinicsclinics

Assessors blinded to conditionAssessors blinded to condition

Trained to assess behavior and biological Trained to assess behavior and biological variablesvariables

Adverse EventsAdverse Events Based on the DPP we will monitor for Based on the DPP we will monitor for

adverse events in both study armsadverse events in both study arms

Musculoskeletal symptomsMusculoskeletal symptoms

HospitalizationsHospitalizationsLength of stay and diagnosisLength of stay and diagnosis

DeathsDeathsCause of deathCause of death

Data AnalysisData Analysis Interim MonitoringInterim Monitoring

After 2 years of the study and every year following After 2 years of the study and every year following until end of studyuntil end of study

Primary AnalysisPrimary Analysis Comparison of Diabetes Incidence between Project Comparison of Diabetes Incidence between Project

PROUD and Standard Care conditionsPROUD and Standard Care conditions Time to outcome assessed using life-table methodsTime to outcome assessed using life-table methods

Secondary AnalysisSecondary Analysis Pair-wise comparisons of secondary outcomesPair-wise comparisons of secondary outcomes

Secondary Outcome: Secondary Outcome: Cost EffectivenessCost Effectiveness

PurposePurpose: to determine if Project PROUD is cost : to determine if Project PROUD is cost effective when savings in long term medical effective when savings in long term medical costs are included ($50,000/quality adjusted life costs are included ($50,000/quality adjusted life year)year)

Decision analysis model projecting results of Decision analysis model projecting results of Project PROUD into the general populationProject PROUD into the general population

We will examine the cost effectiveness of this We will examine the cost effectiveness of this project under different assumptionsproject under different assumptions

Model AssumptionsModel Assumptions Efficacy: Study results relative to standard careEfficacy: Study results relative to standard care

Costs (Project PROUD & standard care): all costs Costs (Project PROUD & standard care): all costs not related to research implementationnot related to research implementation

Costs (Medical): medical costs of diabetes and or Costs (Medical): medical costs of diabetes and or complications treatmentcomplications treatment

Costs (Non-Medical): We will include estimates Costs (Non-Medical): We will include estimates of productivity gained for those not diagnosed of productivity gained for those not diagnosed with DMwith DM

Cost Effectiveness AnalysisCost Effectiveness Analysis Outcome: costs/quality adjusted life year gained Outcome: costs/quality adjusted life year gained

by intervention compared to standard careby intervention compared to standard care

First analysis: based on efficacy and costs in First analysis: based on efficacy and costs in interventionintervention

Second analysis: sensitivity analysis based on Second analysis: sensitivity analysis based on reasonable range of values for efficacy and costs reasonable range of values for efficacy and costs anticipated in actual implementation conditions.anticipated in actual implementation conditions.

Methodologic IssuesMethodologic Issues Unit of randomizationUnit of randomization

Procedures designed to limit cross-arm Procedures designed to limit cross-arm contaminationcontamination

Selection of diabetes incidence as primary Selection of diabetes incidence as primary endpointendpoint

Use of African American churches as Use of African American churches as intervention sitesintervention sites

Other designs considered: 2-armOther designs considered: 2-arm

Eligible participantsEligible participants

RandomizedRandomized

DPP DPP Project PROUDProject PROUD

Pros – Replicate DPP in African AmericansPros – Replicate DPP in African AmericansCons– Small expected effect – sample size approaches infinityCons– Small expected effect – sample size approaches infinity

Other designs considered: 3-armOther designs considered: 3-arm

Eligible participantsEligible participants

RandomizedRandomized

Standard careStandard care DPPDPP Project PROUDProject PROUD

Pros – Replicate DPP in African AmericansPros – Replicate DPP in African AmericansCons– Resource intensiveCons– Resource intensive

Proposed Design: 2-armProposed Design: 2-arm

Eligible participantsEligible participants

RandomizedRandomized

Standard Care Standard Care Project PROUD Project PROUD

ACKNOWLEDGEMENTSACKNOWLEDGEMENTS

Group 1 would like to thank the following Group 1 would like to thank the following faculty for assisting us in designing faculty for assisting us in designing project PROUD Community:project PROUD Community:

Dr. Ron AbelesDr. Ron Abeles Dr. Jim BlumenthalDr. Jim Blumenthal Dr. Lynda PowellDr. Lynda Powell Dr. Michael ProschanDr. Michael Proschan