Adapting the Diabetes Prevention Program for a Developing World Context

Study Overview
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Brief Summary
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This study will examine whether an adapted version of ]he Diabetes Prevention Program (DPP) can be effective when delivered by community health workers (CHWs) in a poor urban community in South Africa. We will randomize existing groups that are part of an non-governmental organization's (NGO) chronic disease management program (anticipated cluster N = 54; anticipated individual N=540), to receive either the program or usual care (wait-list). The primary outcome analysis will compare percentage of baseline weight loss at Y1 between the program and usual care; however, after Y1 usual care participants will also receive the program and both groups will be followed for another year.

Official Title
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Adapting the Diabetes Prevention Program for a Developing World Context

Conditions
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Weight Loss

Intervention / Treatment
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* Behavioral: Lifestyle Program
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: member of participating partner NGO health club (members are medically stabilized individuals with diabetes mellitus or hypertension referred for disease and lifestyle management) BMI greater than or equal to 25 kg per meter squared Exclusion Criteria: unsafe level of blood pressure (greater than or equal to 160 (systolic) and greater than equal to 100 mm (diastolic)) at screening elevated blood sugar (A1C greater than 11) at screening being pregnant, breast-feeding or planning pregnancy within 2 years chronic use of oral steroid medication intellectual disabilities that would prevent ability to understand the program not intending to stay in the health club over the next 2 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: After the end of year 1 outcomes the control arm crosses over and a year 2 follow-up is conducted on both arms.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle Program Intervention<br>Participants receive usual care and group weight loss sessions adapted from the Diabetes Prevention Program delivered by Community Health Workers. | Behavioral: Lifestyle Program<br>* Participants will receive group weight loss sessions addressing healthy eating, exercise, and weight loss principles adapted from the Diabetes Prevention Program delivered by Community Health Workers.<br>Other: Usual Care<br>* Usual care consists of chronic disease management through medication delivery and monitoring of weight, blood pressure, and blood glucose by Community Health Workers.<br>|
| Other: Wait list<br>Participants receive usual care and after 1 year receive the Lifestyle Program intervention | Other: Usual Care<br>* Usual care consists of chronic disease management through medication delivery and monitoring of weight, blood pressure, and blood glucose by Community Health Workers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss | percentage weight loss (weight measured in kilograms) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | systolic blood pressure (mmHG), diastolic blood pressure (mmHG) | 1 year | 
| HbA1c | percent | 1 year | 
| LDL cholesterol | mg/dl | 1 year | 
| Triglycerides | mg/dl | 1 year |