Adapting the Diabetes Prevention Program for a Developing World Context
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Weight Loss
- Sponsor
- Children's Mercy Hospital Kansas City
- Enrollment
- 494
- Locations
- 1
- Primary Endpoint
- Weight loss
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Weight loss
Time Frame: 1 year
percentage weight loss (weight measured in kilograms)
Secondary Outcomes
- LDL cholesterol(1 year)
- Triglycerides(1 year)
- Blood pressure(1 year)
- HbA1c(1 year)