Weight Loss
Conditions
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.
Interventions
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.
Usual care consists of chronic disease management through medication delivery and monitoring of weight, blood pressure, and blood glucose by Community Health Workers.
Sponsors
Study design
Intervention 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.
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight loss | 1 year | percentage weight loss (weight measured in kilograms) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure | 1 year | systolic blood pressure (mmHG), diastolic blood pressure (mmHG) |
| HbA1c | 1 year | percent |
| LDL cholesterol | 1 year | mg/dl |
| Triglycerides | 1 year | mg/dl |
Countries
South Africa