Trials / Completed
CompletedNCT03342274
Adapting the Diabetes Prevention Program for a Developing World Context
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 494 (actual)
- Sponsor
- Children's Mercy Hospital Kansas City · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Lifestyle Program | 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. |
| OTHER | Usual Care | Usual care consists of chronic disease management through medication delivery and monitoring of weight, blood pressure, and blood glucose by Community Health Workers. |
Timeline
- Start date
- 2018-02-16
- Primary completion
- 2019-11-13
- Completion
- 2019-12-17
- First posted
- 2017-11-14
- Last updated
- 2022-05-13
Locations
1 site across 1 country: South Africa
Source: ClinicalTrials.gov record NCT03342274. Inclusion in this directory is not an endorsement.