Clinical Trials Directory

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

TypeNameDescription
BEHAVIORALLifestyle ProgramParticipants 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.
OTHERUsual CareUsual 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.