Adapting the Diabetes Prevention Program for a Developing World Context

Not Applicable

Completed

• Conditions: Weight Loss

• Registration Number: NCT03342274
• Lead Sponsor: Children's Mercy Hospital Kansas City

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-10
• Study First Submitted QC: 2017-11-10
• Study First Posted: 2017-11-14
• Study Start: 2018-02-16
• Primary Completion: 2019-11-13
• Study Completion: 2019-12-17
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-12
• Last Update Posted: 2022-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 494

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Weight loss	1 year	percentage weight loss (weight measured in kilograms)

Secondary Outcome Measures

Name	Time	Method
Triglycerides	1 year	mg/dl
Blood pressure	1 year	systolic blood pressure (mmHG), diastolic blood pressure (mmHG)
HbA1c	1 year	percent
LDL cholesterol	1 year	mg/dl

Trial Locations

Locations (1)

University of the Western Cape; 🇿🇦 Cape Town, South Africa