Adapting the Diabetes Prevention Program for a Developing World Context

Not Applicable

Completed

• Conditions: Weight Loss
• Interventions: Behavioral: Lifestyle Program; Other: Usual Care

• 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

Arm && Interventions

Group	Intervention	Description
Lifestyle Program Intervention	Usual Care	Participants receive usual care and group weight loss sessions adapted from the Diabetes Prevention Program delivered by Community Health Workers.
Lifestyle Program Intervention	Lifestyle Program	Participants receive usual care and group weight loss sessions adapted from the Diabetes Prevention Program delivered by Community Health Workers.
Wait list	Usual Care	Participants receive usual care and after 1 year receive the Lifestyle Program intervention

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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