Adapting the Diabetes Prevention Program for a Developing World Context

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.

Study Overview

• Status: Completed
• Conditions: Weight Loss
• Intervention / Treatment: Behavioral: Lifestyle Program; Other: Usual Care

• Study Type: Interventional
• Enrollment (Actual): 494
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Cape Town, South Africa
    • University of the Western Cape

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lifestyle Program Intervention; Participants receive usual care and group weight loss sessions adapted from the Diabetes Prevention Program delivered by Community Health Workers.	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.
Other: Wait list; Participants receive usual care and after 1 year receive the Lifestyle Program intervention	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight loss	percentage weight loss (weight measured in kilograms)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	systolic blood pressure (mmHG), diastolic blood pressure (mmHG)	1 year
HbA1c	percent	1 year
LDL cholesterol	mg/dl	1 year
Triglycerides	mg/dl	1 year

Collaborators and Investigators

• Sponsor: Children's Mercy Hospital Kansas City
• Collaborators: University of the Western Cape

Publications and helpful links

General Publications

• Catley D, Puoane T, Tsolekile L, Resnicow K, Fleming KK, Hurley EA, Smyth JM, Materia FT, Lambert EV, Vitolins MZ, Levitt NS, Goggin K. Evaluation of an adapted version of the Diabetes Prevention Program for low- and middle-income countries: A cluster randomized trial to evaluate "Lifestyle Africa" in South Africa. PLoS Med. 2022 Apr 15;19(4):e1003964. doi: 10.1371/journal.pmed.1003964. eCollection 2022 Apr.
• Catley D, Puoane T, Tsolekile L, Resnicow K, Fleming K, Hurley EA, Smyth JM, Vitolins MZ, Lambert EV, Levitt N, Goggin K. Adapting the Diabetes Prevention Program for low and middle-income countries: protocol for a cluster randomised trial to evaluate 'Lifestyle Africa'. BMJ Open. 2019 Nov 11;9(11):e031400. doi: 10.1136/bmjopen-2019-031400.

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2018
• Primary Completion (Actual): November 13, 2019
• Study Completion (Actual): December 17, 2019

Study Registration Dates

• First Submitted: November 10, 2017
• First Submitted That Met QC Criteria: November 10, 2017
• First Posted (Actual): November 14, 2017

Study Record Updates

• Last Update Posted (Actual): May 13, 2022
• Last Update Submitted That Met QC Criteria: May 12, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: 15080328

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No