Adapting the Diabetes Prevention Program for a Developing World Context

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

494 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-16

Study Completion Date

2019-12-17

Brief Summary

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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.

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Detailed Description

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Conditions

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Weight Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

After the end of year 1 outcomes the control arm crosses over and a year 2 follow-up is conducted on both arms.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lifestyle Program Intervention

Participants receive usual care and group weight loss sessions adapted from the Diabetes Prevention Program delivered by Community Health Workers.

Group Type EXPERIMENTAL

Lifestyle Program

Intervention Type BEHAVIORAL

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.

Usual Care

Intervention Type OTHER

Usual care consists of chronic disease management through medication delivery and monitoring of weight, blood pressure, and blood glucose by Community Health Workers.

Wait list

Participants receive usual care and after 1 year receive the Lifestyle Program intervention

Group Type OTHER

Usual Care

Intervention Type OTHER

Usual care consists of chronic disease management through medication delivery and monitoring of weight, blood pressure, and blood glucose by Community Health Workers.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No