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Completed

NCT Number: NCT03342274

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.

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Key information

Conditions

Weight Loss Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of the Western Cape

Cape Town, South Africa

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lifestyle program

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

Other

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

Primary outcomes

  1. Weight loss

    Time frame: 1 year

    percentage weight loss (weight measured in kilograms)

Secondary outcomes

  1. Blood pressure

    Time frame: 1 year

    systolic blood pressure (mmHG), diastolic blood pressure (mmHG)

  2. HbA1c

    Time frame: 1 year

    percent

  3. LDL cholesterol

    Time frame: 1 year

    mg/dl

  4. Triglycerides

    Time frame: 1 year

    mg/dl

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Collaborators

  • University of the Western Cape

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 14, 2017
Registry last updated
May 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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