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Adapting the Diabetes Prevention Program for a Developing World Context

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03342274
Recruitment Status : Completed
First Posted : November 14, 2017
Last Update Posted : May 13, 2022
Sponsor:
Collaborator:
University of the Western Cape
Information provided by (Responsible Party):
Children's Mercy Hospital Kansas City

Study Description
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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.

Condition or disease Intervention/treatment Phase
Weight Loss Behavioral: Lifestyle Program Other: Usual Care Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 494 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: After the end of year 1 outcomes the control arm crosses over and a year 2 follow-up is conducted on both arms.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adapting the Diabetes Prevention Program for a Developing World Context
Actual Study Start Date : February 16, 2018
Actual Primary Completion Date : November 13, 2019
Actual Study Completion Date : December 17, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
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.


Outcome Measures
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Primary Outcome Measures :
  1. Weight loss [ Time Frame: 1 year ]
    percentage weight loss (weight measured in kilograms)


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03342274


Locations
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South Africa
University of the Western Cape
Cape Town, South Africa
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
University of the Western Cape
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT03342274    
Other Study ID Numbers: 15080328
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: May 13, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight