Adapting the Diabetes Prevention Program for a Developing World Context

Weight Loss Clinical Trial

Official title:

Adapting the Diabetes Prevention Program for a Developing World Context

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03342274
• Other study ID #: 15080328
• Status: Completed
• Phase: N/A
• Start date: February 16, 2018
• Est. completion date: December 17, 2019

Study information

• Verified date: May 2022
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 494
• Est. completion date: December 17, 2019
• Est. primary completion date: November 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Weight Loss

Intervention

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.

Locations

Country	Name	City	State
South Africa	University of the Western Cape	Cape Town

Sponsors (2)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City	University of the Western Cape

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss	percentage weight loss (weight measured in kilograms)	1 year
Secondary	Blood pressure	systolic blood pressure (mmHG), diastolic blood pressure (mmHG)	1 year
Secondary	HbA1c	percent	1 year
Secondary	LDL cholesterol	mg/dl	1 year
Secondary	Triglycerides	mg/dl	1 year