Adapting the Diabetes Prevention Program for a Developing World Context

Children's Mercy Hospital Kansas City

Status: Completed

Conditions: Weight Loss

Treatments: Behavioral: Lifestyle Program; Other: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT03342274

15080328

Details and patient eligibility

About

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.

Enrollment: 494 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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494 participants in 2 patient groups

Lifestyle Program Intervention

Experimental group

Description:

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

Treatment:

Other: Usual Care

Behavioral: Lifestyle Program

Wait list

Other group

Description:

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

Treatment:

Other: Usual Care