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Adapting the Diabetes Prevention Program for a Developing World Context

Adapting the Diabetes Prevention Program for a Developing World Context

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03342274
Enrollment
494
Registered
2017-11-14
Start date
2018-02-16
Completion date
2019-12-17
Last updated
2022-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Weight Loss

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.

Interventions

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.

OTHERUsual Care

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

Sponsors

University of the Western Cape
CollaboratorOTHER
Children's Mercy Hospital Kansas City
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Weight loss1 yearpercentage weight loss (weight measured in kilograms)

Secondary

MeasureTime frameDescription
Blood pressure1 yearsystolic blood pressure (mmHG), diastolic blood pressure (mmHG)
HbA1c1 yearpercent
LDL cholesterol1 yearmg/dl
Triglycerides1 yearmg/dl

Countries

South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026