Adapting the Diabetes Prevention Program for a Developing World Context
1 other identifier
interventional
494
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2017
CompletedFirst Posted
Study publicly available on registry
November 14, 2017
CompletedStudy Start
First participant enrolled
February 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 13, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 17, 2019
CompletedMay 13, 2022
May 1, 2022
1.7 years
November 10, 2017
May 12, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Weight loss
percentage weight loss (weight measured in kilograms)
1 year
Secondary Outcomes (4)
Blood pressure
1 year
HbA1c
1 year
LDL cholesterol
1 year
Triglycerides
1 year
Study Arms (2)
Lifestyle Program Intervention
EXPERIMENTALParticipants receive usual care and group weight loss sessions adapted from the Diabetes Prevention Program delivered by Community Health Workers.
Wait list
OTHERParticipants receive usual care and after 1 year receive the Lifestyle Program intervention
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.
Usual care consists of chronic disease management through medication delivery and monitoring of weight, blood pressure, and blood glucose by Community Health Workers.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of the Western Cape
Cape Town, South Africa
Related Publications (4)
Materia FT, Smyth JM, Puoane T, Tsolekile L, Goggin K, Kodish SR, Fox AT, Resnicow K, Werntz S, Catley D. Implementing text-messaging to support and enhance delivery of health behavior change interventions in low- to middle-income countries: case study of the Lifestyle Africa intervention. BMC Public Health. 2023 Aug 10;23(1):1526. doi: 10.1186/s12889-023-16388-y.
PMID: 37563595DERIVEDWhittington MD, Goggin K, Tsolekile L, Puoane T, Fox AT, Resnicow K, Fleming KK, Smyth JM, Materia FT, Hurley EA, Vitolins MZ, Lambert EV, Levitt NS, Catley D. Cost-effectiveness of Lifestyle Africa: an adaptation of the diabetes prevention programme for delivery by community health workers in urban South Africa. Glob Health Action. 2023 Dec 31;16(1):2212952. doi: 10.1080/16549716.2023.2212952.
PMID: 37220094DERIVEDCatley D, Puoane T, Tsolekile L, Resnicow K, Fleming KK, Hurley EA, Smyth JM, Materia FT, Lambert EV, Vitolins MZ, Levitt NS, Goggin K. Evaluation of an adapted version of the Diabetes Prevention Program for low- and middle-income countries: A cluster randomized trial to evaluate "Lifestyle Africa" in South Africa. PLoS Med. 2022 Apr 15;19(4):e1003964. doi: 10.1371/journal.pmed.1003964. eCollection 2022 Apr.
PMID: 35427357DERIVEDCatley D, Puoane T, Tsolekile L, Resnicow K, Fleming K, Hurley EA, Smyth JM, Vitolins MZ, Lambert EV, Levitt N, Goggin K. Adapting the Diabetes Prevention Program for low and middle-income countries: protocol for a cluster randomised trial to evaluate 'Lifestyle Africa'. BMJ Open. 2019 Nov 11;9(11):e031400. doi: 10.1136/bmjopen-2019-031400.
PMID: 31719084DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2017
First Posted
November 14, 2017
Study Start
February 16, 2018
Primary Completion
November 13, 2019
Study Completion
December 17, 2019
Last Updated
May 13, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share