Back to resultsAdapting the Diabetes Prevention Program for a Developing World Context
Primary Purpose
Weight Loss
Status
Completed
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Lifestyle Program
Usual Care
Sponsored by
About this trial
This is an interventional treatment trial for Weight Loss
Eligibility 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
Sites / Locations
- University of the Western Cape
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Lifestyle Program Intervention
Wait list
Arm Description
Participants receive usual care and group weight loss sessions adapted from the Diabetes Prevention Program delivered by Community Health Workers.
Participants receive usual care and after 1 year receive the Lifestyle Program intervention
Outcomes
Primary Outcome Measures
Weight loss
percentage weight loss (weight measured in kilograms)
Secondary Outcome Measures
Blood pressure
systolic blood pressure (mmHG), diastolic blood pressure (mmHG)
HbA1c
percent
LDL cholesterol
mg/dl
Triglycerides
mg/dl
Full Information
NCT ID
NCT03342274
First Posted
November 10, 2017
Last Updated
May 12, 2022
Sponsor
Children's Mercy Hospital Kansas City
Collaborators
University of the Western Cape
1. Study Identification
Unique Protocol Identification Number
NCT03342274
Brief Title
Adapting the Diabetes Prevention Program for a Developing World Context
Official Title
Adapting the Diabetes Prevention Program for a Developing World Context
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 16, 2018 (Actual)
Primary Completion Date
November 13, 2019 (Actual)
Study Completion Date
December 17, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Mercy Hospital Kansas City
Collaborators
University of the Western Cape
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
494 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle Program Intervention
Arm Type
Experimental
Arm Description
Participants receive usual care and group weight loss sessions adapted from the Diabetes Prevention Program delivered by Community Health Workers.
Arm Title
Wait list
Arm Type
Other
Arm Description
Participants receive usual care and after 1 year receive the Lifestyle Program intervention
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Usual care consists of chronic disease management through medication delivery and monitoring of weight, blood pressure, and blood glucose by Community Health Workers.
Primary Outcome Measure Information:
Title
Weight loss
Description
percentage weight loss (weight measured in kilograms)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Blood pressure
Description
systolic blood pressure (mmHG), diastolic blood pressure (mmHG)
Time Frame
1 year
Title
HbA1c
Description
percent
Time Frame
1 year
Title
LDL cholesterol
Description
mg/dl
Time Frame
1 year
Title
Triglycerides
Description
mg/dl
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of the Western Cape
City
Cape Town
Country
South Africa
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35427357
Citation
Catley 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.
Results Reference
derived
PubMed Identifier
31719084
Citation
Catley 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.
Results Reference
derived
Learn more about this trial
Adapting the Diabetes Prevention Program for a Developing World Context
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