Clinical trial NCT03342274: 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
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
Collaborators: name: University of the Western Cape
First posted: 2017-11-14
Enrollment: 494
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Weight loss
timeFrame: 1 year
Secondary outcomes:
measure: Blood pressure
timeFrame: 1 year
measure: HbA1c
timeFrame: 1 year
measure: LDL cholesterol
timeFrame: 1 year
measure: Triglycerides
timeFrame: 1 year
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: University of the Western Cape
Study officials:
References:
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.
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.