Adapting the Diabetes Prevention Program for Low and Middle-Income Countries: A Cluster Randomized Trial to Evaluate 'Lifestyle Africa'

Background: Low- and middle-income countries (LMIC) are experiencing major increases in diabetes and cardiovascular conditions linked to overweight and obesity. We evaluated an adapted version of the Diabetes Prevention Program (DPP) named Lifestyle Africa, tailored for an under-resourced community in South Africa. Methods: Participants with BMI ≥ 25 kg/m2 who were members of existing social support groups or “clubs” based in low-income townships were enrolled in a cluster-randomized controlled trial that compared the adapted intervention to usual care. The Lifestyle Africa intervention consisted of 17 video-based group sessions delivered by trained community health workers (CHWs). CHWs, participants, and research team members could not be blinded to condition. Percentage weight loss (primary outcome), HbA1c, blood pressure, triglycerides, and LDL cholesterol were assessed 7–9 months after enrollment. An individual-level intention-to-treat analysis was conducted adjusting for clustering within clubs and baseline values. Findings: Between February 2018 and May 2019, 782 individuals were screened and 494 (89% female) were enrolled. Participants from 28 clusters were allocated to Lifestyle Africa (15, n=240) or usual care (13, n=254). Fidelity assessments indicated the intervention was generally delivered as intended. The modal number of sessions held across all clubs was 17 and the mean attendance of participants across all sessions was 61%. Outcome assessment was completed by 215 (90%) intervention and 223 (88%) control participants. Average weight change was -0·67% (95% CI = -1·28 – -0·06) in Lifestyle Africa and 0·47% (95% CI = -1·08 – 0·14) in control with no significant difference (group difference = -0·20%, 95% CI -1·06 – 0·67; p = 0·65). However, HbA1c was significantly lower at follow-up in Lifestyle Africa compared to the usual care group (mean difference = -0·26, 95% CI -0·41 – -0·11, p = 0·0009). There were no significant differences between groups in the other outcomes. Interpretation: Lifestyle Africa was feasible for CHWs to deliver and although it had no effect on weight loss it had a significant effect on HbA1c. The intervention holds promise for addressing cardiovascular disease and diabetes at scale in LMIC. Clinical Trial Registration Details: ClinicalTrials.gov (NCT03342274). Funding Information: Supported by the National Heart Lung and Blood Institute of the National Institutes of Health (R01HL126099). Declaration of Interests: The authors declare no competing interests. Ethics Approval Statement: The study was approved by the ethics committees at the University of Cape Town (primary) and Children’s Mercy Kansas City. Participants completed written informed consent.