Implementing a Low-Calorie diet to Enhance weight loss in the diabetes Prevention Program during a humanitarian Crisis: A pilot pragmatic randomized trial in Venezuela

Background: Preventing type 2 diabetes during humanitarian crises is under-researched. In Venezuela, a third of adults have prediabetes amid a prolonged crisis. Aim: This study assessed the effectiveness of an intensive weight reduction strategy aimed at achieving a 7% weight loss in Venezuelan individuals with elevated risk of type 2 diabetes. Methods: A six-month pilot randomized clinical trial was conducted at a Community Health Center. Participants were assigned to the Diabetes Prevention Program (DPP) or a low-calorie liquid diet followed by DPP (LD-DPP). The LD-DPP group underwent a two-month liquid diet, followed by food reintroduction and DPP content. The DPP group received a transculturally adapted Group Lifestyle Balance curriculum through 16 group sessions. Both Intention to Treat and Per-Protocol analyses with Inverse Probability Weighting were conducted. Results: Of 127 adults (64 LD-DPP, 63 DPP), 70 (55.1%) completed the intervention. In the ITT analysis, 32.9% achieved the 7% weight loss goal, significantly higher in the LD-DPP arm (54.8%) compared to DPP (15.4%). Conclusion: Initiating the DPP with intensive low-calorie restriction led to greater weight loss and improved chances of meeting weight loss goals during a humanitarian crisis.