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.

Roald Gómez-Pérez, María Inés Marulanda, Eunice Ugel, Ramfis Nieto-Martínez, María M Infante-García, Goodarz Danaei, Juan P González-Rivas, Jeffrey I Mechanick, Rebeca Figueroa Heras

Journal: Diabetes research and clinical practice 2025;222():112051

PMID: 39993643

Free Full Text on Elsevier Science View on PubMed

Abstract

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.

Address: Harvard TH Chan School of Public Health, Departments of Global Health and Population, Boston, MA, USA; International Clinical Research Center (ICRC), St Anne's University Hospital (FNUSA) Brno, Czech Republic; Foundation for Clinic, Public Health, and Epidemiological Research of Venezuela (FISPEVEN), Caracas, Venezuela. Electronic address: [email protected].; International Clinical Research Center (ICRC), St Anne's University Hospital (FNUSA) Brno, Czech Republic; Foundation for Clinic, Public Health, and Epidemiological Research of Venezuela (FISPEVEN), Caracas, Venezuela.; The Marie-Josée and Henry R. Kravis Center for Cardiovascular Health at Mount Sinai Fuster Heart Hospital, and Division of Endocrinology, Diabetes, and Bone, Icahn School of Medicine at Mount Sinai, New York, NY, USA.; Foundation for Clinic, Public Health, and Epidemiological Research of Venezuela (FISPEVEN), Caracas, Venezuela.; Harvard TH Chan School of Public Health, Departments of Global Health and Population, Boston, MA, USA; Foundation for Clinic, Public Health, and Epidemiological Research of Venezuela (FISPEVEN), Caracas, Venezuela; Precision Care Corp, Saint Cloud, Florida, EE. UU, USA.; Foundation for Clinic, Public Health, and Epidemiological Research of Venezuela (FISPEVEN), Caracas, Venezuela; West Orange Endocrinology, Orlando, FL, USA; Venezuelan Society of Internal Medicine, Caracas, Venezuela.; Harvard TH Chan School of Public Health, Departments of Global Health and Population, Boston, MA, USA; Foundation for Clinic, Public Health, and Epidemiological Research of Venezuela (FISPEVEN), Caracas, Venezuela.; University of the Andes, Merida, Venezuela.; Harvard TH Chan School of Public Health, Departments of Global Health and Population, and Epidemiology, Boston, MA, USA.

DOI: 10.1016/j.diabres.2025.112051