Clinical Trial

Effectiveness of the Brazilian Diabetes Prevention Program

Study acronym: PROVEN-DIA
Recruiting
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Summary
The aim of this multicenter, randomized controlled trial is to assess the effectiveness of the Brazilian Diabetes Prevention Program (delivered face-to-face or via e-health) in preventing type 2 diabetes (T2D) in at least 1,305 adults at high risk of T2D over a 3-year follow-up period. Our outcomes include the incidence of T2D, body weight (kg), BMI, glycemic biomarkers, use of antidiabetic drugs, the proportion of individuals achieving controlled glycemia or HbA1c levels without medication, diet quality, moderate-to-vigorous physical activity (min/week), prevalence of physical inactivity, sleep quality, perceived stress, alcohol consumption, smoking, and quality of life. In addition, social, cultural, educational, and geographical factors at the community level will be analyzed throughout the follow-up to determine their association with the incidence of T2D.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-05-21; most recent amendment 2026-06-22.
Status change: Not Yet Recruiting → Recruiting 2025-01-17
Trial Details
NCT Number NCT06426277
Lead Sponsor Beneficência Portuguesa de São Paulo
Conditions Prediabetic State, Pre Diabetes
Enrollment 1,305 participants
Start Date 2024-12-01
Primary Completion 2029-12-31 (estimated)
Study Completion 2029-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-25