Effectiveness of the Diabetes Prevention Program on the Incidence of Type 2 Diabetes Mellitus Among Brazilian Individuals: Randomized Clinical Trial (PROVEN-DIA Study)
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.
• Be 18 years or older (no maximum age for being eligible)
• Have a body mass index (BMI) between 18,5 and 34,9kg/m²
• Have, at least, one electronic device (includes any of the following devices):
‣ Computer
⁃ Laptop/notebook
⁃ Tablet
⁃ Smartphone
• Have access to internet (broadband, 3G, 4G, 5G, among others) Without previous nutritional counseling (within the 6 months prior to recruitment/randomization/intervention) Without supervision by a Physical Education Professional (Personal Trainer) in the past 6 months
• Living near the research center (at maximum 60 minutes)
• Diagnosis of prediabetes defined as two HbA1c measurements between 5.7% and 6.4% collected 7 to 90 days apart.