NCT06426277

Effectiveness of the Brazilian Diabetes Prevention Program

Effectiveness of the Diabetes Prevention Program on the Incidence of Type 2 Diabetes Mellitus Among Brazilian Individuals: Randomized Clinical Trial (PROVEN-DIA Study)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,590 (estimated)
• Sponsor: Beneficência Portuguesa de São Paulo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 1,590 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.

Detailed description

This is a multicenter controlled randomized trial coordinated by the Hospital Beneficência Portuguesa in São Paulo-Brazil and made possible by PROADI-SUS (SUS Institutional Development Support Program).

Conditions

• Prediabetic State
• Pre Diabetes

Interventions

Type	Name	Description
BEHAVIORAL	Brazilian Diabetes Prevention Program (face-to-face care)	A Program structured in 28 visits (in group and individual) and 21 contacts (through phone calls or video calls) to guide the improvement of diet quality, self-care, and regular practice of physical activity
BEHAVIORAL	Diet	Hypocaloric diet prescription
BEHAVIORAL	Brazilian Diabetes Prevention Program (remote care)	A Program structured in 49 contacts delivered through telehealth (through phone calls or video calls between professional and participant) to guide the improvement of diet quality, self-care, and regular practice of physical activity

Timeline

• Start date: 2024-12-01
• Primary completion: 2027-12-31
• Completion: 2029-12-31
• First posted: 2024-05-23
• Last updated: 2025-01-20

Locations

2 sites across 1 country: Brazil