Effectiveness of the Brazilian Diabetes Prevention Program

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.

Conditions

• Prediabetic State
• Pre Diabetes

Interventions

BEHAVIORAL

PROVEN-DIA Hybrid Lifestyle Intervention

A structured lifestyle intervention delivered through a hybrid model combining face-to-face and remote interactions over 36 months. The program includes 17 individual counseling sessions, 15 structured support contacts, and 6 group education sessions designed to improve diet quality, physical activity, sleep quality, stress management, alcohol consumption, smoking behavior, and self-care practices through behavior change strategies tailored to participants' readiness to change

BEHAVIORAL

Usual Care Lifestyle Guidance

Lifestyle guidance based on the Dietary Guidelines for the Brazilian Population and the Physical Activity Guidelines for the Brazilian Population, including recommendations regarding healthy eating, physical activity, sleep, stress management, alcohol consumption, and smoking behavior. Guidance is delivered during scheduled follow-up visits without structured behavioral counseling, goal-setting procedures, self-monitoring support, ongoing support contacts, or group education sessions.

BEHAVIORAL

TelePROVEN-DIA Lifestyle Intervention

A structured lifestyle intervention delivered entirely through telehealth over 36 months. The program includes 17 individual counseling sessions, 15 structured support contacts, and 6 group education sessions designed to improve diet quality, physical activity, sleep quality, stress management, alcohol consumption, smoking behavior, and self-care practices through behavior change strategies tailored to participants' readiness to change.

Sponsors & Collaborators

• Beneficência Portuguesa de São Paulo

  lead OTHER

Principal Investigators

• Angela C Bersch-Ferreira, PhD · Hospital Beneficência Portuguesa de São Paulo

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-01

Primary Completion

2029-12-31

Completion

2029-12-31

Countries

• Brazil

Study Locations