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RECRUITING
NCT06426277
NA

Effectiveness of the Brazilian Diabetes Prevention Program

Sponsor: Beneficência Portuguesa de São Paulo

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1590

Start Date

2024-12-01

Completion Date

2029-12-31

Last Updated

2025-01-20

Healthy Volunteers

No

Interventions

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

Locations (2)

Hospital de Clínicas de Goiás - UFG

Goiânia, Goiás, Brazil

Universidade Federal de Viçosa

Viçosa, Minas Gerais, Brazil