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Effectiveness of the Brazilian Diabetes Prevention Program
Sponsor: Beneficência Portuguesa de São Paulo
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
Conditions
Interventions
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
Diet
Hypocaloric diet prescription
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