RecruitingNot ApplicableNCT06426277

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)


Sponsor

Beneficência Portuguesa de São Paulo

Enrollment

1,590 participants

Start Date

Dec 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether an online Brazilian Diabetes Prevention Program can help people with prediabetes make lifestyle changes to reduce their risk of developing type 2 diabetes. **You may be eligible if...** - You are 18 or older with a BMI between 25 and 34.9 - You have been diagnosed with prediabetes within the last 3 months (HbA1c 5.7–6.4%, or glucose 140–199 mg/dL on a 2-hour test) - You have a smartphone, tablet, or computer with internet access - You have not had nutritional counseling or supervised fitness training in the past 6 months - You live within 60 minutes of the research center **You may NOT be eligible if...** - You already have a diagnosis of type 2 diabetes - You have serious health conditions that limit your life expectancy or ability to exercise (kidney disease, pulmonary disease, heart disease requiring secondary prevention, etc.) - You have lost more than 10% of your body weight in the past 6 months - You have uncontrolled high blood pressure or polycystic ovary syndrome Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALBrazilian 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

BEHAVIORALDiet

Hypocaloric diet prescription

BEHAVIORALBrazilian 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

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NCT06426277


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