Actively Recruiting
Effectiveness of the Brazilian Diabetes Prevention Program
Led by Beneficência Portuguesa de São Paulo · Updated on 2025-01-20
1590
Participants Needed
2
Research Sites
265 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effectiveness of the Brazilian Diabetes Prevention Program
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 18 years or older
- Have a body mass index (BMI) between 25 and 34.9 kg/m²
- Own at least one electronic device (computer, laptop, tablet, or smartphone)
- Have access to the internet (broadband, 3G, 4G, 5G, etc.)
- No nutritional counseling or personal trainer supervision in the past 6 months
- Live within 60 minutes of the research center
- Have a blood test result in the prediabetes range within the last 3 months (HbA1c 5.7-6.4% or blood glucose 2 hours after oral glucose tolerance 140-199 mg/dL)
You will not qualify if you...
- Diagnosis of diabetes mellitus
- Underlying disease limiting life expectancy or affecting diabetes risk
- Diagnosis of renal, pulmonary, or gastrointestinal disease
- Secondary prevention for cardiovascular disease
- Endocrine diseases
- Weight loss over 10% in the last 6 months (except postpartum)
- Uncontrolled hypertension
- Diagnosis of polycystic ovary syndrome (self-reported)
- Currently treated for tuberculosis
- Diseases severely reducing life expectancy or study participation ability
- Pregnant or breastfeeding women
- Severe psychiatric disorders hindering participation
- Excessive acute or chronic alcohol consumption
- Congestive heart failure with NYHA class greater than 2
- Need for cardiologist referral based on Physical Activity Readiness Questionnaire
- Participation in another clinical trial affecting interventions or outcomes in past 6 months
- Likely to move away from research center within 3 years
- Another household member participating or on study team
- Unwilling to accept randomization or participate
- Continuous use of corticosteroids (except topical, ophthalmic, or inhaled), antineoplastic agents, psychoactive agents, or other medications
- Participation in the pilot Brazilian Diabetes Prevention Program trial (PROVEN-Dia)
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Hospital de Clínicas de Goiás - UFG
Goiânia, Goiás, Brazil
Actively Recruiting
2
Universidade Federal de Viçosa
Viçosa, Minas Gerais, Brazil
Actively Recruiting
Research Team
A
Angela C Bersch-Ferreira, PhD
CONTACT
R
Raira Pagano
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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