Actively Recruiting
Effectiveness of the Brazilian Diabetes Prevention Program to Reduce Type 2 Diabetes Risk A Randomized Clinical Trial Among Brazilian Adults at High Risk
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
Researchers are evaluating the Brazilian Diabetes Prevention Program to see how well it prevents type 2 diabetes in adults at high risk over three years. This multicenter, randomized controlled trial involves at least 1,590 adults and also examines factors like body weight, BMI, blood sugar markers, medication use, diet quality, physical activity, sleep, stress, alcohol use, smoking, and quality of life. The study also looks at social, cultural, educational, and geographic factors that might influence the risk of developing type 2 diabetes. Participants will receive either face-to-face or remote care through the Brazilian Diabetes Prevention Program. The face-to-face program includes 28 visits (both group and individual) plus 21 phone or video contacts focusing on diet, self-care, and regular physical activity. The remote program consists of 49 telehealth contacts by phone or video for the same guidance. Additionally, participants receive a hypocaloric diet prescription. The study is coordinated by Hospital Beneficência Portuguesa in São Paulo, Brazil. During the study, participants will be monitored regularly for the development of type 2 diabetes and other health measures such as weight, BMI, blood sugar, and lifestyle behaviors. Researchers will assess diet, physical activity, sleep quality, stress, and quality of life. Data will be collected through visits and contacts over the 36-month follow-up. The study also includes analysis of community-level factors influencing diabetes risk. Safety and adherence will be tracked throughout the trial period.
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
R
Raira Pagano
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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