Preventing type 2 diabetes in high-risk adults in Brazil
Effectiveness of the Diabetes Prevention Program on the Incidence of Type 2 Diabetes Mellitus Among Brazilian Individuals: Randomized Clinical Trial (PROVEN-DIA Study)
This study is testing a diabetes prevention program in Brazil to see if it can help high-risk adults avoid developing type 2 diabetes over three years.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1590 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beneficência Portuguesa de São Paulo Academic / other |
| Locations | 2 sites (Goiânia, Goiás and 1 other locations) |
| Trial ID | NCT06426277 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized controlled trial aims to evaluate the effectiveness of the Brazilian Diabetes Prevention Program, which can be delivered either face-to-face or through e-health platforms, in preventing type 2 diabetes among at least 1,590 adults identified as high-risk over a three-year follow-up period. The study will measure various outcomes including the incidence of type 2 diabetes, changes in body weight and BMI, glycemic biomarkers, and lifestyle factors such as diet quality and physical activity. Additionally, it will analyze the impact of social, cultural, educational, and geographical factors on diabetes incidence throughout the follow-up period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a BMI between 25 and 34.9 kg/m² and recent prediabetes test results.
Not a fit: Patients diagnosed with diabetes mellitus or those with underlying diseases that limit life expectancy may not benefit from this program.
Why it matters
Potential benefit: If successful, this program could significantly reduce the incidence of type 2 diabetes among high-risk individuals in Brazil.
How similar studies have performed: Other studies have shown success with similar diabetes prevention programs, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Be 18 years or older (no maximum age for being eligible) * Have a body mass index (BMI) between 25 and 34,9kg/m² * Have, at least, one electronic device (includes any of the following devices): * Computer * Laptop/notebook * Tablet * Smartphone * Have access to internet (broadband, 3G, 4G, 5G, among others) Without previous nutritional counseling (within the 6 months prior to recruitment/randomization/intervention) Without supervision by a Physical Education Professional (Personal Trainer) in the past 6 months * Living near the research center (at maximum 60 minutes) * Had a blood test result in the prediabetes range within the last three months prior to the recruitment/randomization/intervention (includes any of these tests and results): * Hemoglobin levels (HbA1c): 5.7-6.4% * Blood glucose 2 hours after an oral glucose tolerance: 140-199 mg/dL Exclusion Criteria: * Diagnosis of Diabetes Mellitus * Underlying disease likely to limit life expectancy and/or increase the risk of interventions influencing the risk of developing T2D * Diagnosis of Renal Disease * Diagnosis of Pulmonary Disease * Gastrointestinal Disease * Secondary prevention for Cardiovascular Disease * Endocrine Diseases * Weight loss exceeding 10% in the last 6 months (except postpartum-related) * Uncontrolled Hypertension * Diagnosis of Polycystic Ovary Syndrome (self-reported) * Patients undergoing treatment for Tuberculosis * Presence of diseases that may severely reduce life expectancy or the ability to participate in the study * Pregnant or breastfeeding women * Severe psychiatric disorders that, in the opinion of the clinical team, hinder participation in the program * Acute or chronic excessive alcohol consumption * Congestive Heart Failure (CHF) with a New York Heart Association Functional Class (NYHA) \> 2 * Need for referral to a cardiologist according to the Physical Activity Readiness Questionnaire (PAR-Q) * Current or recent participation (within the last six months) in another clinical trial that impacts the interventions and/or is associated with the study outcomes (in case of doubt, contact the coordinating center) * Likely relocation away from the research collaborating center within the next 3 years * Another household member is a participant or a team member of the PROVEN-DIA study * Unwillingness to accept treatment assignment by randomization and/or refusal to participate in the study (signing the Informed Consent Form) * Continuous use of the following medications: Corticosteroids other than topical, ophthalmic, or inhaled preparations Antineoplastic agents Psychoactive agents Other medications. • Participant from the pilot Randomized Clinical Trial (Brazilian Diabetes Prevention Program: Pilot Study (PROVEN-Dia), NCT05689658)
Where this trial is running
Goiânia, Goiás and 1 other locations
- Hospital de Clínicas de Goiás - UFG — Goiânia, Goiás, Brazil (Recruiting)
- Universidade Federal de Viçosa — Viçosa, Minas Gerais, Brazil (Recruiting)
Study contacts
- Principal investigator: Angela C Bersch-Ferreira, PhD — Hospital Beneficência Portuguesa de São Paulo
- Study coordinator: Angela C Bersch-Ferreira, PhD
- Email: angelacbferreira@gmail.com
- Phone: (55 11) 988295600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.