Preventing type 2 diabetes in high-risk adults in Brazil

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria

* Be 18 years or older (no maximum age for being eligible)
* Have a body mass index (BMI) between 18,5 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)
* Diagnosis of prediabetes defined as two HbA1c measurements between 5.7% and 6.4% collected 7 to 90 days apart.

Exclusion Criteria:

* Diagnosis of Diabetes Mellitus (including current or recent use, within three months, of glucose-lowering medication)
* 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 (except those using isoniazid \[INH\] as prophylaxis)
* 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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.