Effectiveness of the Brazilian Diabetes Prevention Program

Launched by BENEFICÊNCIA PORTUGUESA DE SÃO PAULO · May 21, 2024

Keywords

ClinConnect Summary

The Brazilian Diabetes Prevention Program is a clinical trial aimed at helping adults at high risk of developing type 2 diabetes (T2D). The study will look at how effective this program is in preventing T2D over three years, comparing methods delivered in person and through online platforms. To participate, individuals must be at least 18 years old, have a BMI between 25 and 34.9, and have a recent blood test indicating prediabetes. They should also have access to the internet and a device like a computer or smartphone.

Participants can expect to engage in lifestyle changes related to diet and physical activity, with support from the program. Throughout the trial, researchers will track various health markers, including weight, blood sugar levels, and quality of life, while also considering social and community factors. This study is currently recruiting eligible participants, so if you meet the criteria and are interested in preventing diabetes, this program could be a great opportunity for you.

Gender

ALL

Eligibility 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)