Effectiveness of the Brazilian Diabetes Prevention Program
Effectiveness of the Diabetes Prevention Program on the Incidence of Type 2 Diabetes Mellitus Among Brazilian Individuals: Randomized Clinical Trial (PROVEN-DIA Study)
Beneficência Portuguesa de São Paulo
1,590 participants
Dec 1, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria12
- 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 Criteria24
- 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)
Interventions
A Program structured in 28 visits (in group and individual) and 21 contacts (through phone calls or video calls) to guide the improvement of diet quality, self-care, and regular practice of physical activity
Hypocaloric diet prescription
A Program structured in 49 contacts delivered through telehealth (through phone calls or video calls between professional and participant) to guide the improvement of diet quality, self-care, and regular practice of physical activity
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06426277