Brazilian Diabetes Prevention Program for Prediabetes
Effectiveness of the Brazilian Diabetes Prevention Program
Recruiting
N/AInterventional Study
Prediabetic StatePre Diabetes
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
1,305 (estimated)
Sponsor
Beneficência Portuguesa de São Paulo · Other
Who this trial is looking for
This trial is looking for adults with prediabetes who want to prevent type 2 diabetes. Participants will join either in person or online and will be monitored over three years.
Are You a Good Fit for This Trial?
Rules you outType 1 diabetesSevere psychiatric disordersPregnancyBreastfeeding
You may be able to join if
I am 18 years or older
I have a BMI between 18.5 and 34.9
I have access to an electronic device and the internet
I have not received nutritional counseling in the last 6 months
I have not had a personal trainer in the last 6 months
I live within 60 minutes of the research center
I have been diagnosed with prediabetes based on specific blood test results
You may not be able to join if
I have been diagnosed with diabetes
I have an underlying disease that affects my life expectancy
I have renal disease
I have pulmonary disease
I weigh less than 10% of my body weight in the last 6 months
I have uncontrolled hypertension
I am pregnant or breastfeeding
I have severe psychiatric disorders
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 1,305 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 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 1,305 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.
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Eligibility Criteria
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 inter…
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)
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