Effectiveness of the Brazilian Diabetes Prevention Program (NCT06426277) | Clinical Trial Compass
RecruitingNot Applicable
Effectiveness of the Brazilian Diabetes Prevention Program
Brazil1,305 participantsStarted 2024-12-01
Plain-language 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 1,305 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.