Effectiveness of the Brazilian Diabetes Prevention Program
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeneficência Portuguesa de São Paulo
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Be 18 years or older (no maximum age for being eligible)
Have a body mass index (BMI) between 18,5 and 34,9kg/m²
Computer
Laptop/notebook
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
PROVEN-DIA Hybrid Lifestyle Intervention
BehavioralA structured lifestyle intervention delivered through a hybrid model combining face-to-face and remote interactions over 36 months. The program includes 17 individual counseling sessions, 15 structured support contacts, and 6 group education sessions designed to improve diet quality, physical activity, sleep quality, stress management, alcohol consumption, smoking behavior, and self-care practices through behavior change strategies tailored to participants' readiness to change
Usual Care Lifestyle Guidance
BehavioralLifestyle guidance based on the Dietary Guidelines for the Brazilian Population and the Physical Activity Guidelines for the Brazilian Population, including recommendations regarding healthy eating, physical activity, sleep, stress management, alcohol consumption, and smoking behavior. Guidance is delivered during scheduled follow-up visits without structured behavioral counseling, goal-setting procedures, self-monitoring support, ongoing support contacts, or group education sessions.
TelePROVEN-DIA Lifestyle Intervention
BehavioralA structured lifestyle intervention delivered entirely through telehealth over 36 months. The program includes 17 individual counseling sessions, 15 structured support contacts, and 6 group education sessions designed to improve diet quality, physical activity, sleep quality, stress management, alcohol consumption, smoking behavior, and self-care practices through behavior change strategies tailored to participants' readiness to change.
Treatment groups
1,305 Participants
are divided into 3 treatment groupsGroup A: Brazilian Diabetes Prevention Program (hybrid - a mix of in-person and remote support)Experimental treatment 1 intervention
Group B: Brazilian Diabetes Prevention Program - TeleHealth (remote care)Experimental treatment 1 intervention
Group C: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of type 2 diabetes mellitus (T2DM)
to analyze the incidence of type 2 diabetes mellitus
Time frame
36 monthsSecondary outcomes
1
Mean value of Glycated Hemoglobin level (HbA1c in %)
to compare mean HbA1c(%) obtained through laboratory exams/tests between groups
Time frame
6, 12, 24 and 36 months2
Mean value of Fasting Blood Glucose (mg/dL)
to compare mean fasting blood glucose (mg/dL) obtained through laboratory exams/tests between groups
Time frame
6, 12, 24 and 36 months3
Number of Participants with controlled Fasting blood glucose (<126mg/dL)
to compare the proportion of individuals with controlled blood glucose (\<126mg/dl) obtained through laboratory exams/tests without the use of hypoglycemic medication
Time frame
6, 12, 24 and 36 months4
Number of Participants with controlled Glycated Hemoglobin level (<6.4%)
to compare the proportion of individuals with HbA1c (\<6.4%) obtained through laboratory exams/tests without the use of hypoglycemic medication
Time frame
6, 12, 24 and 36 monthsSponsors and contacts
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Source ClinicalTrials.gov