Effectiveness of the Brazilian Diabetes Prevention Program
PROVEN-DIA
Effectiveness of the Diabetes Prevention Program on the Incidence of Type 2 Diabetes Mellitus Among Brazilian Individuals: Randomized Clinical Trial (PROVEN-DIA Study)
1 other identifier
interventional
1,305
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2024
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2024
CompletedFirst Posted
Study publicly available on registry
May 23, 2024
CompletedStudy Start
First participant enrolled
December 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
June 25, 2026
June 1, 2026
5.1 years
March 19, 2024
June 22, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of type 2 diabetes mellitus (T2DM)
to analyze the incidence of type 2 diabetes mellitus
36 months
Secondary Outcomes (32)
Mean value of Glycated Hemoglobin level (HbA1c in %)
6, 12, 24 and 36 months
Mean value of Fasting Blood Glucose (mg/dL)
6, 12, 24 and 36 months
Number of Participants with controlled Fasting blood glucose (<126mg/dL)
6, 12, 24 and 36 months
Number of Participants with controlled Glycated Hemoglobin level (<6.4%)
6, 12, 24 and 36 months
body weight
6, 12, 24 and 36 months
- +27 more secondary outcomes
Study Arms (3)
Brazilian Diabetes Prevention Program (hybrid - a mix of in-person and remote support)
EXPERIMENTALThe PROVEN-DIA program is a structured lifestyle change initiative organized into modules that include healthy eating, physical activity, sleep, stress management, and self-care. Based on materials developed by the Brazilian Ministry of Health, including the Dietary Guidelines for the Brazilian Population and the Physical Activity Guidelines for the Brazilian Population, the program considers participants' health status, lifestyle habits, and readiness to change in order to establish individualized lifestyle goals. Specifically, in this arm, PROVEN-DIA is delivered through a hybrid model combining in-person individual and group sessions with remote support contacts provided by trained Lifestyle Counselors and Lifestyle Coaches.
Brazilian Diabetes Prevention Program - TeleHealth (remote care)
EXPERIMENTALThe PROVEN-DIA program is a structured lifestyle change initiative organized into modules that include nutrition, physical activity, sleep, stress management, and self-care. Based on materials developed by the Brazilian Ministry of Health, including the Dietary Guidelines for the Brazilian Population and the Physical Activity Guidelines for the Brazilian Population, the program considers participants' health status, lifestyle habits, and readiness to change in order to establish individualized lifestyle goals. Specifically, in this arm, PROVEN-DIA is delivered exclusively through telehealth using videoconferencing and other remote communication technologies.
Control Group
ACTIVE COMPARATORParticipants allocated to the usual care control group receive the same lifestyle guidance content as the intervention groups, including recommendations regarding healthy eating, physical activity, sleep, stress management, alcohol consumption, and smoking behavior. However, this guidance is not delivered through a structured behavior change program. Individual visits are scheduled every six months according to a standardized study protocol.
Interventions
A 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
Lifestyle 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.
A 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hospital de Clínicas de Goiás - UFG
Goiânia, Goiás, Brazil
Universidade Federal de Viçosa
Viçosa, Minas Gerais, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Angela C Bersch-Ferreira, PhD
Hospital Beneficência Portuguesa de São Paulo
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2024
First Posted
May 23, 2024
Study Start
December 1, 2024
Primary Completion (Estimated)
December 31, 2029
Study Completion (Estimated)
December 31, 2029
Last Updated
June 25, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share