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
1,590
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 1,590 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.
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, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
January 20, 2025
December 1, 2024
3.1 years
March 19, 2024
January 17, 2025
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 (face-to-face care)
EXPERIMENTALThe PROVEN-DIA program is a structured lifestyle change initiative organized into modules that include nutrition, physical activity, and self-care. Based on materials already made available by the Brazilian Ministry of Health, such as the Dietary Guidelines for the Brazilian Population and the Physical Activity Guide for the Brazilian Population, we developed a protocol that considers health status, lifestyle habits, and motivation to set lifestyle change goals. Specifically, in this arm of the study, PROVEN-DIA will be delivered through in-person individual and group sessions, as well as virtual interactions with coaches/facilitators. There will be 23 in-person visits and 15 virtual contacts.
Brazilian Diabetes Prevention Program (remote care)
ACTIVE COMPARATORThe PROVEN-DIA program is a structured lifestyle change initiative organized into modules that include nutrition, physical activity, and self-care. Based on materials already made available by the Brazilian Ministry of Health, such as the Dietary Guidelines for the Brazilian Population and the Physical Activity Guide for the Brazilian Population, we developed a protocol that considers health status, lifestyle habits, and motivation to set lifestyle change goals. Specifically, in this arm of the study, PROVEN-DIA will be delivered 100% virtual. There will be 38 virtual contacts.
Control Group
ACTIVE COMPARATORNutritional guidance is based on the Dietary Guidelines for the Brazilian Population, and physical activity recommendations follow the Physical Activity Guide for the Brazilian Population. In other words, this group uses the same tools to guide patients as the PROVEN-DIA intervention. However, it is not structured as a program with a protocol to help professionals set lifestyle change goals with patients. This group simulates the current standard of care in primary healthcare in Brazil.
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +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
Interventions
Condition Hierarchy (Ancestors)
Intervention 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, 2027
Study Completion (Estimated)
December 31, 2029
Last Updated
January 20, 2025
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share