Effectiveness of the Brazilian Diabetes Prevention Program
NCT ID: NCT06426277
Last Updated: 2025-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1590 participants
INTERVENTIONAL
2024-12-01
2029-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Brazilian Diabetes Prevention Program (face-to-face care)
The 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 (face-to-face care)
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
Brazilian Diabetes Prevention Program (remote care)
The 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.
Brazilian Diabetes Prevention Program (remote care)
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
Control Group
Nutritional 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.
Diet
Hypocaloric diet prescription
Interventions
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Brazilian Diabetes Prevention Program (face-to-face care)
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
Diet
Hypocaloric diet prescription
Brazilian Diabetes Prevention Program (remote care)
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
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Beneficência Portuguesa de São Paulo
OTHER
Responsible Party
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Principal Investigators
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Angela C Bersch-Ferreira, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Beneficência Portuguesa de São Paulo
Locations
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Hospital de Clínicas de Goiás - UFG
Goiânia, Goiás, Brazil
Universidade Federal de Viçosa
Viçosa, Minas Gerais, Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PROVEN-DIA ECR
Identifier Type: -
Identifier Source: org_study_id
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