Effectiveness of the Brazilian Diabetes Prevention Program (PROVEN-DIA)

Beneficência Portuguesa de São Paulo

Status: Enrolling

Conditions: Prediabetic State; Pre Diabetes

Treatments: Behavioral: Diet; Behavioral: Brazilian Diabetes Prevention Program (face-to-face care); Behavioral: Brazilian Diabetes Prevention Program (remote care)

Study type: Interventional

Funder types: Other

Identifiers

NCT06426277

PROVEN-DIA ECR

Details and patient eligibility

About

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.

Full description

This is a multicenter controlled randomized trial coordinated by the Hospital Beneficência Portuguesa in São Paulo-Brazil and made possible by PROADI-SUS (SUS Institutional Development Support Program).

Enrollment: 1,590 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• 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

Exclusion Criteria:

• 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
• 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

1,590 participants in 3 patient groups

Brazilian Diabetes Prevention Program (face-to-face care)

Experimental group

Description:

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.

Treatment:

Behavioral: Brazilian Diabetes Prevention Program (face-to-face care)

Brazilian Diabetes Prevention Program (remote care)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Brazilian Diabetes Prevention Program (remote care)

Control Group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Diet