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Effectiveness of the Brazilian Diabetes Prevention Program

NCT06426277 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1590

Last updated 2025-01-20

No results posted yet for this study

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.

Conditions

  • Prediabetic State
  • Pre Diabetes

Interventions

BEHAVIORAL

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

BEHAVIORAL

Diet

Hypocaloric diet prescription

BEHAVIORAL

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

Sponsors & Collaborators

  • Beneficência Portuguesa de São Paulo

    lead OTHER

Principal Investigators

  • Angela C Bersch-Ferreira, PhD · Hospital Beneficência Portuguesa de São Paulo

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2027-12-31
Completion
2029-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06426277 on ClinicalTrials.gov