Effectiveness of the Brazilian Diabetes Prevention Program

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeneficência Portuguesa de São Paulo

About this trial

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.

Eligibility criteria

Qualifiers

Be 18 years or older (no maximum age for being eligible)

Have a body mass index (BMI) between 18,5 and 34,9kg/m²

Computer

Laptop/notebook

Disqualifiers

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

Trial design

Treatments tested in this trial

  • PROVEN-DIA Hybrid Lifestyle Intervention
  • Usual Care Lifestyle Guidance
  • TelePROVEN-DIA Lifestyle Intervention

Treatment groups

1,305 Participants
are divided into 3 treatment groups