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Effectiveness of the Brazilian Diabetes Prevention Program

Study acronym: PROVEN-DIA
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion date: Dec 31, 2027 to Dec 31, 2029v3 Show 4 more changesShow less
    • Enrollment target: 1590 to 1305
    • Interventions: Brazilian Diabetes Prevention Program (face-to-face care) (Behavioral), Brazilian Diabetes Prevention Program (remote care) (Behavioral)… to PROVEN-DIA Hybrid Lifestyle Intervention (Behavioral), TelePROVEN-DIA Lifestyle Intervention (Behavioral), Usual Care Lifestyle Guidance…
    • Secondary endpoints revised (32)
    • Eligibility criteria shortened, about 4 words
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary endpoint revised
    • Start date changed from estimate of Nov 1, 2024 to Dec 1, 2024
    • Eligibility criteria expanded, about 59 words
    • Secondary endpoints: 18 to 32
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06426277
Lead Sponsor Beneficência Portuguesa de São Paulo
Conditions
(from sponsor)		 Prediabetic State, Pre Diabetes
Related terms Glucose Intolerance, Prediabetic State
Enrollment 1,305 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov