Effectiveness of the Diabetes Prevention Program on the Incidence of Type 2 Diabetes Mellitus Among Brazilian Individuals: Randomized Clinical Trial (PROVEN-DIA Study)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Prediabetic State
- Sponsor
- Beneficência Portuguesa de São Paulo
- Enrollment
- 1590
- Locations
- 2
- Primary Endpoint
- Incidence of type 2 diabetes mellitus (T2DM)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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.
Detailed 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).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
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)
Outcomes
Primary Outcomes
Incidence of type 2 diabetes mellitus (T2DM)
Time Frame: 36 months
to analyze the incidence of type 2 diabetes mellitus
Secondary Outcomes
- Mean value of Glycated Hemoglobin level (HbA1c in %)(6, 12, 24 and 36 months)
- Mean value of Fasting Blood Glucose (mg/dL)(6, 12, 24 and 36 months)
- Number of Participants with controlled Fasting blood glucose (<126mg/dL)(6, 12, 24 and 36 months)
- Number of Participants with controlled Glycated Hemoglobin level (<6.4%)(6, 12, 24 and 36 months)
- body weight(6, 12, 24 and 36 months)
- Number of Participants who performed, at least, 150 minutes of moderate-to-vigorous physical activity obtained by International Physical Activity Questionnaire short form(6, 12, 24 and 36 months)
- Minutes spent on moderate-to-vigorous physical activity(6, 12, 24 and 36 months)
- Moderate-to-vigorous physical activity and sedentary behavior(6, 12, 24 and 36 months)
- Physical activity(6, 12, 24 and 36 months)
- Sedentary behavior(6, 12, 24 and 36 months)
- Quality of diet (Mean score of The Diet Quality Index Revised (DQI-R))(6, 12, 24 and 36 months)
- Mean of kcal from ultra processed food intake(6, 12, 24 and 36 months)
- Delta value (Change score from baseline to 6, 12, 24 and 36 months) for each domain of Quality of life obtained through Short Form Health Survey (SF-36)(6, 12, 24 and 36 months)
- Cost(36 months)
- Scholarity(36 months)
- Geo-Stratified Analysis(36 months)
- Household income(36 months)
- Neighbourhood value(36 months)
- Mean value of BMI (kg/m2)(6, 12, 24 and 36 months)
- Number of Participants in use of hypoglycemic medication(6, 12, 24 and 36 months)
- delta body weight(6, 12, 24 and 36 months)
- delta glycemia(6, 12, 24 and 36 months)
- delta HbA1c (%)(6, 12, 24 and 36 months)
- delta Insulin (μU/mL)(6, 12, 24 and 36 months)
- delta HOMA-IR (homeostasis model assessment-estimated insulin resistance)(6, 12, 24 and 36 months)
- delta HOMA-Beta *homeostasis model assessment of β-cell function)(6, 12, 24 and 36 months)
- delta PSQI-BR scores (Pittsburgh Sleep Quality Index - Brazilian version)(6, 12, 24 and 36 months)
- delta PSS-10 (Perceived Stress Scale - 10-item Brazilian version)(6, 12, 24 and 36 months)
- mean alcohol consumption (g/day)(6, 12, 24 and 36 months)
- proportion of smokers(6, 12, 24 and 36 months)
- mean number of cigarettes smoked per day(6, 12, 24 and 36 months)
- mean scores of the eight SF-36 quality of life domains(6, 12, 24 and 36 months)