NCT06426277招募中不适用
Effectiveness of the Diabetes Prevention Program on the Incidence of Type 2 Diabetes Mellitus Among Brazilian Individuals: Randomized Clinical Trial (PROVEN-DIA Study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,305
- 试验地点
- 2
- 主要终点
- Incidence of type 2 diabetes mellitus (T2DM)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be 18 years or older (no maximum age for being eligible)
- •Have a body mass index (BMI) between 18,5 and 34,9kg/m²
- •Have, at least, one electronic device (includes any of the following devices):
- •Laptop/notebook
- •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)
- •Diagnosis of prediabetes defined as two HbA1c measurements between 5.7% and 6.4% collected 7 to 90 days apart.
排除标准
- •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
- •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 (except those using isoniazid [INH] as prophylaxis)
- •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)
结局指标
主要结局
Incidence of type 2 diabetes mellitus (T2DM)
时间窗: 36 months
to analyze the incidence of type 2 diabetes mellitus
次要结局
- 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)
- 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)
- 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)
- Geo-Stratified Analysis(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)
研究者
研究点 (2)
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