Effectiveness of the Brazilian Diabetes Prevention Program

Официальное название

Effectiveness of the Diabetes Prevention Program on the Incidence of Type 2 Diabetes Mellitus Among Brazilian Individuals: Randomized Clinical Trial (PROVEN-DIA Study)

Обзор

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.

Подробное описание

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).

Вмешательства

• Поведенческое PROVEN-DIA Hybrid Lifestyle Intervention
  A structured lifestyle intervention delivered through a hybrid model combining face-to-face and remote interactions over 36 months. The program includes 17 individual counseling sessions, 15 structured support contacts, and 6 group education sessions designed to improve diet quality, physical activity, sleep quality, stress management, alcohol consumption, smoking behavior, and self-care practices through behavior change strategies tailored to participants' readiness to change
• Поведенческое Usual Care Lifestyle Guidance
  Lifestyle guidance based on the Dietary Guidelines for the Brazilian Population and the Physical Activity Guidelines for the Brazilian Population, including recommendations regarding healthy eating, physical activity, sleep, stress management, alcohol consumption, and smoking behavior. Guidance is delivered during scheduled follow-up visits without structured behavioral counseling, goal-setting procedures, self-monitoring support, ongoing support contacts, or group education sessions.
• Поведенческое TelePROVEN-DIA Lifestyle Intervention
  A structured lifestyle intervention delivered entirely through telehealth over 36 months. The program includes 17 individual counseling sessions, 15 structured support contacts, and 6 group education sessions designed to improve diet quality, physical activity, sleep quality, stress management, alcohol consumption, smoking behavior, and self-care practices through behavior change strategies tailored to participants' readiness to change.

Первичные конечные точки

• Incidence of type 2 diabetes mellitus (T2DM) [Срок оценки: 36 months]

Вторичные конечные точки (12)

• Mean value of Glycated Hemoglobin level (HbA1c in %) [Срок оценки: 6, 12, 24 and 36 months]
• Mean value of Fasting Blood Glucose (mg/dL) [Срок оценки: 6, 12, 24 and 36 months]
• Number of Participants with controlled Fasting blood glucose (<126mg/dL) [Срок оценки: 6, 12, 24 and 36 months]
• Number of Participants with controlled Glycated Hemoglobin level (<6.4%) [Срок оценки: 6, 12, 24 and 36 months]
• body weight [Срок оценки: 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 [Срок оценки: 6, 12, 24 and 36 months]
• Minutes spent on moderate-to-vigorous physical activity [Срок оценки: 6, 12, 24 and 36 months]
• Moderate-to-vigorous physical activity and sedentary behavior [Срок оценки: 6, 12, 24 and 36 months]
• Physical activity [Срок оценки: 6, 12, 24 and 36 months]
• Sedentary behavior [Срок оценки: 6, 12, 24 and 36 months]
• Quality of diet (Mean score of The Diet Quality Index Revised (DQI-R)) [Срок оценки: 6, 12, 24 and 36 months]
• Mean of kcal from ultra processed food intake [Срок оценки: 6, 12, 24 and 36 months]

Критерии участия

Критерии включения

• 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):

• Computer
• Laptop/notebook
• Tablet
• 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.

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Бразилия · 2 центра

• Hospital de Clínicas de Goiás - UFG — Goiânia
• Universidade Federal de Viçosa — Viçosa

Идентификаторы

NCT: NCT06426277 · PROVEN-DIA ECR

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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