Clinical trial NCT06426277: Effectiveness of the Brazilian Diabetes Prevention Program
Official title: Effectiveness of the Diabetes Prevention Program on the Incidence of Type 2 Diabetes Mellitus Among Brazilian Individuals: Randomized Clinical Trial (PROVEN-DIA Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prediabetic State
Pre Diabetes
Lead sponsor: Beneficência Portuguesa de São Paulo
Sponsor class: OTHER
First posted: 2024-05-23
Enrollment: 1590
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility criteria: Inclusion Criteria

* Be 18 years or older (no maximum age for being eligible)
* Have a body mass index (BMI) between 25 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)
* Had a blood test result in the prediabetes range within the last three months prior to the recruitment/randomization/intervention (includes any of these tests and results):

  * Hemoglobin levels (HbA1c): 5.7-6.4%
  * Blood glucose 2 hours after an oral glucose tolerance: 140-199 mg/dL

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)
* Patients undergoing treatment for Tuberculosis
* 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)

Primary outcomes:
measure: Incidence of type 2 diabetes mellitus (T2DM)
timeFrame: 36 months
Secondary outcomes:
measure: Mean value of Glycated Hemoglobin level (HbA1c in %)
timeFrame: 6, 12, 24 and 36 months
measure: Mean value of Fasting Blood Glucose (mg/dL)
timeFrame: 6, 12, 24 and 36 months
measure: Number of Participants with controlled Fasting blood glucose (<126mg/dL)
timeFrame: 6, 12, 24 and 36 months
measure: Number of Participants with controlled Glycated Hemoglobin level (<6.4%)
timeFrame: 6, 12, 24 and 36 months
measure: body weight
timeFrame: 6, 12, 24 and 36 months
measure: Number of Participants who performed, at least, 150 minutes of moderate-to-vigorous physical activity obtained by International Physical Activity Questionnaire short form
timeFrame: 6, 12, 24 and 36 months
measure: Minutes spent on moderate-to-vigorous physical activity
timeFrame: 6, 12, 24 and 36 months
measure: Moderate-to-vigorous physical activity and sedentary behavior
timeFrame: 6, 12, 24 and 36 months
measure: Physical activity
timeFrame: 6, 12, 24 and 36 months
measure: Sedentary behavior
timeFrame: 6, 12, 24 and 36 months
measure: Quality of diet (Mean score of The Diet Quality Index Revised (DQI-R))
timeFrame: 6, 12, 24 and 36 months
measure: Mean of kcal from ultra processed food intake
timeFrame: 6, 12, 24 and 36 months
measure: 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)
timeFrame: 6, 12, 24 and 36 months
measure: Cost
timeFrame: 36 months
measure: Scholarity
timeFrame: 36 months
measure: Geo-Stratified Analysis
timeFrame: 36 months
measure: Household income
timeFrame: 36 months
measure: Neighbourhood value
timeFrame: 36 months
measure: Mean value of BMI (kg/m2)
timeFrame: 6, 12, 24 and 36 months
measure: Number of Participants in use of hypoglycemic medication
timeFrame: 6, 12, 24 and 36 months
measure: delta body weight
timeFrame: 6, 12, 24 and 36 months
measure: delta glycemia
timeFrame: 6, 12, 24 and 36 months
measure: delta HbA1c (%)
timeFrame: 6, 12, 24 and 36 months
measure: delta Insulin (μU/mL)
timeFrame: 6, 12, 24 and 36 months
measure: delta HOMA-IR (homeostasis model assessment-estimated insulin resistance)
timeFrame: 6, 12, 24 and 36 months
measure: delta HOMA-Beta *homeostasis model assessment of β-cell function)
timeFrame: 6, 12, 24 and 36 months
measure: delta PSQI-BR scores (Pittsburgh Sleep Quality Index - Brazilian version)
timeFrame: 6, 12, 24 and 36 months
measure: delta PSS-10 (Perceived Stress Scale - 10-item Brazilian version)
timeFrame: 6, 12, 24 and 36 months
measure: mean alcohol consumption (g/day)
timeFrame: 6, 12, 24 and 36 months
measure: proportion of smokers
timeFrame: 6, 12, 24 and 36 months
measure: mean number of cigarettes smoked per day
timeFrame: 6, 12, 24 and 36 months
measure: mean scores of the eight SF-36 quality of life domains
timeFrame: 6, 12, 24 and 36 months
Other outcomes:
Locations:
city: Goiânia
country: Brazil
facility: Hospital de Clínicas de Goiás - UFG
state: Goiás
city: Viçosa
country: Brazil
facility: Universidade Federal de Viçosa
state: Minas Gerais
Study officials:
affiliation: Hospital Beneficência Portuguesa de São Paulo
name: Angela C Bersch-Ferreira, PhD
role: PRINCIPAL_INVESTIGATOR
References: