Effectiveness of the Brazilian Diabetes Prevention Program

Prediabetic State Clinical Trial

— PROVEN-DIA  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06426277
• Other study ID #: PROVEN-DIA ECR
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2024
• Est. completion date: December 31, 2029

Study information

• Verified date: April 2024
• Source: Beneficência Portuguesa de São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this multicenter controlled randomized trial is to assess the effectiveness of Brazilian Diabetes Prevention Program (face-to-face or e-health) in incidence of T2D with, at least, 1590 adults at high risk of developing T2D during 3-yr follow-up. Our primary outcomes are the incidence of T2D, MVPA (min/week), prevalence of physical inactivity, quality of life, BALANCE DI, CDHI, body weight (kg), and biomarkers of glycemia. In addition, social, cultural, educational and geographical factors at community levels will also be analyzed throughout the follow-up to verify their association with the incidence of T2D.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1590
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 6 months prior to the recruitment/randomization/intervention)

• Living near the research center (at maximum 60 minutes of walking)

• 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%

• Fasting blood glucose: 100-125 mg/dL

• Blood glucose 2 hours after an oral glucose tolerance: 140-199 mg/dL

Exclusion Criteria

• Diagnosis of Diabetes Mellitus

• In secondary prevention for Cardiovascular Disease (myocardial infarction, unstable angina or stroke in the past six months)

• Exclusion for underlying disease or condition likely to limit life span and/or increase risk of interventions

o Cardiovascular disease

• Congestive Heart Failure (New York Heart Association Functional Class > 2)

• Uncontrolled hypertension

• Lung disease (asthma or Chronic Obstructive Pulmonary Disease)

• Gastrointestinal disease

• Renal disease

• Major psychiatric disorder

• Anemia (hematocrit < 36.0% in men or < 33.0% in women)

• Weight loss of > 10% in past 6 months for any reason, except post-partum weight loss

• Excessive alcohol intake

• Medication use (antihypertensives, antibiotics, corticoids, antipsychotic, antineoplastic agents, phenytoin, amphetamines, and prescript weight-loss drugs)

• Likely to move away from participating clinics in next 5 years

• Another household member is a participant or staff member in the study

• Unable or unwilling to give informed consent (subject refused to sign the Free and Informed Consent Form)

• Current participation in another Randomized Clinical Trial whose main purpose interferes with any of the interventions and primary outcomes of this study (for instance, food consumption and physical activity level)

• Participant of the pilot Randomized Clinical Trial ( Brazilian Diabetes Prevention Program: Pilot Study (PROVEN-Dia), NCT05689658)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Pre Diabetes
• Prediabetic State

Intervention

Behavioral:
• Brazilian Diabetes Prevention Program (face-to-face care)
A Program structured in 28 visits (in group and individual) and 21 contacts (through phone calls or video calls) to guide the improvement of diet quality, self-care, and regular practice of physical activity
• Diet
Hypocaloric diet prescription
• Brazilian Diabetes Prevention Program (remote care)
A Program structured in 49 contacts delivered through telehealth (through phone calls or video calls between professional and participant) to guide the improvement of diet quality, self-care, and regular practice of physical activity

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beneficência Portuguesa de São Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of type 2 diabetes mellitus	to analyze the incidence of type 2 diabetes mellitus	36 months
Secondary	Mean value of Glycated Hemoglobin level (HbA1c in %)	to compare mean HbA1c(%) obtained through laboratory exams/tests between groups	6, 12, 24 and 36 months
Secondary	Mean value of Fasting Blood Glucose (mg/dL)	to compare mean fasting blood glucose (mg/dL) obtained through laboratory exams/tests between groups	6, 12, 24 and 36 months
Secondary	Number of Participants with controlled Fasting blood glucose (<126mg/dL)	to compare the proportion of individuals with controlled blood glucose (<126mg/dl) obtained through laboratory exams/tests without the use of hypoglycemic medication	6, 12, 24 and 36 months
Secondary	Number of Participants with controlled Glycated Hemoglobin level (<6.4%)	to compare the proportion of individuals with HbA1c (<6.4%) obtained through laboratory exams/tests without the use of hypoglycemic medication	6, 12, 24 and 36 months
Secondary	body weight	to compare mean weight (kg) between groups	6, 12, 24 and 36 months
Secondary	Number of Participants who performed, at least, 150 minutes of moderate-to-vigorous physical activity obtained thourgh International Physical Activity Questionnaire short form	to compare the proportion of individuals who are physically active (>150 minutes of moderate to vigorous physical activity) and inactive (<150 minutes of moderate to vigorous physical activity) between groups	6, 12, 24 and 36 months
Secondary	Minutes spent on moderate-to-vigorous physical activity	to compare mean time in minutes of practice of moderate/vigorous physical activity over a week between groups	6, 12, 24 and 36 months
Secondary	Moderate-to-vigorous physical activity and sedentary behavior	to compare the proportion of individuals engaging in moderate or vigorous physical activity and sedentary behavior	6, 12, 24 and 36 months
Secondary	Physical activity	to compare the proportion of individuals who engage in 150 minutes or more of physical activity per week	6, 12, 24 and 36 months
Secondary	Sedentary behavior	to compare the proportion of sedentary individuals	6, 12, 24 and 36 months
Secondary	Quality of diet (Mean score of the Brazilian Cardioprotective Nutritional Program dietary index)	to compare mean score of Brazilian Cardioprotective Nutritional Program dietary index (BALANCE DI) between groups Minimum: 0 Maximum: 40 When higher the score, better the quality of diet	6, 12, 24 and 36 months
Secondary	Mean of kcal from ultra processed food intake	to compare the mean caloric intake (kcal) from ultra-processed foods obtained through two 24-hour Dietary Recall applied within a period of fifiteen days	6, 12, 24 and 36 months
Secondary	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)	to analyze the quality of life based on delta value of the eight domains (Functional capacity, Physical aspects, Pain, General health status, Vitality, Social aspects, Emotional aspects and Mental health) When higher the score, better the quality of life related to the assessed domain	6, 12, 24 and 36 months
Secondary	Cost	To compare the cost of interventions. To estimate healthcare system costs, we will consider only direct medical costs, which include screening costs, intervention costs, and costs of healthcare service utilization. To estimate social costs, we will consider not only direct medical costs but also non-medical direct costs, such as transportation, food, and accommodation expenses reported by participants when seeking medical assistance, as well as time spent traveling to and participating in group sessions. Additionally, we will include indirect costs, calculated based on the assumption that each necessary hospitalization results in a loss of 9 hours of paid work and each outpatient visit results in a loss of half a day (4.5 hours) of paid work	36 months
Secondary	Scholarity	To analyze the correlation between years of study and the incidence of type 2 diabetes	36 months
Secondary	Geo-Stratified Analysis	T2DM incidence across Brazillian five geographic regions (South, Southeast, Midwest, West, and Northwest)	36 months
Secondary	Household income	Association between T2DM incidence and individual Low or high income (accessed by ABEP - Critério Brasil 2022 questionnaire)	36 months
Secondary	Neighbourhood value	correlation between neighborhood value (as assessed using the Gini index) and incidence of type 2 diabetes (DM2)	36 months