## Protocol Section
### Identification Module
**NCT ID:** NCT06426277

**Acronym:** PROVEN-DIA

**Brief Title:** 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)

#### Organization Study ID Info
**ID:** PROVEN-DIA ECR
#### Organization
**Class:** OTHER
**Full Name:** Beneficência Portuguesa de São Paulo
### Status Module
#### Completion Date
**Date:** 2029-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2027-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-11-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-19
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Beneficência Portuguesa de São Paulo

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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.

**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).

### Conditions Module

**Conditions:**

- Prediabetic State

- Pre Diabetes

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 1590

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Brazilian Diabetes Prevention Program will be delivered face-to-face, including guidance for improving diet and lifestyle (especially physical activity in daily life), as well as stimulating self-care.

**Intervention Names:**

- Behavioral: Brazilian Diabetes Prevention Program (face-to-face care)

**Label:** Brazilian Diabetes Prevention Program (face-to-face care)

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Brazilian Diabetes Prevention Program (remote care) will be delivered either through telephone or video calls (using several media and software application), including guidance for improving diet and lifestyle (especially physical activity in daily life), as well as stimulating self-care.

**Intervention Names:**

- Behavioral: Brazilian Diabetes Prevention Program (remote care)

**Label:** Brazilian Diabetes Prevention Program (remote care)

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

**Description:** Diet prescription for weight loss.

**Intervention Names:**

- Behavioral: Diet

**Label:** Diet Group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Brazilian Diabetes Prevention Program (face-to-face care)

**Description:** 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

**Name:** Brazilian Diabetes Prevention Program (face-to-face care)

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Diet Group

**Description:** Hypocaloric diet prescription

**Name:** Diet

**Type:** BEHAVIORAL

#### Intervention 3

**Arm Group Labels:**

- Brazilian Diabetes Prevention Program (remote care)

**Description:** 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

**Name:** Brazilian Diabetes Prevention Program (remote care)

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** to analyze the incidence of type 2 diabetes mellitus

**Measure:** Incidence of type 2 diabetes mellitus

**Time Frame:** 36 months

#### Secondary Outcomes

**Description:** to compare mean HbA1c(%) obtained through laboratory exams/tests between groups

**Measure:** Mean value of Glycated Hemoglobin level (HbA1c in %)

**Time Frame:** 6, 12, 24 and 36 months

**Description:** to compare mean fasting blood glucose (mg/dL) obtained through laboratory exams/tests between groups

**Measure:** Mean value of Fasting Blood Glucose (mg/dL)

**Time Frame:** 6, 12, 24 and 36 months

**Description:** to compare the proportion of individuals with controlled blood glucose (\<126mg/dl) obtained through laboratory exams/tests without the use of hypoglycemic medication

**Measure:** Number of Participants with controlled Fasting blood glucose (<126mg/dL)

**Time Frame:** 6, 12, 24 and 36 months

**Description:** to compare the proportion of individuals with HbA1c (\<6.4%) obtained through laboratory exams/tests without the use of hypoglycemic medication

**Measure:** Number of Participants with controlled Glycated Hemoglobin level (<6.4%)

**Time Frame:** 6, 12, 24 and 36 months

**Description:** to compare mean weight (kg) between groups

**Measure:** body weight

**Time Frame:** 6, 12, 24 and 36 months

**Description:** 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

**Measure:** Number of Participants who performed, at least, 150 minutes of moderate-to-vigorous physical activity obtained thourgh International Physical Activity Questionnaire short form

**Time Frame:** 6, 12, 24 and 36 months

**Description:** to compare mean time in minutes of practice of moderate/vigorous physical activity over a week between groups

**Measure:** Minutes spent on moderate-to-vigorous physical activity

**Time Frame:** 6, 12, 24 and 36 months

**Description:** to compare the proportion of individuals engaging in moderate or vigorous physical activity and sedentary behavior

**Measure:** Moderate-to-vigorous physical activity and sedentary behavior

**Time Frame:** 6, 12, 24 and 36 months

**Description:** to compare the proportion of individuals who engage in 150 minutes or more of physical activity per week

**Measure:** Physical activity

**Time Frame:** 6, 12, 24 and 36 months

**Description:** to compare the proportion of sedentary individuals

**Measure:** Sedentary behavior

**Time Frame:** 6, 12, 24 and 36 months

**Description:** 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

**Measure:** Quality of diet (Mean score of the Brazilian Cardioprotective Nutritional Program dietary index)

**Time Frame:** 6, 12, 24 and 36 months

**Description:** 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

**Measure:** Mean of kcal from ultra processed food intake

**Time Frame:** 6, 12, 24 and 36 months

**Description:** 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

**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)

**Time Frame:** 6, 12, 24 and 36 months

**Description:** 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

**Measure:** Cost

**Time Frame:** 36 months

**Description:** To analyze the correlation between years of study and the incidence of type 2 diabetes

**Measure:** Scholarity

**Time Frame:** 36 months

**Description:** T2DM incidence across Brazillian five geographic regions (South, Southeast, Midwest, West, and Northwest)

**Measure:** Geo-Stratified Analysis

**Time Frame:** 36 months

**Description:** Association between T2DM incidence and individual Low or high income (accessed by ABEP - Critério Brasil 2022 questionnaire)

**Measure:** Household income

**Time Frame:** 36 months

**Description:** correlation between neighborhood value (as assessed using the Gini index) and incidence of type 2 diabetes (DM2)

**Measure:** Neighbourhood value

**Time Frame:** 36 months

### Eligibility Module

**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 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)

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M14117

- Name: Prediabetic State

- Relevance: HIGH

- As Found: Prediabetic State

- ID: M20295

- Name: Glucose Intolerance

- Relevance: LOW

- As Found: Unknown

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: HIGH

- As Found: Diabetes

- ID: M7119

- Name: Diabetes Mellitus, Type 2

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000011236

- Term: Prediabetic State

### Misc Info Module

- Version Holder: 2024-05-31
