Brazilian Diabetes Prevention Program: Pilot Study

NCT05689658 | Completed

• 1 other identifier: PROVEN-Dia
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 5

Brief Summary

To structure a Brazilian Diabetes Prevention Program based on guidance for changing lifestyle promoted by the American Diabetes Prevention Program, using materials already developed by the Brazilian Ministry of Health and contextualizing it to the Brazilian Public Health System (SUS) and evaluating its effectiveness in a multicentric randomized clinical trial with 220 pre-diabetic patients and a follow up of 3 months. Outcomes are diet quality and time of physical activity. Health care professionals' perceptions regarding its incorporation into clinical practice will also be evaluated.

Conditions

PreDiabetes; Prediabetic State

Outcome Measures

Primary Outcomes (2)

• Quality of diet

  to compare mean score of Brazilian Cardioprotective Nutritional Program dietary index (BALANCE DI) between groups. the index has a score from 0 to 40, with a high score indicating adherence to a healthy diet (BALANCE).

  3 months

• Minutes of Moderate Physical activity

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

  3 months

Secondary Outcomes (7)

• Implementation Barriers and Facilitators

  3 months

• Moderate or vigorous physical activity (according to IPAQ-short)

  3 months

• Cardioprotective diet adherence

  3 months

• Global DNA Methylation

  Baseline and 3 months

• weight

  3 months

Study Arms (2)

Brazilian Diabetes Prevention Program Group

EXPERIMENTAL

The program will be based on the American Diabetes Prevention Program (DPP), whose published results are used as a reference for prediabetic care patients in the Brazilian Diabetes Guideline. In order to reach the weight loss goal estimated at 0.5 to 1 Kg per week and 150 minutes of moderate physical activity per week, the program will offer individual and group visits, qualitative guidelines for improving diet, lifestyle and self-care.

Behavioral: Brazilian Diabetes Prevention Program

Diet Group

ACTIVE COMPARATOR

Diet prescription for weight loss

Behavioral: Diet

Interventions

Brazilian Diabetes Prevention Program BEHAVIORAL

A Program structured in 7 visits (in group and individual) to guide the improvement of diet quality, self-care, and practice of physical activity

Brazilian Diabetes Prevention Program Group

Diet BEHAVIORAL

Hypocaloric diet prescription

Diet Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index greater than or equal to 24kg/m2
• Have one of the following criteria: (CDC criteria for participating in the DPP)
• Diagnosis of prediabetes or
• Fasting blood glucose between 100-125mg/dl or blood glucose 2h after oral glucose tolerance test between 140 and 199mg/dl or HbA1c between 5.7 and 6.4% (maximum test date: last 3 months) or
• Previously diagnosed with gestational diabetes or
• High risk on the CDC prediabetes risk test
• With Internet access
• With personal cell phone access
• No prior nutritional monitoring (6 months)
• Live at least 60 minutes from the survey call center

You may not qualify if:

• Diagnosis of Diabetes Mellitus
• In secondary prevention for cardiovascular disease
• HIV patient with detectable viral load (amount of virus greater than 40 copies per ml of blood)
• Presence of illnesses that could seriously reduce your life expectancy or your ability to participate in the study
• Refuse to participate in the study (signing the Free and Informed Consent Form)
• Participation in another Randomized Clinical Trial whose objective interferes with the primary outcome of this research, such as diet quality and physical activity level
• Pregnant and lactating women

Sponsors & Collaborators

• Beneficência Portuguesa de São Paulo: lead

Study Sites (5)

Hospital Universitário Professor Edgard Santos - HUPES

Salvador, Estado de Bahia, Brazil

Location

Hospital de Clínicas de Goiania

Goiânia, Goiás, Brazil

Location

Universidade Federal de Viçosa

Viçosa, Minas Gerais, Brazil

Location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

Universidade Federal do Tocantins

Palmas, Tocantins, Brazil

Location

MeSH Terms

Conditions

Prediabetic State

Interventions

Diet

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2022
• First Posted: January 19, 2023
• Study Start: March 15, 2023
• Primary Completion: August 4, 2023
• Study Completion: October 31, 2023
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (5)