Brazilian Diabetes Prevention Program: Pilot Study (PROVEN-Dia)

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.

Study Overview

• Status: Completed
• Conditions: PreDiabetes; Prediabetic State
• Intervention / Treatment: Behavioral: Brazilian Diabetes Prevention Program; Behavioral: Diet

Detailed Description

This is a multicentric randomized clinical study coordinated by the Hospital Beneficência Portuguesa in São Paulo-Brazil and made possible by PROADI-SUS (SUS Institutional Development Support Program).

The study's objective is the Brazilian Diabetes Prevention Program development 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).

The program will not include a multidisciplinary orientation, but the prescription will have a multi-professional vision. The objective is to bring the multi-team together to discuss different aspects of the same intervention, such as accessibility, motivation, contexts, and needs, so that the program, to be guided by the nutritionist, can also be recognized and supported by the other teammates.

Once the program is defined, the research teams from the collaborating centers will be trained and qualified. 220 individuals with pre-diabetes will be included in the study and followed for 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.

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Bahia
    • Salvador, Bahia, Brazil
      • Hospital Universitário Professor Edgard Santos - HUPES
  • Goias
    • Goiânia, Goias, Brazil
      • Hospital de Clínicas de Goiania
  • Minas Gerais
    • Viçosa, Minas Gerais, Brazil
      • Universidade Federal de Viçosa
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil
      • Hospital de Clinicas de Porto Alegre
  • Tocantins
    • Palmas, Tocantins, Brazil
      • Universidade Federal do Tocantins

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Body mass index greater than or equal to 24kg/m2

• Have one of the following criteria: (CDC criteria for participating in the DPP)

  1. Diagnosis of prediabetes or
  2. 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
  3. Previously diagnosed with gestational diabetes or
  4. 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brazilian Diabetes Prevention Program Group; 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; A Program structured in 7 visits (in group and individual) to guide the improvement of diet quality, self-care, and practice of physical activity
Active Comparator: Diet Group; Diet prescription for weight loss	Behavioral: Diet; Hypocaloric diet prescription

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Moderate or vigorous physical activity (according to IPAQ-short)	to compare proportion of individuals who perform at the end of the follow-up moderate or vigorous physical activity	3 months
Cardioprotective diet adherence	to compare adherence to a healthy and cardioprotective diet based on the Cardiovascular Health Diet Index (CHDI) between groups. The CHDI had 11 components and a total score ranging from 0 to 110 points. the higher the score, the greater adherence to a healthy and cardioprotective diet	3 months
weight	to compare mean weight (kg) between groups	3 months
HbA1c	to compare mean HbA1c(%) between groups	3 months
Glycemia	to compare mean Glycemia (mg/dL) between groups	3 months
Implementation Barriers and Facilitators	Identification of Barriers and Facilitators of Program implementation from a qualitative analysis approach. This is not a score on a scale. For the qualitative data, thematic content analysis will be performed with the transcription of the focus groups. This analysis will serve to describe and understand perceptions, interpretations and beliefs from the perspective of managers and professionals about the intervention. The thematic nuclei will be defined a posteriori according to the references of models and implementation frameworks also used for the realization of the focus groups	3 months
Global DNA Methylation	participants' global DNA methylation using the RRBS method (Reduced Representation Bisulfite Sequencing).	Baseline and 3 months

Collaborators and Investigators

• Sponsor: Beneficência Portuguesa de São Paulo

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2023
• Primary Completion (Actual): August 4, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: December 23, 2022
• First Submitted That Met QC Criteria: January 9, 2023
• First Posted (Actual): January 19, 2023

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: PROVEN-Dia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No