Skip to main content
OpenTrials
Completed

NCT Number: NCT05689658

Brazilian Diabetes Prevention Program: Pilot Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

PreDiabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitário Professor Edgard Santos - HUPES, Salvador, Estado de Bahia, Brazil

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)
  • 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

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

Treatment and study plan

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

Diet

Behavioral

Hypocaloric diet prescription

Primary outcomes

  1. Quality of diet

    Time frame: 3 months

    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).

  2. Minutes of Moderate Physical activity

    Time frame: 3 months

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

Secondary outcomes

  1. Implementation Barriers and Facilitators

    Time frame: 3 months

    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

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

    Time frame: 3 months

    to compare proportion of individuals who perform at the end of the follow-up moderate or vigorous physical activity

  3. Cardioprotective diet adherence

    Time frame: 3 months

    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

  4. Global DNA Methylation

    Time frame: Baseline and 3 months

    participants' global DNA methylation using the RRBS method (Reduced Representation Bisulfite Sequencing).

  5. weight

    Time frame: 3 months

    to compare mean weight (kg) between groups

  6. HbA1c

    Time frame: 3 months

    to compare mean HbA1c(%) between groups

  7. Glycemia

    Time frame: 3 months

    to compare mean Glycemia (mg/dL) between groups

Sponsors and collaborators

Lead sponsor

Beneficência Portuguesa de São Paulo

Other

Registry information

Acronym: PROVEN-Dia

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 19, 2023
Registry last updated
Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.