AzTrials
AzTrials

PreDiabetesPROVEN-DiaNCT05689658

Brazilian Diabetes Prevention Program: Pilot Study

A study testing Brazilian Diabetes Prevention Program and Diet in people with PreDiabetes and Prediabetic State, run by Beneficência Portuguesa de São Paulo at 5 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
PreDiabetes, Prediabetic State
What is being tested?
Brazilian Diabetes Prevention Program and Diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
5 sitesBrazil
Study dates
15 Mar 2023to 31 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • With Internet access
  • With personal cell phone access
  • No prior nutritional monitoring (6 months)
  • Live at least 60 minutes from the survey call center

Who cannot join

  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Brazil5 sites

  • Hospital de Clínicas de Goiania

    Goiânia, Goiás

  • Universidade Federal do Tocantins

    Palmas, Tocantins

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul

  • Hospital Universitário Professor Edgard Santos - HUPES

    Salvador, Estado de Bahia

  • Universidade Federal de Viçosa

    Viçosa, Minas Gerais

Other trials in Brazil

About this 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.

Read the 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.

Being tested
Brazilian Diabetes Prevention Program, Diet
Medical subject headings
Prediabetic State

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brazilian Diabetes Prevention ProgramBehavioural

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

  • DietBehavioural

    Hypocaloric diet prescription

Study groups in NCT05689658
Study groupRoleWhat they receive
Brazilian Diabetes Prevention Program GroupExperimentalThe 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.
Receives: Behavioral: Brazilian Diabetes Prevention Program
Diet GroupActive comparatorDiet prescription for weight loss
Receives: Behavioral: Diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 3 months

  2. Minutes of Moderate Physical activity

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

    Measured: 3 months

Secondary outcomes (7)

  1. 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

    Measured: 3 months

  2. 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

    Measured: 3 months

  3. 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

    Measured: 3 months

  4. Global DNA Methylation

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

    Measured: Baseline and 3 months

  5. weight

    to compare mean weight (kg) between groups

    Measured: 3 months

  6. HbA1c

    to compare mean HbA1c(%) between groups

    Measured: 3 months

  7. Glycemia

    to compare mean Glycemia (mg/dL) between groups

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2023
  2. Study start15 Mar 2023
  3. Primary completion4 Aug 2023
  4. Study completion31 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
220 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05689658
Sponsor's protocol ID
PROVEN-Dia
Acronym
PROVEN-Dia
Status last verified
Jan 2024
First submitted
23 Dec 2022
Last updated
30 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Brazilian Diabetes Prevention Program and Diet in people with PreDiabetes and Prediabetic State, run by Beneficência Portuguesa de São Paulo at 5 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of diet (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05689658.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in