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Obesity & OverweightNCT07538362

Intervention Based on the Dietary Guidelines for the Brazilian Population for the Treatment of Overweight and Obesity

A study testing Collective Intervention Based on the Dietary Guidelines for the Brazilian Population in people with Obesity & Overweight and Overweight (BMI > 25), run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This clinical trial aims to evaluate how group-based food and nutrition education interventions, grounded in the recommendations of the Dietary Guidelines for the Brazilian Population, can improve participants' dietary quality and support the treatment of overweight and obesity. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Obesity & Overweight, Overweight (BMI > 25)
What is being tested?
Collective Intervention Based on the Dietary Guidelines for the Brazilian Population
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteBrazil
Study dates
1 May 2025to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adults (≥18 years of age)
  • Individuals of both biological sexes
  • Body Mass Index (BMI) ≥ 25 kg/m²

Who cannot join

  • Pregnant or lactating women
  • Cognitive, neurological, or psychiatric disorders that interfere with study compliance or participation

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Federal University of Health Sciences of Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90050170

Other trials in Brazil

About this study

Official title: Efficacy of an Intervention Based on the Dietary Guidelines for the Brazilian Population in the Treatment of Overweight and Obesity: A Randomized Clinical Trial

This clinical trial aims to evaluate how group-based food and nutrition education interventions, grounded in the recommendations of the Dietary Guidelines for the Brazilian Population, can improve participants' dietary quality and support the treatment of overweight and obesity.

The study seeks to determine whether individuals with overweight and obesity receiving outpatient care who participate in collective food and nutrition education activities achieve benefits similar to those receiving individual nutritional counseling, particularly improvements in dietary intake, clinical parameters, and anthropometric measures.

Read more

Participants will be divided into two groups and will be required to attend four monthly sessions, complete questionnaires before and after the sessions, and provide consent for the collection of data from their medical records.

Researchers will compare the outcomes of participants attending group sessions with those receiving individual care to assess whether collective actions provide similar benefits in improving dietary quality, blood test results, and anthropometric measures.

Being tested
Collective Intervention Based on the Dietary Guidelines for the Brazilian Population, Control Group: Individualized Care
Keywords
Nutrition Education, Obesity, Overweight
Medical subject headings
Obesity, Overweight

What participants receive

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

  • Collective Intervention Based on the Dietary Guidelines for the Brazilian PopulationBehavioural

    Participants in the intervention group will attend four monthly in-person Food and Nutrition Education sessions based on the Dietary Guidelines for the Brazilian Population. These sessions will facilitate discussions on healthy eating and incorporate activities designed to dispel nutritional myths. The curriculum will address the NOVA classification system, critical appraisal of food labels, and making informed food choices. Additionally, a culinary workshop will feature healthy, affordable recipes. This component aims to enhance culinary skills, broaden dietary repertoire, and ultimately reduce the consumption of ultra-processed foods.

  • Control Group: Individualized CareBehavioural

    The control group will receive individualized nutritional counseling consisting of four in-person consultations, conducted once monthly over a four-month period. Each session, lasting 50-60 minutes, will be led by a nutritionist. These consultations will focus on establishing goals for dietary habit modification and on developing a personalized nutritional plan to improve overall dietary quality.

Study groups in NCT07538362
Study groupRoleWhat they receive
Individual Care Control GroupActive comparatorThe control group will receive individualized nutritional counseling comprising four in-person consultations over a 4-month period.
Receives: Behavioral: Control Group: Individualized Care
Collective Intervention Group based on the Dietary Guidelines for the Brazilian PopulationExperimentalParticipants will attend four monthly collective Food and Nutrition Education sessions.
Receives: Behavioral: Collective Intervention Based on the Dietary Guidelines for the Brazilian Population

What is being measured

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

  1. Dietary Assessment

    Dietary intake will be assessed using the 24-hour dietary recall available on the Quest Nova platform. This instrument consists of 58 items featuring common foods in the Brazilian diet; participants indicate the consumption of each item via dichotomous (yes/no) responses. The estimated completion time for the questionnaire is 15 minutes. This tool enables the identification of both quantitative and qualitative aspects of the participants' dietary habits. To ensure a representative average of intake, the assessment will be administered twice within the same week, both at baseline (pre-intervention) and post-intervention.

    Measured: Before and After the 4-Month Interventions

  2. Dietary Practice Scale of the Dietary Guidelines for the Brazilian Population

    Adherence to healthy eating practices will be measured using the Dietary Practice Scale based on the Dietary Guidelines for the Brazilian Population. This validated, self-administered instrument consists of 24 statements regarding healthy dietary habits as recommended by the guidelines. For each statement, participants indicate their level of adherence using a 4-point Likert scale ranging from "Strongly Agree" to "Strongly Disagree." The scale is a robust tool designed to quantify compliance with national dietary recommendations and to evaluate the overall quality of food-related behaviors.

    Measured: Before and After the 4-Month Interventions

Secondary outcomes (11)

  1. Body Mass Index (BMI)

    BMI will be calculated as weight (kg) divided by height squared (m²).

    Measured: Before and after the 4-month interventions

  2. Waist circumference

    Waist circumference will be measured using a non-elastic measuring tape at standardized anatomical landmarks. Measurements will be taken three times, and the mean value will be used. Unit of Measure is centimeters (cm).

    Measured: Before and after the 4-month interventions

  3. Fasting blood glucose

    The data will be collected from medical records. The unit of measurement used will be mg/dL.

    Measured: Before and after the 4-month interventions

  4. Glycated hemoglobin (HbA1c)

    Medical records will be used to gather data. Unit of Measure will be %

    Measured: Before and After the 4-Month Interventions

  5. Total cholesterol

    Data will be gathered from medical records. Unit of Measure will be mg/dL

    Measured: Before and After the 4-Month Interventions

  6. HDL cholesterol

    Data will be collected from medical records. Unit of Measure will be mg/dL

    Measured: Before and After the 4-Month Interventions

  7. LDL cholesterol

    Data will be collected from medical records. Unit of Measure will be mg/dL

    Measured: Before and After the 4-Month Interventions

  8. Triglycerides

    Data will be collected from medical records. Unit of Measure will be mg/dL

    Measured: Before and After the 4-Month Interventions

  9. C-reactive protein

    Data will be collected from medical records. Unit of Measure will be mg/L

    Measured: Before and After the 4-Month Interventions

  10. Uric acid

    Data will be collected from medical records. Unit of Measure will be mg/L

    Measured: Before and After the 4-Month Interventions

  11. Transtheoretical Model of Change

    Stage of behavior change will be assessed using the Transtheoretical Model (Prochaska Scale), in which participants will be classified into one of five stages (pre-contemplation, contemplation, preparation, action, or maintenance) based on their readiness to engage in weight management behaviors, and the outcome will be analyzed as a categorical variable representing the participant's stage of change (5 levels).

    Measured: Before and after the 4-month interventions

Timeline

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

  1. First posted20 Apr 2026
  2. Study start1 May 2025
  3. Primary completionNov 2026 (estimated)
  4. Study completionDec 2026 (estimated)

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The clinical trial will compare two nutritional follow-up approaches over a four-month period. The intervention group will participate in monthly group sessions featuring educational activities based on the Brazilian Dietary Guidelines. The control group will receive individualized outpatient nutritional care in accordance with the traditional model. A total of 30 participants will be assigned to each group.
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07538362
Sponsor's protocol ID
ECRGAPB26
Status last verified
Apr 2026
First submitted
31 Mar 2026
Last updated
20 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Due to the sensitive nature of the clinical data and the absence of a data-sharing clause in the Informed Consent Form, these records will not be made publicly available. Access will be strictly limited to the primary investigators.

Questions about this trial

What is this clinical trial studying?

A study testing Collective Intervention Based on the Dietary Guidelines for the Brazilian Population in people with Obesity & Overweight and Overweight (BMI > 25), run by Federal University of Health Science of Porto Alegre at 1 site 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 3 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

This study is still under way. Results are not available in the source record yet.

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?

Dietary Assessment (time frame: Before and After the 4-Month Interventions). 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 NCT07538362.

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 20 Apr 2026.

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