CClinicalTrials.gg
Active, not recruitingNCT07538362Updated Apr 20, 2026

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

An interventional study of Collective Intervention Based on the Dietary Guidelines for the Brazilian Population and Control Group: Individualized Care in Obesity & Overweight and Overweight (BMI > 25), sponsored by Federal University of Health Science of Porto Alegre. Active, not recruiting at 1 site in Brazil. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-20.

Sponsored by Federal University of Health Science of Porto Alegre · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled May 2025, registered Mar 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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.

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.

02

Conditions studied

  • Obesity & Overweight
  • Overweight (BMI > 25)

Keywords

  • Nutrition Education
  • Obesity
  • Overweight
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,695 are open to participants now.

This study's enrollment of 60 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Federal University of Health Science of Porto Alegre is the lead sponsor of 118 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pregnant or lactating women
  • Cognitive, neurological, or psychiatric disorders that interfere with study compliance or participation
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Individual Care Control Group

    The control group will receive individualized nutritional counseling comprising four in-person consultations over a 4-month period.

    Behavioral: Control Group: Individualized Care

  • Experimental
    Collective Intervention Group based on the Dietary Guidelines for the Brazilian Population

    Participants will attend four monthly collective Food and Nutrition Education sessions.

    Behavioral: Collective Intervention Based on the Dietary Guidelines for the Brazilian Population

Interventions

  • BehavioralCollective Intervention Based on the Dietary Guidelines for the Brazilian Population

    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.

  • BehavioralControl Group: Individualized Care

    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.

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: Before and After the 4-Month Interventions

Secondary outcomes

  1. Body Mass Index (BMI)

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

    Time frame: 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).

    Time frame: 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.

    Time frame: Before and after the 4-month interventions

  4. Glycated hemoglobin (HbA1c)

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

    Time frame: Before and After the 4-Month Interventions

  5. Total cholesterol

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

    Time frame: Before and After the 4-Month Interventions

  6. HDL cholesterol

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

    Time frame: Before and After the 4-Month Interventions

  7. LDL cholesterol

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

    Time frame: Before and After the 4-Month Interventions

  8. Triglycerides

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

    Time frame: 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

    Time frame: Before and After the 4-Month Interventions

  10. Uric acid

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

    Time frame: 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).

    Time frame: Before and after the 4-month interventions

07

Study locations

1 site
  • Federal University of Health Sciences of Porto Alegre
    Porto Alegre, Rio Grande do Sul 90050170, Brazil
08

References and documents

Study documents

  • Protocol, analysis plan and consent form · Apr 8, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: 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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07538362
Lead sponsor
Federal University of Health Science of Porto Alegre
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Responsible party
Profª Drª Fernanda Michielin Busnello (RD, PhD, Nutrition Department, Federal University of Health Science of. Porto Alegre, Federal University of Health Science of Porto Alegre) — Principal investigator
First posted
Apr 20, 2026
Start date
May 1, 2025
Primary completion
Nov 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Apr 20, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion