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NCT Number: NCT07538362

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Obesity & Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight (BMI > 25) Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Health Sciences of Porto Alegre

Porto Alegre, Rio Grande do Sul, 90050170, Brazil

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Collective Intervention Based on the Dietary Guidelines for the Brazilian Population

Behavioral

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 Care

Behavioral

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.

Primary outcomes

  1. Dietary Assessment

    Time frame: Before and After the 4-Month Interventions

    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.

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

    Time frame: Before and After the 4-Month Interventions

    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.

Secondary outcomes

  1. Body Mass Index (BMI)

    Time frame: Before and after the 4-month interventions

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

  2. Waist circumference

    Time frame: Before and after the 4-month interventions

    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).

  3. Fasting blood glucose

    Time frame: Before and after the 4-month interventions

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

  4. Glycated hemoglobin (HbA1c)

    Time frame: Before and After the 4-Month Interventions

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

  5. Total cholesterol

    Time frame: Before and After the 4-Month Interventions

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

  6. HDL cholesterol

    Time frame: Before and After the 4-Month Interventions

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

  7. LDL cholesterol

    Time frame: Before and After the 4-Month Interventions

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

  8. Triglycerides

    Time frame: Before and After the 4-Month Interventions

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

  9. C-reactive protein

    Time frame: Before and After the 4-Month Interventions

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

  10. Uric acid

    Time frame: Before and After the 4-Month Interventions

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

  11. Transtheoretical Model of Change

    Time frame: Before and after the 4-month interventions

    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).

Sponsors and collaborators

Lead sponsor

Federal University of Health Science of Porto Alegre

Other

Collaborators

  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 20, 2026
Registry last updated
Apr 20, 2026

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.

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