Intervention Based on the Dietary Guidelines for the Brazilian Population for the Treatment of Overweight and Obesity
Efficacy of an Intervention Based on the Dietary Guidelines for the Brazilian Population in the Treatment of Overweight and Obesity: A Randomized Clinical Trial
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2025
CompletedFirst Submitted
Initial submission to the registry
March 31, 2026
CompletedFirst Posted
Study publicly available on registry
April 20, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
April 20, 2026
April 1, 2026
1.5 years
March 31, 2026
April 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Before and After the 4-Month Interventions
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.
Before and After the 4-Month Interventions
Secondary Outcomes (11)
Body Mass Index (BMI)
Before and after the 4-month interventions
Waist circumference
Before and after the 4-month interventions
Fasting blood glucose
Before and after the 4-month interventions
Glycated hemoglobin (HbA1c)
Before and After the 4-Month Interventions
Total cholesterol
Before and After the 4-Month Interventions
- +6 more secondary outcomes
Study Arms (2)
Individual Care Control Group
ACTIVE COMPARATORThe control group will receive individualized nutritional counseling comprising four in-person consultations over a 4-month period.
Collective Intervention Group based on the Dietary Guidelines for the Brazilian Population
EXPERIMENTALParticipants will attend four monthly collective Food and Nutrition Education sessions.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Adults (≥18 years of age)
- Individuals of both biological sexes
- Body Mass Index (BMI) ≥ 25 kg/m²
You may not qualify if:
- Pregnant or lactating women
- Cognitive, neurological, or psychiatric disorders that interfere with study compliance or participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Federal University of Health Sciences of Porto Alegre
Porto Alegre, Rio Grande do Sul, 90050170, Brazil
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- RD, PhD, Nutrition Department, Federal University of Health Science of. Porto Alegre
Study Record Dates
First Submitted
March 31, 2026
First Posted
April 20, 2026
Study Start
May 1, 2025
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
April 20, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
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.