Obesity & Overweight, Overweight (BMI > 25)
Conditions
Keywords
Nutrition Education, Obesity, Overweight
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.
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.
Sponsors
Federal University of Health Science of Porto Alegre
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dietary Assessment | 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. |
| Dietary Practice Scale of the Dietary Guidelines for the Brazilian Population | 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
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index (BMI) | Before and after the 4-month interventions | BMI will be calculated as weight (kg) divided by height squared (m²). |
| Waist circumference | 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). |
| Fasting blood glucose | Before and after the 4-month interventions | The data will be collected from medical records. The unit of measurement used will be mg/dL. |
| Glycated hemoglobin (HbA1c) | Before and After the 4-Month Interventions | Medical records will be used to gather data. Unit of Measure will be % |
| Total cholesterol | Before and After the 4-Month Interventions | Data will be gathered from medical records. Unit of Measure will be mg/dL |
| HDL cholesterol | Before and After the 4-Month Interventions | Data will be collected from medical records. Unit of Measure will be mg/dL |
| LDL cholesterol | Before and After the 4-Month Interventions | Data will be collected from medical records. Unit of Measure will be mg/dL |
| Triglycerides | Before and After the 4-Month Interventions | Data will be collected from medical records. Unit of Measure will be mg/dL |
| C-reactive protein | Before and After the 4-Month Interventions | Data will be collected from medical records. Unit of Measure will be mg/L |
| Uric acid | Before and After the 4-Month Interventions | Data will be collected from medical records. Unit of Measure will be mg/L |
| Transtheoretical Model of Change | 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). |
Countries
Brazil
Outcome results
None listed