Efficacy of an Intervention Based on the Dietary Guidelines for the Brazilian Population in the Treatment of Overweight and Obesity: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Dietary Assessment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults (≥18 years of age)
- •Individuals of both biological sexes
- •Body Mass Index (BMI) ≥ 25 kg/m²
排除标准
- •Pregnant or lactating women
- •Cognitive, neurological, or psychiatric disorders that interfere with study compliance or participation
研究组 & 干预措施
Individual Care Control Group
The control group will receive individualized nutritional counseling comprising four in-person consultations over a 4-month period.
干预措施: Control Group: Individualized Care (Behavioral)
Collective Intervention Group based on the Dietary Guidelines for the Brazilian Population
Participants will attend four monthly collective Food and Nutrition Education sessions.
干预措施: Collective Intervention Based on the Dietary Guidelines for the Brazilian Population (Behavioral)
结局指标
主要结局
Dietary Assessment
时间窗: 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
时间窗: 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.
次要结局
- 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)
- HDL cholesterol(Before and After the 4-Month Interventions)
- LDL cholesterol(Before and After the 4-Month Interventions)
- Triglycerides(Before and After the 4-Month Interventions)
- C-reactive protein(Before and After the 4-Month Interventions)
- Uric acid(Before and After the 4-Month Interventions)
- Transtheoretical Model of Change(Before and after the 4-month interventions)
研究者
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