Effectiveness of a School-based Obesity Prevention Program on Body Fat At 6 Months of Mexican Children: a Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 240
- 主要终点
- Mean difference in body Fat (%)
研究概览
简要总结
School-based programs are an essential strategy for preventing obesity, yet the most effective way to implement them remains unclear. This study aims to evaluate the effectiveness of a school-based obesity prevention program, delivered by different implementers, in comparison to a control group, focusing on body fat reduction in Mexican children. This is a cluster randomized controlled trial. Approximately six public elementary schools (240 children) in Hermosillo, Mexico, will be invited to participate. Schools will be randomly assigned to one of three groups: a program implemented by advanced undergraduate students in Nutrition and Physical Activity (NUT-PA), a program implemented by Physical Education teachers and Physical Activity students (PEST-PA), or a control group. The intervention will consist of a 6-month obesity prevention program that includes nutrition education, physical activity sessions, and parent participation. The control group will continue with their regular school activities. The primary outcome will be the difference in body fat percentage at 6 months between the NUT-PA group and the control group, as well as between the PEST-PA group and the control group. Secondary outcomes will include BMI Z-score, waist circumference, and various lifestyle parameters. A mixed-effects linear analysis will be conducted using an intention-to-treat approach.
详细描述
This is a cluster randomized controlled trial with three parallel groups and a 1:1:1 allocation ratio. The current protocol represents the definitive phase of the study, which was previously registered and approved in clinical trials (NCT05461703). The project has been approved by the Research Ethics Committee of the Nursing Department at the Universidad de Sonora (EPD-007-2022).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
A nutrition team independent of the recruitment and blinding to the study groups will carry out the measurements. The person that will do the randomly allocation of the schools will be independentof the recruitment and the intervention.
入排标准
- 年龄范围
- 9 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria:
- •School principals, 4th- and 5th- grade teachers willing to participate, availability of space for physical activity classes, and groups with a minimum of 20 students.
排除标准
- •Participating in a similar study.
- •Inclusion Criteria:
- •To be a 4th or 5th grade student (9 to 12 years) in one of the participating schools. To be eligible for this study, parents and children will be required to sign an informed consent and assent form, respectively, and had to complete anthropometric measurements (children) and lifestyle questionnaires (parents).
- •Exclusion Criteria:
- •A personal condition that prevents conducting physical activity or a condition that parents consider should exclude their child from participating.
- •Implementers
- •Inclusion Criteria:
- •Received 80% of the program training. Satisfactory response to a questionnaire that assessed their knowledge of the program following the training.
结局指标
主要结局
Mean difference in body Fat (%)
时间窗: At 6 months ( from baseline to the end of the study).
Body composition will be obtained using electrical bioimpedance RJL Quantum II (Clinton Township, Michigan) following the methodology recommended by the manufacturer. With obtained data (resistance and reactance values in ohms), an equation previously designed to estimate fat-free mass in Mexican children will be used. Fat mass will be obtained by subtracting the kilograms of fat-free mass from the total kilograms of the subject and its percentage with respect to total body weight will be also calculated.
次要结局
- Mean difference in BMI Z-score(At 6 months ( from baseline to the end of the study).)
- Mean difference in waist circumference(At 6 months ( from baseline to the end of the study).)
- Difference in food consumption(At 6 months ( from baseline to the end of the study).)
- Mean difference in physical activity and sedentary behavior(At 6 months ( from baseline to the end of the study).)
- Mean difference in quality of Life scores(At 6 months ( from baseline to the end of the study).)
- Mean difference in nutrition knowledge(At 6 months ( from baseline to the end of the study).)
- Feasibility of the intervention(At 6 months ( from baseline to the end of the study).)
研究者
Rolando Giovanni Díaz Zavala
Full-time professor
Universidad de Sonora