Evaluation of a 4-month Online Lifestyle Intervention on the BMI Z-score of Mexican School Children During COVID-19 Pandemic: Randomized Controlled Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Change in BMI Z-score
研究概览
简要总结
Introduction: School closures due to the COVID-19 pandemic represent a risk factor for the development of childhood obesity due to the increase in unhealthy behaviors. Online lifestyle interventions in schoolchildren could help to mitigate this problem. However, to date, no randomized controlled trials have been performed to prevent obesity in schoolchildren during the COVID-19 pandemic. The aim of this study is to evaluate the effect of a 4-month online lifestyle intervention on the BMI Z-score of Mexican schoolchildren during the COVID-19 pandemic in an intervention group compared to a control group. Methodology: This is a pilot randomized controlled trial. Schoolchildren from a public elementary school in Hermosillo, Sonora, Mexico will be invited to participate. Participants will be randomized to an intervention group (online lifestyle intervention) or a control group. The intervention will include online sessions of nutrition education and physical activity and nutrition information for parents. The control group will receive a digital brochure with nutrition recommendations at the beginning of the study. The measurements will be performed at baseline and 4 months. The primary outcome will be the BMI Z- score. Secondary outcomes: waist circumference, fat percentage, nutritional knowledge, lifestyle parameters, retention, attendance at the program sessions, and acceptability of the intervention. The difference between groups in changes in the outcomes will be analyzed using an intention to treat analysis. The protocol was approved by the Research Ethics Committee of the University of Sonora Nursing Department (EPM-003-2020). Conclusion: The study will provide the first evidence of the evaluation of online interventions for the prevention of obesity in schoolchildren derived from a Randomized Controlled Trial. This information will be important for the development and implementation of other school-level obesity prevention programs around the world.
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
The primary outcome (BMI Z-score) and some secondary outcomes (body fat percentage and waist circumference), will be measured by a person blinded to the assignment group.
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
- •4th, 5th and 6th- grade students from the participating primary school.
- •Have access to the internet.
- •Have an electronic device (e.g. computer, laptop, tablet, or smart cell phone).
- •Nutritional status: normal weight, overweight, or obesity (based on BMI-Z-score for age).
排除标准
- •Have a medical condition that affects body weight.
- •Takes medicine that affects body weight.
- •Participating in another intervention that affects body weight.
- •Have a condition that prevents physical activity.
- •Withdrawal of informed consent or assent.
- •Have a family member who is participating in the study.
结局指标
主要结局
Change in BMI Z-score
时间窗: Baseline to 4 months.
The measurement will be obtained using the sex, age, weight (kg) and height (m) of the participants.The height and weight will be combined (kg/m2) to obtain the BMI Z- score, expressed in units of standard deviation. The WHO Anthro Plus software will be used to obtain the BMI-Z-score for age.
次要结局
- Change in relative fat mass(Baseline to 4 months.)
- Change in nutrition knowledge(Baseline to 4 months)
- Attendance(At 4 months)
- Change in body fat percentage(Baseline and 4 months.)
- Change in quality of life(Baseline to 4 months)
- Retention(At 4 months)
- Acceptability(At 4 months)
- Change in weight(Baseline to 4 months)
- Change in physical activity and sedentary behaviors(Baseline to 4 months)
- Change in height(Baseline to 4 months)
- Change in waist circumference(Baseline to 4 months.)
- Change in food frequency consumption Food consumption frequency questionnaire(Baseline to 4 months.)
研究者
Rolando Giovanni Díaz Zavala
Principal Investigator
Universidad de Sonora