Research on Weight Management of School-age Children in Fangshan District Based on a Digital Intelligence Platform
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,400
- 试验地点
- 1
- 主要终点
- Children's BMl change
研究概览
简要总结
The goal of this study is to evaluate the effectiveness of a school-based weight management intervention delivered through a digital platform (WeChat) in preventing excessive weight gain and improving health behaviors in school-aged children in Fangshan District, Beijing. The main questions it aims to answer are:
Does the intervention group show a significantly lower mean increase in BMI, body fat percentage, and waist circumference compared to the control group? Does the intervention group show a significantly lower obesity rate and new obesity incidence compared to the control group? Does the intervention group show significant improvements in healthy eating, sedentary behavior, sleep, physical activity, and physical fitness test scores compared to the control group? Researchers will compare children in intervention schools (who receive the multi-level intervention targeting students, families, and schools, supported by a digital platform for behavior monitoring and feedback) to children in control schools (who do not receive the intervention during the study period).
Participants in the intervention group will: (1) attend 10 student health education sessions; (2) have their physical activity at school increased to 60 minutes/day of moderate-to-vigorous activity; (3) have parents attend health education lectures and use a WeChat platform to receive health information, log child health data, and receive automated feedback; (4) have their height, weight, waist circumference, and body composition measured monthly by school health staff; and (5) be followed with assessments at 6, 12, and 24 months.
详细描述
Study Design This is a two-arm, cluster-randomized controlled trial (cRCT) designed to evaluate the implementation and effectiveness of a multi-level, digital platform-based weight management intervention for school-aged children in Fangshan District, Beijing. The study consists of a 12-month active intervention period followed by an additional 12 months of follow-up, totaling 24 months of observation post-baseline.
Setting and Participants The study will be conducted in 10 primary schools in Fangshan District, Beijing, recruited through the Fangshan District School Health Care Center. Schools will be randomized (1:1 ratio) to either the intervention or control arm. Participants will be third-grade students (aged 8-9 years) at baseline.
Inclusion Criteria: Eligible students must provide signed informed consent from a parent or guardian and their own assent.
Exclusion Criteria: Students with pre-existing medical conditions that contraindicate physical activity or secondary obesity of known endocrine origin will be excluded from the analytic sample but may participate in the general program activities to avoid exclusion-based stigma.
InterventionThe intervention targets three levels-students, families, and schools-over one academic year. A digital platform embedded within WeChat serves as the central hub for knowledge dissemination, behavior monitoring, and automated feedback.
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)
入排标准
- 年龄范围
- 8 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Schools will be selected based on the consent of primary leadership, demonstrated cooperation, and availability of necessary personnel (e.g., school health professionals).
- •Classes will be limited to grades 2 and 3, with teachers showing strong willingness to collaborate.
- •Both parental informed consent and child assent are required for participation.
排除标准
- •Schools will be excluded if they cater to special populations (e.g., schools for children with disabilities), are involved in other obesity-related interventions within the specified timeframe, or plan to close or relocate within two years.
- •Children will be excluded if they have histories of major organ diseases (e.g., cardiac, pulmonary, hepatic, or renal conditions), special diets (e.g., vegetarian), pathological eating disorders, physical limitations affecting activity, or obesity due to endocrine disorders or medication side effects.
研究组 & 干预措施
A multi-level collaborative intervention
Participants in this arm will receive a 12-month multi-level weight management intervention delivered via a digital intelligence platform (embedded in WeChat). The intervention targets three levels:
Student level: 10 bi-weekly health education sessions and daily promotion of 60-minute moderate-to-vigorous physical activity (MVPA).
Family level: Two parental seminars and access to the digital platform for health education "push" notifications, behavioral monitoring (diet, sleep, activity), and automated monthly BMI feedback reports.
School level: Environmental changes including healthy school policies (limiting sugar-sweetened beverages), health promotion materials (posters), and teacher training.
Monthly anthropometric measurements and weekly self-weighing will be conducted to monitor progress.
干预措施: Digital Intelligence Platform-based Multi-level Weight Management (Behavioral)
usual-care control
Participants in this arm will follow the standard school curriculum and health education as mandated by the local education authority. They will not have access to the digital weight management platform or the specific intervention modules during the 12-month active study period. To ensure ethical standards, control schools will receive the intervention materials and resources after the completion of the 24-month follow-up assessment (wait-list control design). Baseline and follow-up data collection (anthropometric measurements and questionnaires) will be conducted at the same intervals as the intervention group.
结局指标
主要结局
Children's BMl change
时间窗: at the end of the 12-month intervention
Calculated based on height and weight using WHO standards. The primary outcome is the difference between two arms in the change of children's BMI from baseline to the end of the follow-up
次要结局
- Prevalence of Obesity among School-aged Children(at the end of the 12-month intervention; at 24-month follow-up)
- Body Mass Index Z-score(BMI-z)(at the end of the 12-month intervention; at 24-month follow-up)
- Waist Circumference(at the end of the 12-month intervention; at 24-month follow-up)
- Children's Eating Behaviors(at the end of the 12-month intervention)
- Time Spent in Physical Activity(at the end of the 12-month intervention)
- Time Spent in Sedentary Behavior(at the end of the 12-month interventionl)
- body fat percent (BFP)(at the end of the 12-month intervention; at 24-month follow-up)
研究者
Hai-Jun Wang
Professor in Department of Maternal and Child Health, School of Public Health, Peking University
Peking University