BehavioRal Intervention Assisted by diGital Health Technology for Preventing Obesity Among Children（BRIGHT-POC）
试验速览
- 阶段
- 不适用
- 状态
- 进行中（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
This cluster-randomized trial will develop and test an intervention technology for school-aged children. The program combines digital health technology and personalized behavior intervention through a WeChat platform.
Our main question is: Does this integrated approach improve obesity related outcomes and behaviors in children?
Investigator will:
- Compare children receiving the program with those receiving usual care.
- Track physical measures and health behaviors to measure effectiveness of intervention.
- Evaluate the program's safety, implementation process, and cost-effectiveness. Findings will determine if this approach should be expanded to more communities.
详细描述
This study is a one-year cluster randomized controlled trial (cRCT) to be conducted in 10 eligible primary schools. The schools will be randomly allocated to either the intervention group or the control group in a 1:1 ratio.
The technical core of this research involves the development of a multi-level collaborative health management technology system based on a WeChat platform. This platform will serve as the core intervention technology, providing functional support to the intervention group schools, their students, and parents.
Students in the control group schools will receive routine health education and physical examination procedures during the trial period.
To evaluate the effectiveness of this intervention technology, outcome measure data will be collected at multiple time points. All participating students will undergo physical measurements and health behavior questionnaire surveys at baseline (T0) and at the end of the intervention period (T1, i.e., 12 months post-baseline). The changes in primary and secondary outcome measures from baseline (T0) to the end of the intervention (T1) will be compared between the intervention and control groups.
Furthermore, to assess the long-term sustainability of the intervention effects, investigator plan to conduct follow-up surveys annually at 24 months (T2) and 36months (T3) post-intervention for both the intervention and control group students. Generalized linear mixed model or Generalized Estimating Equations (GEE) will be constructed to longitudinally analyze the differential trajectories of health outcomes between the two groups, thereby comprehensively evaluating the immediate effects and long-term sustainability of this integrated intervention technology.
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
Randomization will be performed after the baseline survey. The assessors measuring children's health indicators(e.g.,weight and height) will be blinded at follow up phases.
入排标准
- 年龄范围
- 7 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
The intervention includes: ① Health education: A trained teacher per class delivered 10 lessons during regular health classes, teaching five core messages in simple terms: not eating excessively; not drinking sugar--sweetened beverage; eating less high--energy food; less sedentary behaviours; performing more physical activity. ② Enhanced physical activity and BMI monitoring: physical education teachers guided daily moderate-to-vigorous activity. Teachers monthly measured height/weight, entered data into an app; children received feedback on BMI category and change. Weekly private weight measurements were also taken. ③ Family involvement: Implemented via offline meetings and a digital platform, the family-focused intervention provides health education and behavior change support, enabling parents to track BMI, log behaviors, review feedback, and access personalized consultations from medical professionals.
干预措施: multicomponent, tiered intervention (Behavioral)
usual-care control
In the control group, participating school-aged children will receive no intervention during the study period and will continue their routine educational and management practices without modification. After the study is fully completed, control group school-aged children will have access to all intervention materials and health education resources developed for this project.
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
- Body Mass Index Z-score(BMI-z)(at the end of the 12-month intervention; at 24-month follow-up; at 36-month follow-up)
- Waist Circumference(at the end of the 12-month intervention; at 24-month follow-up; at 36-month follow-up)
- waist-to-Height Ratio, WHtR(at the end of the 12-month intervention; at 24-month follow-up; at 36-month follow-up.)
- Body Composition(at the end of the 12-month intervention; at 24-month follow-up; at 36-month follow-up)
- Carotid Intima-Media Thickness,CIMT(at the end of the 12-month intervention)
- 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)
- Pubertal Milestones Time(at the end of the 12-month intervention; at 24-month follow-up; at 36--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