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| Name | Class |
|---|---|
| Shandong Maternal and Child Health Hospital | UNKNOWN |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A multi-level collaborative intervention | Experimental | The intervention includes: â‘ 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. â‘¡ 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. â‘¢ 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. |
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| usual-care control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| multicomponent, tiered intervention | Behavioral | this intervention is a multi-level collaborative health management system-a digital health platform with four core modules: the Health Education Module, the Growth Monitoring Module, the Health Behavior Module, and the Home-School Partnership Module. The platform facilitates collaboration among schools, families, and hospitals as follows: Schools utilize the platform to manage tasks outlined in health policies, such as delivering educational content, monitoring student activity and diet, and recording monthly height/weight measurements via the Growth Monitoring Module. Families access the platform to receive multi-format health education, set goals, and review personalized feedback. The Home-School Partnership Module also enables communication for motivational interviewing sessions conducted by professionals offline or by phone. Hospitals leverage the platform to provide professional guidance and medical support, ensuring interventions are medically sound. |
| Measure | Description | Time Frame |
|---|---|---|
| children's BMl change | 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. | at the end of the 12-month intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Carotid Intima-Media Thickness,CIMT | Non-invasive measurement of carotid artery wall thickness via high-frequency ultrasound enables the assessment of subclinical atherosclerosis. | at the end of the 12-month intervention |
| Body Mass Index Z-score(BMI-z) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Health Science Center | Beijing | China |
Individual participant data (lPD) will not be shared publicly due to ethical considerations. in accordance with the study's ethical approval and informed consent procedures, the data contain potentially sensitive personal health information and are protected to ensure participant confidentiality and privacy. Data access is therefore restricted to authorized research personnel only and cannot be made publicly available.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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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.
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The BMI-z score is calculated based on height and weight using WHO standards |
| at the end of the 12-month intervention; at 24-month follow-up; at 36-month follow-up |
| Waist Circumference | Waist circumference is measured at the midpoint between the lower margin of the last palpable rib and the top of the iliac crest to evaluate central adiposity. | at the end of the 12-month intervention; at 24-month follow-up; at 36-month follow-up |
| waist-to-Height Ratio, WHtR | Calculated by dividing waist circumference by height, used as an indicator of fat distribution and risk for metabolic complications | at the end of the 12-month intervention; at 24-month follow-up; at 36-month follow-up. |
| Body Composition | Body fat percentage is assessed using a bioelectrical impedance analyzer (MC-780A, TANITA, Tokyo, Japan) | at the end of the 12-month intervention; at 24-month follow-up; at 36-month follow-up |
| Children's Eating Behaviors | Assessed using the Children's Eating Behavior Questionnaire (CEBO), measuring dimensions such as food responsiveness satiety responsiveness, and emotional eating | at the end of the 12-month intervention |
| Time Spent in Physical Activity | Evaluated using the Children's Leisure Activities Study Survey (CLAss), assessing the amount and type of physical activity and sedentary behavior, including screen time. | at the end of the 12-month intervention |
| Pubertal Milestones Time | Pubertal milestones are defined as a sequence of observable, critical physiological markers that arise during the process of adolescent development. Typically assessed through self-report questionnaires, these milestones signify the individual's transition from childhood into sexual maturity. | at the end of the 12-month intervention; at 24-month follow-up; at 36--month follow-up |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |