Childhood Obesity Prevention
Conditions
Keywords
Intervention, Obesity, Overweight, Children, School-aged
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALmulticomponent, tiered intervention
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.
Sponsors
Peking University
Shandong Maternal and Child Health Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
7 Years to 9 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| children's BMl change | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Carotid Intima-Media Thickness,CIMT | at the end of the 12-month intervention | Non-invasive measurement of carotid artery wall thickness via high-frequency ultrasound enables the assessment of subclinical atherosclerosis. |
| 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 | The BMI-z score is calculated based on height and weight using WHO standards |
| Waist Circumference | at the end of the 12-month intervention; at 24-month follow-up; at 36-month follow-up | 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. |
| waist-to-Height Ratio, WHtR | at the end of the 12-month intervention; at 24-month follow-up; at 36-month follow-up. | Calculated by dividing waist circumference by height, used as an indicator of fat distribution and risk for metabolic complications |
| Body Composition | at the end of the 12-month intervention; at 24-month follow-up; at 36-month follow-up | Body fat percentage is assessed using a bioelectrical impedance analyzer (MC-780A, TANITA, Tokyo, Japan) |
| Children's Eating Behaviors | at the end of the 12-month intervention | Assessed using the Children's Eating Behavior Questionnaire (CEBO), measuring dimensions such as food responsiveness satiety responsiveness, and emotional eating |
| Time Spent in Physical Activity | at the end of the 12-month intervention | Evaluated using the Children's Leisure Activities Study Survey (CLAss), assessing the amount and type of physical activity and sedentary behavior, including screen time. |
| Pubertal Milestones Time | at the end of the 12-month intervention; at 24-month follow-up; at 36--month follow-up | 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. |
Countries
China
Outcome results
None listed