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Active, Not Recruiting

NCT Number: NCT07203300

Obesity Prevention in School-aged Children

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

7 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University Health Science Center

Beijing, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. children's BMl change

    Time frame: 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 outcomes

  1. Carotid Intima-Media Thickness,CIMT

    Time frame: 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.

  2. Body Mass Index Z-score(BMI-z)

    Time frame: 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

  3. Waist Circumference

    Time frame: 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.

  4. waist-to-Height Ratio, WHtR

    Time frame: 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

  5. Body Composition

    Time frame: 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)

  6. Children's Eating Behaviors

    Time frame: 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

  7. Time Spent in Physical Activity

    Time frame: 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.

  8. Pubertal Milestones Time

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Peking University

Other

Collaborators

  • Shandong Maternal and Child Health Hospital

Registry information

Official study title

BehavioRal Intervention Assisted by diGital Health Technology for Preventing Obesity Among Children(BRIGHT-POC)

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Oct 2, 2025
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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