Childhood Obesity PreventionNCT07203300
Obesity Prevention in School-aged Children
A study testing multicomponent, tiered intervention in people with Childhood Obesity Prevention, run by Peking University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 9 years
- Conditions the study is for
- Childhood Obesity Prevention
- What is being tested?
- multicomponent, tiered intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 9 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BehavioRal Intervention Assisted by diGital Health Technology for Preventing Obesity Among Children（BRIGHT-POC）
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.
Read the 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.
- Conditions
- Childhood Obesity Prevention
- Being tested
- multicomponent, tiered intervention
- Keywords
- Intervention, Obesity, Overweight, Children, School-aged
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multicomponent, tiered interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| A multi-level collaborative intervention | Experimental | 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. Receives: Behavioral: multicomponent, tiered intervention |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at the end of the 12-month intervention
Secondary outcomes (9)
Carotid Intima-Media Thickness,CIMT
Non-invasive measurement of carotid artery wall thickness via high-frequency ultrasound enables the assessment of subclinical atherosclerosis.
Measured: at the end of the 12-month intervention
Body Mass Index Z-score(BMI-z)
The BMI-z score is calculated based on height and weight using WHO standards
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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.
Measured: at the end of the 12-month intervention; at 24-month follow-up; at 36--month follow-up
Systolic and Diastolic Blood Pressures
Blood pressure is measured using an electronic sphygmomanometer with the child seated after resting, to assess cardiovascular health.
Measured: at the end of the 12-month intervention; at 24-month follow-up; at 36-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start1 Oct 2025
- Primary completion9 Oct 2026 (estimated)
- Study completion9 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood Obesity PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong Provincial Maternal and Child Health Care Hospital
- Responsible party
- Principal investigator, Hai-Jun Wang, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07203300
- Sponsor's protocol ID
- NO.2025-072
- Status last verified
- Mar 2026
- First submitted
- 24 Sep 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BehavioRal Intervention Assisted by diGital Health Technology for Preventing Obesity Among Children（BRIGHT-POC）
- ClinicalTrials.gov ID
- NCT07203300
- Acronym / sponsor ID
- NO.2025-072
- Conditions
- Childhood Obesity Prevention
- Keywords
- Intervention, Obesity, Overweight, Children, School-aged
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- Shandong Provincial Maternal and Child Health Care Hospital
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 9 Oct 2026 (estimated)
- Study completion
- 9 Oct 2028 (estimated)
- First posted
- 2 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A multi-level collaborative intervention | Experimental | Behavioral: multicomponent, tiered interventionThe 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. |
| 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. |
Who may qualify
- Ages
- 7 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multicomponent, tiered interventionthis 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. | Behavioural | A multi-level collaborative intervention |
Primary outcome
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.
9 secondary outcomes
Carotid Intima-Media Thickness,CIMT
Time frame: at the end of the 12-month intervention
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
Waist Circumference
Time frame: at the end of the 12-month intervention; at 24-month follow-up; at 36-month follow-up
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.
Body Composition
Time frame: at the end of the 12-month intervention; at 24-month follow-up; at 36-month follow-up
Children's Eating Behaviors
Time frame: at the end of the 12-month intervention
Time Spent in Physical Activity
Time frame: at the end of the 12-month intervention
Pubertal Milestones Time
Time frame: at the end of the 12-month intervention; at 24-month follow-up; at 36--month follow-up
Systolic and Diastolic Blood Pressures
Time frame: at the end of the 12-month intervention; at 24-month follow-up; at 36-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multicomponent, tiered intervention in people with Childhood Obesity Prevention, run by Peking University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
children's BMl change (time frame: at the end of the 12-month intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.