Pediatric ObesityNCT03665857
Childhood Obesity Intervention Study
A study testing a multicomponent intervention in people with Pediatric Obesity, run by Peking University at 1 site in China.
Trial summary
Globally, childhood overweight and obesity is a public health problem. Although the rising trend in children's body mass index (BMI) has plateaued in some high-income countries, it has accelerated in low- and middle-income countries. Read more about this study
- Who is it for?
- Ages 8 to 10 years
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- a multicomponent intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,392 participants
- Where
- 1 siteChina
- Study dates
- 11 Sep 2018to 29 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 to 10 years
- All sexes
- No healthy volunteers
- Child
- Eligibility criteria for schools The trial recruited a total of 24 schools. A convenience sample of 8 schools were selected from Beijing, Shanxi (Changzhi City) and Xinjiang (Urumqi City) respectively.
- Inclusion Criteria for schools:
- school leader agreeing to implement this intervention; requiring school teachers who can implement this intervention (e.g. school doctors, physical education teachers, physical education teachers, etc.); having at least 50 children from Grade 4 (at the start of the intervention) per school;having a even number of schools within each district.
- Exclusion Criteria for schools:
- boarding schools;schools solely for children with special skills; schools of minor ethnic groups; similar programme (focus on weight gain prevention) would be conducted in schools during the study period; schools having a cancelling or relocation plan during the study period.
- Eligibility criteria for classes One class per school will be selected if the estimated number of students enrolled in the programme is no less than 40 within the selected class; two classes per school will be selected if the estimated number of students enrolled in the programme is less than 40 within the selected class.
- Eligibility criteria for students Eligible children will be those whose primary caregivers will provide written consent to participate the study. After collecting students' medical history from their parents, we will exclude individuals suffering from or having a history of any cardiovascular and metabolic diseases, asthma and disabilities that limit their ability to perform physical activity.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Maternal and Child Health, School of Public Health, Peking University
Beijing
About this study
Official title: A School-based Multicomponent Intervention Study for Preventing Excessive Weight Gain Among Primary School Students
Globally, childhood overweight and obesity is a public health problem. Although the rising trend in children's body mass index (BMI) has plateaued in some high-income countries, it has accelerated in low- and middle-income countries. It is especially true amongst Chinese children with the annual increase rate of obesity during 2010-2014 greater than any other periods from 1985 to 2010.
With the dramatic economic development in China, children are now growing up in an increasingly 'obesogenic' environment. For example, the availability and ubiquity of computers and smart phones promote sedentary time, and access to energy dense food and sugar sweetened beverages is now widespread. Effective childhood obesity intervention is urgently needed in China. Although over 20 intervention studies for overweight/obesity among children and adolescents have been conducted in China since the 1990s, most of them had moderate or serious methodological weaknesses. For example, they did not report the number of students, schools or districts initially approached to participate, raising the possibility of selection and recruitment bias. Additionally, although they stated the allocation of intervention and control were randomized, no description of the method of randomization was reported.
Read more
Given the relative lack of high-quality interventions for childhood overweight/obesity, the investigators designed a cluster randomized controlled trial to assess the effectiveness of a multicomponent one-academic-year intervention among 24 primary schools (approximately 1200 students) in the eastern (Beijing), middle (Shanxi) and western (Xinjiang) part of China.
The study aims to identify: 1) whether the school-based intervention will be effective for preventing excessive weight gain among children; 2) whether the intervention will be beneficial for improving healthy eating, physical activity and reducing sedentary behaviors among children.
- Conditions
- Pediatric Obesity
- Being tested
- a multicomponent intervention
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a multicomponent interventionBehavioural
- School-level policies Students will not be allowed to drink sugar-sweetened beverage or eat unhealthy snacks in schools and drinking water will be advocated.
- Monitoring of students' weight and height Students will be monitored their weight and height monthly.
- Promotion of physical activity Students will be required to perform at least 60 minutes of moderate to vigorous physical activity each day in school and increase their physical activity outside school (reaching 30 minutes per weekday and one hour per weekend day).
- Health education activities Health education activities will be provided for students (10 sessions, 40 minutes per session, 2-3 weeks once), parents and school teachers.
- The mobile application The mobile application will disseminate health education knowledge among students, parents and teachers, monitor and provide feedback of students' BMI status and diet and physical activity behaviors.
| Study group | Role | What they receive |
|---|---|---|
| multicomponent intervention | Experimental | Schools in the intervention arm will receive a multicomponent intervention at the school-, parent- and student-level, with a mobile application to promote the collaboration between investigators, school teachers, parents and students.
The school-level intervention elements will include school policies and health education for teachers.
The parent-level intervention elements will include health education for parents and promoting students' physical activity at home.
The student-level intervention elements will include health education for students, promoting students' physical activity in school and monthly monitoring of weight and height. Receives: Behavioral: a multicomponent intervention |
| usual-care control | No intervention | Schools assigned to the control group will have usual education provision throughout their participation in the trial, and after finishing the study they will be offered the health education package, policy suggestion and materials as the schools in the multicomponent intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Students' BMI change immediately after the intervention completion
the difference between arms in the change of students' BMI immediately after the intervention completion
Measured: at end of the 8-month intervention
Secondary outcomes (17)
Students' BMI change one year after the intervention completion
the difference between arms in the change of students' BMI one year after the intervention completion
Measured: at 15 months following the end of the intervention
Students' BMI-Z change
use BMI to calculate BMI-Z score based on WHO growth chart
Measured: 1. at end of the 8-month intervention; 2. at 15 months following the end of the intervention
The change of prevalence of childhood overweight/obesity
define childhood overweight or obesity based on international BMI percentile criteria (IOTF)
Measured: 1. at end of the 8-month intervention; 2. at 15 months following the end of the intervention
The change of incidence of childhood overweight/obesity
define childhood overweight or obesity based on international BMI percentile criteria (IOTF)
Measured: 1. at end of the 8-month intervention; 2. at 15 months following the end of the intervention
The change of students' waist circumference
measure waist circumference
Measured: 1. at end of the 8-month intervention; 2. at 15 months following the end of the intervention
The change of students' waist-to-hip circumference ratio
measure waist circumference and hip circumference to calculate waist-to-hip circumference ratio
Measured: 1. at end of the 8-month intervention; 2. at 15 months following the end of the intervention
The change of both systolic and diastolic blood pressures among students
measure systolic and diastolic blood pressure by using electronic sphygmomanometer
Measured: 1. at end of the 8-month intervention; 2. at 15 months following the end of the intervention
The change of body fat percentage among students
measure body fat percentage by bioelectrical impedance analysis
Measured: at end of the 8-month intervention
The change of one-minute rope skipping test outcomes among students
count the number of one-minute rope skipping
Measured: at end of the 8-month intervention
The change of one-minute sit-up test outcomes among students
count the number of one-minute sit-up test
Measured: at end of the 8-month intervention
The change of endurance run (50 metre*8) test outcomes among students
record the time of endurance run (50 metre*8)
Measured: at end of the 8-month intervention
The change of standing long jump test outcomes among students
measure the distance of standing long jump
Measured: at end of the 8-month intervention
The change of students' knowledge related to energy balance
We will use a self-designed questionnaire including 8 items to assess the change of students' knowledge related to energy balance. For example, we will ask students, "Is it right that drinking sugar-sweetened beverage cannot substitute drinking water." Three choices will be provided (Right; Wrong; Not clear).
Measured: at end of the 8-month intervention
The change of students'duration of moderate-to-vigorous physical activity
Questions were designed based on a validated 7-day physical activity questionnaire. Kappa values for a two-week test-retest ranged from 0.46 to 0.79.
Measured: at end of the 8-month intervention
The change of students' eating behavior
We will use a parent-rated "Children Eating Behavior Questionnaire" (CEBQ) to assess students' eating behaviors, including responsiveness to food, enjoyment of food etc. This 35-item instrument has been shown relatively good reliability.
Measured: at end of the 8-month intervention
The change of students' sedentary behavior
We will use a self-designed questionnaire to ask the average duration of doing homework, watching television and playing electronic devices per day during the last week, respectively.
Measured: at end of the 8-month intervention
The change of school-level policies for childhood overweight/obesity
We will use a self-designed questionnaire to measure school obesity-related policies involving school administration, health education, management of overweight or obesity, communication with the families of students and school lunch.
Measured: at end of the 8-month intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start11 Sep 2018
- Primary completion30 Jun 2019
- Study completion29 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- 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
- 1,392 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hai-Jun Wang, Peking University
- Investigators
- Hai-Jun Wang, PhD, Principal investigator, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03665857
- Sponsor's protocol ID
- 2016YFC1300204
- Status last verified
- Sep 2021
- First submitted
- 3 Sep 2018
- Last updated
- 17 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yan S, Zhou S, Guo X, Lyu J, Wang H, Fang H, Wang HJ. Economic evaluation of a multi-component obesity prevention intervention in Chinese primary schools. BMC Med. 2025 Nov 24;23(1):653. doi: 10.1186/s12916-025-04451-x.
PubMed 41286848Liu Z, Gao P, Gao AY, Lin Y, Feng XX, Zhang F, Xu LQ, Niu WY, Fang H, Zhou S, Li WH, Yuan JH, Xu CX, Wu N, Li HJ, Wen LM, Patton GC, Wang HJ, Wu YF. Effectiveness of a Multifaceted Intervention for Prevention of Obesity in Primary School Children in China: A Cluster Randomized Clinical Trial. JAMA Pediatr. 2022 Jan 1;176(1):e214375. doi: 10.1001/jamapediatrics.2021.4375. Epub 2022 Jan 4.
PubMed 34747972Liu Z, Wu Y, Niu WY, Feng X, Lin Y, Gao A, Zhang F, Fang H, Gao P, Li HJ, Wang H; study team for the DECIDE-children study. A school-based, multi-faceted health promotion programme to prevent obesity among children: protocol of a cluster-randomised controlled trial (the DECIDE-Children study). BMJ Open. 2019 Nov 2;9(11):e027902. doi: 10.1136/bmjopen-2018-027902.
PubMed 31678935
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A School-based Multicomponent Intervention Study for Preventing Excessive Weight Gain Among Primary School Students
- ClinicalTrials.gov ID
- NCT03665857
- Acronym / sponsor ID
- 2016YFC1300204
- Conditions
- Pediatric Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,392 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 11 Sep 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 29 Apr 2021 (actual)
- First posted
- 11 Sep 2018 (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.
Globally, childhood overweight and obesity is a public health problem. Although the rising trend in children's body mass index (BMI) has plateaued in some high-income countries, it has accelerated in low- and middle-income countries. It is especially true amongst Chinese children with the annual increase rate of obesity during 2010-2014 greater than any other periods from 1985 to 2010.
With the dramatic economic development in China, children are now growing up in an increasingly 'obesogenic' environment. For example, the availability and ubiquity of computers and smart phones promote sedentary time, and access to energy dense food and sugar sweetened beverages is now widespread. Effective childhood obesity intervention is urgently needed in China. Although over 20 intervention studies for overweight/obesity among children and adolescents have been conducted in China since the 1990s, most of them had moderate or serious methodological weaknesses. For example, they did not report the number of students, schools or districts initially approached to participate, raising the possibility of selection and recruitment bias. Additionally, although they stated the allocation of intervention and control were randomized, no description of the method of randomization was reported.
Given the relative lack of high-quality interventions for childhood overweight/obesity, the investigators designed a cluster randomized controlled trial to assess the effectiveness of a multicomponent one-academic-year intervention among 24 primary schools (approximately 1200 students) in the eastern (Beijing), middle (Shanxi) and western (Xinjiang) part of China.
The study aims to identify: 1) whether the school-based intervention will be effective for preventing excessive weight gain among children; 2) whether the intervention will be beneficial for improving healthy eating, physical activity and reducing sedentary behaviors among children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| multicomponent intervention | Experimental | Behavioral: a multicomponent interventionSchools in the intervention arm will receive a multicomponent intervention at the school-, parent- and student-level, with a mobile application to promote the collaboration between investigators, school teachers, parents and students. The school-level intervention elements will include school policies and health education for teachers. The parent-level intervention elements will include health education for parents and promoting students' physical activity at home. The student-level intervention elements will include health education for students, promoting students' physical activity in school and monthly monitoring of weight and height. |
| usual-care control | No intervention | –Schools assigned to the control group will have usual education provision throughout their participation in the trial, and after finishing the study they will be offered the health education package, policy suggestion and materials as the schools in the multicomponent intervention group. |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| a multicomponent intervention1. School-level policies Students will not be allowed to drink sugar-sweetened beverage or eat unhealthy snacks in schools and drinking water will be advocated. 2. Monitoring of students' weight and height Students will be monitored their weight and height monthly. 3. Promotion of physical activity Students will be required to perform at least 60 minutes of moderate to vigorous physical activity each day in school and increase their physical activity outside school (reaching 30 minutes per weekday and one hour per weekend day). 4. Health education activities Health education activities will be provided for students (10 sessions, 40 minutes per session, 2-3 weeks once), parents and school teachers. 5. The mobile application The mobile application will disseminate health education knowledge among students, parents and teachers, monitor and provide feedback of students' BMI status and diet and physical activity behaviors. | Behavioural | multicomponent intervention |
Primary outcome
Students' BMI change immediately after the intervention completion
Time frame: at end of the 8-month intervention
the difference between arms in the change of students' BMI immediately after the intervention completion
17 secondary outcomes
Students' BMI change one year after the intervention completion
Time frame: at 15 months following the end of the intervention
Students' BMI-Z change
Time frame: 1. at end of the 8-month intervention; 2. at 15 months following the end of the intervention
The change of prevalence of childhood overweight/obesity
Time frame: 1. at end of the 8-month intervention; 2. at 15 months following the end of the intervention
The change of incidence of childhood overweight/obesity
Time frame: 1. at end of the 8-month intervention; 2. at 15 months following the end of the intervention
The change of students' waist circumference
Time frame: 1. at end of the 8-month intervention; 2. at 15 months following the end of the intervention
The change of students' waist-to-hip circumference ratio
Time frame: 1. at end of the 8-month intervention; 2. at 15 months following the end of the intervention
The change of both systolic and diastolic blood pressures among students
Time frame: 1. at end of the 8-month intervention; 2. at 15 months following the end of the intervention
The change of body fat percentage among students
Time frame: at end of the 8-month intervention
The change of one-minute rope skipping test outcomes among students
Time frame: at end of the 8-month intervention
The change of one-minute sit-up test outcomes among students
Time frame: at end of the 8-month intervention
The change of endurance run (50 metre*8) test outcomes among students
Time frame: at end of the 8-month intervention
The change of standing long jump test outcomes among students
Time frame: at end of the 8-month intervention
The change of students' knowledge related to energy balance
Time frame: at end of the 8-month intervention
The change of students'duration of moderate-to-vigorous physical activity
Time frame: at end of the 8-month intervention
The change of students' eating behavior
Time frame: at end of the 8-month intervention
The change of students' sedentary behavior
Time frame: at end of the 8-month intervention
The change of school-level policies for childhood overweight/obesity
Time frame: at end of the 8-month intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
- Derived from this study: PubMed 41286848Yan S, Zhou S, Guo X, Lyu J, Wang H, Fang H, Wang HJ. Economic evaluation of a multi-component obesity prevention intervention in Chinese primary schools. BMC Med. 2025 Nov 24;23(1):653. doi: 10.1186/s12916-025-04451-x.
- Derived from this study: PubMed 34747972Liu Z, Gao P, Gao AY, Lin Y, Feng XX, Zhang F, Xu LQ, Niu WY, Fang H, Zhou S, Li WH, Yuan JH, Xu CX, Wu N, Li HJ, Wen LM, Patton GC, Wang HJ, Wu YF. Effectiveness of a Multifaceted Intervention for Prevention of Obesity in Primary School Children in China: A Cluster Randomized Clinical Trial. JAMA Pediatr. 2022 Jan 1;176(1):e214375. doi: 10.1001/jamapediatrics.2021.4375. Epub 2022 Jan 4.
- Derived from this study: PubMed 31678935Liu Z, Wu Y, Niu WY, Feng X, Lin Y, Gao A, Zhang F, Fang H, Gao P, Li HJ, Wang H; study team for the DECIDE-children study. A school-based, multi-faceted health promotion programme to prevent obesity among children: protocol of a cluster-randomised controlled trial (the DECIDE-Children study). BMJ Open. 2019 Nov 2;9(11):e027902. doi: 10.1136/bmjopen-2018-027902.
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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.
Hai-Jun Wang, PhD principal investigator
Peking University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a multicomponent intervention in people with Pediatric Obesity, 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?
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: finished, as of the sponsor's last update on 17 Sep 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Students' BMI change immediately after the intervention completion (time frame: at end of the 8-month intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03665857, which also lists 3 linked publications.
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 17 Sep 2021.