Clinical trial NCT03665857: Childhood Obesity Intervention Study
Official title: A School-based Multicomponent Intervention Study for Preventing Excessive Weight Gain Among Primary School Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2018-09-11
Enrollment: 1392
Sex: ALL
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.


Eligibility criteria: 1. 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.

1. 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.
2. 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.

     2. 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.

     3. 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.

Primary outcomes:
measure: Students' BMI change immediately after the intervention completion
timeFrame: at end of the 8-month intervention
Secondary outcomes:
measure: Students' BMI change one year after the intervention completion
timeFrame: at 15 months following the end of the intervention
measure: Students' BMI-Z change
timeFrame: 1. at end of the 8-month intervention; 2. at 15 months following the end of the intervention
measure: The change of prevalence of childhood overweight/obesity
timeFrame: 1. at end of the 8-month intervention; 2. at 15 months following the end of the intervention
measure: The change of incidence of childhood overweight/obesity
timeFrame: 1. at end of the 8-month intervention; 2. at 15 months following the end of the intervention
measure: The change of students' waist circumference
timeFrame: 1. at end of the 8-month intervention; 2. at 15 months following the end of the intervention
measure: The change of students' waist-to-hip circumference ratio
timeFrame: 1. at end of the 8-month intervention; 2. at 15 months following the end of the intervention
measure: The change of both systolic and diastolic blood pressures among students
timeFrame: 1. at end of the 8-month intervention; 2. at 15 months following the end of the intervention
measure: The change of body fat percentage among students
timeFrame: at end of the 8-month intervention
measure: The change of one-minute rope skipping test outcomes among students
timeFrame: at end of the 8-month intervention
measure: The change of one-minute sit-up test outcomes among students
timeFrame: at end of the 8-month intervention
measure: The change of endurance run (50 metre*8) test outcomes among students
timeFrame: at end of the 8-month intervention
measure: The change of standing long jump test outcomes among students
timeFrame: at end of the 8-month intervention
measure: The change of students' knowledge related to energy balance
timeFrame: at end of the 8-month intervention
measure: The change of students'duration of moderate-to-vigorous physical activity
timeFrame: at end of the 8-month intervention
measure: The change of students' eating behavior
timeFrame: at end of the 8-month intervention
measure: The change of students' sedentary behavior
timeFrame: at end of the 8-month intervention
measure: The change of school-level policies for childhood overweight/obesity
timeFrame: at end of the 8-month intervention
Other outcomes:
measure: The stage of change related to weight reduction behavior
timeFrame: at end of the 8-month intervention
Locations:
city: Beijing
country: China
facility: Department of Maternal and Child Health, School of Public Health, Peking University
Study officials:
affiliation: Peking University
name: Hai-Jun Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liu 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.
citation: Liu 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.