Childhood Obesity Intervention Study

Not Applicable

Completed

• Conditions: Pediatric Obesity
• Interventions: Behavioral: a multicomponent intervention

• Registration Number: NCT03665857
• Lead Sponsor: Peking University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-03
• Study First Submitted QC: 2018-09-07
• Study Start: 2018-09-11
• Study First Posted: 2018-09-11
• Primary Completion: 2019-06-30
• Study Completion: 2021-04-29
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-16
• Last Update Posted: 2021-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1392

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
multicomponent intervention	a multicomponent intervention	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.

Primary Outcome Measures

Name	Time	Method
Students' BMI change immediately after the intervention completion	at end of the 8-month intervention	the difference between arms in the change of students' BMI immediately after the intervention completion

Secondary Outcome Measures

Name	Time	Method
The change of standing long jump test outcomes among students	at end of the 8-month intervention	measure the distance of standing long jump
The change of school-level policies for childhood overweight/obesity	at end of the 8-month intervention	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.
The change of prevalence of childhood overweight/obesity	1. at end of the 8-month intervention; 2. at 15 months following the end of the intervention	define childhood overweight or obesity based on international BMI percentile criteria (IOTF)
The change of students' waist circumference	1. at end of the 8-month intervention; 2. at 15 months following the end of the intervention	measure waist circumference
The change of both systolic and diastolic blood pressures among students	1. at end of the 8-month intervention; 2. at 15 months following the end of the intervention	measure systolic and diastolic blood pressure by using electronic sphygmomanometer
The change of incidence of childhood overweight/obesity	1. at end of the 8-month intervention; 2. at 15 months following the end of the intervention	define childhood overweight or obesity based on international BMI percentile criteria (IOTF)
Students' BMI-Z change	1. at end of the 8-month intervention; 2. at 15 months following the end of the intervention	use BMI to calculate BMI-Z score based on WHO growth chart
Students' BMI change one year after the intervention completion	at 15 months following the end of the intervention	the difference between arms in the change of students' BMI one year after the intervention completion
The change of body fat percentage among students	at end of the 8-month intervention	measure body fat percentage by bioelectrical impedance analysis
The change of one-minute rope skipping test outcomes among students	at end of the 8-month intervention	count the number of one-minute rope skipping
The change of students' knowledge related to energy balance	at end of the 8-month intervention	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).
The change of students' sedentary behavior	at end of the 8-month intervention	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.
The change of students' waist-to-hip circumference ratio	1. at end of the 8-month intervention; 2. at 15 months following the end of the intervention	measure waist circumference and hip circumference to calculate waist-to-hip circumference ratio
The change of one-minute sit-up test outcomes among students	at end of the 8-month intervention	count the number of one-minute sit-up test
The change of endurance run (50 metre*8) test outcomes among students	at end of the 8-month intervention	record the time of endurance run (50 metre\*8)
The change of students'duration of moderate-to-vigorous physical activity	at end of the 8-month intervention	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.
The change of students' eating behavior	at end of the 8-month intervention	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.

Trial Locations

Locations (1)

Department of Maternal and Child Health, School of Public Health, Peking University; 🇨🇳 Beijing, China