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Clinical Trials/NCT03665857
NCT03665857
Completed
N/A

A School-based Multicomponent Intervention Study for Preventing Excessive Weight Gain Among Primary School Students

Peking University1 site in 1 country1,392 target enrollmentSeptember 11, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pediatric Obesity
Sponsor
Peking University
Enrollment
1392
Locations
1
Primary Endpoint
Students' BMI change immediately after the intervention completion
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 11, 2018
End Date
April 29, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Peking University
Responsible Party
Principal Investigator
Principal Investigator

Hai-Jun Wang

Professor in Department of Maternal and Child Health, School of Public Health, Peking University

Peking University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • The change of standing long jump test outcomes among students(at end of the 8-month intervention)
  • The change of school-level policies for childhood overweight/obesity(at end of the 8-month intervention)
  • 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)
  • The change of students' waist circumference(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(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(1. at end of the 8-month intervention; 2. at 15 months following the end of the intervention)
  • Students' BMI-Z change(1. at end of the 8-month intervention; 2. at 15 months following the end of the intervention)
  • Students' BMI change one year after the intervention completion(at 15 months following the end of the intervention)
  • The change of body fat percentage among students(at end of the 8-month intervention)
  • The change of one-minute rope skipping test outcomes among students(at end of the 8-month intervention)
  • The change of one-minute sit-up test outcomes among students(at end of the 8-month intervention)
  • The change of endurance run (50 metre*8) test outcomes among students(at end of the 8-month intervention)
  • The change of students' knowledge related to energy balance(at end of the 8-month intervention)
  • The change of students' sedentary behavior(at end of the 8-month intervention)
  • The change of students'duration of moderate-to-vigorous physical activity(at end of the 8-month intervention)
  • 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)
  • The change of students' eating behavior(at end of the 8-month intervention)

Study Sites (1)

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