A National School-based Health Lifestyles Interventions Among Chinese Children and Adolescents Against Obesity

January 22, 2015 updated by: CHEN Yajun, Sun Yat-sen University

Development and Application of Appropriate Technology for Obesity Prevention and Control in Seven Centers in China

The study was designed as a national multi-centered cluster randomized controlled trial involving more than 70,000 children and adolescents aged 7-18 years from 7 provinces in China. In each center, about 12-16 primary and secondary schools, with totally at least 10000 participants were randomly selected (Primary: Secondary=1:1). All of the selected schools were randomly allocated to either intervention or control group (Intervention: Control=1:1).The multi-components school-based and family-involved scheme was conducted within the intervention group for 9 month, while students in the control group followed their usual health practice. The intervention consisted of four components: a) Create supportive school and family environment, b) Health lifestyles education and related compulsory physical activities, c) Instruct and promote school physical education, d) Self-monitor obesity related behaviors. Four types of outcomes including anthropometric, behavioral, blood chemical and physical fitness were measured to assess the effectiveness of the intervention program.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70000

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

grade of 1 to 5 in primary schools and grade of 6 to 8 and 10 to 11 in secondary schools.

Exclusion Criteria:

Suffering or any history of disabilities, cardiovascular diseases, asthma, metabolic diseases, etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The Health Lifestyles Interventions
  1. Creating a supportive school, family and community environment;
  2. Health lifestyles educational strategies;
  3. Instruct and promote school physical education;
  4. The monitoring and instruction of obesity related behaviors (focus group)
Behavioral: The Health Lifestyles Interventions
  1. Creating supportive school and family environment, whole intervention periods;
  2. Health lifestyles educational strategies, 30min/week for education lessons and six times education activities;
  3. Instruct and promote school physical education, whole intervention periods;
  4. The monitoring and instruction of obesity related behaviors, once a week for physical activity and dietary behavioral log and once a month for parental monitor
No Intervention: Receive no intervention
Usual practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in the prevalence of overweight and obesity
Time Frame: Baseline, Month 9
Baseline, Month 9

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in obesity related anthropometric measurements (waist circumference, hip circumference, blood pressure and skin fold thickness)
Time Frame: Baseline, Month 9
Baseline, Month 9
Change in physical activity and dietary behaviors (Dietary, sedentary or physical activity behaviors and their determents, as measured by validated questionnaires (parent, children and school version)
Time Frame: Baseline, Month 9
Baseline, Month 9
Change in serum lipids and fasting glucose (fasting plasma glucose, fasting triglycerides, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol)
Time Frame: Baseline, Month 9
Baseline, Month 9
Change in physical fitness (standing-board jump, 50 meters speed run, 50 meters × 8 shuttle run (primary students) and run 800/1000 meters (secondary school students)
Time Frame: Baseline, Month 9
Baseline, Month 9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Collaborators

Peking University
Chongqing Medical University
Central South University
Tianjin Medical University
Ningxia Medical University
Shanghai Municipal Center for Disease Control and Prevention

Investigators

  • Study Chair: Jun MA, M.D, Peking University
  • Principal Investigator: Jiayou LUO, M.D, Central South University
  • Principal Investigator: Xin ZHANG, M.D, Tianjin Medical University
  • Principal Investigator: Chunyan LUO, M.D, Shanghai Municipal Center for Disease Control and Prevention & Shanghai Institutes of Preventive Medicine
  • Principal Investigator: Hong WANG, M.D, Chongqing Medical University
  • Principal Investigator: Haiping ZHAO, M.D, Ningxia Medical University
  • Principal Investigator: Dehong PAN, M.D, Liaoning Health Supervision Bureau
  • Principal Investigator: Jin JING, M.D, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

January 7, 2015

First Submitted That Met QC Criteria

January 21, 2015

First Posted (Estimate)

January 22, 2015

Study Record Updates

Last Update Posted (Estimate)

January 26, 2015

Last Update Submitted That Met QC Criteria

January 22, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201202010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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