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
|
|
|
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
Collaborators
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
- Neil-Sztramko SE, Caldwell H, Dobbins M. School-based physical activity programs for promoting physical activity and fitness in children and adolescents aged 6 to 18. Cochrane Database Syst Rev. 2021 Sep 23;9(9):CD007651. doi: 10.1002/14651858.CD007651.pub3.
- Dong Y, Zou Z, Wang H, Dong B, Hu P, Ma Y, Song Y, Ma J. National School-Based Health Lifestyles Intervention in Chinese Children and Adolescents on Obesity and Hypertension. Front Pediatr. 2021 May 28;9:615283. doi: 10.3389/fped.2021.615283. eCollection 2021.
- Diao H, Wang H, Yang L, Li T. The impacts of multiple obesity-related interventions on quality of life in children and adolescents: a randomized controlled trial. Health Qual Life Outcomes. 2020 Jul 6;18(1):213. doi: 10.1186/s12955-020-01459-0.
- Zou Z, Yang Z, Yang Z, Wang X, Gao D, Dong Y, Ma J, Ma Y. Association of high birth weight with overweight and obesity in Chinese students aged 6-18 years: a national, cross-sectional study in China. BMJ Open. 2019 May 22;9(5):e024532. doi: 10.1136/bmjopen-2018-024532.
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
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.