A National School-based Health Lifestyles Interventions Among Chinese Children and Adolescents Against Obesity
Primary Purpose
Pediatric Obesity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
The Health Lifestyles Interventions
Sponsored by
About this trial
This is an interventional prevention trial for Pediatric Obesity focused on measuring Chinese multi-centered school based obesity intervention
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
The Health Lifestyles Interventions
Receive no intervention
Arm Description
Creating a supportive school, family and community environment; Health lifestyles educational strategies; Instruct and promote school physical education; The monitoring and instruction of obesity related behaviors (focus group)
Usual practice
Outcomes
Primary Outcome Measures
Change in the prevalence of overweight and obesity
Secondary Outcome Measures
Change in obesity related anthropometric measurements (waist circumference, hip circumference, blood pressure and skin fold thickness)
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)
Change in serum lipids and fasting glucose (fasting plasma glucose, fasting triglycerides, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol)
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)
Full Information
NCT ID
NCT02343588
First Posted
January 7, 2015
Last Updated
January 22, 2015
Sponsor
Sun Yat-sen University
Collaborators
Peking University, Central South University, Tianjin Medical University, Shanghai Municipal Center for Disease Control and Prevention, Chongqing Medical University, Ningxia Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02343588
Brief Title
A National School-based Health Lifestyles Interventions Among Chinese Children and Adolescents Against Obesity
Official Title
Development and Application of Appropriate Technology for Obesity Prevention and Control in Seven Centers in China
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
Peking University, Central South University, Tianjin Medical University, Shanghai Municipal Center for Disease Control and Prevention, Chongqing Medical University, Ningxia Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity
Keywords
Chinese multi-centered school based obesity intervention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The Health Lifestyles Interventions
Arm Type
Experimental
Arm Description
Creating a supportive school, family and community environment;
Health lifestyles educational strategies;
Instruct and promote school physical education;
The monitoring and instruction of obesity related behaviors (focus group)
Arm Title
Receive no intervention
Arm Type
No Intervention
Arm Description
Usual practice
Intervention Type
Behavioral
Intervention Name(s)
The Health Lifestyles Interventions
Intervention Description
Creating supportive school and family environment, whole intervention periods;
Health lifestyles educational strategies, 30min/week for education lessons and six times education activities;
Instruct and promote school physical education, whole intervention periods;
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
Primary Outcome Measure Information:
Title
Change in the prevalence of overweight and obesity
Time Frame
Baseline, Month 9
Secondary Outcome Measure Information:
Title
Change in obesity related anthropometric measurements (waist circumference, hip circumference, blood pressure and skin fold thickness)
Time Frame
Baseline, Month 9
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun MA, M.D
Organizational Affiliation
Peking University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jiayou LUO, M.D
Organizational Affiliation
Central South University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xin ZHANG, M.D
Organizational Affiliation
Tianjin Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chunyan LUO, M.D
Organizational Affiliation
Shanghai Municipal Center for Disease Control and Prevention & Shanghai Institutes of Preventive Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hong WANG, M.D
Organizational Affiliation
Chongqing Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Haiping ZHAO, M.D
Organizational Affiliation
Ningxia Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dehong PAN, M.D
Organizational Affiliation
Liaoning Health Supervision Bureau
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jin JING, M.D
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
34555181
Citation
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.
Results Reference
derived
PubMed Identifier
34123956
Citation
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.
Results Reference
derived
PubMed Identifier
32631401
Citation
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.
Results Reference
derived
PubMed Identifier
31122966
Citation
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.
Results Reference
derived
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A National School-based Health Lifestyles Interventions Among Chinese Children and Adolescents Against Obesity
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