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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
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pediatric Obesity focused on measuring Chinese multi-centered school based obesity intervention

Eligibility Criteria

7 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

    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
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    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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