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Study on Obesity Intervention With Physical Exercise Among Students in Changping District, Beijing

Primary Purpose

Pediatric Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physical activity guidance
Health education
Sponsored by
Hai-Jun Wang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pediatric Obesity focused on measuring Obesity, Physical activity, Schoolchildren, Intervention Studies

Eligibility Criteria

7 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Grade of 2 to 5 in elementary schools and grade of 1 to 2 in middle 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

    Intervention

    Control

    Arm Description

    Physical activity guidance Health education

    Receive no intervention

    Outcomes

    Primary Outcome Measures

    Change in body mass index (BMI)

    Secondary Outcome Measures

    Change in obesity-related anthropometric measurements
    Change in serum lipids and fasting glucose
    Change in dietary and physical activity behaviors
    Change in physical fitness
    Change in percentage of overweight&obesity

    Full Information

    First Posted
    February 26, 2014
    Last Updated
    April 28, 2015
    Sponsor
    Hai-Jun Wang
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02074332
    Brief Title
    Study on Obesity Intervention With Physical Exercise Among Students in Changping District, Beijing
    Official Title
    Development and Application of Appropriate Technology for Obesity Prevention and Control -- Study on Personalized Aerobic and Appropriate Exercise Technology
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2012 (undefined)
    Primary Completion Date
    January 2013 (Actual)
    Study Completion Date
    February 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Hai-Jun Wang

    4. Oversight

    5. Study Description

    Brief Summary
    The primary objective of this study is to assess the effectiveness of a school based physical activity programme on obesity and related health outcomes in young schoolchildren.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pediatric Obesity
    Keywords
    Obesity, Physical activity, Schoolchildren, Intervention Studies

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    921 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    Physical activity guidance Health education
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Receive no intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Physical activity guidance
    Other Intervention Name(s)
    Physical activity programme
    Intervention Description
    Physical education class amelioration Additional physical activities for overweight&obese students Family physical activities Parent involvement
    Intervention Type
    Behavioral
    Intervention Name(s)
    Health education
    Intervention Description
    Knowledge of obesity prevention and control
    Primary Outcome Measure Information:
    Title
    Change in body mass index (BMI)
    Time Frame
    Baseline, Month 3
    Secondary Outcome Measure Information:
    Title
    Change in obesity-related anthropometric measurements
    Time Frame
    Baseline, Month 3
    Title
    Change in serum lipids and fasting glucose
    Time Frame
    Baseline，Month 3
    Title
    Change in dietary and physical activity behaviors
    Time Frame
    Baseline, Month 3
    Title
    Change in physical fitness
    Time Frame
    Baseline, Month 3
    Title
    Change in percentage of overweight&obesity
    Time Frame
    Baseline, 3 Month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Maximum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Grade of 2 to 5 in elementary schools and grade of 1 to 2 in middle 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
    Hai-Jun Wang, PhD
    Organizational Affiliation
    Institute of Child and Adolescent Health,Peking University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25510313
    Citation
    Li XH, Lin S, Guo H, Huang Y, Wu L, Zhang Z, Ma J, Wang HJ. Effectiveness of a school-based physical activity intervention on obesity in school children: a nonrandomized controlled trial. BMC Public Health. 2014 Dec 16;14:1282. doi: 10.1186/1471-2458-14-1282.
    Results Reference
    derived

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    Study on Obesity Intervention With Physical Exercise Among Students in Changping District, Beijing

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