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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02074332
Other study ID # IRB00001052-12046
Secondary ID
Status Completed
Phase N/A
First received February 26, 2014
Last updated April 28, 2015
Start date September 2012
Est. completion date February 2014

Study information

Verified date April 2015
Source Peking University
Contact n/a
Is FDA regulated No
Health authority China: Ministry of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 921
Est. completion date February 2014
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Both
Age group 7 Years to 15 Years
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Physical activity guidance
Physical education class amelioration Additional physical activities for overweight&obese students Family physical activities Parent involvement
Health education
Knowledge of obesity prevention and control

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hai-Jun Wang

Outcome

Type Measure Description Time frame Safety issue
Primary Change in body mass index (BMI) Baseline, Month 3 No
Secondary Change in obesity-related anthropometric measurements Baseline, Month 3 No
Secondary Change in serum lipids and fasting glucose Baseline,Month 3 No
Secondary Change in dietary and physical activity behaviors Baseline, Month 3 No
Secondary Change in physical fitness Baseline, Month 3 No
Secondary Change in percentage of overweight&obesity Baseline, 3 Month No
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