NCT02074332

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
921

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 28, 2014

Completed
Last Updated

April 29, 2015

Status Verified

April 1, 2015

Enrollment Period

4 months

First QC Date

February 26, 2014

Last Update Submit

April 28, 2015

Conditions

Keywords

ObesityPhysical activitySchoolchildrenIntervention Studies

Outcome Measures

Primary Outcomes (1)

  • Change in body mass index (BMI)

    Baseline, Month 3

Secondary Outcomes (5)

  • Change in obesity-related anthropometric measurements

    Baseline, Month 3

  • Change in serum lipids and fasting glucose

    Baseline,Month 3

  • Change in dietary and physical activity behaviors

    Baseline, Month 3

  • Change in physical fitness

    Baseline, Month 3

  • Change in percentage of overweight&obesity

    Baseline, 3 Month

Study Arms (2)

Intervention

EXPERIMENTAL

Physical activity guidance Health education

Behavioral: Physical activity guidanceBehavioral: Health education

Control

NO INTERVENTION

Receive no intervention

Interventions

Physical education class amelioration Additional physical activities for overweight\&obese students Family physical activities Parent involvement

Also known as: Physical activity programme
Intervention

Knowledge of obesity prevention and control

Intervention

Eligibility Criteria

Age7 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Suffering or any history of disabilities, cardiovascular diseases, asthma, metabolic diseases, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Pediatric ObesityObesityMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Hai-Jun Wang, PhD

    Institute of Child and Adolescent Health,Peking University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 26, 2014

First Posted

February 28, 2014

Study Start

September 1, 2012

Primary Completion

January 1, 2013

Study Completion

February 1, 2014

Last Updated

April 29, 2015

Record last verified: 2015-04