- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04587765
Effect of Extra-curricular Sports Activities After School on Primary School Children's Academic Performance
April 23, 2022 updated by: Zhongshan Ophthalmic Center, Sun Yat-sen University
Effect of Extra-curricular Sports Activities After School on Primary School Children's Academic Performance in China: A Non-inferiority Cluster Randomized Controlled Trial
The process of urbanization and the rapid development of information technology have greatly reduced the space and time available for children's outdoor activities.
In this study, we expect to study the effects of the addition of physical education classes after school on the academic performance, mental health, physical fitness, and myopia among primary school children.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Urbanization has led to a shrinking of the space suitable for residential activities and a dramatic change in the behavioural patterns, which is particularly evident in children.
The spread and development of information technology has reduced children's time for physical activity.
Previous studies have found that physical activity is essential for the growth and development of adolescents, preventing and reducing obesity, slowing the development of myopia, and is closely linked to mental health.
However, parents in China are concerned that increased outdoor activity will reduce the amount of time spent studying and affect academic performance.
Currently, there is a lack of strong evidence on the impact of physical activity on academic performance.
In this study, we propose to provide after-school physical education classes for students in primary schools in a rapidly urbanizing area, and assess the effects of the intervention on children's academic performance, physical fitness, myopia, and mental health to provide evidence for the development of educational programs and arrangements for after-school activities.
Study Type
Interventional
Enrollment (Actual)
2032
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangxi
-
Ganzhou, Jiangxi, China, 342300
- Yudu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 11 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Pupils in the third and fourth grades of primary schools in Yudu County;
- Voluntary participation in this study with consent and informed consent signed by guardians.
Exclusion Criteria:
Exclusion criteria for school
- Lack of a third or fourth grade;
- Average class size less than 30 students;
- No conditions for two classes to play sports at the same time.
- Exclusion criteria for students 4. Two or more days Monday to Friday not available to participate in studies under the project programme; 5. Unsuitability for health or physical reasons to participate in sports activities; 6. Refusal to sign informed consent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Extra sports group
The group follows the schedule of school teaching programme.
Extra-curricular sports classes will be organized and provided in this group of schools in the afternoon after school until 6 p.m. (Monday to Friday).
|
The group follows the schedule of school teaching programme.
Extra-curricular sports classes will be organized and provided in this group of schools in the afternoon after school until 6 p.m. (Monday to Friday).
|
No Intervention: Conventional group
The group follows the schedule of school teaching programme.
Students arrange their own after-school time after school.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mathematics test scores at the end of the first academic year
Time Frame: 1 year
|
The test paper will follow the design principles of International Mathematics and science learning, and referring to the local unified examination papers of grade three and grade four, the unified examination questions are formulated to evaluate the students' learning in school
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Combined physical fitness test score at the end of the first academic year
Time Frame: 1 year
|
Total scores of physical fitness tests according to 2018 National Physical Fitness Survey Monitoring Programme
|
1 year
|
Incidence of myopia in the first school year
Time Frame: 1 year
|
Spherical equivalent after mydriasis ≤ -0.5 D in either eye
|
1 year
|
Happiness Assessment at the end of the first academic year
Time Frame: 1 year
|
Happiness score is rated by Chinese version of the WHO-5 including 5 items with ratings: 0, at no time-5, all of the time.
The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being
|
1 year
|
Mathematics test scores at the end of the second school year
Time Frame: up to 2 years
|
The test paper will follow the design principles of International Mathematics and science learning, and referring to the local unified examination papers of grade three and grade four, the unified examination questions are formulated to evaluate the students' learning in school
|
up to 2 years
|
Combined physical fitness test scores at the end of the second academic year
Time Frame: up to 2 years
|
Total scores of physical fitness tests according to 2018 National Physical Fitness Survey Monitoring Programme
|
up to 2 years
|
Cumulative incidence of myopia over two school years
Time Frame: up to 2 years
|
Spherical equivalent after mydriasis ≤ -0.5 D in either eye
|
up to 2 years
|
Happiness assessment at the second school year
Time Frame: up to 2 years
|
Happiness score is rated by Chinese (September, 2007) version of the WHO-5 including 5 items with ratings: 0, at no time-5, all of the time.
The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being
|
up to 2 years
|
Satisfaction assessment
Time Frame: 1 year
|
Satisfaction of pupils in the intervention group with the addition of PE after school will be measured by a questionnaire which is designed by reaserchers.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Yangfa Zeng, Master, Zhongshan Ophthalmic Center, Sun Yat-sen University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- He M, Zeng J, Liu Y, Xu J, Pokharel GP, Ellwein LB. Refractive error and visual impairment in urban children in southern china. Invest Ophthalmol Vis Sci. 2004 Mar;45(3):793-9. doi: 10.1167/iovs.03-1051.
- He M, Xiang F, Zeng Y, Mai J, Chen Q, Zhang J, Smith W, Rose K, Morgan IG. Effect of Time Spent Outdoors at School on the Development of Myopia Among Children in China: A Randomized Clinical Trial. JAMA. 2015 Sep 15;314(11):1142-8. doi: 10.1001/jama.2015.10803.
- Nunes HEG, Silva DAS, Goncalves ECA. Prevalence and factors associated with stages of behavior change for physical activity in adolescents: a systematic review. World J Pediatr. 2017 Jun;13(3):202-209. doi: 10.1007/s12519-017-0027-4. Epub 2017 Mar 22.
- Cai Y, Zhu X, Wu X. Overweight, obesity, and screen-time viewing among Chinese school-aged children: National prevalence estimates from the 2016 Physical Activity and Fitness in China-The Youth Study. J Sport Health Sci. 2017 Dec;6(4):404-409. doi: 10.1016/j.jshs.2017.09.002. Epub 2017 Sep 6.
- Gray C, Gibbons R, Larouche R, Sandseter EB, Bienenstock A, Brussoni M, Chabot G, Herrington S, Janssen I, Pickett W, Power M, Stanger N, Sampson M, Tremblay MS. What Is the Relationship between Outdoor Time and Physical Activity, Sedentary Behaviour, and Physical Fitness in Children? A Systematic Review. Int J Environ Res Public Health. 2015 Jun 8;12(6):6455-74. doi: 10.3390/ijerph120606455.
- Grgic J, Dumuid D, Bengoechea EG, Shrestha N, Bauman A, Olds T, Pedisic Z. Health outcomes associated with reallocations of time between sleep, sedentary behaviour, and physical activity: a systematic scoping review of isotemporal substitution studies. Int J Behav Nutr Phys Act. 2018 Jul 13;15(1):69. doi: 10.1186/s12966-018-0691-3.
- French AN, Morgan IG, Mitchell P, Rose KA. Risk factors for incident myopia in Australian schoolchildren: the Sydney adolescent vascular and eye study. Ophthalmology. 2013 Oct;120(10):2100-8. doi: 10.1016/j.ophtha.2013.02.035. Epub 2013 May 11.
- Biddle SJ, Asare M. Physical activity and mental health in children and adolescents: a review of reviews. Br J Sports Med. 2011 Sep;45(11):886-95. doi: 10.1136/bjsports-2011-090185. Epub 2011 Aug 1.
- Alvarez-Bueno C, Pesce C, Cavero-Redondo I, Sanchez-Lopez M, Garrido-Miguel M, Martinez-Vizcaino V. Academic Achievement and Physical Activity: A Meta-analysis. Pediatrics. 2017 Dec;140(6):e20171498. doi: 10.1542/peds.2017-1498.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 14, 2020
Primary Completion (Actual)
November 20, 2021
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
October 2, 2020
First Submitted That Met QC Criteria
October 7, 2020
First Posted (Actual)
October 14, 2020
Study Record Updates
Last Update Posted (Actual)
April 26, 2022
Last Update Submitted That Met QC Criteria
April 23, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SYSU-OPH-008
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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