Extra-curricular SportsNCT04587765
Effect of Extra-curricular Sports Activities After School on Primary School Children's Academic Performance
A study testing Extra-curricular sports in people with Extra-curricular Sports, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Extra-curricular Sports
- What is being tested?
- Extra-curricular sports
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,032 participants
- Where
- 1 siteChina
- Study dates
- 14 Oct 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Extra-curricular Sports
- Being tested
- Extra-curricular sports
- Keywords
- academic performance, physical activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extra-curricular sportsBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Extra sports group | Experimental | 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). Receives: Behavioral: Extra-curricular sports |
| Conventional group | No intervention | The group follows the schedule of school teaching programme. Students arrange their own after-school time after school. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mathematics test scores at the end of the first academic 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
Measured: 1 year
Secondary outcomes (8)
Combined physical fitness test score at the end of the first academic year
Total scores of physical fitness tests according to 2018 National Physical Fitness Survey Monitoring Programme
Measured: 1 year
Incidence of myopia in the first school year
Spherical equivalent after mydriasis ≤ -0.5 D in either eye
Measured: 1 year
Happiness Assessment at the end of the first academic 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
Measured: 1 year
Mathematics test scores at the end of the second school 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
Measured: up to 2 years
Combined physical fitness test scores at the end of the second academic year
Total scores of physical fitness tests according to 2018 National Physical Fitness Survey Monitoring Programme
Measured: up to 2 years
Cumulative incidence of myopia over two school years
Spherical equivalent after mydriasis ≤ -0.5 D in either eye
Measured: up to 2 years
Happiness assessment at the second school year
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
Measured: up to 2 years
Satisfaction assessment
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start14 Oct 2020
- Primary completion20 Nov 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Extra-curricular SportsStudies of the same condition, open and under way.
- More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- open,non-inferiority cluster randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 2,032 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yangfa Zeng, Master, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04587765
- Sponsor's protocol ID
- SYSU-OPH-008
- Status last verified
- Apr 2022
- First submitted
- 2 Oct 2020
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28332101Cai 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.
PubMed 30356639He 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.
PubMed 14985292Gray 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.
PubMed 26062039Grgic 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.
PubMed 30001713French 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.
PubMed 23672971He 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.
PubMed 26372583Biddle 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.
PubMed 21807669Alvarez-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.
PubMed 29175972Wang D, Xiong R, Zhang J, Han X, Jin L, Liu W, Qu Y, Chen Q, Chen S, Chen X, Li Y, He M, Zeng Y, Liu Y. Effect of Extracurricular After-School Physical Activities on Academic Performance of Schoolchildren: A Cluster Randomized Clinical Trial. JAMA Pediatr. 2023 Nov 1;177(11):1141-1148. doi: 10.1001/jamapediatrics.2023.3615.
PubMed 37721735
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Extra-curricular Sports Activities After School on Primary School Children's Academic Performance in China: A Non-inferiority Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04587765
- Acronym / sponsor ID
- SYSU-OPH-008
- Conditions
- Extra-curricular Sports
- Keywords
- academic performance, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,032 participants (actual)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 14 Oct 2020 (actual)
- Primary completion
- 20 Nov 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- open,non-inferiority cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Extra sports group | Experimental | Behavioral: Extra-curricular sportsThe 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). |
| Conventional group | No intervention | –The group follows the schedule of school teaching programme. Students arrange their own after-school time after school. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extra-curricular sportsThe 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). | Behavioural | Extra sports group |
Primary outcome
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
8 secondary outcomes
Combined physical fitness test score at the end of the first academic year
Time frame: 1 year
Incidence of myopia in the first school year
Time frame: 1 year
Happiness Assessment at the end of the first academic year
Time frame: 1 year
Mathematics test scores at the end of the second school year
Time frame: up to 2 years
Combined physical fitness test scores at the end of the second academic year
Time frame: up to 2 years
Cumulative incidence of myopia over two school years
Time frame: up to 2 years
Happiness assessment at the second school year
Time frame: up to 2 years
Satisfaction assessment
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- Background: PubMed 28332101Nunes 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.
- Background: PubMed 30356639Cai 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.
- Background: PubMed 14985292He 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.
- Background: PubMed 26062039Gray 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.
- Background: PubMed 30001713Grgic 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.
- Background: PubMed 23672971French 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.
- Background: PubMed 26372583He 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.
- Background: PubMed 21807669Biddle 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.
- Background: PubMed 29175972Alvarez-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.
- Derived from this study: PubMed 37721735Wang D, Xiong R, Zhang J, Han X, Jin L, Liu W, Qu Y, Chen Q, Chen S, Chen X, Li Y, He M, Zeng Y, Liu Y. Effect of Extracurricular After-School Physical Activities on Academic Performance of Schoolchildren: A Cluster Randomized Clinical Trial. JAMA Pediatr. 2023 Nov 1;177(11):1141-1148. doi: 10.1001/jamapediatrics.2023.3615.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yangfa Zeng, Master principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extra-curricular sports in people with Extra-curricular Sports, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mathematics test scores at the end of the first academic year (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04587765, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2022.