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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2032

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • China
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

7 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Pupils in the third and fourth grades of primary schools in Yudu County;
  2. Voluntary participation in this study with consent and informed consent signed by guardians.

Exclusion Criteria:

  • Exclusion criteria for school

    1. Lack of a third or fourth grade;
    2. Average class size less than 30 students;
    3. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
Behavioral: Extra-curricular sports
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhongshan Ophthalmic Center, Sun Yat-sen University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 14, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 20, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 14, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 26, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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