The Role of After-school Exercise Services in Promoting Myopia and Physical and Mental Health in Children

September 28, 2024 updated by: Fangbiao Tao

A Cohort Study of After-school Exercise Services in Promoting Myopia and Physical and Mental Health in Children

This project is a prospective cohort study to evaluate the impact of after-school extended physical education services on the visual health, physical health indicators, and mental health of children and adolescents participating in these services over a one-year period. The study collected data on the participation rate, duration, activity content, and organisational form of the after-school extended hours service through a questionnaire; the demographic characteristics, sleeping habits, and dietary habits of the participants through a self-administered questionnaire on the multidisease behaviour of children and adolescents; the intensity of the activities of the students who participated in the after-school extended hours service was investigated through an accelerometer and a physical activity questionnaire; and data on students' visual acuity, body mass index, and mental health status were collected through a medical check-up. Students' visual acuity data, body mass index, maximum oxygen uptake, and other indicators of physical health and mental health were collected through physical examination, and data on changes in one year were collected through half-yearly/follow-up visits to establish a cohort to evaluate the effects of after-school extended hours services on students' myopia rates, physical health and mental health levels by different types, intensity and duration of exercise.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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

Students in grades 1-6 of several primary schools were selected as the study subjects. According to the baseline survey, the study subjects were divided into after-school extended physical education service group and non-after-school extended physical education service group, and their behavioural habits as well as the contents of the after-school extended physical education service, visual acuity, BMI, cardiorespiratory fitness, spinal curvature abnormality, and mental health were investigated by means of questionnaires and other tools, so as to analyse the relationship between after-school extended physical education service and the physical and mental health of the students.

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.
Observational

Enrollment (Estimated)

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.
2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Students in grades 1-6 in a number of primary schools in a city were selected for the study

Description

Inclusion Criteria:

  • ① Those who voluntarily participate in the after-school extended hours service;

    • Those who voluntarily participate in this study and sign the informed consent; ③ Basic reading, writing and comprehension skills to understand the questionnaire and be able to answer it;

Exclusion Criteria:

  • ① Unfit to participate in sports activities for health or physical reasons; ② Suffering from glaucoma, glaucoma and other diseases.

    • Those who suffer from glaucoma, strabismus, refractive error and other eye diseases that affect vision;

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
after-school extended sports service
Impact of voluntary participation in different types (e.g. outdoor physical activities, indoor physical activities, ball games, calisthenics, etc.), intensity and duration of after-school extended physical education services on children's myopia and other physical and psychological well-being
Behavioral: after-school extended sports service
Impact of voluntary participation in different types (e.g. outdoor physical activities, indoor physical activities, ball games, calisthenics, etc.), intensity and duration of after-school extended physical education services on children's myopia and other physical and psychological well-being
non-after school extended sports service
Students in the same grade as the exposure group but participating in after-school non-physical education extended services (e.g., homework help, static activities such as calligraphy, chess, etc.) served as a control group, aiming to maximise the control of the influence of potential factors other than physical activity on the results of the study.
Behavioral: non-after school extended sports service
Students in the same grade as the exposure group but participating in after-school non-physical education extended services (e.g., homework help, static activities such as calligraphy, chess, etc.) served as a control group, aiming to maximise the control of the influence of potential factors other than physical activity on the results of the study.

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
body mass index
Time Frame: At baseline, month 6 and month 12
Among school-age children (5-9 years) and adolescents (10-19 years), BMI to determine whether they are obese or underweight depends on age and gender. Referring to the 2014 National Physical Fitness Standards for Students cut-off values were classified as normal, low weight, overweight, and obese.
At baseline, month 6 and month 12
cardiorespiratory fitness
Time Frame: At baseline, month 6 and month 12
Cardiorespiratory endurance in children and adolescents was measured using the 20 m shutle run test.Extrapolated maximal oxygen uptake in children and adolescents using a 20 m round trip run = 62.103 + (0.302*Number of 20 mSRTs) - (0.877*BMI) - (4.874*Sex) - (0.465*Age) (M=0, F=1)
At baseline, month 6 and month 12
Spinal curvature abnormalities
Time Frame: At baseline, month 6 and month 12
Referring to the standard 'Primary screening of spinal curvature abnormalities in children and adolescents' (GB/T 16133-2014), the visual inspection method, the forward bending test (FBT), and the angle of trunk rotation measurement (ATR), and the combination of the three methods were used to carry out the screening of spinal curvature abnormalities in children and adolescents. The type of scoliosis was assessed according to the combination of the three tests, and was classified as no scoliosis, scoliosis I degree, scoliosis II degree, and scoliosis III degree.
At baseline, month 6 and month 12
mental health
Time Frame: At baseline, month 6 and month 12
Mental health status was measured using the Strengths and Difficulties Questionnaire (SDQ) (Chinese version) , which consists of 25 questions with five dimensions: emotional problems, peer relationships, conduct problems, hyperactivity/attention problems and pro-social behaviour. Each question was assigned a score of 0-2 according to 'does not meet', 'somewhat meets' and 'fully meets', with some of the entries reversed; the total score for all questions was calculated, with a range of 0-40, with higher scores representing closer to abnormality.
At baseline, month 6 and month 12
myopic
Time Frame: At baseline, month 6 and month 12
Screening myopia was defined as SE≤-0.50D determined by computerised optometry under non-ciliary muscle paralysis when children and adolescents aged 6 years or older had a UCVA < 5.0; mild myopia: -3.00D< SE≤-0.50D; moderate myopia: -6.00D <SE≤﹣3.00D; high myopia: SE ≤ -6.00 D. Myopia progression was defined as myopia progression if the study subjects baseline myopia progressed to more severe myopia at follow-up.
At baseline, month 6 and month 12

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.
Fangbiao Tao

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: Cao Cai yun, Anhui Medical University

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 (Estimated)

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 1, 2024

Primary Completion (Estimated)

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.
December 30, 2025

Study Completion (Estimated)

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 30, 2025

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).
September 28, 2024

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.
September 28, 2024

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 1, 2024

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.
October 1, 2024

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.
September 28, 2024

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.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • 20240909

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

product manufactured in and exported from the U.S.

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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