Common DiseasesNCT06619925
The Role of After-school Exercise Services in Promoting Myopia and Physical and Mental Health in Children
An observational study of Common Diseases and Joint Prevention, run by Fangbiao Tao.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Common Diseases, Joint Prevention, Students
- What is being tested?
- after-school extended sports service and non-after school extended sports service
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 30 Dec 2025
- Phase
- Observational
- 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 5 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Students in grades 1-6 in a number of primary schools in a city were selected for the study
Who may be able to join
- 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;
Who cannot join
- 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;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Being tested
- after-school extended sports service, non-after school extended sports service
- Keywords
- common diseases, joint prevention, after-school extended sports service
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
after-school extended sports serviceBehavioural
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 serviceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: after-school extended sports service | |
| 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. Receives: Behavioral: non-after school extended sports service |
What is being measured
The primary outcome is the main question the study is designed to answer.
body mass index
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.
Measured: At baseline, month 6 and month 12
cardiorespiratory fitness
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)
Measured: At baseline, month 6 and month 12
Spinal curvature abnormalities
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.
Measured: At baseline, month 6 and month 12
mental health
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.
Measured: At baseline, month 6 and month 12
myopic
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.
Measured: At baseline, month 6 and month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start1 Oct 2024 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common DiseasesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fangbiao Tao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fangbiao Tao, Anhui Medical University
- Investigators
- Cao Cai yun, Principal investigator, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06619925
- Sponsor's protocol ID
- 20240909
- Status last verified
- Sep 2024
- First submitted
- 28 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study of After-school Exercise Services in Promoting Myopia and Physical and Mental Health in Children
- ClinicalTrials.gov ID
- NCT06619925
- Acronym / sponsor ID
- 20240909
- Keywords
- common diseases, joint prevention, after-school extended sports service
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Fangbiao TaoUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 1 Oct 2024 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| after-school extended sports service | – | Behavioral: after-school extended sports serviceImpact 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 | – | Behavioral: non-after school extended sports serviceStudents 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. |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Students in grades 1-6 in a number of primary schools in a city were selected for the study
Key inclusion criteria (2 listed)
- ① Those who voluntarily participate in the after-school extended hours service;
Key exclusion criteria (2 listed)
- ① Unfit to participate in sports activities for health or physical reasons; ② Suffering from glaucoma, glaucoma and other diseases.
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 |
|---|---|---|
| after-school extended sports serviceImpact 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 | Behavioural | after-school extended sports service |
| non-after school extended sports serviceStudents 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. | Behavioural | non-after school extended sports service |
Primary outcome
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.
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)
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Cao Cai yun principal investigator
Anhui Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of Common Diseases and Joint Prevention, run by Fangbiao Tao.
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 2 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: status not confirmed, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tao Fang biao professor (13856986775, taofangbiao@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
body mass index (time frame: At baseline, month 6 and month 12). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2024.