- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06619925
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
Not yet recruiting
Intervention / Treatment
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
Observational
Enrollment (Estimated)
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
- Name: Tao Fang biao professor
- Phone Number: 13856986775
- Email: taofangbiao@126.com
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
- 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 |
Intervention / Treatment |
|---|---|
|
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
|
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.
|
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
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
Investigators
- 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)
October 1, 2024
Primary Completion (Estimated)
December 30, 2025
Study Completion (Estimated)
December 30, 2025
Study Registration Dates
First Submitted
September 28, 2024
First Submitted That Met QC Criteria
September 28, 2024
First Posted (Actual)
October 1, 2024
Study Record Updates
Last Update Posted (Actual)
October 1, 2024
Last Update Submitted That Met QC Criteria
September 28, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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