NCT06619925

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 1, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

October 1, 2024

Status Verified

September 1, 2024

Enrollment Period

1.2 years

First QC Date

September 28, 2024

Last Update Submit

September 28, 2024

Conditions

Keywords

common diseasesjoint preventionafter-school extended sports service

Outcome Measures

Primary Outcomes (5)

  • 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.

    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)

    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.

    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.

    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.

    At baseline, month 6 and month 12

Study Arms (2)

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

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

Interventions

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\&#39;s myopia and other physical and psychological well-being

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.

non-after school extended sports service

Eligibility Criteria

Age5 Years - 14 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Cao Cai yun

    Anhui Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tao Fang biao professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 28, 2024

First Posted

October 1, 2024

Study Start

October 1, 2024

Primary Completion

December 30, 2025

Study Completion

December 30, 2025

Last Updated

October 1, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share