NCT06667219

Brief Summary

The goal of this clinical trial is to examine the relationship between children's physical exercise behavior and children's Fundamental Motor Skills (FMS) before and after changing the influencing factors of 6-year-old children's physical exercise behavior in Guangdong Province, China. The main question it aims to answer is: Is there any change of the relationship (time, group, and interaction) between 6-year-old children's physical exercise behaviour and children's Fundamental Motor Skills (FMS) before and after the physical activity intervention of the influencing factors in Guangdong Province, China? Participants will: Intervention group, Length: 12 weeks, 40 minutes, twice a week. The intervention will be conducted using a relevant physical fitness training program. Control group, Length: 12 weeks. Content: Physical exercise using kindergarten standards. Researchers will compare the data before and after the intervention to know whether the Fundamental Motor Skills (FMS) of 6-year-old children have changed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 17, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2024

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 31, 2024

Completed
Last Updated

October 31, 2024

Status Verified

April 1, 2024

Enrollment Period

4 months

First QC Date

October 24, 2024

Last Update Submit

October 29, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes in test values of 13 indicators of Fundmental Motor Skills in 6-year-old children at 12 weeks

    The FMS is measured with the tool TGMD-3. TGMD-3 is scored based on the completion quality of children. The unit of measurement is "scores". The 13-item test consists of two subscales: six locomotor skills (LM) (i.e., run, gallop, hop, slide, jump, and skip) and seven ball skills (BS), formerly known as object control skills (i.e., forehand strike, two-hand strike, overhand throw, underhand throw, dribble, catch, and kick). According to the TGMD-3, each skill has a set of performance criteria that is evaluated. In this case, raw scores for locomotor skills could range from 0 to 46. Similarly, ball skills could range from 0 to 54. The total score of all movements was 100 scores. The higher score represents a higher level of motor skill development, and the low score indicates a lack of some critical movement development.

    5 months

Study Arms (2)

Intervention group, a children's physical fitness training program

EXPERIMENTAL

Length:12 weeks, 40 minutes one time, twice a week. Intervention content: The intervention will be conducted using a relevant physical fitness training program.

Behavioral: A relevant physical fitness training program intervention

control group, Physical exercise using kindergarten standards

EXPERIMENTAL

Duration: 12 weeks. Content: Physical exercise using kindergarten standards.

Behavioral: control group,Physical exercise using kindergarten standards

Interventions

54children who participated in after-school sports activities in Guangzhou Kindergarten (Guangzhou, China) were randomly selected as the experimental group. Intervention group Length:12 weeks, 40 minutes, twice a week. Intervention content: The intervention will be conducted using a relevant physical fitness training program , as follows: Week 1 / 4 first: Run quickly;Durian ball;Throw;Fast jogging (200 m) Week 1 / 4 second: Dodge run,Raise your legs high and go over the small hurdles; Durian ball (standing on one foot);standing long jump Week 2 / 5 first: Bow step transformation jump;Throw;Turn back 10 meters Week 2 / 5 second: Hop ;Stand on one foot with your eyes open Week 3 / 6 first:Skip over the small hurdles;Durian ball (standing on one foot);Throw; Fast jogging (200 m) Week 3 / 6 second:Jump on your feet and dodge running;Durian ball (squat);Jump support Weeks 7-12,Repeat the above content. FMS index was tested before the experiment, and once after the intervention.

Intervention group, a children's physical fitness training program

54 children who did not participate in after-school sports activities were selected as the control group. control group Duration: 12 weeks. Content: Physical exercise using kindergarten standards. FMS index was tested the same to intervention group before the test and FMS index was measured once again after 12 weeks.

control group, Physical exercise using kindergarten standards

Eligibility Criteria

Age6 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Preschool children aged 6 years old in Guangdong, China;
  • Children who are of Chinese nationality;
  • Male and female;
  • Parents/guardians signed an informed consent form;

You may not qualify if:

  • Have a mental illness with cognitive impairment problems;
  • Children with speech or ear function impairment;
  • Recent or imminent surgery (within 3 months), or medical co-morbidities;
  • Parents/guardians did not sign the informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou Huali College

Guangzhou, Guangdong, 511325, China

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Children will be invited to participate in the after-school physical activity experiment.This experiment will include more than 108 participants randomly assigned to the experimental group (n=54) and the control group (n=54) (randomly selected two kindergartens, one as experimental group and one as control group). All studies will be conducted in Zengcheng Kindergarten, Guangdong, China. Children will participate in this study and participats (parents/guardians) will receive a prescription for childhood exercise.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 24, 2024

First Posted

October 31, 2024

Study Start

April 17, 2024

Primary Completion

August 17, 2024

Study Completion

October 17, 2024

Last Updated

October 31, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations