Physical Exercise BehaviourNCT06667219
Influencing Factors and Interventions of Physical Exercise Behaviour of 6-Year-Old Children in Guangdong, China
A study testing A relevant physical fitness training program intervention in people with Physical Exercise Behaviour and Fundamental Motor Skills, run by Universiti Sains Malaysia at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 7 years
- Conditions the study is for
- Physical Exercise Behaviour, Fundamental Motor Skills, 6-Year-Old Children
- What is being tested?
- A relevant physical fitness training program intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 17 Apr 2024to 17 Oct 2024
- Phase
- Interventional
- 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 6 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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?
Read more
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.
- Being tested
- A relevant physical fitness training program intervention, control group,Physical exercise using kindergarten standards
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A relevant physical fitness training program interventionBehavioural
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.
control group,Physical exercise using kindergarten standardsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: control group,Physical exercise using kindergarten standards |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start17 Apr 2024
- Primary completion17 Aug 2024
- Study completion17 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical Exercise BehaviourStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Haiyan, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06667219
- Sponsor's protocol ID
- USM/JEPeM/KK/23030260
- Status last verified
- Apr 2024
- First submitted
- 24 Oct 2024
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influencing Factors and Interventions of Physical Exercise Behaviour of 6-Year-Old Children in Guangdong, China
- ClinicalTrials.gov ID
- NCT06667219
- Acronym / sponsor ID
- USM/JEPeM/KK/23030260
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- 17 Aug 2024 (actual)
- Study completion
- 17 Oct 2024 (actual)
- First posted
- 31 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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group, a children's physical fitness training program | Experimental | Behavioral: A relevant physical fitness training program interventionLength:12 weeks, 40 minutes one time, twice a week. Intervention content: The intervention will be conducted using a relevant physical fitness training program. |
| control group, Physical exercise using kindergarten standards | Experimental | Behavioral: control group,Physical exercise using kindergarten standardsDuration: 12 weeks. Content: Physical exercise using kindergarten standards. |
Who may qualify
- Ages
- 6 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| A relevant physical fitness training program intervention54children 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. | Behavioural | Intervention group, a children's physical fitness training program |
| control group,Physical exercise using kindergarten standards54 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. | Behavioural | control group, Physical exercise using kindergarten standards |
Primary outcome
Changes in test values of 13 indicators of Fundmental Motor Skills in 6-year-old children at 12 weeks
Time frame: 5 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A relevant physical fitness training program intervention in people with Physical Exercise Behaviour and Fundamental Motor Skills, run by Universiti Sains Malaysia at 1 site in China.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in test values of 13 indicators of Fundmental Motor Skills in 6-year-old children at 12 weeks (time frame: 5 months). 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 31 Oct 2024.