Preschool ChildrenNCT05290584
Influence of Preschool Children's Fundamental Movement Skills, Physical Activity, and Physical Fitness on Executive Function: A Prospective Observation Study
An observational study of Preschool Children and Executive Function, run by Hong Kong Baptist University at 2 sites in China.
Trial summary
Background: Early childhood is the most critical and rapid period of complete and healthy physical and cognitive development in human life. Executive function appears in early childhood and develops rapidly through complex coaction between environment and developmental processes. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Preschool Children, Executive Function, Fundamental Movement Skills
- How many people
- 505 participants
- Where
- 2 sitesChina
- Study dates
- 11 Oct 2021to 30 Jun 2023
- 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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children will be recruited from kindergartens in Zhuhai through the support of Zhuhai Early Childhood Education Association and United International College. These two organizations have cooperated with many local kindergartens, which can help to recruit preschoolers.
Who may be able to join
- aged 3-5 years
- normally developing children with corresponding cognitive ability to participate in the data collection
- without heart, lung, liver, kidney and other important organ diseases or any neurological disorders (e.g., intellectual disability or autism spectrum disorder) that prevent children from performing normal PA.
Who cannot join
- children with cognitive disability
- with heart, lung, liver, kidney and other important organ diseases or any neurological disorders (e.g., intellectual disability or autism spectrum disorder) that prevent children from performing normal PA.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Hong Kong Baptist University
Hong Kong, Hong Kong
Beijing Normal University - Hong Kong Baptist University United International College
Zhuhai, Guangdong
About this study
Background: Early childhood is the most critical and rapid period of complete and healthy physical and cognitive development in human life. Executive function appears in early childhood and develops rapidly through complex coaction between environment and developmental processes. The preschool period is also characterized by a rapid growth in fundamental movement skills, physical activity and physical fitness. The scientific research on the relationship between fundamental movement skills, physical activity, physical fitness and executive function in preschoolers remains to be explored.
Objective: The purpose of this study was to examine the cross-sectional relationship between fundamental movement skills, physical activity, physical fitness and executive function in preschool children while controlling for potential confounding variables, examine the prospective influence (independent and interactive role) of preschooler's fundamental movement skills, physical activity and physical fitness on executive function, observe the preschoolers' fundamental movement skills, physical activity, physical fitness and executive function changes with age, and investigate gender and age differences in preschoolers' fundamental movement skills, physical activity, physical fitness and executive function.
Method: The proposed study consists of two phases, phase 1 is a cross-sectional study. Five hundred and five children aged 3-5 years will be recruited. The Test of Gross Motor Development Third Edition (TGMD-3) was used to assess children's fundamental movement skills. Preschool children's physical activity was monitored by accelerometer ActiGraph GT3X-BT. Physical fitness was tested using handgrip, 4*10m shuttle run, 20m shuttle run, 30s sit-ups, sit and reach, and balance beam. Executive function was tested by computer-based tasks including animal stroop, safari training and stop signal task. Phase 2 is a 12-month follow-up study. In the phase 2, all children enrolled in the baseline study will be followed up, the measurements and contents of the follow-up are the same as the baseline instrument.
- Conditions
- Preschool Children, Executive Function, Fundamental Movement Skills, Physical Activity, Physical Fitness
- Medical subject headings
- Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of body mass index
Weight (measured in kilograms) and height (measured in meters) will be combined to report body mass index in kg/m^2. Change of body mass index between baseline and follow-up test is assessed.
Measured: through study completion, 12 months
Change of fundamental movement skills
The Test of Gross Motor Development: Third Edition (TGMD-3) will be used to assess children's fundamental movement skills. The TGMD-3 provides two subscale and an overall composite score. Change of fundamental movement skills between baseline and follow-up test is assessed.
Measured: through study completion, 12 months
Change of sedentary behavior time
Physical activity level will be objectively monitored using a tri-axial accelerometer ActiGraph GT3X-BT and is analyzed with the ActiLife 6.13 data analysis software. Counts per minute are recorded.The activity with lower than 819 counts per minute is categorized as sedentary behaviors. Overall time in sedentary behavior in minute is recorded as sedentary behavior time. Change of sedentary behavior time between baseline and follow-up test is assessed.
Measured: through study completion, 12 months
Change of light physical activity time
Physical activity level will be objectively monitored using a tri-axial accelerometer ActiGraph GT3X-BT and is analyzed with the ActiLife 6.13 data analysis software. Counts per minute are recorded. The activity with higher than 820 counts per minute but lower than 3907 counts per minute is categorized as light physical activity. Overall time in light physical activity in minute is recorded as light physical activity time. Change of light physical activity time between baseline and follow-up test is assessed.
Measured: through study completion, 12 months
Change of moderate-to-vigorous physical activity time
Physical activity level will be objectively monitored using a tri-axial accelerometer ActiGraph GT3X-BT and is analyzed with the ActiLife 6.13 data analysis software. Counts per minute are recorded. The activity with higher than 3908 counts per minute is categorized as moderate-to-vigorous physical activity. Overall time in moderate-to-vigorous physical activity in minute is recorded as moderate-to-vigorous physical activity time. Change of moderate-to-vigorous physical activity time between baseline and post-intervention tests is assessed. Change of moderate-to-vigorous physical activity time between baseline and follow-up test is assessed.
Measured: through study completion, 12 months
Change of cardiorespiratory fitness
A 20-meter shuttle run is used to assess cardiorespiratory fitness. During the test, participants run back and forth on two running tracks 20 meters apart at an initial speed of 8.0km/h, followed by an increase of 0.5km/h per minute. Using a compact disc (CD) to control the speed, which systematically increases during the test. During the test, participants run back and forth, based on the timing of a beep from the CD recorder. If the participant fails to pass the other end of the 20 meters distance before the beep (after two attempts), the test is terminated and the number of shuttle legs completed is recorded and converted to an estimate of aerobic capacity. As we work with preschoolers, the track will be marked and the children will be led by an adult so they can master the pace of the run. Change of cardiorespiratory fitness between baseline and follow-up test is assessed.
Measured: through study completion, 12 months
Change of flexibility
Flexibility will be assessed by sit and reach. During the test, the participants sit barefoot on the mat, feet straight with heels together, toes separated naturally, and the sole of their feet on the tester plate. Then the participant is asked to slowly bend forward and use their arms to push the edge of a movable board as far as they can without bending knees. The test is repeated twice, and the maximum value is recorded. Change of flexibility between baseline and follow-up test is assessed.
Measured: through study completion, 12 months
Change of muscular endurance
Sit ups will be used to assess the muscular endurance of the trunk. The participants lie on their back with knees bent and arms crossed on the other shoulder. They stand up, sit up, and return to the starting position. The assistant holds the child's feet. The number of lifts in 30 seconds performed correctly to the seated position is recorded.Change of muscular endurance between baseline and follow-up test is assessed.
Measured: through study completion, 12 months
Change of muscular strength
Hand grip strength is a classic strength test with high safety, accuracy, and suitability for younger children. Muscle strength is measured using a WCS-100 electronic dynamometer (Shanghai Wanqing Electronics Co., LTD.). During the test, participants stand in a quiet environment, relaxed, with their arms hanging down naturally. They hold the dynamometer, adjust the grip distance, grasp the dynamometer once with maximum strength, and the value is recorded. The left and right hands are measured alternately for three times, and the maximum value is recorded. To allow for proper rest, the interval between the three tests should be at least 15 seconds. Change of muscular strength between baseline and follow-up test is assessed.
Measured: through study completion, 12 months
Change of balance
Dynamic balance will be measured by the balance beam test. The participants will stand on the platform behind the starting line, face the balance beam (3 m long, 10 cm wide, and 30 cm high), and raise their arms horizontally. When participants hear the start command, they will move their feet to the finish line in turn. The tester will give orders on the front side of the participant, start the stopwatch at the same time when the participant starts, and follow the participant to the finish line. At the same time, the tester will pay attention to observe the movements of the participant to prevent accidents. When either tiptoe of the participant crosses the finish line, the tester stops the clock immediately. The test is repeated twice, and the best result is recorded. Change of balance between baseline and follow-up test is assessed.
Measured: through study completion, 12 months
Change of speed-agility
Speed-agility will be assessed by the 4 × 10-meter shuttle run test. When the participants hear the start signal, they run and turn a 10-meter track as fast as they can to cover a distance of 40 meters. At the end of each section of the track, participants have to touch the hand of one of the testers who have crossed the limit with their feet and then go back at maximum speed. The participant will be given two tests with one to two minutes breaks in between. The best of two tests is recorded. Change of speed-agility between baseline and follow-up test is assessed.
Measured: through study completion, 12 months
Change of inhibitory control
Animal Stroop task will be used to assess inhibitory control. The reaction time difference between conflict and congruent conditions reflects the ability to handle cognitive conflicts. Change of inhibitory control between baseline and follow-up test is assessed.
Measured: through study completion, 12 months
Change of cognitive flexibility
Stop-signal task will measure the ability to inhibit response and control impulsivity. The mean stop-signal delay indicates the ability to inhibit portent responses. Change of cognitive flexibility between baseline and follow-up test is assessed.
Measured: through study completion, 12 months
Change of working memory
Safari training task will measure working memory. There are 90 trials in total and the task takes about 8 minutes. Change of working memory between baseline and follow-up test is assessed.
Measured: through study completion, 12 months
Secondary outcomes (3)
Demographics questionnaire
Participant's background information (gender, age, gestational week, delivery mode, gestation, feeding mode, main caregivers), sleep, parental PA behaviors and attitudes, and family information (family economic status, parents' education level, family structure) are recorded.
Measured: through study completion, 12 months
Screen time
Screen time will be measured by the Parents' Role in Establishing healthy Physical activity and Sedentary behavior habits study (PREPS) questionnaire developed. The weighted minutes per day for each variable are then summed to generate total screen time.
Measured: through study completion, 12 months
Sleep
Sleep will be assessed with the Children's Sleep Habits Questionnaire (CSHQ). It contains 56 items, 52 of which are rated on a three-point Likert scale. Each question is asked in relation to the previous one week.
Measured: through study completion, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start11 Oct 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preschool ChildrenStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 505 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hong Kong Baptist University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Normal University, National Fitness Research Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05290584
- Sponsor's protocol ID
- HKBU19481772
- Status last verified
- Mar 2022
- First submitted
- 24 Feb 2022
- Last updated
- 22 Mar 2022
- 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 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Preschool Children's Fundamental Movement Skills, Physical Activity, and Physical Fitness on Executive Function: A Prospective Observation Study
- ClinicalTrials.gov ID
- NCT05290584
- Acronym / sponsor ID
- HKBU19481772
- Conditions
- Preschool Children, Executive Function, Fundamental Movement Skills, Physical Activity, Physical Fitness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 505 participants (estimated)
- Lead sponsor
- Hong Kong Baptist UniversityUniversity, hospital or other
- Collaborators
- Beijing Normal University, National Fitness Research Center
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 22 Mar 2022 (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.
Background: Early childhood is the most critical and rapid period of complete and healthy physical and cognitive development in human life. Executive function appears in early childhood and develops rapidly through complex coaction between environment and developmental processes. The preschool period is also characterized by a rapid growth in fundamental movement skills, physical activity and physical fitness. The scientific research on the relationship between fundamental movement skills, physical activity, physical fitness and executive function in preschoolers remains to be explored.
Objective: The purpose of this study was to examine the cross-sectional relationship between fundamental movement skills, physical activity, physical fitness and executive function in preschool children while controlling for potential confounding variables, examine the prospective influence (independent and interactive role) of preschooler's fundamental movement skills, physical activity and physical fitness on executive function, observe the preschoolers' fundamental movement skills, physical activity, physical fitness and executive function changes with age, and investigate gender and age differences in preschoolers' fundamental movement skills, physical activity, physical fitness and executive function.
Method: The proposed study consists of two phases, phase 1 is a cross-sectional study. Five hundred and five children aged 3-5 years will be recruited. The Test of Gross Motor Development Third Edition (TGMD-3) was used to assess children's fundamental movement skills. Preschool children's physical activity was monitored by accelerometer ActiGraph GT3X-BT. Physical fitness was tested using handgrip, 4*10m shuttle run, 20m shuttle run, 30s sit-ups, sit and reach, and balance beam. Executive function was tested by computer-based tasks including animal stroop, safari training and stop signal task. Phase 2 is a 12-month follow-up study. In the phase 2, all children enrolled in the baseline study will be followed up, the measurements and contents of the follow-up are the same as the baseline instrument.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children will be recruited from kindergartens in Zhuhai through the support of Zhuhai Early Childhood Education Association and United International College. These two organizations have cooperated with many local kindergartens, which can help to recruit preschoolers.
Key inclusion criteria (3 listed)
- aged 3-5 years
- normally developing children with corresponding cognitive ability to participate in the data collection
- without heart, lung, liver, kidney and other important organ diseases or any neurological disorders (e.g., intellectual disability or autism spectrum disorder) that prevent children from performing normal PA.
Key exclusion criteria (2 listed)
- children with cognitive disability
- with heart, lung, liver, kidney and other important organ diseases or any neurological disorders (e.g., intellectual disability or autism spectrum disorder) that prevent children from performing normal PA.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change of body mass index
Time frame: through study completion, 12 months
Weight (measured in kilograms) and height (measured in meters) will be combined to report body mass index in kg/m^2. Change of body mass index between baseline and follow-up test is assessed.
Change of fundamental movement skills
Time frame: through study completion, 12 months
The Test of Gross Motor Development: Third Edition (TGMD-3) will be used to assess children's fundamental movement skills. The TGMD-3 provides two subscale and an overall composite score. Change of fundamental movement skills between baseline and follow-up test is assessed.
Change of sedentary behavior time
Time frame: through study completion, 12 months
Physical activity level will be objectively monitored using a tri-axial accelerometer ActiGraph GT3X-BT and is analyzed with the ActiLife 6.13 data analysis software. Counts per minute are recorded.The activity with lower than 819 counts per minute is categorized as sedentary behaviors. Overall time in sedentary behavior in minute is recorded as sedentary behavior time. Change of sedentary behavior time between baseline and follow-up test is assessed.
Change of light physical activity time
Time frame: through study completion, 12 months
Physical activity level will be objectively monitored using a tri-axial accelerometer ActiGraph GT3X-BT and is analyzed with the ActiLife 6.13 data analysis software. Counts per minute are recorded. The activity with higher than 820 counts per minute but lower than 3907 counts per minute is categorized as light physical activity. Overall time in light physical activity in minute is recorded as light physical activity time. Change of light physical activity time between baseline and follow-up test is assessed.
Change of moderate-to-vigorous physical activity time
Time frame: through study completion, 12 months
Physical activity level will be objectively monitored using a tri-axial accelerometer ActiGraph GT3X-BT and is analyzed with the ActiLife 6.13 data analysis software. Counts per minute are recorded. The activity with higher than 3908 counts per minute is categorized as moderate-to-vigorous physical activity. Overall time in moderate-to-vigorous physical activity in minute is recorded as moderate-to-vigorous physical activity time. Change of moderate-to-vigorous physical activity time between baseline and post-intervention tests is assessed. Change of moderate-to-vigorous physical activity time between baseline and follow-up test is assessed.
Change of cardiorespiratory fitness
Time frame: through study completion, 12 months
A 20-meter shuttle run is used to assess cardiorespiratory fitness. During the test, participants run back and forth on two running tracks 20 meters apart at an initial speed of 8.0km/h, followed by an increase of 0.5km/h per minute. Using a compact disc (CD) to control the speed, which systematically increases during the test. During the test, participants run back and forth, based on the timing of a beep from the CD recorder. If the participant fails to pass the other end of the 20 meters distance before the beep (after two attempts), the test is terminated and the number of shuttle legs completed is recorded and converted to an estimate of aerobic capacity. As we work with preschoolers, the track will be marked and the children will be led by an adult so they can master the pace of the run. Change of cardiorespiratory fitness between baseline and follow-up test is assessed.
Change of flexibility
Time frame: through study completion, 12 months
Flexibility will be assessed by sit and reach. During the test, the participants sit barefoot on the mat, feet straight with heels together, toes separated naturally, and the sole of their feet on the tester plate. Then the participant is asked to slowly bend forward and use their arms to push the edge of a movable board as far as they can without bending knees. The test is repeated twice, and the maximum value is recorded. Change of flexibility between baseline and follow-up test is assessed.
Change of muscular endurance
Time frame: through study completion, 12 months
Sit ups will be used to assess the muscular endurance of the trunk. The participants lie on their back with knees bent and arms crossed on the other shoulder. They stand up, sit up, and return to the starting position. The assistant holds the child's feet. The number of lifts in 30 seconds performed correctly to the seated position is recorded.Change of muscular endurance between baseline and follow-up test is assessed.
Change of muscular strength
Time frame: through study completion, 12 months
Hand grip strength is a classic strength test with high safety, accuracy, and suitability for younger children. Muscle strength is measured using a WCS-100 electronic dynamometer (Shanghai Wanqing Electronics Co., LTD.). During the test, participants stand in a quiet environment, relaxed, with their arms hanging down naturally. They hold the dynamometer, adjust the grip distance, grasp the dynamometer once with maximum strength, and the value is recorded. The left and right hands are measured alternately for three times, and the maximum value is recorded. To allow for proper rest, the interval between the three tests should be at least 15 seconds. Change of muscular strength between baseline and follow-up test is assessed.
Change of balance
Time frame: through study completion, 12 months
Dynamic balance will be measured by the balance beam test. The participants will stand on the platform behind the starting line, face the balance beam (3 m long, 10 cm wide, and 30 cm high), and raise their arms horizontally. When participants hear the start command, they will move their feet to the finish line in turn. The tester will give orders on the front side of the participant, start the stopwatch at the same time when the participant starts, and follow the participant to the finish line. At the same time, the tester will pay attention to observe the movements of the participant to prevent accidents. When either tiptoe of the participant crosses the finish line, the tester stops the clock immediately. The test is repeated twice, and the best result is recorded. Change of balance between baseline and follow-up test is assessed.
Change of speed-agility
Time frame: through study completion, 12 months
Speed-agility will be assessed by the 4 × 10-meter shuttle run test. When the participants hear the start signal, they run and turn a 10-meter track as fast as they can to cover a distance of 40 meters. At the end of each section of the track, participants have to touch the hand of one of the testers who have crossed the limit with their feet and then go back at maximum speed. The participant will be given two tests with one to two minutes breaks in between. The best of two tests is recorded. Change of speed-agility between baseline and follow-up test is assessed.
Change of inhibitory control
Time frame: through study completion, 12 months
Animal Stroop task will be used to assess inhibitory control. The reaction time difference between conflict and congruent conditions reflects the ability to handle cognitive conflicts. Change of inhibitory control between baseline and follow-up test is assessed.
Change of cognitive flexibility
Time frame: through study completion, 12 months
Stop-signal task will measure the ability to inhibit response and control impulsivity. The mean stop-signal delay indicates the ability to inhibit portent responses. Change of cognitive flexibility between baseline and follow-up test is assessed.
Change of working memory
Time frame: through study completion, 12 months
Safari training task will measure working memory. There are 90 trials in total and the task takes about 8 minutes. Change of working memory between baseline and follow-up test is assessed.
3 secondary outcomes
Demographics questionnaire
Time frame: through study completion, 12 months
Screen time
Time frame: through study completion, 12 months
Sleep
Time frame: through study completion, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preschool Children and Executive Function, run by Hong Kong Baptist University at 2 sites 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 3 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 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
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?
Change of body mass index (time frame: through study completion, 12 months). The study lists 14 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 22 Mar 2022.