NCT05290584

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
505

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

2 active sites

Status
unknown

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

October 11, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 22, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

March 22, 2022

Status Verified

March 1, 2022

Enrollment Period

1.2 years

First QC Date

February 24, 2022

Last Update Submit

March 13, 2022

Conditions

Outcome Measures

Primary Outcomes (14)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    through study completion, 12 months

  • Change of speed-agility

    Speed-agility will be assessed by the 4 Ă— 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.

    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.

    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.

    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.

    through study completion, 12 months

Secondary Outcomes (3)

  • Demographics questionnaire

    through study completion, 12 months

  • Screen time

    through study completion, 12 months

  • Sleep

    through study completion, 12 months

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beijing Normal University - Hong Kong Baptist University United International College

Zhuhai, Guangdong, China

Location

Hong Kong Baptist University

Hong Kong, Hong Kong, China

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2022

First Posted

March 22, 2022

Study Start

October 11, 2021

Primary Completion

December 31, 2022

Study Completion

June 30, 2023

Last Updated

March 22, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations