- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06742294
Physical Activity Routines, Education, Assessment, Literacy, and Information Technology Application in Young Children (PA-REALITY)
Physical Activity Routines, Education, Assessment, Literacy, and Information Technology Application in Young Children (PA REALITY): A Social Cognitive Theory-based Movement Education Programme for Preschool Students
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Physical activity (PA) is related to better health and well-being of children. Research has also shown that PA is associated with young children's physical, cognitive, and social-emotional developments, which encompass three out of five objectives of pre-primary education in Hong Kong. By contrast, physical inactivity accounts for paediatric overweight/ obesity, which is on a rise globally. Such phenomena emerge as soon as in the first 6 years of lifespan. In 2019, the World Health Organization released their first global PA guidelines for children below 5 years old. World Health Organization (WHO) recommends that preschool-aged children should spend at least 180 minutes in a variety of physical activities at any intensity (i.e., light, moderate, or vigorous) daily, of which 60 minutes should be at a moderate intensity or above. However, few preschool-aged children in Hong Kong meet these standards. To address the aforementioned difficulties and challenges, we propose to develop and evaluate an intervention to improve the quantity and quality of PA in preschool-aged children.
To this end, four core intervention components will be applied in the proposed study: 1. Teacher professional development and support. Training and on-going support will be provided to in-service preschool teachers to equip them with knowledge, pedagogical skills, and assessment literacy pertaining physical literacy and FMS instruction. Specific intervention activities and contents will be co-designed with each participating school, and will be integrated to the curriculum and monthly themes of each school.
2. Development of a smartphone-based FMS-rating machines learning system. To allow efficient and objective assessment of children's FMS, an application will be developed to allow teachers and parents to rate children's FMS using a smartphone application. The application will be based on a machine learning system that was developed, and filed for patent by project team members. Additional information regarding the system will be provided in the sections below.
3. Teaching materials for teachers. A series of print and digital materials will be developed to support teachers' FMS instruction. The materials will cover key knowledge, pedagogical skills, games and activity ideas pertaining to PA and FMS, where these materials could be adopted into existing school-based curricula and allow for crossdomain instruction (e.g., infusing PA and FMS instruction into storytelling activities).
4. Parent materials. A set of materials on PA and FMS instruction will be developed for parents. The key concepts and contents will match the developed teaching materials; teachers' and parents' understanding for each development stage will be aligned. In turn, children will be able to receive non-conflicting feedback and instruction from teachers and parents. This form of engagement can foster strong family-school collaboration.
The required sample size was calculated based on a prudent expectation to achieve a small effect (Cohen's d = 0.2) in terms of primary outcome of accelerometer-measured physical activity in preschool-aged children. Using G*Power 3.1.9.4 with a 1:1 experimental versus control ratio, an alpha level at .05 and a power of .8, the required total sample size will be 156. To avoid potential contamination of intervention effects within schools, randomization will be conducted by clusters, at the school level. Based on previous work conducted in Hong Kong, the compliance rate of deployed accelerometers is approximately at 70%. Based on this rate, and from a cluster size of 15 (i.e., 5 children per grade), the effective average cluster size is 10.5. With an intraclass coefficient of .07 (He et al., 2021), the design effect is 1+(10.5-1)*0.07 = 1.67. Therefore, the sample size required is 260, and therefore 26 schools will be recruited to the main trial. From these schools, 13 of them will be randomised to the experimental group, and the remaining 13 will be allocated to the wait-list control group. Participation consent will first be sought at the school level.
Eligible preschools should be 1) government funded or subsidised, 2) coeducational so that the potential findings could be more generalizable in Hong Kong. Parents of all K1-3 children attending the preschools who have agreed to take part will be invited to take part in the research study. To enhance sample representativeness, we will aim at recruiting at even numbers of kindergarten from each region (i.e., Kowloon, Hong Kong Island, the New Territories). We will also purposefully invite preschool-aged children that are attending half-day, full-day, and long full-day preschools. For each participant, data will be collected on three measurement occasions, i.e., at baseline, the end of Year 1 (primary endpoint of the study), and two years after baseline. Randomisation will take place at the school (i.e., cluster) level after baseline measures have been taken. A random number generation sequence conducted by the research team will be employed for the randomisation of preschools to the experimental or control groups. Preschools randomized to the experimental group will be exposed to the intervention between the first two time points. The control group will receive no intervention during the same period, but will be exposed to the same components the following year. Parents who agreed to take part will be invited to complete a questionnaire at each time point. The FMS competence of their children will also be measured at all three times. A subsample of participants (i.e., 5 per grade per school) who agreed to take part will be invited to provide accelerometer measures for their physical activity (MVPA). This study will be based on Social Cognitive theory (SCT; Bandura, 2004). Within SCT, personal factors, the social environment, and behaviours are related intricately and reciprocally. Behaviours of preschool-aged children, by and large, are shaped by key socialising agents (i.e., parents and teachers) and the environments created by these key members. Therefore, SCT is an appropriate framework for the design of PA interventions. In the proposed study, intervention components were designed based on the theoretical underpinnings of SCT. Specifically, intervention components were designed to target six key SCT constructs, namely self-efficacy, behavioural capacity, outcome expectations, self-regulation, social environment, and physical environment.
Quantitative outcomes will be measured at all time points of the proposed study to evaluate the effectiveness of the intervention, using a clustered randomised controlled trial. Analyses will be conducted by assessors blinded to group allocation. The primary outcomes of the current trial are MVPA and FMS of preschool-aged children. Secondary outcomes include parent-child co-PA, parents' PA, children and parents' sleep time (accelerometry), children and parents' screen time, emotional well-being, socioemotional outcomes, physical health, family PA routines (parent questionnaires), and executive functioning (Head-ToesShoulders task). Teachers' teaching self-efficacy and competence will also be measured as a secondary outcome of the trial.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hong Kong, Hong Kong
- The Chinese University of Hong Kong
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- preschool children aged 3-6 with no history of neurological, psychiatric or physical illness
Exclusion Criteria:
- - preschool children aged 3-6 with with physical illness
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Movement Education
Schools allocated to the intervention group will receive interventions including teacher professional development and support, smartphone FMS rating system, teacher training materials, parent materials
|
(1) providing preschool teachers professional development training in pedagogical knowledge and methods in the physical domain, (2) creating a set of teaching materials (in printed and digital formats) and methods that could be incorporated into the overall and preschool-based curricula, (3) creating a parental toolkit with contents mirroring the school materials, to enhance parents' knowledge and promote family-school collaboration, and (4) developing a smartphone-based artificial intelligence rating system to help preschool teachers conveniently and accurately assess children's motor skills, and provide appropriate instructional feedback.
|
|
Other: Wait-list control group
The wait-list control group will receive the same intervention after post-test
|
(1) providing preschool teachers professional development training in pedagogical knowledge and methods in the physical domain, (2) creating a set of teaching materials (in printed and digital formats) and methods that could be incorporated into the overall and preschool-based curricula, (3) creating a parental toolkit with contents mirroring the school materials, to enhance parents' knowledge and promote family-school collaboration, and (4) developing a smartphone-based artificial intelligence rating system to help preschool teachers conveniently and accurately assess children's motor skills, and provide appropriate instructional feedback.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
moderate-to-vigorous physical activity (MVPA)
Time Frame: baseline
|
ActiGraph GT3X+
|
baseline
|
|
moderate-to-vigorous physical activity (MVPA)
Time Frame: 8 to 10 months after baseline (post-test)
|
ActiGraph GT3X+
|
8 to 10 months after baseline (post-test)
|
|
moderate-to-vigorous physical activity (MVPA)
Time Frame: two years after baseline (follow-up)
|
ActiGraph GT3X+
|
two years after baseline (follow-up)
|
|
fundamental movement skills performance
Time Frame: baseline
|
fundamental movement skills (using the developed assessment tool) of preschool children assessed based on TGMD-3
|
baseline
|
|
fundamental movement skills performance
Time Frame: 8 to 10 months after baseline (post-test)
|
fundamental movement skills (using the developed assessment tool) of preschool children assessed based on TGMD-3
|
8 to 10 months after baseline (post-test)
|
|
fundamental movement skills performance
Time Frame: two-year after baseline (follow-up)
|
fundamental movement skills (using the developed assessment tool) of preschool children assessed based on TGMD-3
|
two-year after baseline (follow-up)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
parent-child co-PA
Time Frame: baseline
|
ActiGraph wGT3X-BT
|
baseline
|
|
parent-child co-PA
Time Frame: 8 to 10 months after baseline (post-test)
|
ActiGraph wGT3X-BT
|
8 to 10 months after baseline (post-test)
|
|
parent-child co-PA
Time Frame: two-year after baseline (follow-up)
|
ActiGraph wGT3X-BT
|
two-year after baseline (follow-up)
|
|
parents' PA
Time Frame: baseline
|
ActiGraph wGT3X-BT
|
baseline
|
|
parents' PA
Time Frame: 8 to 10 months after baseline (post-test)
|
ActiGraph wGT3X-BT
|
8 to 10 months after baseline (post-test)
|
|
parents' PA
Time Frame: two years after baseline (follow-up)
|
ActiGraph wGT3X-BT
|
two years after baseline (follow-up)
|
|
children and parents' sleep time
Time Frame: baseline
|
ActiGraph wGT3X-BT
|
baseline
|
|
children and parents' sleep time
Time Frame: 8 to 10 months after baseline (post-test)
|
ActiGraph wGT3X-BT
|
8 to 10 months after baseline (post-test)
|
|
children and parents' sleep time
Time Frame: two years after baseline (follow-up)
|
ActiGraph wGT3X-BT
|
two years after baseline (follow-up)
|
|
children and parents' screen time
Time Frame: baseline
|
ActiGraph wGT3X-BT
|
baseline
|
|
children and parents' screen time
Time Frame: 8 to 10 months after baseline (post-test)
|
ActiGraph wGT3X-BT
|
8 to 10 months after baseline (post-test)
|
|
children and parents' screen time
Time Frame: two years after baseline (follow-up)
|
ActiGraph wGT3X-BT
|
two years after baseline (follow-up)
|
|
executive functioning
Time Frame: baseline
|
Head-Toes Shoulders task
|
baseline
|
|
executive functioning
Time Frame: 8 to 10 months after baseline (post-test)
|
Head-Toes Shoulders task
|
8 to 10 months after baseline (post-test)
|
|
executive functioning
Time Frame: two years after baseline (follow-up)
|
Head-Toes Shoulders task
|
two years after baseline (follow-up)
|
|
socioemotional outcomes, physical health, family PA routines
Time Frame: baseline
|
Socioemotional outcomes will be measured by the Strength and Difficulties Questionnaire (SDQ).
Using the SDQ, parents respond by reporting if their children fitted 25 attributes related to their emotional problems (e.g., "Often unhappy, downhearted"), conduct problems (e.g., "Often fights with other children"), hyperactivity (e.g., "Easily distracted, concentration wanders"), peer problems (e.g., "Picked on or bullied by other children"), and prosocial behaviours (e.g., "Shares readily with other children").
Parents report how true each item describing their children on a 3-point scale, 1-not real, partly real, completely real.
Except for prosocial behaviours items, higher scores indicate less socioemotional well-being.
|
baseline
|
|
socioemotional outcomes, physical health, family PA routines
Time Frame: 8 to 10 months after baseline (post-test)
|
Socioemotional outcomes will be measured by the Strength and Difficulties Questionnaire (SDQ).
Using the SDQ, parents respond by reporting if their children fitted 25 attributes related to their emotional problems (e.g., "Often unhappy, downhearted"), conduct problems (e.g., "Often fights with other children"), hyperactivity (e.g., "Easily distracted, concentration wanders"), peer problems (e.g., "Picked on or bullied by other children"), and prosocial behaviours (e.g., "Shares readily with other children").
Parents report how true each item describing their children on a 3-point scale, 1-not real, partly real, completely real.
Except for prosocial behaviours items, higher scores indicate less socioemotional well-being.
|
8 to 10 months after baseline (post-test)
|
|
socioemotional outcomes, physical health, family PA routines
Time Frame: two years after baseline (follow-up)
|
Socioemotional outcomes will be measured by the Strength and Difficulties Questionnaire (SDQ).
Using the SDQ, parents respond by reporting if their children fitted 25 attributes related to their emotional problems (e.g., "Often unhappy, downhearted"), conduct problems (e.g., "Often fights with other children"), hyperactivity (e.g., "Easily distracted, concentration wanders"), peer problems (e.g., "Picked on or bullied by other children"), and prosocial behaviours (e.g., "Shares readily with other children").
Parents report how true each item describing their children on a 3-point scale, 1-not real, partly real, completely real.
Except for prosocial behaviours items, higher scores indicate less socioemotional well-being.
|
two years after baseline (follow-up)
|
|
Teachers' teaching self-efficacy and competence
Time Frame: baseline
|
Teachers' self-efficacy in teaching motor skills will be measured using self-report questionnaires.
Teachers will report their perceived competence in identifying students' difference, provinding instructions, assessments and using technology in FMS teaching on 23 items.
Higher scores indicate better self-efficacy.
|
baseline
|
|
Teachers' teaching self-efficacy and competence
Time Frame: 8 to 10 months after baseline (post-test)
|
Teachers' self-efficacy in teaching motor skills will be measured using self-report questionnaires.
Teachers will report their perceived competence in identifying students' difference, provinding instructions, assessments and using technology in FMS teaching on 23 items.
Higher scores indicate better self-efficacy.
|
8 to 10 months after baseline (post-test)
|
|
Teachers' teaching self-efficacy and competence
Time Frame: two years after baseline (follow-up)
|
Teachers' self-efficacy in teaching motor skills will be measured using self-report questionnaires.
Teachers will report their perceived competence in identifying students' difference, provinding instructions, assessments and using technology in FMS teaching on 23 items.
Higher scores indicate better self-efficacy.
|
two years after baseline (follow-up)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Amy S. Ha, Ph.D, Chinese University of Hong Kong
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- R4024-21F
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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