Physical ActivityNCT05521490
Combating Physical Inactivity Pandemic in Kindergartens
A study testing Physical Activity Enhanced Curriculum in people with Physical Activity and Cardiorespiratory Fitness, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The aim of this study is to examine the effects of a kindergarten-based, parent-involved intervention during the upper kindergarten year (K3) on physical activity and physical fitness in preschool children. Read more about this study
- Who is it for?
- Ages 5 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Cardiorespiratory Fitness
- What is being tested?
- Physical Activity Enhanced Curriculum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,300 participants
- Where
- 1 siteHong Kong
- Study dates
- Aug 2022to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 5 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 5-6 years (limited number of children may be between 4-5 and 6-7 years)
- Able to communicate in Chinese
- Able to participate in physical activity in a standard kindergarten setting
Who cannot join
- Inherent or serious disease limiting participation in physical activity (e.g., congenital heart disease, pediatric cancer, Down syndrome).
- Diagnosed mental illness impairing daily behavior and performance (e.g., anxiety disorder, depression, attention deficit hyperactivity disorder, psychotic disorders, autism spectrum disorder).
- Physical disability (e.g., physical handicap, assistive device to walk).
- Visual or hearing impairment.
- Cognitive deficit or intellectual disability that requires special care and educational needs (e.g., handicapped children with learning difficulties).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
LKS Faculty of Medicine
Hong Kong
Parco M Siu, PhD
About this study
Official title: Combating Physical Inactivity Pandemic by Promoting Physical Fitness Education and Physical Activity-Embedded Curriculum in Kindergartens
The aim of this study is to examine the effects of a kindergarten-based, parent-involved intervention during the upper kindergarten year (K3) on physical activity and physical fitness in preschool children.
Read the detailed description
This study is a two-arm cluster randomized controlled trial. Kindergartens will be randomly allocated to two groups: the usual care group and the intervention group. The usual care group will continue with their usual curriculum, which includes 30 minutes of daily physical activity stipulated by the Hong Kong SAR Government's Education Bureau. The intervention group will receive an additional 2.5 hours of physical activity per week in addition to the stipulated 30 minutes of daily physical activity. Outcome measures will be examined at baseline, 10 months (post-intervention), and 16 months (follow-up).
- Conditions
- Physical Activity, Cardiorespiratory Fitness
- Being tested
- Usual Care Control, Physical Activity Enhanced Curriculum
- Keywords
- Childhood Physical Inactivity, Childhood Obesity
- Medical subject headings
- Motor Activity, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual Care ControlOther
30 minutes of physical activity on each school day.
Physical Activity Enhanced CurriculumBehavioural
Additional 2.5 hours of physical activity per week in addition to the stipulated 30 minutes of daily physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Control | Other | Children allocated to the control group will continue with their usual curriculum, which includes the stipulated 30 minutes of daily physical activity. Receives: Other: Usual Care Control |
| Physical Activity Enhanced Curriculum | Experimental | Children allocated to the intervention group will receive enhanced physical fitness and healthy lifestyle education and a physical activity enhanced curriculum during their school year. Receives: Behavioral: Physical Activity Enhanced Curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physical Activity
Physical activity will be assessed using an actigraph device with a three-axis accelerometer.
Measured: Baseline and 10 months
Change in Cardiorespiratory Fitness
Cardiorespiratory fitness will be assessed using the 20-meter shuttle run test.
Measured: Baseline and 10 months
Secondary outcomes (16)
Change in Physical Activity
Physical activity will be assessed using an actigraph device with a three-axis accelerometer.
Measured: Baseline and 16 months
Change in Cardiorespiratory Fitness
Cardiorespiratory fitness will be assessed using the 20-meter shuttle run test.
Measured: Baseline and 16 months
Change in Muscular Strength
Muscular strength will be assessed using a handgrip dynamometer.
Measured: Baseline, 10 months, and 16 months
Change in Flexibility
Flexibility will be assessed using the sit-and-reach test.
Measured: Baseline, 10 months, and 16 months
Change in Agility
Agility will be assessed using a 4 x 10-meter shuttle run test.
Measured: Baseline, 10 months, and 16 months
Change in Balance Ability
Balance ability will be assessed by the number of successful steps performed on a balance beam.
Measured: Baseline, 10 months, and 16 months
Change in Muscle Power
Muscle power will be assessed using a vertical jump and a stationary long jump test.
Measured: Baseline, 10 months, and 16 months
Change in Body Mass Index
Weight and height will be assessed using a calibrated electronic digital weighing scale and stadiometer respectively.
Measured: Baseline, 10 months, and 16 months
Change in Waist Circumference
Waist circumference will be assessed using an inelastic measuring tape to the nearest 0.1cm.
Measured: Baseline, 10 months, and 16 months
Change in Body Fat
Body fat will be assessed using a bioelectrical impedance-based multi-frequency segmental body composition analyzer (MC780, Tanita, Japan).
Measured: Baseline, 10 months, and 16 months
Change in Fat-Free Mass
Fat-free mass will be assessed using a bioelectrical impedance-based multi-frequency segmental body composition analyzer (MC780, Tanita, Japan).
Measured: Baseline, 10 months, and 16 months
Change in Sedentary Behavior and Screen Time
Sedentary behavior and screen time will be assessed using a 7-day activities logbook and accelerometer data.
Measured: Baseline, 10 months, and 16 months
Change in Treatment Self-Regulation Questionnaire Score
Treatment Self-Regulation Questionnaire (TSRQ) will be used to assess the children's autonomous motivation and beliefs on active healthy lifestyles. The items in TSRQ will be answered on a 3-point Likert scale with a higher score corresponding to greater autonomous motivation.
Measured: Baseline, 10 months, and 16 months
Change in Theory of Planned Behavior Scale Score
Theory of Planned Behavior Scale (TPBS) will be used to assess the children's social cognitive beliefs of health and physical activity behavior. The items in TPBS will be answered on a 3-point Likert scale with a higher score corresponding to a greater willingness to engage in the mentioned behaviors.
Measured: Baseline, 10 months, and 16 months
Change in Kiddy-KINDL
Kiddy-KINDL will be used to assess the health-related quality of life in children.
Measured: Baseline, 10 months, and 16 months
Change in Early Development Instrument
Early Development Instrument (EDI) will be used to assess the children's general well-being.
Measured: Baseline, 10 months, and 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study startAug 2022 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Hong Kong Baptist University, Chinese University of Hong Kong, Education University of Hong Kong, The Hong Kong Polytechnic University, Sun Yat-sen University, Georgia State University, Physical Fitness Association of Hong Kong, China
- Responsible party
- Sponsor
- Investigators
- Parco M Siu, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05521490
- Sponsor's protocol ID
- HK-KIDFIT
- Status last verified
- Aug 2022
- First submitted
- 22 Aug 2022
- Last updated
- 30 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data of individual participants that underlie the results reported in this trial, after de-identification including text, tables, figures, and appendices, as well as study protocol and statistical analysis plan, will be shared after 3 months of study publication. Data will be shared with researchers who provide a methodologically sound proposal for academic purposes. Proposals should be directed to pmsiu@hku.hk to gain access and for data request, a data-access agreement needs to be signed.
Publications
Au WW, Leung CK, Lin SH, Yu AP, Fong DY, Wong SHS, Chan DKC, Capio CM, Yu CCW, Wong SWS, Chen YJ, Thompson WR, Siu PM. Effects of a physical activity-enhanced curriculum on increasing physical activity and improving physical fitness in preschoolers: Study protocol for a cluster randomized controlled trial (KID-FIT study). J Exerc Sci Fit. 2025 Apr;23(2):122-132. doi: 10.1016/j.jesf.2025.03.001. Epub 2025 Mar 13.
PubMed 40206326
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combating Physical Inactivity Pandemic by Promoting Physical Fitness Education and Physical Activity-Embedded Curriculum in Kindergartens
- ClinicalTrials.gov ID
- NCT05521490
- Acronym / sponsor ID
- HK-KIDFIT
- Conditions
- Physical Activity, Cardiorespiratory Fitness
- Keywords
- Childhood Physical Inactivity, Childhood Obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,300 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Hong Kong Baptist University, Chinese University of Hong Kong, Education University of Hong Kong, The Hong Kong Polytechnic University, Sun Yat-sen University, Georgia State University, Physical Fitness Association of Hong Kong, China
- Study start
- Aug 2022 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Aug 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.
The aim of this study is to examine the effects of a kindergarten-based, parent-involved intervention during the upper kindergarten year (K3) on physical activity and physical fitness in preschool children.
Detailed description
This study is a two-arm cluster randomized controlled trial. Kindergartens will be randomly allocated to two groups: the usual care group and the intervention group. The usual care group will continue with their usual curriculum, which includes 30 minutes of daily physical activity stipulated by the Hong Kong SAR Government's Education Bureau. The intervention group will receive an additional 2.5 hours of physical activity per week in addition to the stipulated 30 minutes of daily physical activity. Outcome measures will be examined at baseline, 10 months (post-intervention), and 16 months (follow-up).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care Control | Other | Other: Usual Care ControlChildren allocated to the control group will continue with their usual curriculum, which includes the stipulated 30 minutes of daily physical activity. |
| Physical Activity Enhanced Curriculum | Experimental | Behavioral: Physical Activity Enhanced CurriculumChildren allocated to the intervention group will receive enhanced physical fitness and healthy lifestyle education and a physical activity enhanced curriculum during their school year. |
Who may qualify
- Ages
- 5 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 5-6 years (limited number of children may be between 4-5 and 6-7 years)
- Able to communicate in Chinese
- Able to participate in physical activity in a standard kindergarten setting
Key exclusion criteria (5 listed)
- Inherent or serious disease limiting participation in physical activity (e.g., congenital heart disease, pediatric cancer, Down syndrome).
- Diagnosed mental illness impairing daily behavior and performance (e.g., anxiety disorder, depression, attention deficit hyperactivity disorder, psychotic disorders, autism spectrum disorder).
- Physical disability (e.g., physical handicap, assistive device to walk).
- Visual or hearing impairment.
- Cognitive deficit or intellectual disability that requires special care and educational needs (e.g., handicapped children with learning difficulties).
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 |
|---|---|---|
| Usual Care Control30 minutes of physical activity on each school day. | Other | Usual Care Control |
| Physical Activity Enhanced CurriculumAdditional 2.5 hours of physical activity per week in addition to the stipulated 30 minutes of daily physical activity. | Behavioural | Physical Activity Enhanced Curriculum |
Primary outcome
Change in Physical Activity
Time frame: Baseline and 10 months
Physical activity will be assessed using an actigraph device with a three-axis accelerometer.
Change in Cardiorespiratory Fitness
Time frame: Baseline and 10 months
Cardiorespiratory fitness will be assessed using the 20-meter shuttle run test.
16 secondary outcomes
Change in Physical Activity
Time frame: Baseline and 16 months
Change in Cardiorespiratory Fitness
Time frame: Baseline and 16 months
Change in Muscular Strength
Time frame: Baseline, 10 months, and 16 months
Change in Flexibility
Time frame: Baseline, 10 months, and 16 months
Change in Agility
Time frame: Baseline, 10 months, and 16 months
Change in Balance Ability
Time frame: Baseline, 10 months, and 16 months
Change in Muscle Power
Time frame: Baseline, 10 months, and 16 months
Change in Body Mass Index
Time frame: Baseline, 10 months, and 16 months
Change in Waist Circumference
Time frame: Baseline, 10 months, and 16 months
Change in Body Fat
Time frame: Baseline, 10 months, and 16 months
Change in Fat-Free Mass
Time frame: Baseline, 10 months, and 16 months
Change in Sedentary Behavior and Screen Time
Time frame: Baseline, 10 months, and 16 months
Change in Treatment Self-Regulation Questionnaire Score
Time frame: Baseline, 10 months, and 16 months
Change in Theory of Planned Behavior Scale Score
Time frame: Baseline, 10 months, and 16 months
Change in Kiddy-KINDL
Time frame: Baseline, 10 months, and 16 months
Change in Early Development Instrument
Time frame: Baseline, 10 months, and 16 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2022.
- Derived from this study: PubMed 40206326Au WW, Leung CK, Lin SH, Yu AP, Fong DY, Wong SHS, Chan DKC, Capio CM, Yu CCW, Wong SWS, Chen YJ, Thompson WR, Siu PM. Effects of a physical activity-enhanced curriculum on increasing physical activity and improving physical fitness in preschoolers: Study protocol for a cluster randomized controlled trial (KID-FIT study). J Exerc Sci Fit. 2025 Apr;23(2):122-132. doi: 10.1016/j.jesf.2025.03.001. Epub 2025 Mar 13.
- Individual participant dataSharing planned: Yes. The data of individual participants that underlie the results reported in this trial, after de-identification including text, tables, figures, and appendices, as well as study protocol and statistical analysis plan, will be shared after 3 months of study publication. Data will be shared with researchers who provide a methodologically sound proposal for academic purposes. Proposals should be directed to pmsiu@hku.hk to gain access and for data request, a data-access agreement needs to be signed.
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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.
Parco M Siu, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity Enhanced Curriculum in people with Physical Activity and Cardiorespiratory Fitness, run by The University of Hong Kong at 1 site in Hong Kong.
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 5 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: looking for participants now, as of the sponsor's last update on 30 Aug 2022. 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 Hong Kong. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Parco M Siu, PhD (2831 ext. 5262, pmsiu@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Physical Activity (time frame: Baseline and 10 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05521490, which also lists 1 linked publication.
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 30 Aug 2022.