NCT05521490

Brief 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
3,300

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Aug 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress87%
Aug 2022Dec 2026

Study Start

First participant enrolled

August 1, 2022

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 22, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 30, 2022

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

August 30, 2022

Status Verified

August 1, 2022

Enrollment Period

4 years

First QC Date

August 22, 2022

Last Update Submit

August 25, 2022

Conditions

Keywords

Childhood Physical InactivityChildhood Obesity

Outcome Measures

Primary Outcomes (2)

  • Change in Physical Activity

    Physical activity will be assessed using an actigraph device with a three-axis accelerometer.

    Baseline and 10 months

  • Change in Cardiorespiratory Fitness

    Cardiorespiratory fitness will be assessed using the 20-meter shuttle run test.

    Baseline and 10 months

Secondary Outcomes (16)

  • Change in Physical Activity

    Baseline and 16 months

  • Change in Cardiorespiratory Fitness

    Baseline and 16 months

  • Change in Muscular Strength

    Baseline, 10 months, and 16 months

  • Change in Flexibility

    Baseline, 10 months, and 16 months

  • Change in Agility

    Baseline, 10 months, and 16 months

  • +11 more secondary outcomes

Study Arms (2)

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.

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.

Behavioral: Physical Activity Enhanced Curriculum

Interventions

30 minutes of physical activity on each school day.

Usual Care Control

Additional 2.5 hours of physical activity per week in addition to the stipulated 30 minutes of daily physical activity.

Physical Activity Enhanced Curriculum

Eligibility Criteria

Age5 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LKS Faculty of Medicine

Hong Kong, Hong Kong

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Motor ActivityPediatric Obesity

Condition Hierarchy (Ancestors)

BehaviorObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Parco M Siu, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Parco M Siu, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2022

First Posted

August 30, 2022

Study Start

August 1, 2022

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

August 30, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Beginning 3 months and ending 3 years following the publication of the article.
Access Criteria
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.

Locations