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Recruiting NCT05521490

Combating Physical Inactivity Pandemic in Kindergartens

No phase Interventional Physical Activity Cardiorespiratory Fitness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Usual Care Control, Physical Activity Enhanced Curriculum.
Who it may be relevant to
Registry conditions: Physical Activity, Cardiorespiratory Fitness. Basic parameters: 5 years — 6 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Combating Physical Inactivity Pandemic by Promoting Physical Fitness Education and Physical Activity-Embedded Curriculum in Kindergartens

Overview

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).

Interventions

  • Other Usual Care Control
    30 minutes of physical activity on each school day.
  • Behavioral Physical Activity Enhanced Curriculum
    Additional 2.5 hours of physical activity per week in addition to the stipulated 30 minutes of daily physical activity.

Primary outcome measures

  • Change in Physical Activity [Time frame: Baseline and 10 months]
  • Change in Cardiorespiratory Fitness [Time frame: Baseline and 10 months]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Hong Kong · 1 center
  • LKS Faculty of Medicine — Hong Kong

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. Ep PMID 40206326

Identifiers

NCT: NCT05521490 · HK-KIDFIT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗