Clinical trial NCT05521490: Combating Physical Inactivity Pandemic in Kindergartens
Official title: Combating Physical Inactivity Pandemic by Promoting Physical Fitness Education and Physical Activity-Embedded Curriculum in Kindergartens
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Physical Activity
Cardiorespiratory Fitness
Keywords: Childhood Physical Inactivity
Childhood Obesity
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Hong Kong Baptist University
name: Chinese University of Hong Kong
name: Education University of Hong Kong
name: The Hong Kong Polytechnic University
name: Sun Yat-sen University
name: Georgia State University
name: Physical Fitness Association of Hong Kong, China
First posted: 2022-08-30
Enrollment: 3300
Sex: ALL
Minimum age (years): 5
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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).

Eligibility criteria: Inclusion Criteria

1. Children aged 5-6 years (limited number of children may be between 4-5 and 6-7 years)
2. Able to communicate in Chinese
3. Able to participate in physical activity in a standard kindergarten setting

Exclusion Criteria:

1. Inherent or serious disease limiting participation in physical activity (e.g., congenital heart disease, pediatric cancer, Down syndrome).
2. Diagnosed mental illness impairing daily behavior and performance (e.g., anxiety disorder, depression, attention deficit hyperactivity disorder, psychotic disorders, autism spectrum disorder).
3. Physical disability (e.g., physical handicap, assistive device to walk).
4. Visual or hearing impairment.
5. Cognitive deficit or intellectual disability that requires special care and educational needs (e.g., handicapped children with learning difficulties).

Primary outcomes:
measure: Change in Physical Activity
timeFrame: Baseline and 10 months
measure: Change in Cardiorespiratory Fitness
timeFrame: Baseline and 10 months
Secondary outcomes:
measure: Change in Physical Activity
timeFrame: Baseline and 16 months
measure: Change in Cardiorespiratory Fitness
timeFrame: Baseline and 16 months
measure: Change in Muscular Strength
timeFrame: Baseline, 10 months, and 16 months
measure: Change in Flexibility
timeFrame: Baseline, 10 months, and 16 months
measure: Change in Agility
timeFrame: Baseline, 10 months, and 16 months
measure: Change in Balance Ability
timeFrame: Baseline, 10 months, and 16 months
measure: Change in Muscle Power
timeFrame: Baseline, 10 months, and 16 months
measure: Change in Body Mass Index
timeFrame: Baseline, 10 months, and 16 months
measure: Change in Waist Circumference
timeFrame: Baseline, 10 months, and 16 months
measure: Change in Body Fat
timeFrame: Baseline, 10 months, and 16 months
measure: Change in Fat-Free Mass
timeFrame: Baseline, 10 months, and 16 months
measure: Change in Sedentary Behavior and Screen Time
timeFrame: Baseline, 10 months, and 16 months
measure: Change in Treatment Self-Regulation Questionnaire Score
timeFrame: Baseline, 10 months, and 16 months
measure: Change in Theory of Planned Behavior Scale Score
timeFrame: Baseline, 10 months, and 16 months
measure: Change in Kiddy-KINDL
timeFrame: Baseline, 10 months, and 16 months
measure: Change in Early Development Instrument
timeFrame: Baseline, 10 months, and 16 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: LKS Faculty of Medicine
Study officials:
affiliation: The University of Hong Kong
name: Parco M Siu, PhD
role: PRINCIPAL_INVESTIGATOR
References: