Combating Physical Inactivity Pandemic in Kindergartens

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Physical Activity, Cardiorespiratory Fitness

Intervention / Treatment
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* Other: Usual Care Control
* Behavioral: Physical Activity Enhanced Curriculum


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Usual Care Control<br>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<br>* 30 minutes of physical activity on each school day.<br>|
| Experimental: Physical Activity Enhanced Curriculum<br>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<br>* Additional 2.5 hours of physical activity per week in addition to the stipulated 30 minutes of daily physical activity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Physical Activity | Physical activity will be assessed using an actigraph device with a three-axis accelerometer. | Baseline and 16 months | 
| Change in Cardiorespiratory Fitness | Cardiorespiratory fitness will be assessed using the 20-meter shuttle run test. | Baseline and 16 months | 
| Change in Muscular Strength | Muscular strength will be assessed using a handgrip dynamometer. | Baseline, 10 months, and 16 months | 
| Change in Flexibility | Flexibility will be assessed using the sit-and-reach test. | Baseline, 10 months, and 16 months | 
| Change in Agility | Agility will be assessed using a 4 x 10-meter shuttle run test. | 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. | 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. | 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. | 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. | 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). | 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). | 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. | 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. | 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. | 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. | 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. | Baseline, 10 months, and 16 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Childhood Physical Inactivity, Childhood Obesity