Combating Physical Inactivity Pandemic in Kindergartens

Physical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05521490
• Other study ID #: HK-KIDFIT
• Status: Recruiting
• Phase: N/A
• Start date: August 2022
• Est. completion date: December 2026

Study information

• Verified date: August 2022
• Source: The University of Hong Kong
• Contact: Parco M Siu, PhD
• Phone: 2831
• Email: pmsiu[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3300
• Est. completion date: December 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 6 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cardiorespiratory Fitness
• Physical Activity

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	LKS Faculty of Medicine	Hong Kong

Sponsors (8)

Lead Sponsor	Collaborator
The University of Hong Kong	Chinese University of Hong Kong, Education University of Hong Kong, Georgia State University, Hong Kong Baptist University, Physical Fitness Association of Hong Kong, China, Sun Yat-sen University, The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

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