Combating Physical Inactivity Pandemic in Kindergartens

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

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.

Study Overview

• Status: Recruiting
• Conditions: Physical Activity; Cardiorespiratory Fitness
• Intervention / Treatment: Other: Usual Care Control; Behavioral: Physical Activity Enhanced Curriculum

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).

• Study Type: Interventional
• Enrollment (Anticipated): 3300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Parco M Siu, PhD; Phone Number: 5262 2831; Email: pmsiu@hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • LKS Faculty of Medicine
    • Contact: Parco M Siu, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 6 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Usual Care Control; 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; 30 minutes of physical activity on each school day.
EXPERIMENTAL: Physical Activity Enhanced Curriculum; 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; Additional 2.5 hours of physical activity per week in addition to the stipulated 30 minutes of daily physical activity.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Collaborators: Sun Yat-sen University; Chinese University of Hong Kong; The Hong Kong Polytechnic University; Hong Kong Baptist University; Georgia State University; Education University of Hong Kong; Physical Fitness Association of Hong Kong, China

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 1, 2022
• Primary Completion (ANTICIPATED): August 1, 2026
• Study Completion (ANTICIPATED): December 1, 2026

Study Registration Dates

• First Submitted: August 22, 2022
• First Submitted That Met QC Criteria: August 25, 2022
• First Posted (ACTUAL): August 30, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 30, 2022
• Last Update Submitted That Met QC Criteria: August 25, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Childhood Obesity; Childhood Physical Inactivity
• Other Study ID Numbers: HK-KIDFIT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Beginning 3 months and ending 3 years following the publication of the article.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No