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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05521490
Other study ID # HK-KIDFIT
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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
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