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NCT Number: NCT05521490

Combating Physical Inactivity Pandemic 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.

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Key information

Conditions

Physical Activity Behavior Body Weight Cardiorespiratory Fitness Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

5 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LKS Faculty of Medicine

Hong Kong

Location status: Recruiting

Location contact

Parco M Siu, PhD

CONTACT

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Usual Care Control

Other

30 minutes of physical activity on each school day.

Physical Activity Enhanced Curriculum

Behavioral

Additional 2.5 hours of physical activity per week in addition to the stipulated 30 minutes of daily physical activity.

Primary outcomes

  1. Change in Physical Activity

    Time frame: Baseline and 10 months

    Physical activity will be assessed using an actigraph device with a three-axis accelerometer.

  2. Change in Cardiorespiratory Fitness

    Time frame: Baseline and 10 months

    Cardiorespiratory fitness will be assessed using the 20-meter shuttle run test.

Secondary outcomes

  1. Change in Physical Activity

    Time frame: Baseline and 16 months

    Physical activity will be assessed using an actigraph device with a three-axis accelerometer.

  2. Change in Cardiorespiratory Fitness

    Time frame: Baseline and 16 months

    Cardiorespiratory fitness will be assessed using the 20-meter shuttle run test.

  3. Change in Muscular Strength

    Time frame: Baseline, 10 months, and 16 months

    Muscular strength will be assessed using a handgrip dynamometer.

  4. Change in Flexibility

    Time frame: Baseline, 10 months, and 16 months

    Flexibility will be assessed using the sit-and-reach test.

  5. Change in Agility

    Time frame: Baseline, 10 months, and 16 months

    Agility will be assessed using a 4 x 10-meter shuttle run test.

  6. Change in Balance Ability

    Time frame: Baseline, 10 months, and 16 months

    Balance ability will be assessed by the number of successful steps performed on a balance beam.

  7. Change in Muscle Power

    Time frame: Baseline, 10 months, and 16 months

    Muscle power will be assessed using a vertical jump and a stationary long jump test.

  8. Change in Body Mass Index

    Time frame: Baseline, 10 months, and 16 months

    Weight and height will be assessed using a calibrated electronic digital weighing scale and stadiometer respectively.

  9. Change in Waist Circumference

    Time frame: Baseline, 10 months, and 16 months

    Waist circumference will be assessed using an inelastic measuring tape to the nearest 0.1cm.

  10. Change in Body Fat

    Time frame: Baseline, 10 months, and 16 months

    Body fat will be assessed using a bioelectrical impedance-based multi-frequency segmental body composition analyzer (MC780, Tanita, Japan).

  11. Change in Fat-Free Mass

    Time frame: Baseline, 10 months, and 16 months

    Fat-free mass will be assessed using a bioelectrical impedance-based multi-frequency segmental body composition analyzer (MC780, Tanita, Japan).

  12. Change in Sedentary Behavior and Screen Time

    Time frame: Baseline, 10 months, and 16 months

    Sedentary behavior and screen time will be assessed using a 7-day activities logbook and accelerometer data.

  13. Change in Treatment Self-Regulation Questionnaire Score

    Time frame: Baseline, 10 months, and 16 months

    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.

  14. Change in Theory of Planned Behavior Scale Score

    Time frame: Baseline, 10 months, and 16 months

    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.

  15. Change in Kiddy-KINDL

    Time frame: Baseline, 10 months, and 16 months

    Kiddy-KINDL will be used to assess the health-related quality of life in children.

  16. Change in Early Development Instrument

    Time frame: Baseline, 10 months, and 16 months

    Early Development Instrument (EDI) will be used to assess the children's general well-being.

Study contacts

Contact information is provided by the study sponsor or research team.

Parco M Siu, PhD

CONTACT

[email protected]

2831 ext. 5262

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • 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

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Aug 30, 2022
Registry last updated
Aug 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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