Combating Physical Inactivity Pandemic in Kindergartens

August 25, 2022 updated by: The University of Hong Kong

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Physical Activity
Time Frame: Baseline and 10 months
Physical activity will be assessed using an actigraph device with a three-axis accelerometer.
Baseline and 10 months
Change in Cardiorespiratory Fitness
Time Frame: Baseline and 10 months
Cardiorespiratory fitness will be assessed using the 20-meter shuttle run test.
Baseline and 10 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Physical Activity
Time Frame: Baseline and 16 months
Physical activity will be assessed using an actigraph device with a three-axis accelerometer.
Baseline and 16 months
Change in Cardiorespiratory Fitness
Time Frame: Baseline and 16 months
Cardiorespiratory fitness will be assessed using the 20-meter shuttle run test.
Baseline and 16 months
Change in Muscular Strength
Time Frame: Baseline, 10 months, and 16 months
Muscular strength will be assessed using a handgrip dynamometer.
Baseline, 10 months, and 16 months
Change in Flexibility
Time Frame: Baseline, 10 months, and 16 months
Flexibility will be assessed using the sit-and-reach test.
Baseline, 10 months, and 16 months
Change in Agility
Time Frame: Baseline, 10 months, and 16 months
Agility will be assessed using a 4 x 10-meter shuttle run test.
Baseline, 10 months, and 16 months
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.
Baseline, 10 months, and 16 months
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.
Baseline, 10 months, and 16 months
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.
Baseline, 10 months, and 16 months
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.
Baseline, 10 months, and 16 months
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).
Baseline, 10 months, and 16 months
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).
Baseline, 10 months, and 16 months
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.
Baseline, 10 months, and 16 months
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.
Baseline, 10 months, and 16 months
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.
Baseline, 10 months, and 16 months
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.
Baseline, 10 months, and 16 months
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.
Baseline, 10 months, and 16 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Hong Kong

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2022

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 22, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 30, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 30, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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