Physical Activity Intervention Effects on Executive Function, Physical Activity and Sedentary Behaviour in Children

October 16, 2024 updated by: Gao Yang, Hong Kong Baptist University

A Pilot Study Investigating the Effects of a Classroom-based Physical Activity Intervention on Executive Function, Physical Activity and Sedentary Behaviour in 8-12-year-old Children

The current study aims to implement the Activity Breaks intervention and evaluate its effectiveness on outcome measures of executive function (EF), physical activity (PA), and sedentary behaviour (SB) in school children.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In Hong Kong, as well as globally, children fail to meet the current physical activity recommendations of 60-minutes of moderate-to-vigorous physical activity (MVPA) per day. Childhood and adolescence are critical periods for developing favourable lifestyle behaviours that can continue into adulthood. Health-promoting interventions that target physical inactivity are vitally important. Researchers have repeatedly demonstrated that higher academic achievement and better attendance at school occurs among children who are more physically active, healthy and fit. To promote improvements in health and education, it is essential to recognize movement as assistive to establishing cognitive and social skills. The current study aims to implement the Activity Breaks intervention and evaluate its effectiveness on outcome measures of executive function (EF), physical activity (PA), and sedentary behaviour (SB) in school children. The Activity Breaks intervention is a 5-minute Activity Breaks programme that allows classroom teachers of all ages and ability levels to lead simple movement activities within their classrooms, negating the need for additional personnel or space. It is expected that the 5-minute Activity Breaks programme performed three times a day over 8 weeks will not only increases daily PA, but also decreases SB through interrupting prolonged sitting time. The Activity Breaks Programme also improves executive functioning among primary school-aged children.

This study will be a pilot clustered randomised controlled trial involving 8 primary schools in Hong Kong. One class from each school will be recruited from primaries 4-6 (8-11-year-old children) as our target population. Schools randomised into the intervention will receive the Activity Breaks Programme whereas schools assigned to the control group will continue to receive their normal daily instruction.

Data will be collected from all participants (intervention and control) at three time points: Time 1 (T1) (baseline), Time 2 (T2) (Post-intervention), and Time 3 (T3) (3-month follow-up). The following pupil measures will be captured at all time points: 1. EF; 2. PA levels and SB patterns using accelerometers; and 3. anthropometric measurements. Two measures will be conducted among teachers including teacher interviews and teacher fidelity checks conducted using log books. All analyses will be performed using IBM SPSS statistical programmes. Multi-level modelling regression analyses with repeated measures will be used to determine the effects of the intervention. A mixed-design ANOVA with time (pre, post and follow-up) as a within-subject variable and group (intervention and control) as a between-subjects variable will be conducted, while adjusting for age, gender and body mass index.

Study Type

Interventional

Enrollment (Actual)

450

Phase

  • 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 Locations

      • Kowloon Tong, Hong Kong
        • Department of Sport, Physical Education, and Health, Hong Kong Bapist University

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

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • School children in primary school (exclude private or special education schools), grades 4-6 (8-12 years old)
  • children with parental consent.

Exclusion Criteria:

  • Children with diagnosed behavioural or learning problems (e.g., attention-deficit hyperactivity disorder, ADHD)

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 Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Activity Breaks intervention
The intervention arm will receive the Activity Breaks intervention.
The Activity Breaks intervention is a 5-minute Activity Breaks programme that allows classroom teachers of all ages and ability levels to lead simple movement activities within their classrooms, negating the need for additional personnel or space.
No Intervention: The control group
The control arm will continue to receive their normal instruction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Executive function
Time Frame: baseline, 8 weeks, and 20 weeks
The Wisconsin Card Sorting Test (WCST): The computerized version of the WCST will be used to assess flexibility in decision making in this study. The number of total errors and perseverative errors and failure to maintain a set will be used as scores.
baseline, 8 weeks, and 20 weeks
Psychological capacities
Time Frame: baseline, 8 weeks, and 20 weeks
Stroop Task. A computerized modified Stroop task will be used to reflect inhibition skills that help individuals override a prepotent response in favour of an alternative response.
baseline, 8 weeks, and 20 weeks
Working memory
Time Frame: baseline, 8 weeks, and 20 weeks
Digit Span Backward: In this test, a participant will be presented with a series of digits to be repeated backwards.
baseline, 8 weeks, and 20 weeks
Attention
Time Frame: baseline, 8 weeks, and 20 weeks
Measures of child attention levels will be measured using the online version of d2-R test of attention. TN-E is a total performance score which gives a measure of the relationship between performance accuracy and speed. TN-E scores are defined as 50-60% bad, 60-70% medium, 70-85% normal and over 85% is good.
baseline, 8 weeks, and 20 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical activity (min/week)
Time Frame: baseline, 8 weeks, and 20 weeks
The ActiGraph GT3X+ monitor (ActiGraph LLC, Pensacola, FL, USA) will be used to measure physical activity levels.
baseline, 8 weeks, and 20 weeks
Sedentary behavior (hour)
Time Frame: baseline, 8 weeks, and 20 weeks
The ActiGraph GT3X+ monitor (ActiGraph LLC, Pensacola, FL, USA) will be used to measure sedentary behavior.
baseline, 8 weeks, and 20 weeks
Body weight (kg)
Time Frame: baseline, 8 weeks, and 20 weeks
Body weight will be measured in light clothing to the nearest 0.1 kg with a calibrated electronic scale.
baseline, 8 weeks, and 20 weeks
Height (cm)
Time Frame: baseline, 8 weeks, and 20 weeks
Height will be measured without shoes to the nearest 0.1 cm using a stadiometer in accordance with standard procedures.
baseline, 8 weeks, and 20 weeks

Collaborators and Investigators

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

Investigators

  • Study Chair: Julien S. BAKER, PhD, HKBU
  • Study Director: Wendy Yajun HUANG, PhD, Sport, Physical Education and Health/SOSC/HKBU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

January 1, 2023

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

July 30, 2024

Study Registration Dates

First Submitted

February 28, 2024

First Submitted That Met QC Criteria

April 17, 2024

First Posted (Actual)

April 19, 2024

Study Record Updates

Last Update Posted (Actual)

October 18, 2024

Last Update Submitted That Met QC Criteria

October 16, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • RC- FNRA-IG /20-21/SOSC/01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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