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Completed

NCT Number: NCT06376864

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

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Key information

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Kowloon Tong, Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

Activity Breaks

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Hong Kong Baptist University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 19, 2024
Registry last updated
Oct 18, 2024

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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