Clinical trial NCT06376864: Physical Activity Intervention Effects on Executive Function, Physical Activity and Sedentary Behaviour in Children
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Behavior
Keywords: physical activity
sedentary behaviour
executive fundtion
health promotion
children
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
First posted: 2024-04-19
Enrollment: 450
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Executive function
timeFrame: baseline, 8 weeks, and 20 weeks
measure: Psychological capacities
timeFrame: baseline, 8 weeks, and 20 weeks
measure: Working memory
timeFrame: baseline, 8 weeks, and 20 weeks
measure: Attention
timeFrame: baseline, 8 weeks, and 20 weeks
Secondary outcomes:
measure: Physical activity (min/week)
timeFrame: baseline, 8 weeks, and 20 weeks
measure: Sedentary behavior (hour)
timeFrame: baseline, 8 weeks, and 20 weeks
measure: Body weight (kg)
timeFrame: baseline, 8 weeks, and 20 weeks
measure: Height (cm)
timeFrame: baseline, 8 weeks, and 20 weeks
Other outcomes:
Locations:
city: Kowloon Tong
country: Hong Kong
facility: Department of Sport, Physical Education, and Health, Hong Kong Bapist University
Study officials:
affiliation: HKBU
name: Julien S. BAKER, PhD
role: STUDY_CHAIR
affiliation: Sport, Physical Education and Health/SOSC/HKBU
name: Wendy Yajun HUANG, PhD
role: STUDY_DIRECTOR
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