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临床试验/NCT06376864
NCT06376864已完成不适用

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

Hong Kong Baptist University1 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2023年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
450
试验地点
1
主要终点
Working memory

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
8 Years 至 12 Years(Child)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

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

研究组 & 干预措施

Activity Breaks intervention

Experimental

The intervention arm will receive the Activity Breaks intervention.

干预措施: Activity Breaks (Behavioral)

The control group

No Intervention

The control arm will continue to receive their normal instruction.

结局指标

主要结局

Working memory

时间窗: 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.

Executive function

时间窗: 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.

Psychological capacities

时间窗: 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.

Attention

时间窗: 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.

次要结局

  • Sedentary behavior (hour)(baseline, 8 weeks, and 20 weeks)
  • Body weight (kg)(baseline, 8 weeks, and 20 weeks)
  • Height (cm)(baseline, 8 weeks, and 20 weeks)
  • Physical activity (min/week)(baseline, 8 weeks, and 20 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gao Yang

Associate Professor

Hong Kong Baptist University

研究点 (1)

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