Classroom Movement Strategies to Increase Physical Activity and Improve Cognition and Academic Performance in a School-Aged Population: Protocol for the Break4Brain Type II Hybrid Effectiveness-Implementation Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Change From Baseline in Everyday Executive Function Measured by the BRIEF-2 Teacher Form
研究概览
简要总结
Break4Brain Evolution is a school-based programme designed to help teachers incorporate brief, safe and inclusive movement activities into normal classroom routines. The study aims to examine both how the programme is adopted and delivered in real-world schools and whether it improves students' physical activity, attention, executive functions and academic achievement.
This is a type II hybrid implementation-effectiveness study with two complementary components. The implementation component will examine the scale-up of Break4Brain Evolution across at least 50 preschool, primary and secondary schools in the Balearic Islands and mainland Spain. Information from school leaders, teachers and students will be used to assess programme reach, adoption, acceptability, feasibility, appropriateness, fidelity, adaptations and maintenance.
The effectiveness component is an embedded cluster-randomized controlled trial conducted in six primary schools in Mallorca. Schools will be randomly allocated to either the Break4Brain Evolution programme or usual school practice, with three schools in each group. Two classrooms from each school, one grade 5 and one grade 6 classroom, will participate, resulting in an estimated sample of 300 students.
Baseline assessments will be conducted in September 2026. Schools allocated to the intervention group will begin implementing Break4Brain Evolution in October 2026 and will use the programme during the academic year. Follow-up assessments will be conducted in February 2027, June 2027 and December 2027.
详细描述
Break4Brain Evolution is a digitally supported behavioural and environmental intervention designed to introduce movement into routine classroom practice. The programme provides teachers with structured but flexible resources that can be adapted to different classroom needs, curricular demands, available space and school contexts.
The programme includes four main movement typologies: active videos, physically active learning activities, an active card game and movement activities proposed or adapted by teachers. All programme components are provided through the Break4Brain digital platform, which includes training materials, classroom resources, implementation planning tools, a teacher forum, a resource bank, monitoring procedures and communication with the research team.
Study design
The study uses a type II hybrid implementation-effectiveness design to concurrently evaluate the implementation, scale-up and effectiveness of Break4Brain Evolution under real-world school conditions. The study includes a large-scale implementation component and an embedded effectiveness trial.
Implementation component
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 10 to 12 years.
- •Enrolled in Grade 5 or Grade 6 in a classroom participating in the cluster-randomized controlled trial.
- •Written informed consent provided by a parent or legal guardian.
- •Assent provided by the child.
排除标准
- •Presence of a physical impairment.
- •Failure to provide parental or legal guardian informed consent.
- •Failure to provide child assent.
研究组 & 干预措施
Break4Brain Evolution intervention
Schools allocated to this arm will implement the B4B Evolution classroom movement programme from October 2026 throughout the academic year.
干预措施: Break4Brain Evolution (Behavioral)
Usual school practice
Schools allocated to this arm will continue their usual school practices and will not receive access to the B4B Evolution programme during the intervention period.
结局指标
主要结局
Change From Baseline in Everyday Executive Function Measured by the BRIEF-2 Teacher Form
时间窗: Baseline and Month 9
Change From Baseline in Academic Achievement Measured by the Woodcock-Muñoz Battery
时间窗: Baseline, Month 9, and Month 15
Change From Baseline in Processing Speed, Inhibition, and Cognitive Flexibility Measured by the Five Digit Test
时间窗: Baseline, Month 9, and Month 15
Change From Baseline in Selective Attention and Concentration Measured by the d2 Test of Attention
时间窗: Baseline and Month 9
Change From Baseline in Processing Speed, Inhibition, and Cognitive Flexibility Measured by the Trail Making Test
时间窗: Baseline, Month 9, and Month 15
次要结局
- Change From Baseline in Habitual Physical Activity Measured by the Physical Activity Questionnaire for Children(Baseline, Month 9, and Month 15)
- Change From Baseline in Daily Moderate-to-Vigorous Physical Activity Measured by ActiGraph Accelerometry(Baseline, and Month 9)
- Change From Baseline in Daily Sedentary Time Measured by ActiGraph Accelerometry(Baseline, and Month 9)
- Change From Baseline in Daily Sleep Duration Measured by ActiGraph Accelerometry(Baseline, and Month 9)
- Percentage of B4B Evolution Session Time Spent in Moderate-to-Vigorous Physical Activity(Month 5)