Clinical trial NCT06319833: Effects of Brain Breaks on Educational Achievement in School Settings: The Break4Brain Project
Official title: Effects of Brain Breaks on Educational Achievement in Children With and Without ADHD: The Break4Brain Project
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Physical Activity
Keywords: active breaks
executive functions
academic performance
exercise
Lead sponsor: University of the Balearic Islands
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Innovation, Spain
name: European Regional Development Fund
name: State Research Agency, Spain
First posted: 2024-03-20
Enrollment: 600
Sex: ALL
Minimum age (years): 10
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A total of 600 children between 10 and 12 years of age will be randomized among two experimental conditions: physical activity interacting with a video (n = 300), and sedentary activity (n = 300). The experimental condition will take place in the school settings during the school day through a between-subject design with a total of two measurements, pre, and post-test. Using the latest advances, the transient effects of the experimental conditions on cognitive and academic performance will be measured. The experimental condition was crafted through a qualitative design involving semi-structured interviews with teachers (n = 41) and members of the management team (n = 16), along with questionnaires administered to students (n = 600). To enhance and ensure its sustainability, the same process will be replicated after the intervention. Interviews and questionnaires were meticulously crafted by the RE-AIM framework, and subsequently validated through a rigorous process involving an expert panel (n = 30) utilizing the Delphi methodology. This project has the potential to substantially contribute to the field of acute physical activity and could have a meaningful transference on the educational system. This method might be prescribed as an effective teaching strategy.


Eligibility criteria: Inclusion Criteria:

* Children aged 10-12 years.

Exclusion Criteria:

* Children who have serious physical or mental disorders (autism spectrum disorder, intellectual disability, and cerebral palsy) that would impede participation in the experimental conditions.

Primary outcomes:
measure: Academic achievement
timeFrame: 8 weeks
measure: Inhibition-attention and cognitive flexibility
timeFrame: 8 weeks
measure: Working memory
timeFrame: 8 weeks
measure: Selective attention
timeFrame: 8 weeks
measure: Design of active breaks: semi-structured questionnaires
timeFrame: 2 months (november and may)
measure: Design of active breaks: semi-structured interviews
timeFrame: 2 months (november and may)
Secondary outcomes:
measure: Physical activity patterns
timeFrame: 8 weeks
measure: Self-report physical activity patterns
timeFrame: 8 weeks
measure: Self-report sedentary patterns
timeFrame: 8 weeks
measure: Self-report physical fitness
timeFrame: 8 weeks
measure: Socioeconomic level
timeFrame: 8 weeks
measure: Student's behavior
timeFrame: 8 weeks
measure: Body composition
timeFrame: 8 weeks
measure: Creativity
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Palma
country: Spain
facility: University of the Balearic Islands
state: Balearic Islands
Study officials:
References: