Effects of Brain Breaks on Educational Achievement in School Settings: The Break4Brain Project

Physical Activity Clinical Trial

Official title:

Effects of Brain Breaks on Educational Achievement in Children With and Without ADHD: The Break4Brain Project

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06319833
• Other study ID #: 348CER23
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 8, 2024
• Est. completion date: July 2024

Study information

• Verified date: March 2024
• Source: University of the Balearic Islands
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: July 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Physical Activity

Intervention

Behavioral:
• Physical activity interacting with a video
This experimental condition will be implemented five times a week, once per day, over 8 weeks. It will follow a structured format, including seven consecutive 40-second blocks of physical activity. The total video duration will amount to 9 minutes (40 seconds of activity followed by 20 seconds of rest, maintaining a 2:1 work-to-rest ratio). Additionally, participants will engage in 5 minutes of warm-up exercises and 5 minutes of cool-down activities. The experimental condition will consist of 10 videos, each centered around one of five different themes (a different one will be administered every day).

Locations

Country	Name	City	State
Spain	University of the Balearic Islands	Palma	Balearic Islands

Sponsors (4)

Lead Sponsor	Collaborator
University of the Balearic Islands	European Regional Development Fund, Ministry of Science and Innovation, Spanish State Research Agency

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Academic achievement	Only the general academic fluency index was administered, consisting of the reading, mathematics, and writing fluency subtests. Reading fluency assessed the participant's capacity to read simple sentences rapidly, mathematical fluency gauged the ability to quickly solve simple addition, subtraction, and multiplication problems, and writing fluency measured the skill to formulate and write sentences promptly.	8 weeks
Primary	Inhibition-attention and cognitive flexibility	The assessment of inhibition-attention and cognitive flexibility was conducted using the "Trail Making Test".	8 weeks
Primary	Working memory	The measurement of working memory through "The Digit Memory Test," specifically focusing on auditory attention and verbal memory.	8 weeks
Primary	Selective attention	The measurement of selective attention within a limited timeframe was carried out using the "D2 test."	8 weeks
Primary	Design of active breaks: semi-structured questionnaires	Pre- and post-intervention, to guarantee a proper design and future sustainability of the experimental condition, semi-structured questionnaires are administered to students. The responses are systematically categorized.	2 months (november and may)
Primary	Design of active breaks: semi-structured interviews	Pre- and post-intervention, to guarantee a proper design and future sustainability of the experimental condition, semi-structured interviews are administered to teachers and the management team. The responses are systematically categorized.	2 months (november and may)
Secondary	Physical activity patterns	Physical activity patterns will be measured through accelerometry using the ActiGraph wGT3X-BT. Additionally, the intensity of the brain breaks will also be calculated with the same tool.	8 weeks
Secondary	Self-report physical activity patterns	Physical activity levels over the preceding seven days were assessed using the PAQ-C.	8 weeks
Secondary	Self-report sedentary patterns	Sedentary patterns over the preceding 7 days were assessed using the YAP-S.	8 weeks
Secondary	Self-report physical fitness	The level of physical fitness was assessed using the self-administered IFIS questionnaire.	8 weeks
Secondary	Socioeconomic level	The socioeconomic status was assessed through the Family Affluence Scale-II.	8 weeks
Secondary	Student's behavior	The behavior of students in a regular classroom setting was examined using the "Child and Adolescent Behavior Inventory", inattention and hyperactivity-impulsivity parts, for teachers.	8 weeks
Secondary	Body composition	Parents self-reported the body composition. In this case, parents will just report height (cm) and weight (kg).	8 weeks
Secondary	Creativity	Participants were required to complete the maximum number of unusual uses for two objects within a 5-minute timeframe.	8 weeks