- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06319833
Effects of Brain Breaks on Educational Achievement in School Settings: The Break4Brain Project
March 12, 2024 updated by: Josep1, University of the Balearic Islands
Effects of Brain Breaks on Educational Achievement in Children With and Without ADHD: The Break4Brain Project
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
600
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Balearic Islands
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Palma, Balearic Islands, Spain, 07122
- University of the Balearic Islands
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control condition
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Experimental: Physical activity interacting with a video
This experimental condition involves engaging in physical activity interspersed with rest periods.
The type of exercises are based on phase I.
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Academic achievement
Time Frame: 8 weeks
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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.
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8 weeks
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Inhibition-attention and cognitive flexibility
Time Frame: 8 weeks
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The assessment of inhibition-attention and cognitive flexibility was conducted using the "Trail Making Test".
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8 weeks
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Working memory
Time Frame: 8 weeks
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The measurement of working memory through "The Digit Memory Test," specifically focusing on auditory attention and verbal memory.
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8 weeks
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Selective attention
Time Frame: 8 weeks
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The measurement of selective attention within a limited timeframe was carried out using the "D2 test."
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8 weeks
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Design of active breaks: semi-structured questionnaires
Time Frame: 2 months (november and may)
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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.
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2 months (november and may)
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Design of active breaks: semi-structured interviews
Time Frame: 2 months (november and may)
|
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.
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2 months (november and may)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Physical activity patterns
Time Frame: 8 weeks
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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.
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8 weeks
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Self-report physical activity patterns
Time Frame: 8 weeks
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Physical activity levels over the preceding seven days were assessed using the PAQ-C.
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8 weeks
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Self-report sedentary patterns
Time Frame: 8 weeks
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Sedentary patterns over the preceding 7 days were assessed using the YAP-S.
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8 weeks
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Self-report physical fitness
Time Frame: 8 weeks
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The level of physical fitness was assessed using the self-administered IFIS questionnaire.
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8 weeks
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Socioeconomic level
Time Frame: 8 weeks
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The socioeconomic status was assessed through the Family Affluence Scale-II.
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8 weeks
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Student's behavior
Time Frame: 8 weeks
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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.
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8 weeks
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Body composition
Time Frame: 8 weeks
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Parents self-reported the body composition.
In this case, parents will just report height (cm) and weight (kg).
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8 weeks
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Creativity
Time Frame: 8 weeks
|
Participants were required to complete the maximum number of unusual uses for two objects within a 5-minute timeframe.
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8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 8, 2024
Primary Completion (Estimated)
April 1, 2024
Study Completion (Estimated)
July 1, 2024
Study Registration Dates
First Submitted
February 2, 2024
First Submitted That Met QC Criteria
March 12, 2024
First Posted (Actual)
March 20, 2024
Study Record Updates
Last Update Posted (Actual)
March 20, 2024
Last Update Submitted That Met QC Criteria
March 12, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 348CER23
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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