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

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

    • Balearic Islands
      • Palma, Balearic Islands, Spain, 07122
        • University of the Balearic Islands

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
No Intervention: Control condition
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.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Academic achievement
Time Frame: 8 weeks
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
Inhibition-attention and cognitive flexibility
Time Frame: 8 weeks
The assessment of inhibition-attention and cognitive flexibility was conducted using the "Trail Making Test".
8 weeks
Working memory
Time Frame: 8 weeks
The measurement of working memory through "The Digit Memory Test," specifically focusing on auditory attention and verbal memory.
8 weeks
Selective attention
Time Frame: 8 weeks
The measurement of selective attention within a limited timeframe was carried out using the "D2 test."
8 weeks
Design of active breaks: semi-structured questionnaires
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 questionnaires are administered to students. The responses are systematically categorized.
2 months (november and may)
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.
2 months (november and may)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical activity patterns
Time Frame: 8 weeks
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
Self-report physical activity patterns
Time Frame: 8 weeks
Physical activity levels over the preceding seven days were assessed using the PAQ-C.
8 weeks
Self-report sedentary patterns
Time Frame: 8 weeks
Sedentary patterns over the preceding 7 days were assessed using the YAP-S.
8 weeks
Self-report physical fitness
Time Frame: 8 weeks
The level of physical fitness was assessed using the self-administered IFIS questionnaire.
8 weeks
Socioeconomic level
Time Frame: 8 weeks
The socioeconomic status was assessed through the Family Affluence Scale-II.
8 weeks
Student's behavior
Time Frame: 8 weeks
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
Body composition
Time Frame: 8 weeks
Parents self-reported the body composition. In this case, parents will just report height (cm) and weight (kg).
8 weeks
Creativity
Time Frame: 8 weeks
Participants were required to complete the maximum number of unusual uses for two objects within a 5-minute timeframe.
8 weeks

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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