An interventional study of Break4Brain Evolution in Physical Activity, Sedentary Behavior and Cognition, sponsored by University of the Balearic Islands. Enrolling by invitation at 1 site in Spain. Open to participants aged 10 Years to 13 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by University of the Balearic Islands · Not applicable, Interventional, and Other
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.
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
The implementation component will examine the delivery and scale-up of Break4Brain Evolution across preschool, primary and secondary schools in the Balearic Islands and mainland Spain. The objective is for the programme to be adopted by at least 50 schools, with a minimum of two classrooms participating in each school.
School leaders, teachers and students will contribute information related to Reach, Adoption, Implementation and Maintenance. Implementation outcomes will include school and teacher participation, training completion, digital platform engagement, use of programme resources, classroom movement delivery, intervention dose, fidelity, adaptations, acceptability, appropriateness, feasibility, barriers and facilitators, implementation leadership, implementation climate and sustained programme use.
Implementation will be supported through teacher training, multiple dissemination channels, free access to a digital platform, flexible and context-sensitive delivery, use of existing school resources, monitoring and feedback, an online support network and resources intended to support long-term sustainability.
Effectiveness component
The effectiveness study will use a cluster-randomized controlled trial design, with schools as the unit of randomization. Six primary schools in Mallorca will be included. Three schools will be allocated to the intervention group and three schools to the control group.
Two classrooms will be recruited from each school, including one grade 5 and one grade 6 classroom. The effectiveness sample will therefore include 12 classrooms and an estimated 300 students.
Schools allocated to the intervention group will implement Break4Brain Evolution from October 2026 and throughout the academic year. Teachers will select and adapt movement activities according to their classroom context while preserving the core purpose of introducing brief, safe and inclusive movement opportunities into classroom routines.
Schools allocated to the control group will continue with usual school practice and will not have access to the Break4Brain Evolution programme during the intervention period.
Data collection
Baseline assessments for the effectiveness trial will be conducted in September 2026, before the intervention begins. Subsequent assessments will take place in February 2027, June 2027 and December 2027.
Programme effectiveness will be evaluated through changes in students' physical activity, attention, executive functions and academic achievement. Mixed-methods data will be collected at school, teacher and student levels using digital platform metrics, questionnaires, accelerometry, academic and cognitive assessments, interviews and focus groups.
The December 2027 assessment will examine maintenance of the programme and the extent to which schools and teachers continue to integrate classroom movement into routine educational practice.
1,273 studies on the registry are indexed under Sedentary Behavior; 300 are open to participants now.
This study's planned enrollment of 300 is above the median of 60 across 1,076 interventional studies indexed under Sedentary Behavior.
Browse Sedentary Behavior studies →University of the Balearic Islands is the lead sponsor of 39 studies on the registry; 5 are open to participants now.
Compared within Sedentary Behavior, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Motor Activity. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Schools allocated to this arm will implement the B4B Evolution classroom movement programme from October 2026 throughout the academic year.
Behavioral: Break4Brain Evolution
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.
B4B Evolution is a digitally supported school-based classroom movement programme. Teachers receive training and access to a digital platform containing active videos, physically active learning activities, an active card game, and movement activities that can be proposed or adapted by teachers. The programme is designed to integrate brief, safe, and inclusive movement opportunities into usual classroom routines. Schools assigned to the intervention arm will begin implementing the programme in October 2026 and will continue throughout the academic year. Teachers may adapt activities to the classroom context while maintaining the core components of the programme.
Change From Baseline in Everyday Executive Function Measured by the BRIEF-2 Teacher Form
Time frame: Baseline and Month 9
Change From Baseline in Academic Achievement Measured by the Woodcock-Muñoz Battery
Time frame: Baseline, Month 9, and Month 15
Change From Baseline in Processing Speed, Inhibition, and Cognitive Flexibility Measured by the Trail Making Test
Time frame: Baseline, Month 9, and Month 15
Change From Baseline in Selective Attention and Concentration Measured by the d2 Test of Attention
Time frame: Baseline and Month 9
Change From Baseline in Habitual Physical Activity Measured by the Physical Activity Questionnaire for Children
Habitual physical activity during the previous 7 days will be assessed using the Physical Activity Questionnaire for Older Children (PAQ-C). The overall PAQ-C score is calculated as the mean of 9 scored items. Scores range from 1 to 5, with higher scores indicating higher levels of habitual physical activity and therefore a better outcome. Between-group differences in change from baseline will be evaluated.
Time frame: Baseline, Month 9, and Month 15
Change From Baseline in Daily Moderate-to-Vigorous Physical Activity Measured by ActiGraph Accelerometry
Time frame: Baseline, and Month 9
Change From Baseline in Daily Sedentary Time Measured by ActiGraph Accelerometry
Time frame: Baseline, and Month 9
Change From Baseline in Daily Sleep Duration Measured by ActiGraph Accelerometry
Time frame: Baseline, and Month 9
Percentage of B4B Evolution Session Time Spent in Moderate-to-Vigorous Physical Activity
Time frame: Month 5
Plan to share: Yes — De-identified individual participant data underlying the results reported in study publications may be made available to qualified researchers upon reasonable request. Data sharing will be subject to approval by the study team and to applicable ethical, institutional, and data-protection requirements. Data will not be made publicly available because of the potential risk of identifying participating students, teachers, and schools.
Time frame: Data will be available beginning 12 months after publication of the main study results and for 5 years thereafter.
Access criteria: Requests must be submitted to the corresponding investigator and include a scientifically sound research proposal, the objectives of the proposed analyses, the data requested, and a data-management plan. Access will be granted only after review and approval by the study team and, where required, the relevant ethics committee or institutional authority. Researchers receiving data will be required to sign a data-use agreement and use the data only for the approved purpose.
Start is estimated for Sep 2026; primary completion for Sep 2026, 0 months later.
Of 733 non-industry interventional studies with no phase under Sedentary Behavior, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 31. This study's planned 0 months is below that.
Counting every sponsor, half of 741 studies reached it within 14 months; a quarter within 6 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
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University of the Balearic Islands