Physical ActivityB4B EvolutionNCT07726732
B4B Evolution Type II Hybrid Effectiveness-Implementation Trial
A study testing Break4Brain Evolution in people with Physical Activity and Sedentary Behavior, run by University of the Balearic Islands at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 10 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Sedentary Behavior, Cognition
- What is being tested?
- Break4Brain Evolution
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 15 Sep 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 10 to 12 years.
- Enrolled in Grade 5 or Grade 6 in a classroom participating in the cluster-randomized controlled trial.
- Written informed consent provided by a parent or legal guardian.
- Assent provided by the child.
Who cannot join
- Presence of a physical impairment.
- Failure to provide parental or legal guardian informed consent.
- Failure to provide child assent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Classroom Movement Strategies to Increase Physical Activity and Improve Cognition and Academic Performance in a School-Aged Population: Protocol for the Break4Brain Type II Hybrid Effectiveness-Implementation Trial
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Physical Activity, Sedentary Behavior, Cognition, Academic Acheivement
- Being tested
- Break4Brain Evolution
- Keywords
- classroom movement, active breaks, hybrid effectiveness-implementation trial, executive function, digital platform, cluster-randomized controlled trial
- Medical subject headings
- Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Break4Brain EvolutionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Break4Brain Evolution intervention | Experimental | Schools allocated to this arm will implement the B4B Evolution classroom movement programme from October 2026 throughout the academic year. Receives: Behavioral: Break4Brain Evolution |
| Usual school practice | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Everyday Executive Function Measured by the BRIEF-2 Teacher Form
Measured: Baseline and Month 9
Change From Baseline in Academic Achievement Measured by the Woodcock-Muñoz Battery
Measured: Baseline, Month 9, and Month 15
Change From Baseline in Processing Speed, Inhibition, and Cognitive Flexibility Measured by the Trail Making Test
Measured: Baseline, Month 9, and Month 15
Change From Baseline in Selective Attention and Concentration Measured by the d2 Test of Attention
Measured: Baseline and Month 9
Secondary outcomes (5)
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.
Measured: Baseline, Month 9, and Month 15
Change From Baseline in Daily Moderate-to-Vigorous Physical Activity Measured by ActiGraph Accelerometry
Measured: Baseline, and Month 9
Change From Baseline in Daily Sedentary Time Measured by ActiGraph Accelerometry
Measured: Baseline, and Month 9
Change From Baseline in Daily Sleep Duration Measured by ActiGraph Accelerometry
Measured: Baseline, and Month 9
Percentage of B4B Evolution Session Time Spent in Moderate-to-Vigorous Physical Activity
Measured: Month 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start15 Sep 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a Type II hybrid effectiveness-implementation study with an embedded two-arm cluster-randomized controlled trial. Six primary schools will be randomized in a 1:1 ratio to the B4B Evolution intervention or usual school practice. The school is the unit of randomization. The broader implementation component evaluates program delivery and scale-up in participating schools and does not constitute an additional randomized arm.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the Balearic Islands
- Sponsor type
- University, hospital or other
- Collaborators
- State Research Agency, Spain
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07726732
- Sponsor's protocol ID
- B4BEVO-EFF-01
- Other IDs
- PID2024-156331OB-I00
- Acronym
- B4B Evolution
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Classroom Movement Strategies to Increase Physical Activity and Improve Cognition and Academic Performance in a School-Aged Population: Protocol for the Break4Brain Type II Hybrid Effectiveness-Implementation Trial
- ClinicalTrials.gov ID
- NCT07726732
- Acronym / sponsor ID
- B4B Evolution / B4BEVO-EFF-01
- Conditions
- Physical Activity, Sedentary Behavior, Cognition, Academic Acheivement
- Keywords
- classroom movement, active breaks, hybrid effectiveness-implementation trial, executive function, digital platform, cluster-randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of the Balearic IslandsUniversity, hospital or other
- Collaborators
- State Research Agency, Spain
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a Type II hybrid effectiveness-implementation study with an embedded two-arm cluster-randomized controlled trial. Six primary schools will be randomized in a 1:1 ratio to the B4B Evolution intervention or usual school practice. The school is the unit of randomization. The broader implementation component evaluates program delivery and scale-up in participating schools and does not constitute an additional randomized arm.
| Arm | Type | Receives |
|---|---|---|
| Break4Brain Evolution intervention | Experimental | Behavioral: Break4Brain EvolutionSchools allocated to this arm will implement the B4B Evolution classroom movement programme from October 2026 throughout the academic year. |
| Usual school practice | No intervention | –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. |
Who may qualify
- Ages
- 10 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 10 to 12 years.
- Enrolled in Grade 5 or Grade 6 in a classroom participating in the cluster-randomized controlled trial.
- Written informed consent provided by a parent or legal guardian.
- Assent provided by the child.
Key exclusion criteria (3 listed)
- Presence of a physical impairment.
- Failure to provide parental or legal guardian informed consent.
- Failure to provide child assent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Break4Brain EvolutionB4B 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. | Behavioural | Break4Brain Evolution intervention |
Primary outcome
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
5 secondary outcomes
Change From Baseline in Habitual Physical Activity Measured by the Physical Activity Questionnaire for Children
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Break4Brain Evolution in people with Physical Activity and Sedentary Behavior, run by University of the Balearic Islands at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Everyday Executive Function Measured by the BRIEF-2 Teacher Form (time frame: Baseline and Month 9). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.