B4B Evolution Type II Hybrid Effectiveness-Implementation Trial

NCT07726732 | Enrolling By Invitation DMC

• 2 other identifiers: B4BEVO-EFF-01PID2024-156331OB-I00
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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, 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.

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

Outcome Measures

Primary Outcomes (4)

• Change From Baseline in Everyday Executive Function Measured by the BRIEF-2 Teacher Form

  Baseline and Month 9

• Change From Baseline in Academic Achievement Measured by the Woodcock-Muñoz Battery

  Baseline, Month 9, and Month 15

• Change From Baseline in Processing Speed, Inhibition, and Cognitive Flexibility Measured by the Trail Making Test

  Baseline, Month 9, and Month 15

• Change From Baseline in Selective Attention and Concentration Measured by the d2 Test of Attention

  Baseline and Month 9

Secondary Outcomes (5)

• Change From Baseline in Habitual Physical Activity Measured by the Physical Activity Questionnaire for Children

  Baseline, Month 9, and Month 15

• Change From Baseline in Daily Moderate-to-Vigorous Physical Activity Measured by ActiGraph Accelerometry

  Baseline, and Month 9

• Change From Baseline in Daily Sedentary Time Measured by ActiGraph Accelerometry

  Baseline, and Month 9

• Change From Baseline in Daily Sleep Duration Measured by ActiGraph Accelerometry

  Baseline, and Month 9

• Percentage of B4B Evolution Session Time Spent in Moderate-to-Vigorous Physical Activity

  Month 5

Study Arms (2)

Break4Brain Evolution intervention

EXPERIMENTAL

Schools allocated to this arm will implement the B4B Evolution classroom movement programme from October 2026 throughout the academic year.

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.

Interventions

Break4Brain Evolution BEHAVIORAL

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.

Break4Brain Evolution intervention

Eligibility Criteria

• Age: 10 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Presence of a physical impairment.
• Failure to provide parental or legal guardian informed consent.
• Failure to provide child assent.

Sponsors & Collaborators

• University of the Balearic Islands: lead
• State Research Agency, Spain: collaborator

Study Sites (1)

Faculty of Education

Palma, Spain, 07122, Spain

Location

Related Links

• Related Info

MeSH Terms

Conditions

Motor Activity; Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 24, 2026
• Study Start: September 15, 2026
• Primary Completion: September 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

ES (1)