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B4B Evolution Type II Hybrid Effectiveness-Implementation Trial

NCT07726732 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-07-30

No results posted yet for this study

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

Interventions

BEHAVIORAL

Break4Brain Evolution

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.

Sponsors & Collaborators

  • State Research Agency, Spain

    collaborator OTHER_GOV

  • University of the Balearic Islands

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-15
Primary Completion
2026-09-30
Completion
2027-06-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07726732 on ClinicalTrials.gov