- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07427329
Benefits of Physical Activity During the School Day to Reduce Mental Fatigue and Optimize Cognitive and Psychosocial Processes in Secondary School Students (MENTALFIT)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background and Rationale Mental Fatigue (MF) is a dynamic psychobiological state induced by prolonged cognitive and emotional demands. In educational contexts, particularly in secondary education, it manifests as a cascading deterioration affecting attention, executive function, emotional regulation, and learning capacity. Despite its relevance, MF remains understudied in adolescents. Secondary school students face substantial sedentary demands, spending an average of 78% of the school day in sedentary activities. These schedules, characterized by extended periods of continuous instruction with minimal breaks, create conditions conducive to MF development. The MENTALFIT project aims to address this by reintegrating movement into school routines to counteract MF and its associated cognitive decrements.
Study Design and Methodology This quasi-experimental study (Study 3 of the MENTALFIT overarching protocol) employs a multifactorial design to evaluate the differential effectiveness of three physical activity (PA) interventions. The study is conducted over a full academic year (2024-2025) across several secondary schools in Extremadura, Spain. The sample comprises adolescents in their 3rd and 4th year of secondary education (aged 13-17).
The sample is divided into four groups: one control group ("business as usual") and three experimental groups. To compare the effectiveness of different approaches, each experimental center implements three distinct physically active strategies in a counterbalanced rotation across the three trimesters. This ensures that each experimental group receives every type of intervention while controlling for order effects.
Intervention Components
The multicomponent intervention includes:
Physically Active Lessons (PAL): Integrating motor activities with curriculum content.
Active Breaks (AB): Short bouts of physical activity delivered between or during lessons.
Active Recess (AR): Structured opportunities for physical activity during break times.
Data Collection Data are collected at six measurement points throughout the academic year (at the beginning and end of each trimester). Assessments include standardized self-report measures evaluating mental fatigue perception, academic burnout, school engagement, academic motivation, and well-being. Furthermore, objective measures are collected, including academic grades (GPA), computerised neuropsychological batteries (Stroop, PASAT, PVT-B), continuous heart rate and physical activity monitoring via Fitbit devices, and brain activity via Electroencephalography (EEG) in a selected subsample to capture objective neural correlates of mental fatigue.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Cáceres, Spain, 10003
- University of Extremadura
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Enrolment in the 3rd or 4th year of compulsory secondary education (Educación Secundaria Obligatoria).
- Attending one of the participating secondary schools.
- Providing written informed consent from parents/guardians and verbal assent from the students.
Exclusion Criteria:
- Medical or physical inability to participate in the physically active interventions.
- Refusal to participate or lack of parental consent.
- Schools participating in any other physical activity or health promotion program
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Experimental: Rotation Sequence A
Experimental center 1. Participants will receive all three interventions in a counterbalanced rotation across the academic year (e.g., Physically Active Lessons in Trimester 1, Active Breaks in Trimester 2, and Active Recess in Trimester 3).
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AB are implemented three times per week on days without physical education classes, providing a total of six active break sessions weekly (two per day on intervention days).
Each session consists of 5 minutes of physical activity scheduled after the second and fifth academic periods to interrupt prolonged sedentary behaviour.
Delivered over 9 weeks per trimester.
A specialised facilitator provides direct support during all intervention sessions to coordinate the timing and implementation of activities.
Other Names:
PAL integrates physical movement into academic instruction.
Two 55-minute lessons per week are dedicated to integrating motor activities with curriculum content.
The intervention is coordinated by a specialised facilitator who co-designs the sessions with subject-matter teachers to maintain academic rigor while promoting physical engagement.
Delivered over 9 weeks per trimester.
Other Names:
AR provides structured opportunities for physical activity during school breaks.
Every day of the week, two activities are offered during recess: one involving moderate physical activity and another involving more vigorous or intense activity (alternative games).
The intervention modifies playground spaces and provides diverse sports equipment to encourage movement.
Delivered over 9 weeks per trimester.
A specialised facilitator provides direct support during all intervention sessions to coordinate the implementation of the activities.
Other Names:
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Experimental: Experimental: Rotation Sequence B
Experimental center 2. Participants will receive all three interventions in a counterbalanced rotation across the academic year (e.g., Active Breaks in Trimester 1, Active Recess in Trimester 2, and Physically Active Lessons in Trimester 3).
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AB are implemented three times per week on days without physical education classes, providing a total of six active break sessions weekly (two per day on intervention days).
Each session consists of 5 minutes of physical activity scheduled after the second and fifth academic periods to interrupt prolonged sedentary behaviour.
Delivered over 9 weeks per trimester.
A specialised facilitator provides direct support during all intervention sessions to coordinate the timing and implementation of activities.
Other Names:
PAL integrates physical movement into academic instruction.
Two 55-minute lessons per week are dedicated to integrating motor activities with curriculum content.
The intervention is coordinated by a specialised facilitator who co-designs the sessions with subject-matter teachers to maintain academic rigor while promoting physical engagement.
Delivered over 9 weeks per trimester.
Other Names:
AR provides structured opportunities for physical activity during school breaks.
Every day of the week, two activities are offered during recess: one involving moderate physical activity and another involving more vigorous or intense activity (alternative games).
The intervention modifies playground spaces and provides diverse sports equipment to encourage movement.
Delivered over 9 weeks per trimester.
A specialised facilitator provides direct support during all intervention sessions to coordinate the implementation of the activities.
Other Names:
|
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Experimental: Experimental: Rotation Sequence C
Experimental center 3. Participants will receive all three interventions in a counterbalanced rotation across the academic year (e.g., Active Recess in Trimester 1, Physically Active Lessons in Trimester 2, and Active Breaks in Trimester 3).
|
AB are implemented three times per week on days without physical education classes, providing a total of six active break sessions weekly (two per day on intervention days).
Each session consists of 5 minutes of physical activity scheduled after the second and fifth academic periods to interrupt prolonged sedentary behaviour.
Delivered over 9 weeks per trimester.
A specialised facilitator provides direct support during all intervention sessions to coordinate the timing and implementation of activities.
Other Names:
PAL integrates physical movement into academic instruction.
Two 55-minute lessons per week are dedicated to integrating motor activities with curriculum content.
The intervention is coordinated by a specialised facilitator who co-designs the sessions with subject-matter teachers to maintain academic rigor while promoting physical engagement.
Delivered over 9 weeks per trimester.
Other Names:
AR provides structured opportunities for physical activity during school breaks.
Every day of the week, two activities are offered during recess: one involving moderate physical activity and another involving more vigorous or intense activity (alternative games).
The intervention modifies playground spaces and provides diverse sports equipment to encourage movement.
Delivered over 9 weeks per trimester.
A specialised facilitator provides direct support during all intervention sessions to coordinate the implementation of the activities.
Other Names:
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No Intervention: No Intervention: Control Group
The control group will maintain their regular academic schedule and usual classroom routines (business as usual) without any additional physically active interventions during the academic year.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Subjective Mental Fatigue (VAS-F)
Time Frame: Assessed at 6 time points across the academic year: beginning and end of trimesters 1, 2, and 3 (Baseline up to 9 months).
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Assessed through the Visual Analogue Scale for Fatigue (VAS-F; Smith et al., 2019).
It is a 100mm single-item measure of overall fatigue intensity.
Scores range from 0 to 100, where higher scores indicate a higher perception of mental fatigue.
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Assessed at 6 time points across the academic year: beginning and end of trimesters 1, 2, and 3 (Baseline up to 9 months).
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Multidimensional Mental Fatigue (PedsQL MFS)
Time Frame: Assessed at 6 time points across the academic year (Baseline up to 9 months).
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Pediatric Quality of Life Inventory Multidimensional Fatigue Scale (Varni & Limbers, 2008), 9-item Spanish version.
It measures general, sleep/rest, and cognitive fatigue.
A composite score is calculated as the mean across items.
Higher scores indicate greater problems with fatigue.
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Assessed at 6 time points across the academic year (Baseline up to 9 months).
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Objective Neurophysiological Mental Fatigue (Brain Activity)
Time Frame: Assessed at 6 time points across the academic year in a subsample of 160 students (Baseline up to 9 months).
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Assessed via EEG recordings using Emotiv EPOC X headsets.
Recordings are taken during resting-state and cognitive tasks (Stroop, PASAT, PVT-B) to characterize neural correlates (theta, alpha, and beta frequency bands) of cognitive performance under conditions of mental fatigue.
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Assessed at 6 time points across the academic year in a subsample of 160 students (Baseline up to 9 months).
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Objective Cardiovascular Indicators (Heart Rate and HRV)
Time Frame: Assessed at 6 time points across the academic year in a subsample of 160 students (Baseline up to 9 months).
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Fitbit Charge 6 devices worn continuously for one week at each measurement point to provide 24-hour assessments of heart rate and heart rate variability (HRV) as indicators of fatigue and autonomic nervous system state.
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Assessed at 6 time points across the academic year in a subsample of 160 students (Baseline up to 9 months).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Objective Physical Activity and Sleep Patterns
Time Frame: Assessed at 6 time points across the academic year in a subsample of 160 students (Baseline up to 9 months).
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Fitbit Charge 6 devices worn continuously for one week providing assessments of sleep metrics (duration, efficiency) and PA patterns (steps, intensity minutes, sedentary time).
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Assessed at 6 time points across the academic year in a subsample of 160 students (Baseline up to 9 months).
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Self-reported Physical Activity Frequency
Time Frame: Assessed at 6 time points across the academic year (Baseline up to 9 months).
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Assessed via a single-item question asking participants about their weekly physical activity volume (including PE classes and outside school).
Rated on a 5-point scale ranging from "None" to "More than 7 hours".
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Assessed at 6 time points across the academic year (Baseline up to 9 months).
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Self-reported Sleep Duration
Time Frame: Assessed at 6 time points across the academic year (Baseline up to 9 months).
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Assessed via a single-item question asking about the average hours of sleep per day (including night sleep and naps).
Responses range from "Less than 3 hours" to "More than 10 hours".
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Assessed at 6 time points across the academic year (Baseline up to 9 months).
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Self-reported Screen Time
Time Frame: Assessed at 6 time points across the academic year (Baseline up to 9 months).
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Assessed separately for weekdays and weekends via a single question about hours spent on screens (TV, mobile, video games, social media).
Rated on a 7-point scale ranging from "0 minutes" to "5 hours or more".
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Assessed at 6 time points across the academic year (Baseline up to 9 months).
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Cognitive Performance (Neuropsychological Battery)
Time Frame: Assessed at 6 time points across the academic year in a subsample of 160 students (Baseline up to 9 months).
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A computerized battery assessing cognitive inhibition, selective attention, working memory, and sustained attention using three specific tasks: the Stroop task, the Paced Auditory Serial Addition Test (PASAT), and the Psychomotor Vigilance Task-Brief (PVT-B).
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Assessed at 6 time points across the academic year in a subsample of 160 students (Baseline up to 9 months).
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Perceived Executive Functioning (WEBEX)
Time Frame: Assessed at 6 time points across the academic year (Baseline up to 9 months).
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Perceived difficulties and efficacy in everyday executive functioning evaluated using the WEBEX Scale (Morea & Calvete, 2020).
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Assessed at 6 time points across the academic year (Baseline up to 9 months).
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Academic Performance (GPA)
Time Frame: Assessed at 3 time points across the academic year (Baseline up to 9 months).
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Grade point average (GPA) obtained from students' official academic records across all compulsory subjects.
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Assessed at 3 time points across the academic year (Baseline up to 9 months).
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Academic Burnout (MBI-SS)
Time Frame: Assessed at 6 time points across the academic year (Baseline up to 9 months).
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Maslach Burnout Inventory-Student Survey (12 items).
Comprises three dimensions: emotional exhaustion, cynicism, and academic efficacy.
A composite burnout score is calculated.
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Assessed at 6 time points across the academic year (Baseline up to 9 months).
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School Engagement (UWES-S)
Time Frame: Assessed at 6 time points across the academic year (Baseline up to 9 months).
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Assessed using 3 items from the Utrecht Work Engagement Scale for Students measuring vigor, dedication, and absorption.
Items are rated on a 7-point scale (0-6).
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Assessed at 6 time points across the academic year (Baseline up to 9 months).
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Perceived Mental Load
Time Frame: Assessed at 6 time points across the academic year (Baseline up to 9 months).
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Assessed using an adapted 3-item scale (Díaz-García et al., 2018) measuring perceived physical, cognitive, and emotional demands of the school week.
Rated on an 11-point scale (0-10).
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Assessed at 6 time points across the academic year (Baseline up to 9 months).
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Motivation towards Exercise (BREQ-3)
Time Frame: Assessed at 3 time points: beginning, middle, and end of the academic year (Months 0, 4.5, and 9).
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Assessed using 6 items representing the six regulation types of the Behavioral Regulation in Exercise Questionnaire-3.
Rated on a 5-point scale (0-4).
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Assessed at 3 time points: beginning, middle, and end of the academic year (Months 0, 4.5, and 9).
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Classroom Social Dynamics (CCQ-SF)
Time Frame: Assessed at 3 time points: at the end of trimesters 1, 2, and 3 (Months 3, 6, and 9).
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Class Cohesion Questionnaire Short-Form (Leo et al., 2023) measuring task and social cohesion (6 items total).
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Assessed at 3 time points: at the end of trimesters 1, 2, and 3 (Months 3, 6, and 9).
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Subjective Happiness (SHS)
Time Frame: Assessed at 2 time points: beginning and end of the academic year (Month 0 and Month 9).
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Assessed using the Spanish adaptation of the Subjective Happiness Scale (Extremera & Fernández-Berrocal, 2014).
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Assessed at 2 time points: beginning and end of the academic year (Month 0 and Month 9).
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Adherence to the Mediterranean Diet (KIDMED 2.0)
Time Frame: Assessed at measurement point 5 (approximately Month 7.5 of the academic year).
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Assessed using the KIDMED 2.0 questionnaire (Spanish version; López-Gajardo et al., 2022) to evaluate adherence to the Mediterranean diet.
Higher scores indicate better adherence to healthy dietary habits.
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Assessed at measurement point 5 (approximately Month 7.5 of the academic year).
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Inmaculada González-Ponce, PhD, University of Extremadura - Faculty of Teacher Training
- Principal Investigator: Tomás García-Calvo, PhD, University of Extremadura - Faculty of Sport Science
- Study Director: Rosa Ayuso-Moreno, MSc, University of Extremadura - Faculty of Sport Science
Publications and helpful links
General Publications
- Smith MR, Chai R, Nguyen HT, Marcora SM, Coutts AJ. Comparing the Effects of Three Cognitive Tasks on Indicators of Mental Fatigue. J Psychol. 2019;153(8):759-783. doi: 10.1080/00223980.2019.1611530. Epub 2019 Jun 12.
- Bandera-Campos FJ, Grao-Cruces A, Camiletti-Moiron D, Martin-Acosta F, Munoz-Gonzalez R, Gonzalez-Perez M, Ruiz-Hermosa A, Vaquero-Solis M, Padilla-Moledo C, Sanchez-Oliva D. Effectiveness of a multicomponent intervention to promote physical activity during the school day: rationale and methods of the MOVESCHOOL study. Front Public Health. 2025 Mar 12;13:1565914. doi: 10.3389/fpubh.2025.1565914. eCollection 2025.
- Diaz-Garcia J, Gonzalez-Ponce I, Ponce-Bordon JC, Lopez-Gajardo MA, Ramirez-Bravo I, Rubio-Morales A, Garcia-Calvo T. Mental Load and Fatigue Assessment Instruments: A Systematic Review. Int J Environ Res Public Health. 2021 Dec 31;19(1):419. doi: 10.3390/ijerph19010419.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PID2022-140903NB-I00
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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