Physical ActivityALPHYLNCT05812118
A Classroom-based Intervention to Promote Physical Literacy in Children: ALPHYL Study Protocol
A study testing Physical active learning in people with Physical Activity, run by University of Valencia at 1 site in Spain.
Trial summary
The goal of this study, named the Active Learning for PHYsical Literacy (ALPHYL) study, was to describe a multicomponent class-based physically-active learning randomized control trial (RCT) in primary school children. Read more about this study
- Who is it for?
- Ages 10 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Physical active learning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2022to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participants enrolled in 5th grade (i.e., 10-11 years old).
- Schools must have at least two groups of primary school 5th grade and the teachers involved in both agree to participate.
- Each class group includes at least 75% of the participants.
- Children must not have taken part in other physical activity promotion interventions in the two previous years.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Classroom-based Randomized Controlled Trial to Promote Physical Literacy in Children: ALPHYL Study Protocol
The goal of this study, named the Active Learning for PHYsical Literacy (ALPHYL) study, was to describe a multicomponent class-based physically-active learning randomized control trial (RCT) in primary school children. The main purpose was to promote children's physical literacy, academic achievement and cognitive function. The ALPHYL study is mainly based on physical literacy, active school models and Supportive, Active, Autonomous, Fair and Enjoyable principles.
Read the detailed description
The ALPHYL is an 8-10-week RCT that will be conducted in six primary schools (12 classes) in Valencia and its metropolitan area. Schools will be randomly assigned to the intervention or a waiting-list control group. After a 30 h in-person training course for teachers and weekly meetings in the three months of resource preparation, the ALPHYL intervention will be conducted in physical education (PE) and non-PE lessons by teachers. The intervention consists of at least three physically active learning sessions per day plus model-based PE classes. Its feasibility will be evaluated weekly according to the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. To assess its effectiveness, a pre-test, post-test and retention (8-10 weeks after the intervention) with primary outcomes (i.e. physical activity level, motor competence, perceived motor competence and physical literacy, motivation, perceived social support, academic achievement and cognitive function), secondary outcomes and covariates will be collected.
- Conditions
- Physical Activity
- Being tested
- Physical active learning
- Keywords
- Physical Literacy, Academic Achievement, Cognitive Function, Children, School-based Intervention
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical active learningBehavioural
The intervention will last for 8-10 weeks. The ALPHYL intervention will be conducted in physical education (PE) and non-PE lessons by teachers. In addition to the PE lessons, at least three physically active activities in subjects other than PE will be conducted every day (5 days per week), with a total duration of approximately 30 minutes of light and moderate-to-vigorous physical activity per day. The weekly dose of physically active learning will thus be 100-150 minutes, so that a volume of 800-1200 minutes is foreseen during the 8-10 weeks. The PE classes will also be conducted in a mix of cooperative learning, non-linear pedagogy and health-based PE.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Control group |
| Experimental group | Experimental | Physical active learning intervention Receives: Behavioral: Physical active learning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the actual motor competence
Assessment of the actual motor competence using Canadian Agility Movement Skill Assessment test
Measured: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Change of the physical activity level
Assessment of the physical activity by accelerometers
Measured: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Change of the perceived physical literacy
Assessment of this variable using Physical Literacy for Children Questionnaire. Minimum and maximum response values are from 1 to 4. Higher scores mean a better outcome.
Measured: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Change of the perceived motor competence
Assessment of this variable using Pictorial scale of Perceived Movement Skill Competence. Minimum and maximum response values are from 1 to 4. Higher scores mean a better outcome.
Measured: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Change of the self-determined motivation for physical activity
Adapted version for children of the Behavioural Regulation Exercise Questionnaire. Minimum and maximum response values are from 1 to 5. Higher scores mean a better outcome.
Measured: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Change of the perceived social support
The Physical Activity Family and Friends Support Scale. Minimum and maximum response values are from 1 to 5. Higher scores mean a better outcome.
Measured: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Change of the academic achievement
Final grade scores at school
Measured: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Change of the working memory
Digit Span test
Measured: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Change of the executive function
Stroop test
Measured: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Secondary outcomes (14)
Change of the active commuting to/from school
Survey adapted from Centers for Disease Control Kids-Walk-to-School programme by investigators of the International Physical Activity and the Environment Network. Participants will indicate the number of days travelling both to and from school by walking, bicycling or skateboarding in an average school week. Total number of active trips per week to and from school will be summed (range = 0-10 trips). Higher scores mean a better outcome.
Measured: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Change of the body Mass Index
The assessment of height and weight will be use to calculate body mass index
Measured: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Change of the cardiorespiratory fitness
Assessment of this fitness component using Progressive Aerobic Cardiovascular Endurance Run test
Measured: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Change of the physical activity participation (self-reported)
Physical activity will be self-reported using Physical Activity Questionnaire for Children. Minimum and maximum response values are from 1 to 5. Higher scores mean a better outcome.
Measured: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Change of the alienation with school
Health Behaviour in school-age children questionnaire. Minimum and maximum response values are from 1 to 5. Higher scores mean a better outcome.
Measured: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Change of the body image perception
Children Body Figure Silhouette evaluation. Minimum and maximum response values are from 1 to 7. Higher scores mean overweight and obese appearance.
Measured: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Change of the physical activity intention
Future intention of physical activity scale. Minimum and maximum response values are from 1 to 5. Higher scores mean a better outcome.
Measured: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Change of the physical activity psychological need satisfaction according to the Self-Determination Theory at physical education
Basic psychological needs satisfaction scale within physical education setting. Minimum and maximum response values are from 1 to 5. Higher scores mean a better outcome.
Measured: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Change of the perceived physical self-concept
The pictorial scale of Physical Self-Concept in Children. Minimum and maximum response values are from 1 to 4. Higher scores mean a better outcome.
Measured: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Change of the sedentary behaviour
Youth Leisure-Time Sedentary Behaviour Questionaire in minutes
Measured: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Change of the school satisfaction
Intrinsic Satisfaction Classroom Scale. Minimum and maximum response values are from 1 to 5. Higher scores mean a better outcome.
Measured: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Change of the social identity
Social Identity Questionnaire for Physical Education/Sport. Minimum and maximum response values are from 1 to 5. Higher scores mean a better outcome.
Measured: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Change of the knowledge related to physical activity and healthy lifestyles
This variable will be evaluated using the Self-Determination index. Minimum and maximum response values are from 1 to 5. Higher scores mean a better outcome.
Measured: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Change of the math fluency calculation
The Spanish version of the Woodcock-Johnson III test
Measured: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start1 May 2022
- Primary completion21 Jun 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A classroom-based randomised controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isaac Estevan, PhD, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05812118
- Sponsor's protocol ID
- UV1564606
- Acronym
- ALPHYL
- Status last verified
- Mar 2023
- First submitted
- 14 Mar 2023
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Romero-Martinez J, Menescardi C, Ortega-Benavent N, Montalt-Garcia S, Barnett LM, Garcia-Masso X, Estevan I. Effects of a classroom-based intervention to promote physical literacy in children: the randomized and controlled ALPHYL Study. J Sci Med Sport. 2025 Oct;28(10):833-839. doi: 10.1016/j.jsams.2025.05.006. Epub 2025 May 22.
PubMed 40450427
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Classroom-based Randomized Controlled Trial to Promote Physical Literacy in Children: ALPHYL Study Protocol
- ClinicalTrials.gov ID
- NCT05812118
- Acronym / sponsor ID
- ALPHYL / UV1564606
- Conditions
- Physical Activity
- Keywords
- Physical Literacy, Academic Achievement, Cognitive Function, Children, School-based Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 21 Jun 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 13 Apr 2023 (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.
The goal of this study, named the Active Learning for PHYsical Literacy (ALPHYL) study, was to describe a multicomponent class-based physically-active learning randomized control trial (RCT) in primary school children. The main purpose was to promote children's physical literacy, academic achievement and cognitive function. The ALPHYL study is mainly based on physical literacy, active school models and Supportive, Active, Autonomous, Fair and Enjoyable principles.
Detailed description
The ALPHYL is an 8-10-week RCT that will be conducted in six primary schools (12 classes) in Valencia and its metropolitan area. Schools will be randomly assigned to the intervention or a waiting-list control group. After a 30 h in-person training course for teachers and weekly meetings in the three months of resource preparation, the ALPHYL intervention will be conducted in physical education (PE) and non-PE lessons by teachers. The intervention consists of at least three physically active learning sessions per day plus model-based PE classes. Its feasibility will be evaluated weekly according to the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. To assess its effectiveness, a pre-test, post-test and retention (8-10 weeks after the intervention) with primary outcomes (i.e. physical activity level, motor competence, perceived motor competence and physical literacy, motivation, perceived social support, academic achievement and cognitive function), secondary outcomes and covariates will be collected.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A classroom-based randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Control group |
| Experimental group | Experimental | Behavioral: Physical active learningPhysical active learning intervention |
Who may qualify
- Ages
- 10 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Participants enrolled in 5th grade (i.e., 10-11 years old).
- Schools must have at least two groups of primary school 5th grade and the teachers involved in both agree to participate.
- Each class group includes at least 75% of the participants.
- Children must not have taken part in other physical activity promotion interventions in the two previous years.
Key exclusion criteria (1 listed)
- None.
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 |
|---|---|---|
| Physical active learningThe intervention will last for 8-10 weeks. The ALPHYL intervention will be conducted in physical education (PE) and non-PE lessons by teachers. In addition to the PE lessons, at least three physically active activities in subjects other than PE will be conducted every day (5 days per week), with a total duration of approximately 30 minutes of light and moderate-to-vigorous physical activity per day. The weekly dose of physically active learning will thus be 100-150 minutes, so that a volume of 800-1200 minutes is foreseen during the 8-10 weeks. The PE classes will also be conducted in a mix of cooperative learning, non-linear pedagogy and health-based PE. | Behavioural | Experimental group |
Primary outcome
Change of the actual motor competence
Time frame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Assessment of the actual motor competence using Canadian Agility Movement Skill Assessment test
Change of the physical activity level
Time frame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Assessment of the physical activity by accelerometers
Change of the perceived physical literacy
Time frame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Assessment of this variable using Physical Literacy for Children Questionnaire. Minimum and maximum response values are from 1 to 4. Higher scores mean a better outcome.
Change of the perceived motor competence
Time frame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Assessment of this variable using Pictorial scale of Perceived Movement Skill Competence. Minimum and maximum response values are from 1 to 4. Higher scores mean a better outcome.
Change of the self-determined motivation for physical activity
Time frame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Adapted version for children of the Behavioural Regulation Exercise Questionnaire. Minimum and maximum response values are from 1 to 5. Higher scores mean a better outcome.
Change of the perceived social support
Time frame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
The Physical Activity Family and Friends Support Scale. Minimum and maximum response values are from 1 to 5. Higher scores mean a better outcome.
Change of the academic achievement
Time frame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Final grade scores at school
Change of the working memory
Time frame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Digit Span test
Change of the executive function
Time frame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Stroop test
14 secondary outcomes
Change of the active commuting to/from school
Time frame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Change of the body Mass Index
Time frame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Change of the cardiorespiratory fitness
Time frame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Change of the physical activity participation (self-reported)
Time frame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Change of the alienation with school
Time frame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Change of the body image perception
Time frame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Change of the physical activity intention
Time frame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Change of the physical activity psychological need satisfaction according to the Self-Determination Theory at physical education
Time frame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Change of the perceived physical self-concept
Time frame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Change of the sedentary behaviour
Time frame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Change of the school satisfaction
Time frame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Change of the social identity
Time frame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Change of the knowledge related to physical activity and healthy lifestyles
Time frame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Change of the math fluency calculation
Time frame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Derived from this study: PubMed 40450427Romero-Martinez J, Menescardi C, Ortega-Benavent N, Montalt-Garcia S, Barnett LM, Garcia-Masso X, Estevan I. Effects of a classroom-based intervention to promote physical literacy in children: the randomized and controlled ALPHYL Study. J Sci Med Sport. 2025 Oct;28(10):833-839. doi: 10.1016/j.jsams.2025.05.006. Epub 2025 May 22.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Isaac Estevan, PhD principal investigator
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical active learning in people with Physical Activity, run by University of Valencia 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 1 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: finished, as of the sponsor's last update on 6 Dec 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 of the actual motor competence (time frame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05812118, which also lists 1 linked publication.
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 6 Dec 2023.