- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05812118
A Classroom-based Intervention to Promote Physical Literacy in Children: ALPHYL Study Protocol (ALPHYL)
December 5, 2023 updated by: University of Valencia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
285
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Valencia, Spain, 46022
- University of Valencia
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
• None.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control group
|
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Experimental: Experimental group
Physical active learning intervention
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
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Change of the physical activity level
Time Frame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
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Assessment of the physical activity by accelerometers
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Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
|
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.
|
Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
|
Change of the perceived motor competence
Time Frame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
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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 at baseline, immediately after the intervention and 8-10 weeks after the intervention
|
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.
|
Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
|
Change of the perceived social support
Time Frame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
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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 at baseline, immediately after the intervention and 8-10 weeks after the intervention
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Change of the academic achievement
Time Frame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
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Final grade scores at school
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Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
|
Change of the working memory
Time Frame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
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Digit Span test
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Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
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Change of the executive function
Time Frame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
|
Stroop test
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Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of the body Mass Index
Time Frame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
|
The assessment of height and weight will be use to calculate body mass index
|
Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
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Change of the cardiorespiratory fitness
Time Frame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
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Assessment of this fitness component using Progressive Aerobic Cardiovascular Endurance Run test
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Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
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Change of the physical activity participation (self-reported)
Time Frame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
|
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 at baseline, immediately after the intervention and 8-10 weeks after the intervention
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Change of the alienation with school
Time Frame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
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Health Behaviour in school-age children questionnaire.
Minimum and maximum response values are from 1 to 5. Higher scores mean a better outcome.
|
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
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Future intention of physical activity scale.
Minimum and maximum response values are from 1 to 5. Higher scores mean a better outcome.
|
Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
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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
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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.
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Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
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Change of the perceived physical self-concept
Time Frame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
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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.
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Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
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Change of the sedentary behaviour
Time Frame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
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Youth Leisure-Time Sedentary Behaviour Questionaire in minutes
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Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
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Change of the school satisfaction
Time Frame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
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Intrinsic Satisfaction Classroom Scale.
Minimum and maximum response values are from 1 to 5. Higher scores mean a better outcome.
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Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
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Change of the social identity
Time Frame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
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Social Identity Questionnaire for Physical Education/Sport.
Minimum and maximum response values are from 1 to 5. Higher scores mean a better outcome.
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Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
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Change of the math fluency calculation
Time Frame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
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The Spanish version of the Woodcock-Johnson III test
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Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
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Change of the active commuting to/from school
Time Frame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
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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.
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Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
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Change of the body image perception
Time Frame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
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Children Body Figure Silhouette evaluation.
Minimum and maximum response values are from 1 to 7. Higher scores mean overweight and obese appearance.
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Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
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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
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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.
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Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parental perceptions of the home neighborhood built environment
Time Frame: Measured at baseline
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Parental perceptions will be evaluated using Neighborhood Environment Walkability Scale for Youth.
Minimum and maximum response values are from 1 to 4. Higher scores mean a better outcome.
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Measured at baseline
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School and home macro-scale neighborhood built environments
Time Frame: Measured at baseline
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Evaluation of the macro-scale neighborhood attributes using Geographic Information System-based data such as population density, land-use mix (green areas, commercial areas, recreational areas, etc.), distance to destinations (schools, parks, shops, etc.), intersection density, etc.
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Measured at baseline
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School and home micro-scale neighborhood built environments
Time Frame: Measured at baseline
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Evaluation of the micro-scale neighborhood attributes using Microscale Audit of Pedestrian Streetscapes-Global audit tool.
Overall positive score ranges from 0 to 210.
Higher scores mean a better outcome.
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Measured at baseline
|
Internal physical school characteristics in relation to physical activity
Time Frame: Measured at baseline
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Evaluation of the physical school characteristics using International Study of Childhood Obesity, Lifestyle and the Environment School Audit Tool.
Minimum and maximum values are from 0 to 37. Higher scores mean a better outcome.
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Measured at baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Isaac Estevan, PhD, University of Valencia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2022
Primary Completion (Actual)
June 21, 2023
Study Completion (Actual)
July 31, 2023
Study Registration Dates
First Submitted
March 14, 2023
First Submitted That Met QC Criteria
March 31, 2023
First Posted (Actual)
April 13, 2023
Study Record Updates
Last Update Posted (Estimated)
December 6, 2023
Last Update Submitted That Met QC Criteria
December 5, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UV1564606
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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