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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
285

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Spain
      • Valencia, Spain, 46022
        • University of Valencia

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control group
Experimental: Experimental group
Physical active learning intervention
Behavioral: Physical active learning
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
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
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
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
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
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
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
Digit Span test
Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Change of the executive function
Time Frame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Stroop test
Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Change of the cardiorespiratory fitness
Time Frame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Assessment of this fitness component using Progressive Aerobic Cardiovascular Endurance Run test
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
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
Change of the alienation with school
Time Frame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
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
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
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
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 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
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 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
Youth Leisure-Time Sedentary Behaviour Questionaire in minutes
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
Intrinsic Satisfaction Classroom 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
Change of the social identity
Time Frame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Social Identity Questionnaire for Physical Education/Sport. 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 math fluency calculation
Time Frame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
The Spanish version of the Woodcock-Johnson III test
Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Change of the active commuting to/from school
Time Frame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
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 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
Children Body Figure Silhouette evaluation. Minimum and maximum response values are from 1 to 7. Higher scores mean overweight and obese appearance.
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
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 at baseline, immediately after the intervention and 8-10 weeks after the intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Parental perceptions of the home neighborhood built environment
Time Frame: Measured at baseline
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.
Measured at baseline
School and home macro-scale neighborhood built environments
Time Frame: Measured at baseline
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.
Measured at baseline
School and home micro-scale neighborhood built environments
Time Frame: Measured at baseline
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.
Measured at baseline
Internal physical school characteristics in relation to physical activity
Time Frame: Measured at baseline
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.
Measured at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Valencia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 21, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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