NCT05812118

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
285

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 13, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

December 6, 2023

Status Verified

March 1, 2023

Enrollment Period

1.1 years

First QC Date

March 14, 2023

Last Update Submit

December 5, 2023

Conditions

Keywords

Physical LiteracyAcademic AchievementCognitive FunctionChildrenSchool-based Intervention

Outcome Measures

Primary Outcomes (9)

  • Change of the actual motor competence

    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

    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

    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

    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

    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

    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

    Final grade scores at school

    Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention

  • Change of the working memory

    Digit Span test

    Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention

  • Change of the executive function

    Stroop test

    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

    Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention

  • Change of the body Mass Index

    Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention

  • Change of the cardiorespiratory fitness

    Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention

  • Change of the physical activity participation (self-reported)

    Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention

  • Change of the alienation with school

    Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention

  • +9 more secondary outcomes

Other Outcomes (4)

  • School and home macro-scale neighborhood built environments

    Measured at baseline

  • School and home micro-scale neighborhood built environments

    Measured at baseline

  • Internal physical school characteristics in relation to physical activity

    Measured at baseline

  • +1 more other outcomes

Study Arms (2)

Control group

NO INTERVENTION

Control group

Experimental group

EXPERIMENTAL

Physical active learning intervention

Behavioral: Physical active learning

Interventions

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.

Experimental group

Eligibility Criteria

Age10 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Valencia

Valencia, 46022, Spain

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Isaac Estevan, PhD

    University of Valencia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will not be aware of whether or not they received the intervention.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A classroom-based randomised controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2023

First Posted

April 13, 2023

Study Start

May 1, 2022

Primary Completion

June 21, 2023

Study Completion

July 31, 2023

Last Updated

December 6, 2023

Record last verified: 2023-03

Locations