Clinical trial NCT05812118: A Classroom-based Intervention to Promote Physical Literacy in Children: ALPHYL Study Protocol
Official title: A Classroom-based Randomized Controlled Trial to Promote Physical Literacy in Children: ALPHYL Study Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Keywords: Physical Literacy
Academic Achievement
Cognitive Function
Children
School-based Intervention
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2023-04-13
Enrollment: 285
Sex: ALL
Minimum age (years): 10
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A classroom-based randomised controlled trial
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of the actual motor competence
timeFrame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
measure: Change of the physical activity level
timeFrame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
measure: Change of the perceived physical literacy
timeFrame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
measure: Change of the perceived motor competence
timeFrame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
measure: Change of the self-determined motivation for physical activity
timeFrame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
measure: Change of the perceived social support
timeFrame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
measure: Change of the academic achievement
timeFrame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
measure: Change of the working memory
timeFrame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
measure: Change of the executive function
timeFrame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Secondary outcomes:
measure: Change of the active commuting to/from school
timeFrame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
measure: Change of the body Mass Index
timeFrame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
measure: Change of the cardiorespiratory fitness
timeFrame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
measure: Change of the physical activity participation (self-reported)
timeFrame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
measure: Change of the alienation with school
timeFrame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
measure: Change of the body image perception
timeFrame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
measure: Change of the physical activity intention
timeFrame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
measure: Change of the physical activity psychological need satisfaction according to the Self-Determination Theory at physical education
timeFrame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
measure: Change of the perceived physical self-concept
timeFrame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
measure: Change of the sedentary behaviour
timeFrame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
measure: Change of the school satisfaction
timeFrame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
measure: Change of the social identity
timeFrame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
measure: Change of the knowledge related to physical activity and healthy lifestyles
timeFrame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
measure: Change of the math fluency calculation
timeFrame: Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Other outcomes:
measure: School and home macro-scale neighborhood built environments
timeFrame: Measured at baseline
measure: School and home micro-scale neighborhood built environments
timeFrame: Measured at baseline
measure: Internal physical school characteristics in relation to physical activity
timeFrame: Measured at baseline
measure: Parental perceptions of the home neighborhood built environment
timeFrame: Measured at baseline
Locations:
city: Valencia
country: Spain
facility: University of Valencia
Study officials:
affiliation: University of Valencia
name: Isaac Estevan, PhD
role: PRINCIPAL_INVESTIGATOR
References: