A Classroom-based Intervention to Promote Physical Literacy in Children: ALPHYL Study Protocol

Physical Activity Clinical Trial

— ALPHYL  

Official title:

A Classroom-based Randomized Controlled Trial to Promote Physical Literacy in Children: ALPHYL Study Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05812118
• Other study ID #: UV1564606
• Status: Completed
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: March 2023
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 285
• Est. completion date: July 31, 2023
• Est. primary completion date: June 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Physical Activity

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.

Locations

Country	Name	City	State
Spain	University of Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	School and home macro-scale neighborhood built environments	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
Other	School and home micro-scale neighborhood built environments	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
Other	Internal physical school characteristics in relation to physical activity	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
Other	Parental perceptions of the home neighborhood built environment	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Change of the academic achievement	Final grade scores at school	Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Primary	Change of the working memory	Digit Span test	Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Primary	Change of the executive function	Stroop test	Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Secondary	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 at baseline, immediately after the intervention and 8-10 weeks after the intervention
Secondary	Change of the body Mass Index	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
Secondary	Change of the cardiorespiratory fitness	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
Secondary	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 at baseline, immediately after the intervention and 8-10 weeks after the intervention
Secondary	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 at baseline, immediately after the intervention and 8-10 weeks after the intervention
Secondary	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 at baseline, immediately after the intervention and 8-10 weeks after the intervention
Secondary	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 at baseline, immediately after the intervention and 8-10 weeks after the intervention
Secondary	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 at baseline, immediately after the intervention and 8-10 weeks after the intervention
Secondary	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 at baseline, immediately after the intervention and 8-10 weeks after the intervention
Secondary	Change of the sedentary behaviour	Youth Leisure-Time Sedentary Behaviour Questionaire in minutes	Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention
Secondary	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 at baseline, immediately after the intervention and 8-10 weeks after the intervention
Secondary	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 at baseline, immediately after the intervention and 8-10 weeks after the intervention
Secondary	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 at baseline, immediately after the intervention and 8-10 weeks after the intervention
Secondary	Change of the math fluency calculation	The Spanish version of the Woodcock-Johnson III test	Measured at baseline, immediately after the intervention and 8-10 weeks after the intervention