Viewing Study NCT05812118


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Study NCT ID: NCT05812118
Status: COMPLETED
Last Update Posted: 2023-12-06
First Post: 2023-03-14
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: A Classroom-based Intervention to Promote Physical Literacy in Children: ALPHYL Study Protocol
Sponsor: University of Valencia
Organization:

Study Overview

Official Title: A Classroom-based Randomized Controlled Trial to Promote Physical Literacy in Children: ALPHYL Study Protocol
Status: COMPLETED
Status Verified Date: 2023-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: ALPHYL
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.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: