Viewing Study NCT04863040



Ignite Creation Date: 2024-05-06 @ 4:04 PM
Last Modification Date: 2024-10-26 @ 2:03 PM
Study NCT ID: NCT04863040
Status: COMPLETED
Last Update Posted: 2024-06-04
First Post: 2021-03-30

Brief Title: The Impact of Activity Breaks on Cognitive Function Adiposity and Fitness in Preschoolers
Sponsor: University of Castilla-La Mancha
Organization: University of Castilla-La Mancha

Study Overview

Official Title: The Impact of a Classroom-based Physical Activity Breaks on Cognitive Function Adiposity and Fitness in Preschool Children MOVI-HIIT
Status: COMPLETED
Status Verified Date: 2024-06
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: MOVI-HIIT
Brief Summary: Project which objective is a to test the effectiveness in preschool children of an integrated physical activity intervention in the classroom based on intervallic training MOVI-HIIT on improving executive function body composition cardiorespiratory fitness and b to evaluate teachers perceptions of barriers and facilitating elements for the implementation and monitoring of MOVI-HIIT interventions in the classroom
Detailed Description: In the last decade this research group has tested the effectiveness of five interventions in school settings The first one MOVI was carried out in children 8 to 11 years children 4th and 5th year of primary education and showed a moderate effect in reducing adiposity of schoolchildren with higher body mass index BMI and an improvement of the lipid profile without significantly improving the global cardiometabolic risk because it did not produce a reduction in insulinemia

The second edition MOVI-2 carried out with schoolchildren of the same age range increased the duration and intensity of the sessions and was focused on the development of muscular strength in order to improve insulinemia levels The intervention proved to be effective in addition data from this intervention showed a modest improvement in girls aerobic capacity but not in boys

The third edition MOVI-KIDS was aimed at children aged 4 to 7 years to test the hypotheses that vigorous physical activity at early ages could produce lifelong cardio-metabolic benefits This study show that as in the case of the IDEFICS study in children of similar age the intervention was not effective in improving fitness

The fourth edition MOVI-da10 was carried out at schoolchildren of the same age range but focusing on active breaks designs and as a controlled cluster-randomized trial to test the effectiveness of a classroom-based physical activity intervention on improving body composition cardiorespiratory fitness and executive function

The fifth edition MOVI-daFit was carried out with 9 to 11 years schoolchildren and consisted in a standardized recreative non-competitive physical activity intervention based on games adapted to high intensity interval training methodology out of school hours four times by week one hour session The aim was to test the effectiveness of an extracurricular physical activity intervention based on high intensity interval training MOVI-daFit on improving cardiorespiratory fitness cardiometabolic risk executive function and academic performance

The results from these last two editions are currently under process of publishing

The new edition MOVI-HIIT has been designed controlled cluster-randomized trial including 10 schools from Ciudad Real province Spain It will include two arms one intervention and one control arm in which 5 schools will be randomly assigned to the group in which a physical activity intervention will be performed MOVI-HIIT and another 5 schools to the control group in which the usual tasks will be performed

With the MOVI-HIIT intervention based on high intensity interval training integrated into the classroom for children of 2nd and 3rd grade of preschool education of one year of duration

1 Cardiorespiratory fitness VO2max will increase in the intervention group IG whose values are below the 50th percentile for their age and sex compared to those with the same condition in the control group CG with an effect size standardized mean difference of 03 moderate This hypothesis will be used to calculate the sample size in this proposal Considering only half of schoolchildren with lower cardiorespiratory fitness in IG and CG is due to the fact that VO2 max cannot be increased in trained subjects and it is possible to increase it very little less than 2 in those with acceptable levels of aerobic capacity
2 It will reduce the percentage of body fat in the IG versus the CG by 6
3 It will improve the executive function

Study Oversight

Has Oversight DMC: None
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?: None