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Clinical Trial 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.


Clinical Trial 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 0.3 (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 Design


Related Conditions & MeSH terms


NCT number NCT04863040
Study type Interventional
Source University of Castilla-La Mancha
Contact
Status Active, not recruiting
Phase N/A
Start date June 1, 2020
Completion date June 1, 2024

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