Clinical trial NCT05243784: The MOVI-HIIT Pilot Trial: The Impact of Activity Breaks on Cognitive Function, Adiposity and Fitness in Preschoolers
Official title: The Impact of a Classroom-based Physical Activity Breaks on Cognitive Function, Adiposity and Fitness in Preschool Children. A Pilot Trial Study (MOVI- HIIT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Obesity, Childhood
Cardiovascular Diseases
High Intensity Interval Training
Cognition
Keywords: Children
obesity
High Intensity Interval Training
cognition
cardiorespiratory fitness
Aerobic capacity
Preschool
Adiposity
Physical Activity
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
Collaborators: name: Ministerio de Ciencia e Innovación, Spain
First posted: 2022-02-17
Enrollment: 62
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Pilot study to test the acceptability and feasibility of an intervention aimed 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 and cardiorespiratory fitness.

Detailed description: The evolution of the MOVI studies, conducted by the research group, has led to create the last project (MOVI-HIIT; ClinicalTrials.gov Identifier: NCT04863040).

This pilot study will include children aged 4-6 years from 2 public schools of the province of Ciudad Real, Spain, with 2 arms (intervention and control) and the intervention will last 8 weeks.

The intervention proposed in the study is implemented through an online platform developed to achieved the intensities required for the age-range of participants, but this platform has never been tested accurately in the classroom.

Thus, it seems necessary to pilot the intervention to evaluate the acceptability and feasibility of the intervention, in order to improve facts, if necessary, to achieved proposed objectives.

Eligibility criteria: Inclusion Criteria:

* The participating schoolchildren must belong to the 2nd and 3rd year of preschool education, not have any malformation that prevents them from learning the Spanish language (or Spanish sign language), not have any type of physical or mental disorder that parents and/or teachers have identified that prevents the performance of physical activities, not suffer from any chronic disease such as heart disease, diabetes or asthma that, according to the criteria of their pediatrician - after analysis of the program of activities - prevents their participation in the measurements and/or the intervention.
* As this is an intervention in the classroom, the school faculty will include the active breaks proposed in the center's programming, for which reason the intervention will be received by all the children in the intervention group school. However, the investigators will consider school participants to be those who have the consent of the parent or guardian for participation in the study. In addition, schoolchildren must verbally express their willingness to participate in the baseline and final physical examinations.

Exclusion Criteria:

* Children with severe Spanish language learning difficulties.
* Children with serious physical or mental disorders identified by parents or teachers that would impede participation in the programme's activities.
* Children diagnoses of chronic disorders, such as heart disease, diabetes or asthma, which in the opinion of their paediatricians would prevent their participation in the programme's activities (MOVI-HIIT)

Primary outcomes:
measure: Evaluation of the perceived effort and exercise enjoyment within the use of the MOVI-HIIT platform by questionnaires.
timeFrame: 4 months
measure: Acceptance rate and adverse effects of the MOVI-HIIT intervention.
timeFrame: 4 months
measure: Evaluation of schoolchildren's compliance with the MOVI-HIIT intervention.
timeFrame: 4 months
measure: Participant's satisfaction with the MOVI-HIIT program by questionnaire
timeFrame: 4 months
measure: Teacher's perception about the suitability of the MOVI-HIIT platform by interviews.
timeFrame: 4 months
Secondary outcomes:
measure: VO2max
timeFrame: 4 months
measure: Inhibition/Attention (Executive Function)
timeFrame: 4 months
measure: Working memory (Executive Function)
timeFrame: 4 months
measure: Cognitive flexibility (Executive Function)
timeFrame: 4 months
measure: Percentage of body fat
timeFrame: 4 months
measure: Health Related Quality of Life for children and parents
timeFrame: 4 months
measure: Amount of daily performed physical activity
timeFrame: 4 months
measure: The acute effect of physical exercise on the brain's electrical activity
timeFrame: 4 months
measure: Children's active commuting to school questionnaire
timeFrame: 4 months
Other outcomes:
Locations:
city: Cuenca
country: Spain
facility: Social and Health Research Center. Universidad de Castilla-La Mancha
Study officials:
References: