The MOVI-HIIT Pilot Trial: The Impact of Activity Breaks on Cognitive Function, Adiposity and Fitness in Preschoolers

Cardiovascular Diseases Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05243784
• Other study ID #: PID2019-104160RB-I00-Pilot
• Status: Completed
• Phase: N/A
• Start date: January 27, 2022
• Est. completion date: June 30, 2022

Study information

• Verified date: November 2022
• Source: University of Castilla-La Mancha
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: June 30, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cognition
• High Intensity Interval Training
• Obesity
• Obesity, Childhood
• Pediatric Obesity
• Physical Activity

Intervention

Behavioral:
• MOVI-HIIT intervention
Each HIIT break will last approximately 5 minutes and will not require any specific materials. The structure of the HIIT-Rest will be as follows: 1' to describe the work to be done; 3' of work following the HIIT protocol: 6 repetitions of a functional movement such as squats, Jumping Jack or running on site for 20" at high intensity (85-90% of HR -heart rate- max) followed by 10" of recovery (65-75% of HR max); and 1' to perform a return to calm in order to lower the activation and prepare the student body to return to class activities.

Locations

Country	Name	City	State
Spain	Social and Health Research Center. Universidad de Castilla-La Mancha	Cuenca

Sponsors (2)

Lead Sponsor	Collaborator
University of Castilla-La Mancha	Ministerio de Ciencia e Innovación, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the perceived effort and exercise enjoyment within the use of the MOVI-HIIT platform by questionnaires.	The schoolchildren's exercise enjoyment will be measured with the short version of the Physical Activity Enjoyment Scale, PACES-S [10.3390/ijerph182111035]), (range from 4 to 12, where the highest rate indicates more satisfaction); and the schoolchildren's perceived effort will be assessed with the Children's Effort Rating Table, Pictorial-CERT [10.1111/j.1365-2214.2007.00767.x.], with a range from 1 to 10 (where 10 indicates the highest perceived effort).	4 months
Primary	Acceptance rate and adverse effects of the MOVI-HIIT intervention.	The acceptability of the exercise program will be assessed recording adherence (rate of school's session attendance recorded in the online platform) and safety of the exercise programme (number and type of adverse events recorded by the teacher everyday after the session).	4 months
Primary	Evaluation of schoolchildren's compliance with the MOVI-HIIT intervention.	These trial feasibility outcomes will include: (1) recruitment (percentage achieved of the targeted study sample), (2) retention (drop-out rate and reasons for withdrawal), (3) outcome completion (percentage of children with both measurements at the end of the study).	4 months
Primary	Participant's satisfaction with the MOVI-HIIT program by questionnaire	An ad-hoc questionnarie will ask participants' about their satisfaction with the program (5-item pictorial scale questions, where the higher rate indicates higher satisfaction).	4 months
Primary	Teacher's perception about the suitability of the MOVI-HIIT platform by interviews.	It will be assessed with teachers feedback via interviews on the use of the exercise platform (user-friendliness, connectivity, attractiveness, practicality) and the barriers and facilitators to implementing the programme.	4 months
Secondary	VO2max	Cardiorespiratory fitness (Course Navette or 20-m shuttle run test), validated to measure maximum aerobic capacity in children. It will be carried out according to the Léger protocol included in the PREFIT Battery: Assessing FITness in PREschoolers adapted to children under the age of 6.	4 months
Secondary	Inhibition/Attention (Executive Function)	Measured by means of the Flanker Inhibitory Control and Attention test included in the NIH toolbox battery.	4 months
Secondary	Working memory (Executive Function)	Working memory with the Word Span test included in the NIH toolbox battery. This test is the Spanish version of the procedure developed by Thorell and Wählstedt (2006), based on the Digit Span subtest from the Wechsler Intelligence Test for Children-3rd edition (WISC-III; Wechsler, 1991).	4 months
Secondary	Cognitive flexibility (Executive Function)	NIH toolbox battery. Cognitive flexibility through the DCCS (Dimensional Change Card Sort) test, included in the NIH toolbox battery.	4 months
Secondary	Percentage of body fat	It will be measured twice in each participant by bioimpedance analysis.	4 months
Secondary	Health Related Quality of Life for children and parents	Kiddy-KINDL-R questionnaire version for children and parents accordingly, which has a 0-100 score scale (the higher score, the better perceived quality of life).	4 months
Secondary	Amount of daily performed physical activity	Physical activity will be objectively measured with pedometers during the day at school and in three moments across the pilot project (before, during and after the intervention).	4 months
Secondary	The acute effect of physical exercise on the brain's electrical activity	The brain activity will be measured with a portable electroencephalogram (EMOTIV EPOC X - 14-channel EEG - for whole brain sensing (AF3, AF4, F3, F4, F7, F8, T7, T8, P3, P4, P7, P8, O1, O2)) in 30 schoolchildren (15 children in the intervention group and 15 in the control group).	4 months
Secondary	Children's active commuting to school questionnaire	Patterns of commuting to school will be collected through a questionnaire for the children's parents, including 2 questions about the mode and duration of the commute to school: (1) ''How does your son/daughter usually go from home to school?'' and (2) ''How long does it usually take for your son/daughter to go from home to school?''. These questions are obtained from a 7-item questionnaire whose validity and reliability have been shown (Evenson KR et al. J Phys Act Health. 2008;5(suppl 1):S1-S15).	4 months