Physical ActivityNCT05243784
The MOVI-HIIT Pilot Trial: The Impact of Activity Breaks on Cognitive Function, Adiposity and Fitness in Preschoolers
A study testing MOVI-HIIT intervention in people with Physical Activity and Obesity, Childhood, run by University of Castilla-La Mancha at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Obesity, Childhood, Cardiovascular Diseases
- What is being tested?
- MOVI-HIIT intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSpain
- Study dates
- 27 Jan 2022to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Spain1 site
Social and Health Research Center. Universidad de Castilla-La Mancha
Cuenca, 16071
About this study
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)
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.
Read the 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.
- Conditions
- Physical Activity, Obesity, Childhood, Cardiovascular Diseases, High Intensity Interval Training, Cognition
- Being tested
- MOVI-HIIT intervention
- Keywords
- Children, obesity, High Intensity Interval Training, cognition, cardiorespiratory fitness, Aerobic capacity, Preschool, Adiposity, Physical Activity
- Medical subject headings
- Motor Activity, Pediatric Obesity, Cardiovascular Diseases, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOVI-HIIT interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The design of the MOVI-HIIT intervention is framed within the socio-ecological model of behavior modification, in such a way that it will be designed to intervene in the individual, family and school environment. It will have a duration of 8 weeks and will consist of two 5-minute daily physical activity breaks based on intervallic training, five days a week. Receives: Behavioral: MOVI-HIIT intervention |
| Control | No intervention | Students in the control group (CG) will receive mandatory lessons on Spain (one 45-minute session of Psychomotor/Physical Education), and the usual classroom teaching methodology. Teachers in the CG schools will be asked not to make any changes to their methodology during the time of the study, with the promise by the research team to share and explain the MOVI-HIIT program once the interventions are completed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 months
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).
Measured: 4 months
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).
Measured: 4 months
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).
Measured: 4 months
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.
Measured: 4 months
Secondary outcomes (9)
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.
Measured: 4 months
Inhibition/Attention (Executive Function)
Measured by means of the Flanker Inhibitory Control and Attention test included in the NIH toolbox battery.
Measured: 4 months
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).
Measured: 4 months
Cognitive flexibility (Executive Function)
NIH toolbox battery. Cognitive flexibility through the DCCS (Dimensional Change Card Sort) test, included in the NIH toolbox battery.
Measured: 4 months
Percentage of body fat
It will be measured twice in each participant by bioimpedance analysis.
Measured: 4 months
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).
Measured: 4 months
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).
Measured: 4 months
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).
Measured: 4 months
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).
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start27 Jan 2022
- Primary completion1 Apr 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Ciencia e Innovación, Spain
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05243784
- Sponsor's protocol ID
- PID2019-104160RB-I00-Pilot
- Status last verified
- Nov 2022
- First submitted
- 3 Jan 2022
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05243784
- Acronym / sponsor ID
- PID2019-104160RB-I00-Pilot
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Collaborators
- Ministerio de Ciencia e Innovación, Spain
- Study start
- 27 Jan 2022 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 17 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: MOVI-HIIT interventionThe design of the MOVI-HIIT intervention is framed within the socio-ecological model of behavior modification, in such a way that it will be designed to intervene in the individual, family and school environment. It will have a duration of 8 weeks and will consist of two 5-minute daily physical activity breaks based on intervallic training, five days a week. |
| Control | No intervention | –Students in the control group (CG) will receive mandatory lessons on Spain (one 45-minute session of Psychomotor/Physical Education), and the usual classroom teaching methodology. Teachers in the CG schools will be asked not to make any changes to their methodology during the time of the study, with the promise by the research team to share and explain the MOVI-HIIT program once the interventions are completed. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOVI-HIIT interventionEach 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. | Behavioural | Intervention |
Primary outcome
Evaluation of the perceived effort and exercise enjoyment within the use of the MOVI-HIIT platform by questionnaires.
Time frame: 4 months
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).
Acceptance rate and adverse effects of the MOVI-HIIT intervention.
Time frame: 4 months
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).
Evaluation of schoolchildren's compliance with the MOVI-HIIT intervention.
Time frame: 4 months
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).
Participant's satisfaction with the MOVI-HIIT program by questionnaire
Time frame: 4 months
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).
Teacher's perception about the suitability of the MOVI-HIIT platform by interviews.
Time frame: 4 months
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.
9 secondary outcomes
VO2max
Time frame: 4 months
Inhibition/Attention (Executive Function)
Time frame: 4 months
Working memory (Executive Function)
Time frame: 4 months
Cognitive flexibility (Executive Function)
Time frame: 4 months
Percentage of body fat
Time frame: 4 months
Health Related Quality of Life for children and parents
Time frame: 4 months
Amount of daily performed physical activity
Time frame: 4 months
The acute effect of physical exercise on the brain's electrical activity
Time frame: 4 months
Children's active commuting to school questionnaire
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MOVI-HIIT intervention in people with Physical Activity and Obesity, Childhood, run by University of Castilla-La Mancha at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the perceived effort and exercise enjoyment within the use of the MOVI-HIIT platform by questionnaires. (time frame: 4 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.