Physical ActivityMOVI-HIITNCT04863040
The Impact of Activity Breaks on Cognitive Function, Adiposity and Fitness in Preschoolers
A study testing MOVI intervention in people with Physical Activity and Obesity, run by University of Castilla-La Mancha at 1 site in Spain.
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… 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, Children
- What is being tested?
- MOVI intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 522 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2020to 1 Jun 2024
- 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
- Schools in the province of Ciudad Real with at least one class (classroom) at each level (2nd and 3rd of preschool education), and in which the School Board gives its approval to the interventions and to the basal and final evaluations.
- 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 them.
- 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 each IG school. However, we 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 (MOVI-HIIT)
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.
Read the 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:
- 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.
- It will reduce the percentage of body fat in the IG versus the CG by 6%.
- It will improve the executive function.
- Conditions
- Physical Activity, Obesity, Children, Cardiovascular, High Intensity Interval Training, Cognition
- Being tested
- MOVI intervention
- Keywords
- Physical activity, Obesity, Children, Cognitive function, Academic achievement, Cardiorespiratory fitness, Adiposity, Cardiovascular fitness, Aerobic capacity, High Intensity Interval Training, Preschool
- Medical subject headings
- Motor Activity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOVI interventionBehavioural
Also called MOVI-HIIT
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 10" at high intensity (85-90% of HR max) followed by 20" 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. To increase the workload, and after evaluation of cardiorespiratory capacity, after 12 weeks of program, the HIIT protocol will be changed to 20" of high intensity work alternating with 10" of recovery.
| Study group | Role | What they receive |
|---|---|---|
| Usual classroom teaching methodology | No intervention | Students in the 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 materials once the interventions are completed. |
| Usual classroom teaching methodology + MOVI-HIIT 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 one school year and will consist of two 5-minute daily physical activity breaks based on intervallic training, five days a week. Receives: Behavioral: MOVI intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2max
Cardiorespiratory fitness, with the 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. This battery adapts the Course Navette test to children under the age of 6.
Measured: One year
Executive function
NIH toolbox battery.
- Inhibition/Attention by means of the Flanker Inhibitory Control and Attention test.
- Working memory with the List Sorting Working Memory test.
- Cognitive flexibility through the DCCS (Dimensional Change Card Sort) test.
Measured: One year
Body fat percent
Body fat percentage measured by Bioimpedance analysis
Measured: One year
Secondary outcomes (10)
Health-related quality of life - Parents
Kiddy-KINDL-R questionnaire version for parents, which has a 0-100 score scale.
Measured: One year
Health-related quality of life - Children
Kiddy-KINDL-R questionnaire version for children, which has a 0-100 score scale.
Measured: One year
Mothers' breastfeeding
Parents are going to be ask about what type of feeding had been chosen during their children's first 24 months of life. In each month, systematically, mothers can indicate if their children had been fed by breast milk, artificial milk, both and/or complementary feeding. Mothers can mark one or several options from all those indicated.
Measured: Baseline measurements
Questionnaire ad-hoc about pregnancy
birth weight of their child (Kgr.); maternal weight gain during pregnancy (Kgr.); and parental weight (Kgr.) via direct written questions.
Measured: Baseline measurements
Eating habits
Children's Eating Habits Questionnaire, which has a 0-30 score scale.
Measured: One year
Motor competence
Movement Assessment Battery for Children - Second Edition (MABC-2). Red zone below 5th percentile which denotes significant movement difficulty; amber zone below or equial to 15th percentile which suggests child at risk of motor problems; green zone, above 15th percentile which indicates no movement problems detected.
Measured: One year
Physical activity
Physical activity will be objectively measured in a subsample of 300 children randomly selected. GENEActive® accelerometers (ActivInsights) will be worn for seven consecutive days, with a fixed frequency of 85.7Hz to collect raw acceleration data measured in "g" for each axis of motion (x,y,z). The data shall be stored directly in the memory of the device and expressed in milli-g units (1000mg =1 g =9.81 m/s2).
Measured: One year
Sleep quality
Sleep quality via acelerometer will be objectively measured in a subsample of 300 children randomly selected. GENEActive® accelerometers (ActivInsights) will be worn for seven consecutive days during nights, with a fixed frequency of 85.7Hz to collect raw acceleration data measured in "g" for each axis of motion (x,y,z). The data shall be stored directly in the memory of the device and expressed in milli-g units (1000mg =1 g =9.81 m/s2).
Measured: One year
Energy expenditure from MOVI-HIIIT breaks
40 schoolchildren of an IG school will be estimated from the oxygen consumption measured with a portable gas analyzer (COSMED® k4b2).
Measured: One year
The acute effect of physical exercise on the brain's electrical activity
40 schoolchildren (20 from the CG and 20 from the IG) will be estimated from the brain activity 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)
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start1 Jun 2020
- Primary completion1 Jun 2023
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 522 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
- Investigators
- Mairena Sanchez-Lopez, PhD, Principal investigator, University of Castilla-La Mancha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04863040
- Sponsor's protocol ID
- PID2019-104160RB-I00
- Acronym
- MOVI-HIIT
- Status last verified
- Jun 2024
- First submitted
- 30 Mar 2021
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Henriquez-Maquehue F, Diez-Fernandez A, Ruiz-Hermosa A, Bermejo-Cantarero A, Navarro-Martinez O, Rodriguez-Martin B, Sanchez-Lopez M. Rationale and methods of the MOVI-HIIT! cluster-randomized controlled trial: an avatar-guided virtual platform for classroom activity breaks and its impact on cognition, adiposity, and fitness in preschoolers. Front Digit Health. 2026 May 8;8:1829401. doi: 10.3389/fdgth.2026.1829401. eCollection 2026.
PubMed 42179814
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. 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 (MOVI-HIIT)
- ClinicalTrials.gov ID
- NCT04863040
- Acronym / sponsor ID
- MOVI-HIIT / PID2019-104160RB-I00
- Conditions
- Physical Activity, Obesity, Children, Cardiovascular, High Intensity Interval Training, Cognition
- Keywords
- Physical activity, Obesity, Children, Cognitive function, Academic achievement, Cardiorespiratory fitness, Adiposity, Cardiovascular fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 522 participants (actual)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Collaborators
- Ministerio de Ciencia e Innovación, Spain
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 28 Apr 2021 (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.
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:
- 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.
- It will reduce the percentage of body fat in the IG versus the CG by 6%.
- It will improve the executive function.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual classroom teaching methodology | No intervention | –Students in the 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 materials once the interventions are completed. |
| Usual classroom teaching methodology + MOVI-HIIT intervention | Experimental | Behavioral: MOVI 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 one school year and will consist of two 5-minute daily physical activity breaks based on intervallic training, five days a week. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Schools in the province of Ciudad Real with at least one class (classroom) at each level (2nd and 3rd of preschool education), and in which the School Board gives its approval to the interventions and to the basal and final evaluations.
- 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 them.
- 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 each IG school. However, we 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 interventionAlso: MOVI-HIITEach 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 10" at high intensity (85-90% of HR max) followed by 20" 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. To increase the workload, and after evaluation of cardiorespiratory capacity, after 12 weeks of program, the HIIT protocol will be changed to 20" of high intensity work alternating with 10" of recovery. | Behavioural | Usual classroom teaching methodology + MOVI-HIIT intervention |
Primary outcome
VO2max
Time frame: One year
Cardiorespiratory fitness, with the 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. This battery adapts the Course Navette test to children under the age of 6.
Executive function
Time frame: One year
NIH toolbox battery. 1. Inhibition/Attention by means of the Flanker Inhibitory Control and Attention test. 2. Working memory with the List Sorting Working Memory test. 3. Cognitive flexibility through the DCCS (Dimensional Change Card Sort) test.
Body fat percent
Time frame: One year
Body fat percentage measured by Bioimpedance analysis
10 secondary outcomes
Health-related quality of life - Parents
Time frame: One year
Health-related quality of life - Children
Time frame: One year
Mothers' breastfeeding
Time frame: Baseline measurements
Questionnaire ad-hoc about pregnancy
Time frame: Baseline measurements
Eating habits
Time frame: One year
Motor competence
Time frame: One year
Physical activity
Time frame: One year
Sleep quality
Time frame: One year
Energy expenditure from MOVI-HIIIT breaks
Time frame: One year
The acute effect of physical exercise on the brain's electrical activity
Time frame: One year
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 4 Jun 2024.
- Derived from this study: PubMed 42179814Henriquez-Maquehue F, Diez-Fernandez A, Ruiz-Hermosa A, Bermejo-Cantarero A, Navarro-Martinez O, Rodriguez-Martin B, Sanchez-Lopez M. Rationale and methods of the MOVI-HIIT! cluster-randomized controlled trial: an avatar-guided virtual platform for classroom activity breaks and its impact on cognition, adiposity, and fitness in preschoolers. Front Digit Health. 2026 May 8;8:1829401. doi: 10.3389/fdgth.2026.1829401. eCollection 2026.
- 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.
Mairena Sanchez-Lopez, PhD principal investigator
University of Castilla-La Mancha
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 intervention in people with Physical Activity and Obesity, 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 3 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 4 Jun 2024. 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?
VO2max (time frame: One year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04863040, which also lists 1 linked publication.
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 4 Jun 2024.