Physical ActivityMOVI-da10!NCT03236363
Effectiveness of MOVI Interventions on Adiposity, Cognition and Motor Competence: MOVI-da10!
A study testing MOVI-da10! active breaks and MOVI-da10! integrated physical activity in people with Physical Activity and Children, run by University of Castilla-La Mancha at 1 site in Spain.
Trial summary
Project which objective is to test the effectiveness of a classroom-based physical activity intervention (MOVI-da10!) on improving, body composition, cardio-respiratory fitness and executive function. Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Children, Obesity
- What is being tested?
- MOVI-da10! active breaks and MOVI-da10! integrated physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- 1 siteSpain
- Study dates
- 19 Sep 2017to 30 Jun 2018
- 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 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Schools must have at least one full classrooms for the 3rd year of preschool.
- The approval of boards of governors will be necessary to participate in the intervention and in the measurements at the beginning and end of academic year.
- Children's parents or legal representatives will sign an informed consent to participate.
- Children's parents will be invited to collaborate by filling in questionnaires with regard to family leisure habits, sleeping, eating and getting around town.
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-da10!).
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: Effectiveness of MOVI Interventions on Improving Adiposity, Cognition and Motor Competence by Increasing Aerobic Cardiorespiratory Fitness: MOVI-da10!
Project which objective is to test the effectiveness of a classroom-based physical activity intervention (MOVI-da10!) on improving, body composition, cardio-respiratory fitness and executive function.
Read the detailed description
In the last decade, this research group has tested the effectiveness of three interventions following after-school intervention model. The first one (MOVI) was carried out in peripuberal age children (4th and 5th year of primary education, 8-11 years) and showed a moderate effect in reducing the adiposity of schoolchildren with higher BMI, 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 at 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 showed proved effectiveness; in addition, the data from this intervention showed a modest improvement in girls' aerobic capacity, but not in boys.
The last 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. Data submitted for publication in 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.
This new edition (MOVI-da10!) has been designed following integrated physical activity intervention and active breaks designs, and as a controlled cluster-randomized trial including 9 schools from Cuenca province, Spain. Six schools will be randomized to the two intervention groups (IG), where the intervention of MOVI-da10! will be conducted for third grade preschool children (about 5 years old), using two different design. Three of them will receive an active breaks intervention, in which twice a day a 10 minutes breaks standard physical activity will be developed, and the other three will receive twice a day a 10 minutes of enriched physical activity integrated in the curriculum. The other three schools will be allocated to the control group (CG).
During an academic year the MOVIda10! interventions will consist of: i) an integrated across the curriculum cognitive demanding physical activity program including two active breaks lasting 10 min, five days/week; and ii) an active breaks physical activity program including two active breaks lasting 10 min, five days/week. In the CG regular physical activity will continue.
At the end of the school year the researchers will determine main outcome variables: changes in VO2max, body fat by bioimpedance and executive function.
The hypotheses of this new edition will be that: the MOVI-da10 intervention! based on physical activity integrated in the curriculum for third grade preschool children, will be:
- Moderately increase the executive function and academic performance in the IGs versus the CG (effect size 0.5).
- Increase aerobic capacity (VO2max) in IGs versus CG by 3%.
- Reduced body fat in IGs versus CG by 3%
- Conditions
- Physical Activity, Children, Obesity, Cardiovascular, Cardiorespiratory Fitness
- Being tested
- MOVI-da10! active breaks, MOVI-da10! integrated physical activity
- Keywords
- Physical activity, Obesity, Children, Cognitive function, Academic achievement, Cardiorespiratory fitness, Adiposity, Cardiovascular fitness, Aerobic capacity
- 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-da10! active breaksBehavioural
MOVI-da10! active breaks, is a physical activity intervention that consists on two daily physical activity breaks of 10 minutes of duration (intensity: 4-6 METs, Heart rate ≥150 bpm). It is aimed to enhance physical activity, motor skills and cognition among 5 years old children
MOVI-da10! integrated physical activityBehavioural
MOVI-da10! integrated lessons, is a physical activity intervention that consists on two daily cognitive demanding physical activity breaks of 10 minutes of duration (intensity: 2-3 METs, Heart rate <150 bpm). It is aimed to enhance physical activity, motor skills and cognition among 5 years old children
| Study group | Role | What they receive |
|---|---|---|
| MOVI-da 10! active breaks | Experimental | It is a physical activity intervention that consists on two daily physical activity active breaks of 10 minutes of duration (intensity: 4-6 METs, Heart rate ≥150 bpm). It is aimed to enhance physical activity, motor skills and cognition among 5 years old children Receives: Behavioral: MOVI-da10! active breaks |
| Control | No intervention | No intervention |
| MOVI-da10! integrated physical activity | Experimental | It is an integrated physical activity intervention that consists on two daily cognitive demanding physical activity breaks of 10 minutes of duration (intensity: 2-3 METs, Heart rate <150 bpm). It is aimed to enhance physical activity, motor skills and cognition among 5 years old children Receives: Behavioral: MOVI-da10! integrated physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Executive function
Executive function will be measured by standardized test using the NIH toolbox
Measured: One year
Secondary outcomes (4)
VO2 max
It will be assessed by using 20-m shuttle run test, which is validated to measure maximal aerobic capacity in children.
Measured: One year
Motor skills
By using the Movement Assessment Battery for Children 2 (M-ABC 2)
Measured: One year
Body fat%
Body fat percentage measured by Bioimpedance analysis
Measured: One year
Health-related quality of life
By using the validated version in Spanish of KIDL for children of 4-7 years and their parents.
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 posted1 Aug 2017
- Study start19 Sep 2017
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
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
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Collaborators
- Carlos III Health Institute
- Responsible party
- Sponsor
- Investigators
- Vicente Martinez-Vizcaino, PhD, MD, Principal investigator, Social and Health Care Research Center, University of Castilla-La Mancha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03236363
- Sponsor's protocol ID
- PI16b/01919
- Acronym
- MOVI-da10!
- Status last verified
- Jul 2018
- First submitted
- 21 Jul 2017
- Last updated
- 13 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sanchez-Lopez M, Ruiz-Hermosa A, Redondo-Tebar A, Visier-Alfonso ME, Jimenez-Lopez E, Martinez-Andres M, Solera-Martinez M, Soriano-Cano A, Martinez-Vizcaino V; MOVI group. Rationale and methods of the MOVI-da10! Study -a cluster-randomized controlled trial of the impact of classroom-based physical activity programs on children's adiposity, cognition and motor competence. BMC Public Health. 2019 Apr 18;19(1):417. doi: 10.1186/s12889-019-6742-0.
PubMed 30999870
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of MOVI Interventions on Improving Adiposity, Cognition and Motor Competence by Increasing Aerobic Cardiorespiratory Fitness: MOVI-da10!
- ClinicalTrials.gov ID
- NCT03236363
- Acronym / sponsor ID
- MOVI-da10! / PI16b/01919
- Conditions
- Physical Activity, Children, Obesity, Cardiovascular, Cardiorespiratory Fitness
- Keywords
- Physical activity, Obesity, Children, Cognitive function, Academic achievement, Cardiorespiratory fitness, Adiposity, Cardiovascular fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Collaborators
- Carlos III Health Institute
- Study start
- 19 Sep 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 1 Aug 2017 (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 to test the effectiveness of a classroom-based physical activity intervention (MOVI-da10!) on improving, body composition, cardio-respiratory fitness and executive function.
Detailed description
In the last decade, this research group has tested the effectiveness of three interventions following after-school intervention model. The first one (MOVI) was carried out in peripuberal age children (4th and 5th year of primary education, 8-11 years) and showed a moderate effect in reducing the adiposity of schoolchildren with higher BMI, 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 at 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 showed proved effectiveness; in addition, the data from this intervention showed a modest improvement in girls' aerobic capacity, but not in boys.
The last 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. Data submitted for publication in 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.
This new edition (MOVI-da10!) has been designed following integrated physical activity intervention and active breaks designs, and as a controlled cluster-randomized trial including 9 schools from Cuenca province, Spain. Six schools will be randomized to the two intervention groups (IG), where the intervention of MOVI-da10! will be conducted for third grade preschool children (about 5 years old), using two different design. Three of them will receive an active breaks intervention, in which twice a day a 10 minutes breaks standard physical activity will be developed, and the other three will receive twice a day a 10 minutes of enriched physical activity integrated in the curriculum. The other three schools will be allocated to the control group (CG).
During an academic year the MOVIda10! interventions will consist of: i) an integrated across the curriculum cognitive demanding physical activity program including two active breaks lasting 10 min, five days/week; and ii) an active breaks physical activity program including two active breaks lasting 10 min, five days/week. In the CG regular physical activity will continue.
At the end of the school year the researchers will determine main outcome variables: changes in VO2max, body fat by bioimpedance and executive function.
The hypotheses of this new edition will be that: the MOVI-da10 intervention! based on physical activity integrated in the curriculum for third grade preschool children, will be:
- Moderately increase the executive function and academic performance in the IGs versus the CG (effect size 0.5).
- Increase aerobic capacity (VO2max) in IGs versus CG by 3%.
- Reduced body fat in IGs versus CG by 3%
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MOVI-da 10! active breaks | Experimental | Behavioral: MOVI-da10! active breaksIt is a physical activity intervention that consists on two daily physical activity active breaks of 10 minutes of duration (intensity: 4-6 METs, Heart rate ≥150 bpm). It is aimed to enhance physical activity, motor skills and cognition among 5 years old children |
| Control | No intervention | –No intervention |
| MOVI-da10! integrated physical activity | Experimental | Behavioral: MOVI-da10! integrated physical activityIt is an integrated physical activity intervention that consists on two daily cognitive demanding physical activity breaks of 10 minutes of duration (intensity: 2-3 METs, Heart rate <150 bpm). It is aimed to enhance physical activity, motor skills and cognition among 5 years old children |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Schools must have at least one full classrooms for the 3rd year of preschool.
- The approval of boards of governors will be necessary to participate in the intervention and in the measurements at the beginning and end of academic year.
- Children's parents or legal representatives will sign an informed consent to participate.
- Children's parents will be invited to collaborate by filling in questionnaires with regard to family leisure habits, sleeping, eating and getting around town.
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-da10!).
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-da10! active breaksMOVI-da10! active breaks, is a physical activity intervention that consists on two daily physical activity breaks of 10 minutes of duration (intensity: 4-6 METs, Heart rate ≥150 bpm). It is aimed to enhance physical activity, motor skills and cognition among 5 years old children | Behavioural | MOVI-da 10! active breaks |
| MOVI-da10! integrated physical activityMOVI-da10! integrated lessons, is a physical activity intervention that consists on two daily cognitive demanding physical activity breaks of 10 minutes of duration (intensity: 2-3 METs, Heart rate <150 bpm). It is aimed to enhance physical activity, motor skills and cognition among 5 years old children | Behavioural | MOVI-da10! integrated physical activity |
Primary outcome
Executive function
Time frame: One year
Executive function will be measured by standardized test using the NIH toolbox
4 secondary outcomes
VO2 max
Time frame: One year
Motor skills
Time frame: One year
Body fat%
Time frame: One year
Health-related quality of life
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 13 Jul 2018.
- Derived from this study: PubMed 30999870Sanchez-Lopez M, Ruiz-Hermosa A, Redondo-Tebar A, Visier-Alfonso ME, Jimenez-Lopez E, Martinez-Andres M, Solera-Martinez M, Soriano-Cano A, Martinez-Vizcaino V; MOVI group. Rationale and methods of the MOVI-da10! Study -a cluster-randomized controlled trial of the impact of classroom-based physical activity programs on children's adiposity, cognition and motor competence. BMC Public Health. 2019 Apr 18;19(1):417. doi: 10.1186/s12889-019-6742-0.
- Individual participant dataSharing planned: No
Related trials for Physical Activity
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
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.
Vicente Martinez-Vizcaino, PhD, MD principal investigator
Social and Health Care Research Center, 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-da10! active breaks and MOVI-da10! integrated physical activity in people with Physical Activity and Children, 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 4 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 13 Jul 2018. 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?
Executive function (time frame: One year). 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 NCT03236363, 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 13 Jul 2018.