Physical ActivityNCT03236337
Effectiveness of MOVI Interventions on Adiposity, Cognition and Subclinical Atherosclerosis: MOVI-daFit!
A study testing MOVI intervention in people with Physical Activity and Obesity, run by University of Castilla-La Mancha at 2 sites in Spain.
Trial summary
Project which objective is to test the effectiveness of an extracurricular physical activity intervention based on high intensity interval training (MOVI-daFit!) on improving cardiorespiratory fitness (CRF), cardiometabolic risk, executive function, and academic performance. Read more about this study
- Who is it for?
- Ages 8 to 11 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
- 570 participants
- Where
- 2 sitesSpain
- 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 8 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Schools must have at least one full classrooms for both the 4th and 5th grade of primary school.
- The approval of boards of governors will be necessary.
- Children's parents or legal representatives will sign an informed consent to participate.
- 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
- Severe Spanish language learning difficulties.
- 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-daFit!).
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Health and Social Research Centre, University of Castilla-La Mancha
Cuenca, 16071
Mairena Sánchez-López
Cuenca, 16071
About this study
Official title: Effectiveness of MOVI Interventions on Improving Adiposity, Cognition and Subclinical Atherosclerosis by Increasing Aerobic Cardiorespiratory Fitness: MOVI-daFit
Project which objective is to test the effectiveness of an extracurricular physical activity intervention based on high intensity interval training (MOVI-daFit!) on improving cardiorespiratory fitness (CRF), cardiometabolic risk, executive function, and academic performance.
Read the detailed description
In the last decade, this research group has tested the effectiveness of three interventions following this 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-daFit!) has been designed as controlled cluster-randomized trial including 10 schools from Cuenca province, Spain. Five schools will be randomized to intervention group (IG), in which the intervention MOVI-daFit! will be conducted for children in fourth and fifth school grades (9-11 years old). The other five schools will be allocated to the control group (CG).
During an academic year the 4th and 5th schoolchildren allocated to IG will be carry out, in out of school hours, four times by week, one hour sessions of a standardized recreative, non competitive, physical activity intervention based on games adapted to high intensity interval training methodology (MOVI-daFit!). 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, reactive hyperemia index, academic achievement, executive function, and biochemical analytic procedures including lipid profile, insulin, HbA1, C ultrasensitive reactive protein and BDNF.
The hypotheses of this new edition will be that the MOVI-daFit! based on high intensity interval training (HITT) adapted for the 4th and 5th schoolchildren, will:
- Increase the aerobic capacity (VO2max).
- Reduce the percentage of body fat in the GI versus the GC by 6%.
- Improve executive function and academic performance.
- Improve subclinical markers of atherosclerosis (endothelial function and carotid intima-media thickness).
- Conditions
- Physical Activity, Obesity, Children, Cardiovascular, Cardiorespiratory Fitness
- Being tested
- MOVI intervention
- Keywords
- Physical activity, Obesity, Children, Cognitive function, Academic achievement, Cardiorespiratory fitness, Adiposity, Cardiovascular fitness, Atherosclerosis, Aerobic capacity
- Medical subject headings
- Motor Activity, Obesity, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOVI interventionBehavioural
Also called MOVI-da Fit!
MOVI-da Fit! is a multidimensional intervention that consists on: a) 4h/week of a standardized recreative, non-competitive physical activity extracurricular program; and b) informative sessions to parents and teachers about how schoolchildren can became more active. It is aimed to enhance physical fitness, motor skills, physical activity time and active behaviours among 9-to-11 years old children.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No intervention |
| MOVI intervention | Experimental | - MOVI-da Fit! is a high intensity interval training intervention that consists on: a) 4 h/week of a standardized recreative, non-competitive physical activity extracurricular program; and b) informative sessions to parents and teachers about how schoolchildren can became more active. It is aimed to enhance physical fitness, motor skills, physical activity time and active behaviours among 9-to-11 years old children. Receives: Behavioral: MOVI intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2 max
It will be assessed by using 20-m shuttle run test, which is validated to measure maximal aerobic capacity in children from 5 years.
Measured: One year
Secondary outcomes (16)
BDNF blood determination
Biochemical determinations will be performed in order to determine Brain-derived neurotrophic factor. It is a protein that, in humans, is encoded by the BDNF gene. BDNF acts on certain neurons of the central nervous system and the peripheral nervous system, helping to support the survival of existing neurons, and encourage the growth and differentiation of new neurons and synapses. In the brain, it is active in the hippocampus, cortex, and basal forebrain-areas vital to learning, memory, and higher thinking.
Measured: One year
Health-related quality of life
By using the KIDSCREEN-27 for children from 8 years.
Measured: One year
Sleep behaviors and sleep problems by questionnaire
By using the Spanish version of the Children's Sleep Habits Questionnaire (CSHQ) completed by parents. Four questions will be added in order to ask about bedtime, waking up, getting up, and total number of hours of sleep.
Measured: One year
Sleep quality by accelerometry
The latency, quantity, duration of sleep and the number of awakenings will also be measured by accelerometry in a subsample of 242 school children.
Actigraphy (ACT) is a non-invasive method used to study sleep-wake patterns and circadian rhythms by assessing movement. The GENEActive (ActivInsights) monitor will be used, a wristwatch device that monitors activity levels for extended continuous periods.
Measured: One year
Motor skills
By using the Movement Assessment Battery for Children 2 (M-ABC 2)
Measured: One year
Physical activity
In a sub-sample of 242 randomly selected school children will be measured objectively by GENEActive (ActivInsights) accelerometers during seven consecutive days (including nights), with a fixed frequency of 85.7Hz to collect raw acceleration data measured in g for each axis of motion (x, y, z).
Measured: One year
Body fat%
Body fat percentage measured by Bioimpedance analysis
Measured: One year
Academic achievement
Children´s mean scores on mathematics and language will be considered
Measured: One year
Arterial Stiffness
Carotid intima-media thickness measurement through Sonosite Micromax ultrasound (Sonosite Inc., Bothell, Washington, USA).
Measured: One year
Pulse wave velocity
Pulse wave velocity measurement through SphymgoCor System (AtCor Medical Pty Ltd Head Office, West Ryde, Australia)
Measured: One year
Subclinical atherosclerosis
Reactive Hyperemia index measurement through ENDO- PAT (Moerland et al. Int J Vasc Med, 2012; 17; 682-86)
Measured: One year
Executive function
Executive function will be measured by standardized tests using the NIH toolbox
Measured: One year
Glucose profile
Glucose (mg/dl) level will be determined by using a system Cobas 8000 of Roche Diagnostics
Measured: One year
Lipid profile
Apolipoproteins (mg/dl) level will be determined by using a system Cobas 8000 of Roche Diagnostics.
Measured: One year
Insulin profile
Insulin (µU/L) level will be determined by using the Architect platform of Abbott ®
Measured: One year
Ultrasensitive protein profile
C-reactive protein ultrasensitive (mg/l) level will be determined by using a system Cobas 8000 of Roche Diagnostics
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 (3)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
- 570 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 Martínez-Vizcaíno, PhD, MD, Principal investigator, Social and Health Care Research Center, University of Castilla-La Mancha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03236337
- Sponsor's protocol ID
- PI16/01919
- 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
Visier-Alfonso ME, Jimenez-Lopez E, Rodriguez-Gutierrez E, Mesas AE, Nunez de Arenas-Arroyo S, Diaz-Goni V, Alvarez-Bueno C, Martinez-Vizcaino V. Internal Consistency and Validity of a Short Spanish Version (10-Items) of the Center for Epidemiological Studies Depression Scale for Children and Adolescents (CES-DC). Depress Anxiety. 2024 Sep 25;2024:5409747. doi: 10.1155/2024/5409747. eCollection 2024.
PubMed 40226705Pozuelo-Carrascosa DP, Martinez-Vizcaino V, Torres-Costoso A, Martinez MS, Rodriguez-Gutierrez E, Garrido-Miguel M. "Fat but Fit" Paradox and Cardiometabolic Risk in Children: The Role of Physical Activity. Child Obes. 2023 Jun;19(4):282-291. doi: 10.1089/chi.2022.0073. Epub 2022 Jul 26.
PubMed 35881859Martinez-Vizcaino V, Garrido-Miguel M, Redondo-Tebar A, Notario-Pacheco B, Rodriguez-Martin B, Sanchez-Lopez M. The "Fat but Fit" Paradigm from a Children's Health-Related Quality of Life Perspective. Child Obes. 2021 Oct;17(7):449-456. doi: 10.1089/chi.2021.0041. Epub 2021 May 18.
PubMed 34009010
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 Subclinical Atherosclerosis by Increasing Aerobic Cardiorespiratory Fitness: MOVI-daFit
- ClinicalTrials.gov ID
- NCT03236337
- Acronym / sponsor ID
- PI16/01919
- Conditions
- Physical Activity, Obesity, Children, Cardiovascular, Cardiorespiratory Fitness
- Keywords
- Physical activity, Obesity, Children, Cognitive function, Academic achievement, Cardiorespiratory fitness, Adiposity, Cardiovascular fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 570 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 an extracurricular physical activity intervention based on high intensity interval training (MOVI-daFit!) on improving cardiorespiratory fitness (CRF), cardiometabolic risk, executive function, and academic performance.
Detailed description
In the last decade, this research group has tested the effectiveness of three interventions following this 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-daFit!) has been designed as controlled cluster-randomized trial including 10 schools from Cuenca province, Spain. Five schools will be randomized to intervention group (IG), in which the intervention MOVI-daFit! will be conducted for children in fourth and fifth school grades (9-11 years old). The other five schools will be allocated to the control group (CG).
During an academic year the 4th and 5th schoolchildren allocated to IG will be carry out, in out of school hours, four times by week, one hour sessions of a standardized recreative, non competitive, physical activity intervention based on games adapted to high intensity interval training methodology (MOVI-daFit!). 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, reactive hyperemia index, academic achievement, executive function, and biochemical analytic procedures including lipid profile, insulin, HbA1, C ultrasensitive reactive protein and BDNF.
The hypotheses of this new edition will be that the MOVI-daFit! based on high intensity interval training (HITT) adapted for the 4th and 5th schoolchildren, will:
- Increase the aerobic capacity (VO2max).
- Reduce the percentage of body fat in the GI versus the GC by 6%.
- Improve executive function and academic performance.
- Improve subclinical markers of atherosclerosis (endothelial function and carotid intima-media thickness).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No intervention |
| MOVI intervention | Experimental | Behavioral: MOVI intervention- MOVI-da Fit! is a high intensity interval training intervention that consists on: a) 4 h/week of a standardized recreative, non-competitive physical activity extracurricular program; and b) informative sessions to parents and teachers about how schoolchildren can became more active. It is aimed to enhance physical fitness, motor skills, physical activity time and active behaviours among 9-to-11 years old children. |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Schools must have at least one full classrooms for both the 4th and 5th grade of primary school.
- The approval of boards of governors will be necessary.
- Children's parents or legal representatives will sign an informed consent to participate.
- 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)
- Severe Spanish language learning difficulties.
- 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-daFit!).
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-da Fit!MOVI-da Fit! is a multidimensional intervention that consists on: a) 4h/week of a standardized recreative, non-competitive physical activity extracurricular program; and b) informative sessions to parents and teachers about how schoolchildren can became more active. It is aimed to enhance physical fitness, motor skills, physical activity time and active behaviours among 9-to-11 years old children. | Behavioural | MOVI intervention |
Primary outcome
VO2 max
Time frame: One year
It will be assessed by using 20-m shuttle run test, which is validated to measure maximal aerobic capacity in children from 5 years.
16 secondary outcomes
BDNF blood determination
Time frame: One year
Health-related quality of life
Time frame: One year
Sleep behaviors and sleep problems by questionnaire
Time frame: One year
Sleep quality by accelerometry
Time frame: One year
Motor skills
Time frame: One year
Physical activity
Time frame: One year
Body fat%
Time frame: One year
Academic achievement
Time frame: One year
Arterial Stiffness
Time frame: One year
Pulse wave velocity
Time frame: One year
Subclinical atherosclerosis
Time frame: One year
Executive function
Time frame: One year
Glucose profile
Time frame: One year
Lipid profile
Time frame: One year
Insulin profile
Time frame: One year
Ultrasensitive protein profile
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 40226705Visier-Alfonso ME, Jimenez-Lopez E, Rodriguez-Gutierrez E, Mesas AE, Nunez de Arenas-Arroyo S, Diaz-Goni V, Alvarez-Bueno C, Martinez-Vizcaino V. Internal Consistency and Validity of a Short Spanish Version (10-Items) of the Center for Epidemiological Studies Depression Scale for Children and Adolescents (CES-DC). Depress Anxiety. 2024 Sep 25;2024:5409747. doi: 10.1155/2024/5409747. eCollection 2024.
- Derived from this study: PubMed 35881859Pozuelo-Carrascosa DP, Martinez-Vizcaino V, Torres-Costoso A, Martinez MS, Rodriguez-Gutierrez E, Garrido-Miguel M. "Fat but Fit" Paradox and Cardiometabolic Risk in Children: The Role of Physical Activity. Child Obes. 2023 Jun;19(4):282-291. doi: 10.1089/chi.2022.0073. Epub 2022 Jul 26.
- Derived from this study: PubMed 34009010Martinez-Vizcaino V, Garrido-Miguel M, Redondo-Tebar A, Notario-Pacheco B, Rodriguez-Martin B, Sanchez-Lopez M. The "Fat but Fit" Paradigm from a Children's Health-Related Quality of Life Perspective. Child Obes. 2021 Oct;17(7):449-456. doi: 10.1089/chi.2021.0041. Epub 2021 May 18.
- 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.
Vicente Martínez-Vizcaíno, PhD, MD principal investigator
Social and Health Care Research Center, University of Castilla-La Mancha
2 sites 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 2 sites 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 2 sites 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?
VO2 max (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 NCT03236337, which also lists 3 linked publications.
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; AzTrials last refreshed its copy on 7 Nov 2026.