An interventional study of MOVI intervention in Physical Activity, Obesity and Children, sponsored by University of Castilla-La Mancha. Completed at 2 sites in Spain. Open to participants aged 8 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-13.
Sponsored by University of Castilla-La Mancha · Not applicable, Interventional, and Prevention
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.
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:
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Exclusion criteria:
No 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.
Behavioral: MOVI intervention
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.
Also known as: MOVI-da Fit!
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.
Time frame: One year
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.
Time frame: One year
Health-related quality of life
By using the KIDSCREEN-27 for children from 8 years.
Time frame: 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.
Time frame: 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.
Time frame: One year
Motor skills
By using the Movement Assessment Battery for Children 2 (M-ABC 2)
Time frame: 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).
Time frame: One year
Body fat%
Body fat percentage measured by Bioimpedance analysis
Time frame: One year
Academic achievement
Children´s mean scores on mathematics and language will be considered
Time frame: One year
Arterial Stiffness
Carotid intima-media thickness measurement through Sonosite Micromax ultrasound (Sonosite Inc., Bothell, Washington, USA).
Time frame: One year
Pulse wave velocity
Pulse wave velocity measurement through SphymgoCor System (AtCor Medical Pty Ltd Head Office, West Ryde, Australia)
Time frame: One year
Subclinical atherosclerosis
Reactive Hyperemia index measurement through ENDO- PAT (Moerland et al. Int J Vasc Med, 2012; 17; 682-86)
Time frame: One year
Executive function
Executive function will be measured by standardized tests using the NIH toolbox
Time frame: One year
Glucose profile
Glucose (mg/dl) level will be determined by using a system Cobas 8000 of Roche Diagnostics
Time frame: One year
Lipid profile
Apolipoproteins (mg/dl) level will be determined by using a system Cobas 8000 of Roche Diagnostics.
Time frame: One year
Insulin profile
Insulin (µU/L) level will be determined by using the Architect platform of Abbott ®
Time frame: One year
Ultrasensitive protein profile
C-reactive protein ultrasensitive (mg/l) level will be determined by using a system Cobas 8000 of Roche Diagnostics
Time frame: One year
Plan to share: No
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University of Castilla-La Mancha