Effectiveness of MOVI Interventions on Adiposity, Cognition and Subclinical Atherosclerosis: MOVI-daFit!

Obesity Clinical Trial

Official title:

Effectiveness of MOVI Interventions on Improving Adiposity, Cognition and Subclinical Atherosclerosis by Increasing Aerobic Cardiorespiratory Fitness: MOVI-daFit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03236337
• Other study ID #: PI16/01919
• Status: Completed
• Phase: N/A
• Start date: September 19, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: July 2018
• Source: University of Castilla-La Mancha
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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:

1. Increase the aerobic capacity (VO2max).

2. Reduce the percentage of body fat in the GI versus the GC by 6%.

3. Improve executive function and academic performance.

4. Improve subclinical markers of atherosclerosis (endothelial function and carotid intima-media thickness).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 570
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 11 Years

Eligibility

Inclusion criteria:

• 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.

Exclusion criteria:

• 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!).

Related Conditions & MeSH terms

• Atherosclerosis
• Cardiorespiratory Fitness
• Cardiovascular
• Children
• Obesity
• Physical Activity

Intervention

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.

Locations

Country	Name	City	State
Spain	Health and Social Research Centre, University of Castilla-La Mancha	Cuenca
Spain	Mairena Sánchez-López	Cuenca

Sponsors (2)

Lead Sponsor	Collaborator
University of Castilla-La Mancha	Carlos III Health Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One year
Secondary	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.	One year
Secondary	Health-related quality of life	By using the KIDSCREEN-27 for children from 8 years.	One year
Secondary	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.	One year
Secondary	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.	One year
Secondary	Motor skills	By using the Movement Assessment Battery for Children 2 (M-ABC 2)	One year
Secondary	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).	One year
Secondary	Body fat%	Body fat percentage measured by Bioimpedance analysis	One year
Secondary	Academic achievement	Children´s mean scores on mathematics and language will be considered	One year
Secondary	Arterial Stiffness	Carotid intima-media thickness measurement through Sonosite Micromax ultrasound (Sonosite Inc., Bothell, Washington, USA).	One year
Secondary	Pulse wave velocity	Pulse wave velocity measurement through SphymgoCor System (AtCor Medical Pty Ltd Head Office, West Ryde, Australia)	One year
Secondary	Subclinical atherosclerosis	Reactive Hyperemia index measurement through ENDO- PAT (Moerland et al. Int J Vasc Med, 2012; 17; 682-86)	One year
Secondary	Executive function	Executive function will be measured by standardized tests using the NIH toolbox	One year
Secondary	Glucose profile	Glucose (mg/dl) level will be determined by using a system Cobas 8000 of Roche Diagnostics	One year
Secondary	Lipid profile	Apolipoproteins (mg/dl) level will be determined by using a system Cobas 8000 of Roche Diagnostics.	One year
Secondary	Insulin profile	Insulin (µU/L) level will be determined by using the Architect platform of Abbott ®	One year
Secondary	Ultrasensitive protein profile	C-reactive protein ultrasensitive (mg/l) level will be determined by using a system Cobas 8000 of Roche Diagnostics	One year