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

July 12, 2018 updated by: University of Castilla-La Mancha

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

  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).

Study Type

Interventional

Enrollment (Actual)

570

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Cuenca, Spain, 16071
        • Health and Social Research Centre, University of Castilla-La Mancha
      • Cuenca, Spain, 16071
        • Mairena Sánchez-López

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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!).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
No intervention
Experimental: 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.
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.
Other Names:
  • MOVI-da Fit!

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor skills
Time Frame: One year
By using the Movement Assessment Battery for Children 2 (M-ABC 2)
One year
Body fat%
Time Frame: One year
Body fat percentage measured by Bioimpedance analysis
One year
BDNF blood determination
Time Frame: One year
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
Health-related quality of life
Time Frame: One year
By using the KIDSCREEN-27 for children from 8 years.
One year
Sleep behaviors and sleep problems by questionnaire
Time Frame: One year
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
Sleep quality by accelerometry
Time Frame: One year

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
Physical activity
Time Frame: One year
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
Academic achievement
Time Frame: One year
Children´s mean scores on mathematics and language will be considered
One year
Arterial Stiffness
Time Frame: One year
Carotid intima-media thickness measurement through Sonosite Micromax ultrasound (Sonosite Inc., Bothell, Washington, USA).
One year
Pulse wave velocity
Time Frame: One year
Pulse wave velocity measurement through SphymgoCor System (AtCor Medical Pty Ltd Head Office, West Ryde, Australia)
One year
Subclinical atherosclerosis
Time Frame: One year
Reactive Hyperemia index measurement through ENDO- PAT (Moerland et al. Int J Vasc Med, 2012; 17; 682-86)
One year
Executive function
Time Frame: One year
Executive function will be measured by standardized tests using the NIH toolbox
One year
Glucose profile
Time Frame: One year
Glucose (mg/dl) level will be determined by using a system Cobas 8000 of Roche Diagnostics
One year
Lipid profile
Time Frame: One year
Apolipoproteins (mg/dl) level will be determined by using a system Cobas 8000 of Roche Diagnostics.
One year
Insulin profile
Time Frame: One year
Insulin (µU/L) level will be determined by using the Architect platform of Abbott ®
One year
Ultrasensitive protein profile
Time Frame: One year
C-reactive protein ultrasensitive (mg/l) level will be determined by using a system Cobas 8000 of Roche Diagnostics
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Castilla-La Mancha

Collaborators

Carlos III Health Institute

Investigators

  • Principal Investigator: Vicente Martínez-Vizcaíno, PhD, MD, Social and Health Care Research Center, University of Castilla-La Mancha

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 19, 2017

Primary Completion (Actual)

June 30, 2018

Study Completion (Actual)

June 30, 2018

Study Registration Dates

First Submitted

July 21, 2017

First Submitted That Met QC Criteria

July 27, 2017

First Posted (Actual)

August 1, 2017

Study Record Updates

Last Update Posted (Actual)

July 13, 2018

Last Update Submitted That Met QC Criteria

July 12, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI16/01919

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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