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

Primary Purpose

Physical Activity, Obesity, Children

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
MOVI intervention
Sponsored by
University of Castilla-La Mancha
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Physical Activity focused on measuring Physical activity, Obesity, Children, Cognitive function, Academic achievement, Cardiorespiratory fitness, Adiposity, Cardiovascular fitness, Atherosclerosis, Aerobic capacity

Eligibility Criteria

8 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

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!).

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

MOVI intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
July 21, 2017
Last Updated
July 12, 2018
Sponsor
University of Castilla-La Mancha
Collaborators
Carlos III Health Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03236337
Brief Title
Effectiveness of MOVI Interventions on Adiposity, Cognition and Subclinical Atherosclerosis: MOVI-daFit!
Official Title
Effectiveness of MOVI Interventions on Improving Adiposity, Cognition and Subclinical Atherosclerosis by Increasing Aerobic Cardiorespiratory Fitness: MOVI-daFit
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
September 19, 2017 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Castilla-La Mancha
Collaborators
Carlos III Health Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Activity, Obesity, Children, Cardiovascular, Cardiorespiratory Fitness
Keywords
Physical activity, Obesity, Children, Cognitive function, Academic achievement, Cardiorespiratory fitness, Adiposity, Cardiovascular fitness, Atherosclerosis, Aerobic capacity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
570 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention
Arm Title
MOVI intervention
Arm Type
Experimental
Arm Description
- 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.
Intervention Type
Behavioral
Intervention Name(s)
MOVI intervention
Other Intervention Name(s)
MOVI-da Fit!
Intervention Description
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.
Primary Outcome Measure Information:
Title
VO2 max
Description
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
Secondary Outcome Measure Information:
Title
BDNF blood determination
Description
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
Title
Health-related quality of life
Description
By using the KIDSCREEN-27 for children from 8 years.
Time Frame
One year
Title
Sleep behaviors and sleep problems by questionnaire
Description
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
Title
Sleep quality by accelerometry
Description
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
Title
Motor skills
Description
By using the Movement Assessment Battery for Children 2 (M-ABC 2)
Time Frame
One year
Title
Physical activity
Description
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
Title
Body fat%
Description
Body fat percentage measured by Bioimpedance analysis
Time Frame
One year
Title
Academic achievement
Description
Children´s mean scores on mathematics and language will be considered
Time Frame
One year
Title
Arterial Stiffness
Description
Carotid intima-media thickness measurement through Sonosite Micromax ultrasound (Sonosite Inc., Bothell, Washington, USA).
Time Frame
One year
Title
Pulse wave velocity
Description
Pulse wave velocity measurement through SphymgoCor System (AtCor Medical Pty Ltd Head Office, West Ryde, Australia)
Time Frame
One year
Title
Subclinical atherosclerosis
Description
Reactive Hyperemia index measurement through ENDO- PAT (Moerland et al. Int J Vasc Med, 2012; 17; 682-86)
Time Frame
One year
Title
Executive function
Description
Executive function will be measured by standardized tests using the NIH toolbox
Time Frame
One year
Title
Glucose profile
Description
Glucose (mg/dl) level will be determined by using a system Cobas 8000 of Roche Diagnostics
Time Frame
One year
Title
Lipid profile
Description
Apolipoproteins (mg/dl) level will be determined by using a system Cobas 8000 of Roche Diagnostics.
Time Frame
One year
Title
Insulin profile
Description
Insulin (µU/L) level will be determined by using the Architect platform of Abbott ®
Time Frame
One year
Title
Ultrasensitive protein profile
Description
C-reactive protein ultrasensitive (mg/l) level will be determined by using a system Cobas 8000 of Roche Diagnostics
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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!).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vicente Martínez-Vizcaíno, PhD, MD
Organizational Affiliation
Social and Health Care Research Center, University of Castilla-La Mancha
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health and Social Research Centre, University of Castilla-La Mancha
City
Cuenca
ZIP/Postal Code
16071
Country
Spain
Facility Name
Mairena Sánchez-López
City
Cuenca
ZIP/Postal Code
16071
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35881859
Citation
Pozuelo-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.
Results Reference
derived
PubMed Identifier
34009010
Citation
Martinez-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.
Results Reference
derived

Learn more about this trial

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

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