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Effectiveness of MOVI Interventions on Adiposity, Cognition and Motor Competence: MOVI-da10! (MOVI-da10!)

Primary Purpose

Physical Activity, Children, Obesity

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
MOVI-da10! active breaks
MOVI-da10! integrated physical activity
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, Aerobic capacity

Eligibility Criteria

4 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Schools must have at least one full classrooms for the 3rd year of preschool.
  • The approval of boards of governors will be necessary to participate in the intervention and in the measurements at the beginning and end of academic year.
  • Children's parents or legal representatives will sign an informed consent to participate.
  • Children's parents will be invited to collaborate by filling in questionnaires with regard to family leisure habits, sleeping, eating and getting around town.

Exclusion Criteria:

  • Children with severe Spanish language learning difficulties.
  • Children with 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-da10!).

Sites / Locations

  • Social and Health Research Center. Universidad de Castilla-La Mancha

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Experimental

Arm Label

MOVI-da 10! active breaks

Control

MOVI-da10! integrated physical activity

Arm Description

It is a physical activity intervention that consists on two daily physical activity active breaks of 10 minutes of duration (intensity: 4-6 METs, Heart rate ≥150 bpm). It is aimed to enhance physical activity, motor skills and cognition among 5 years old children

No intervention

It is an integrated physical activity intervention that consists on two daily cognitive demanding physical activity breaks of 10 minutes of duration (intensity: 2-3 METs, Heart rate <150 bpm). It is aimed to enhance physical activity, motor skills and cognition among 5 years old children

Outcomes

Primary Outcome Measures

Executive function
Executive function will be measured by standardized test using the NIH toolbox

Secondary 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.
Motor skills
By using the Movement Assessment Battery for Children 2 (M-ABC 2)
Body fat%
Body fat percentage measured by Bioimpedance analysis
Health-related quality of life
By using the validated version in Spanish of KIDL for children of 4-7 years and their parents.

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
NCT03236363
Brief Title
Effectiveness of MOVI Interventions on Adiposity, Cognition and Motor Competence: MOVI-da10!
Acronym
MOVI-da10!
Official Title
Effectiveness of MOVI Interventions on Improving Adiposity, Cognition and Motor Competence by Increasing Aerobic Cardiorespiratory Fitness: MOVI-da10!
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 a classroom-based physical activity intervention (MOVI-da10!) on improving, body composition, cardio-respiratory fitness and executive function.
Detailed Description
In the last decade, this research group has tested the effectiveness of three interventions following after-school intervention 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-da10!) has been designed following integrated physical activity intervention and active breaks designs, and as a controlled cluster-randomized trial including 9 schools from Cuenca province, Spain. Six schools will be randomized to the two intervention groups (IG), where the intervention of MOVI-da10! will be conducted for third grade preschool children (about 5 years old), using two different design. Three of them will receive an active breaks intervention, in which twice a day a 10 minutes breaks standard physical activity will be developed, and the other three will receive twice a day a 10 minutes of enriched physical activity integrated in the curriculum. The other three schools will be allocated to the control group (CG). During an academic year the MOVIda10! interventions will consist of: i) an integrated across the curriculum cognitive demanding physical activity program including two active breaks lasting 10 min, five days/week; and ii) an active breaks physical activity program including two active breaks lasting 10 min, five days/week. 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 and executive function. The hypotheses of this new edition will be that: the MOVI-da10 intervention! based on physical activity integrated in the curriculum for third grade preschool children, will be: Moderately increase the executive function and academic performance in the IGs versus the CG (effect size 0.5). Increase aerobic capacity (VO2max) in IGs versus CG by 3%. Reduced body fat in IGs versus CG by 3%

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
MOVI-da 10! active breaks
Arm Type
Experimental
Arm Description
It is a physical activity intervention that consists on two daily physical activity active breaks of 10 minutes of duration (intensity: 4-6 METs, Heart rate ≥150 bpm). It is aimed to enhance physical activity, motor skills and cognition among 5 years old children
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention
Arm Title
MOVI-da10! integrated physical activity
Arm Type
Experimental
Arm Description
It is an integrated physical activity intervention that consists on two daily cognitive demanding physical activity breaks of 10 minutes of duration (intensity: 2-3 METs, Heart rate <150 bpm). It is aimed to enhance physical activity, motor skills and cognition among 5 years old children
Intervention Type
Behavioral
Intervention Name(s)
MOVI-da10! active breaks
Intervention Description
MOVI-da10! active breaks, is a physical activity intervention that consists on two daily physical activity breaks of 10 minutes of duration (intensity: 4-6 METs, Heart rate ≥150 bpm). It is aimed to enhance physical activity, motor skills and cognition among 5 years old children
Intervention Type
Behavioral
Intervention Name(s)
MOVI-da10! integrated physical activity
Intervention Description
MOVI-da10! integrated lessons, is a physical activity intervention that consists on two daily cognitive demanding physical activity breaks of 10 minutes of duration (intensity: 2-3 METs, Heart rate <150 bpm). It is aimed to enhance physical activity, motor skills and cognition among 5 years old children
Primary Outcome Measure Information:
Title
Executive function
Description
Executive function will be measured by standardized test using the NIH toolbox
Time Frame
One year
Secondary 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.
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
Body fat%
Description
Body fat percentage measured by Bioimpedance analysis
Time Frame
One year
Title
Health-related quality of life
Description
By using the validated version in Spanish of KIDL for children of 4-7 years and their parents.
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Schools must have at least one full classrooms for the 3rd year of preschool. The approval of boards of governors will be necessary to participate in the intervention and in the measurements at the beginning and end of academic year. Children's parents or legal representatives will sign an informed consent to participate. Children's parents will be invited to collaborate by filling in questionnaires with regard to family leisure habits, sleeping, eating and getting around town. Exclusion Criteria: Children with severe Spanish language learning difficulties. Children with 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-da10!).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vicente Martinez-Vizcaino, PhD, MD
Organizational Affiliation
Social and Health Care Research Center, University of Castilla-La Mancha
Official's Role
Principal Investigator
Facility Information:
Facility Name
Social and Health Research Center. Universidad de Castilla-La Mancha
City
Cuenca
ZIP/Postal Code
16071
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30999870
Citation
Sanchez-Lopez M, Ruiz-Hermosa A, Redondo-Tebar A, Visier-Alfonso ME, Jimenez-Lopez E, Martinez-Andres M, Solera-Martinez M, Soriano-Cano A, Martinez-Vizcaino V; MOVI group. Rationale and methods of the MOVI-da10! Study -a cluster-randomized controlled trial of the impact of classroom-based physical activity programs on children's adiposity, cognition and motor competence. BMC Public Health. 2019 Apr 18;19(1):417. doi: 10.1186/s12889-019-6742-0.
Results Reference
derived

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Effectiveness of MOVI Interventions on Adiposity, Cognition and Motor Competence: MOVI-da10!

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