Effectiveness of a Physical Activity Intervention on Preventing Obesity During the Adiposity Rebound Period. (MOVI-KIDS)
Primary Purpose
Physical Activity, Adiposity, Children
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
MOVI-KIDS
Sponsored by

About this trial
This is an interventional prevention trial for Physical Activity focused on measuring Physical activity, Physical fitness, Obesity, Adiposity, Adiposity rebound period, Children, Blood pressure, Randomized controlled trials, Barriers and facilitators of the environment
Eligibility Criteria
Inclusion Criteria:
- Schools with at least one full course of 3rd of early childhood education and one of 1st primary school.
- The Boards of Governors (community participatory organ in each school) give its approval to the intervention and measurements at the beginning and end of the course.
- Children 4 to 7 years old.
- Children's parents/caregivers will give their written consent to the children's participation.
- Collaboration in the family to respond to questionnaires on family leisure habits, sleeping, eating, getting around town, etc., included in the measurement protocol of this project.
Exclusion Criteria:
- Have a malformation that prevents learning of the Spanish language (or Spanish sign language).
- Have some kind of physical or mental disorder identified by parents or teachers that prevent physical activity.
- Have a chronic illness such as heart disease, diabetes or asthma, as determined by your pediatrician/family doctor -after analysis of the activities program- prevents participation in them.
Sites / Locations
- Health and Social Research Centre, University of Castilla-La Mancha
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
MOVI-KIDS Program
Control
Arm Description
Intervention group
No intervention
Outcomes
Primary Outcome Measures
Body fat percentage
To reduce body fat percentage in the intervention group versus the control group in 2% in children during the adiposity rebound 4-7 years).
Mean of two measurements of body fat percentage using an eight-electrode BC-418 MA bioimpedance analysis system (Tanita Corp. Tokyo, Japan).
Secondary Outcome Measures
Physical fitness
It will be assessed the main components of fitness: a) muscle strength by using standing long jump test b) Flexibility by using the sit and reach test c) speed-agility (The 4x10 meters shuttle run test), d) aerobic capacity, by using 20-m shuttle run test, which is validated to measure maximal aerobic capacity in children from 5 years.
Waist circumference
Waist circumference will be measured 3 times at the midpoint between the last rib and the iliac crest at the end of a normal expiration and using a flexible tape.
Tricipital skinfold thickness
Skinfold thickness will be measured 3 times at the triceps using a Holtain Ltd. caliper (0.2 mm accuracy and consistent 10 g/mm2 pressure between valves)
Blood pressure
Blood pressure will be measured twice, with a 5-min interval between measurements. The first measurement will be made after at least 5 min rest. The child will be seated, in relaxing conditions, with the right arm semi-flexed at heart level. Blood pressure will be measured with an Omron M5-I monitor (Omron Healthcare UK Ltd.) using one of 3 different cuff sizes according to arm circumference.
Full Information
NCT ID
NCT01971840
First Posted
October 7, 2013
Last Updated
December 22, 2013
Sponsor
University of Castilla-La Mancha
Collaborators
Carlos III Health Institute
1. Study Identification
Unique Protocol Identification Number
NCT01971840
Brief Title
Effectiveness of a Physical Activity Intervention on Preventing Obesity During the Adiposity Rebound Period.
Acronym
MOVI-KIDS
Official Title
Effectiveness of an Intervention of Physical Activity Promotion in Schoolchildren on Preventing Obesity During the Adiposity Rebound Period: a Cross-over Randomized Cluster Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
June 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Castilla-La Mancha
Collaborators
Carlos III Health Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Coordinated project whose objectives are: a) to assess the effectiveness of a physical activity intervention (MOVI-KIDS) on preventing obesity and improving fitness during the adiposity rebound period; and b) to examine the effectiveness of MOVI-KIDS on reducing the carotid intima-media thickness.
Detailed Description
The prevalence of overweight in Spanish children in the puberty age is among the highest in the world and increasing quickly. Our group has done so far two interventions based on after-school programs of recreational physical activity to control obesity and other cardiovascular risk factors in primary school children (8-to-11 years)in Cuenca, Spain.
The first edition, called MOVI, showed moderate effect in reducing adiposity and improving the lipid profile, but did not significantly improve overall cardiometabolic risk, mainly because of did not reduce blood insulin levels. A second edition (MOVI-2), increased duration and intensity of the sessions and was more focused on increased muscle strength. Preliminary analysis also show a decrease in body fat, a reduction of global cardiometabolic because of decreased insulin levels.
Our project integrates a multidimensional intervention to promote physical activity, with a mixed design (cross-over randomized trial, and a qualitative study) and consist of two sub-projects that share the same study population: "Effectiveness of an intervention of physical activity promotion in schoolchildren on preventing obesity during the adiposity rebound period: a cross-over randomized cluster trial" and "Effectiveness of physical activity intervention to prevent obesity and improve academic performance in children with and without ADHD risk".
The two interventions are based on a cross-over randomized trial aimed to test the effectiveness of an intervention to promote physical activity in the school environment (MOVI-KIDS) during two-years in 22 schools (20 public and two private schools) in the provinces of Cuenca and Ciudad Real, Spain.
This principal subproject consisted of a mixed study including both the trial cited above and a nested qualitative study aimed to identify barriers and facilitators to physical activity in children in the school environment (social and family factors, urban planning, etc.), and produce knowledge about the perceptions of children, parents and teachers on how you can improve conditions of physical and social environment to facilitate physical activity.
The hypotheses of this third edition are that a multidimensional intervention promoting physical activity in children at the adiposity rebound period (4-7 years),in the school environment (MOVI-KIDS), lasting two-years, will to:
Reduce the body fat percentage in the intervention group versus the control group in 2%.
Improve the several components of fitness: aerobic capacity, strength, speed and agility.
Reduce the carotid intima-media thickness and
Reduce fat, increase fat free mass, and reduce sedentary behavior.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Activity, Adiposity, Children, Obesity, Cardiovascular Disease
Keywords
Physical activity, Physical fitness, Obesity, Adiposity, Adiposity rebound period, Children, Blood pressure, Randomized controlled trials, Barriers and facilitators of the environment
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MOVI-KIDS Program
Arm Type
Experimental
Arm Description
Intervention group
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Behavioral
Intervention Name(s)
MOVI-KIDS
Intervention Description
MOVI-KIDS is a multidimensional intervention that consist of: a) for children, 4.5 h/week of a standardized recreative, non-competitive physical activity extracurricular program; b) informative sessions to parents and teachers about how schoolchildren can became more active, and c) interventions in the playground (environmental changes: equipment, facilities, painting, etc.) aimed to promote physical activity during recess (MOVI-Playground).
Primary Outcome Measure Information:
Title
Body fat percentage
Description
To reduce body fat percentage in the intervention group versus the control group in 2% in children during the adiposity rebound 4-7 years).
Mean of two measurements of body fat percentage using an eight-electrode BC-418 MA bioimpedance analysis system (Tanita Corp. Tokyo, Japan).
Time Frame
One year (interim analysis)
Secondary Outcome Measure Information:
Title
Physical fitness
Description
It will be assessed the main components of fitness: a) muscle strength by using standing long jump test b) Flexibility by using the sit and reach test c) speed-agility (The 4x10 meters shuttle run test), d) aerobic capacity, by using 20-m shuttle run test, which is validated to measure maximal aerobic capacity in children from 5 years.
Time Frame
One year (interim analysis)
Title
Waist circumference
Description
Waist circumference will be measured 3 times at the midpoint between the last rib and the iliac crest at the end of a normal expiration and using a flexible tape.
Time Frame
One year (interim analysis)
Title
Tricipital skinfold thickness
Description
Skinfold thickness will be measured 3 times at the triceps using a Holtain Ltd. caliper (0.2 mm accuracy and consistent 10 g/mm2 pressure between valves)
Time Frame
one year (interim analysis)
Title
Blood pressure
Description
Blood pressure will be measured twice, with a 5-min interval between measurements. The first measurement will be made after at least 5 min rest. The child will be seated, in relaxing conditions, with the right arm semi-flexed at heart level. Blood pressure will be measured with an Omron M5-I monitor (Omron Healthcare UK Ltd.) using one of 3 different cuff sizes according to arm circumference.
Time Frame
one year (interim analysis)
Other Pre-specified Outcome Measures:
Title
Prior assessment of barriers and facilitators
Description
Nested qualitative study aimed to understand the barriers and limitations perceived by children, parents, and teachers for the physical activity of schoolchildren, using focus groups under a phenomenologic framework.
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 with at least one full course of 3rd of early childhood education and one of 1st primary school.
The Boards of Governors (community participatory organ in each school) give its approval to the intervention and measurements at the beginning and end of the course.
Children 4 to 7 years old.
Children's parents/caregivers will give their written consent to the children's participation.
Collaboration in the family to respond to questionnaires on family leisure habits, sleeping, eating, getting around town, etc., included in the measurement protocol of this project.
Exclusion Criteria:
Have a malformation that prevents learning of the Spanish language (or Spanish sign language).
Have some kind of physical or mental disorder identified by parents or teachers that prevent physical activity.
Have a chronic illness such as heart disease, diabetes or asthma, as determined by your pediatrician/family doctor -after analysis of the activities program- prevents participation in them.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vicente Martínez-Vizcaíno, PhD
Organizational Affiliation
Health and Social Research Centre, University of Castilla-La Mancha, Cuenca, Spain
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
30626597
Citation
Martinez-Vizcaino V, Pozuelo-Carrascosa DP, Garcia-Prieto JC, Cavero-Redondo I, Solera-Martinez M, Garrido-Miguel M, Diez-Fernandez A, Ruiz-Hermosa A, Sanchez-Lopez M. Effectiveness of a school-based physical activity intervention on adiposity, fitness and blood pressure: MOVI-KIDS study. Br J Sports Med. 2020 Mar;54(5):279-285. doi: 10.1136/bjsports-2018-099655. Epub 2019 Jan 9.
Results Reference
derived
PubMed Identifier
27912924
Citation
Pozuelo-Carrascosa DP, Sanchez-Lopez M, Cavero-Redondo I, Torres-Costoso A, Bermejo-Cantarero A, Martinez-Vizcaino V. Obesity as a Mediator between Cardiorespiratory Fitness and Blood Pressure in Preschoolers. J Pediatr. 2017 Mar;182:114-119.e2. doi: 10.1016/j.jpeds.2016.11.005. Epub 2016 Nov 29.
Results Reference
derived
PubMed Identifier
25884885
Citation
Martinez-Vizcaino V, Mota J, Solera-Martinez M, Notario-Pacheco B, Arias-Palencia N, Garcia-Prieto JC, Gonzalez-Garcia A, Alvarez-Bueno C, Sanchez-Lopez M; MOVI-KIDS group. Rationale and methods of a randomised cross-over cluster trial to assess the effectiveness of MOVI-KIDS on preventing obesity in pre-schoolers. BMC Public Health. 2015 Feb 22;15:176. doi: 10.1186/s12889-015-1512-0.
Results Reference
derived
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Effectiveness of a Physical Activity Intervention on Preventing Obesity During the Adiposity Rebound Period.
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