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Trial record 1 of 1 for:    NCT01971840
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Effectiveness of a Physical Activity Intervention on Preventing Obesity During the Adiposity Rebound Period. (MOVI-KIDS)

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ClinicalTrials.gov Identifier: NCT01971840
Recruitment Status : Unknown
Verified October 2013 by FRANCISCO QUILES VICECHANCELLOR OF RESEARCH, University of Castilla-La Mancha.
Recruitment status was:  Enrolling by invitation
First Posted : October 29, 2013
Last Update Posted : December 24, 2013
Carlos III Health Institute
Information provided by (Responsible Party):

Tracking Information
First Submitted Date  ICMJE October 7, 2013
First Posted Date  ICMJE October 29, 2013
Last Update Posted Date December 24, 2013
Study Start Date  ICMJE September 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2013)
Body fat percentage [ Time Frame: One year (interim analysis) ]
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2013)
  • Physical fitness [ Time Frame: One year (interim analysis) ]
    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 [ Time Frame: One year (interim analysis) ]
    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 [ Time Frame: one year (interim analysis) ]
    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 [ Time Frame: one year (interim analysis) ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 23, 2013)
Prior assessment of barriers and facilitators [ Time Frame: One year ]
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.
Original Other Pre-specified Outcome Measures Same as current
Descriptive Information
Brief Title  ICMJE Effectiveness of a Physical Activity Intervention on Preventing Obesity During the Adiposity Rebound Period.
Official Title  ICMJE Effectiveness of an Intervention of Physical Activity Promotion in Schoolchildren on Preventing Obesity During the Adiposity Rebound Period: a Cross-over Randomized Cluster Trial.
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:

  1. Reduce the body fat percentage in the intervention group versus the control group in 2%.
  2. Improve the several components of fitness: aerobic capacity, strength, speed and agility.
  3. Reduce the carotid intima-media thickness and
  4. Reduce fat, increase fat free mass, and reduce sedentary behavior.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Physical Activity
  • Adiposity
  • Children
  • Obesity
  • Cardiovascular Disease
Intervention  ICMJE Behavioral: MOVI-KIDS
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).
Study Arms  ICMJE
  • Experimental: MOVI-KIDS Program
    Intervention group
    Intervention: Behavioral: MOVI-KIDS
  • No Intervention: Control
    No intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 23, 2013)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2015
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 7 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01971840
Other Study ID Numbers  ICMJE PI12/02400
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party FRANCISCO QUILES VICECHANCELLOR OF RESEARCH, University of Castilla-La Mancha
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Castilla-La Mancha
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Carlos III Health Institute
Investigators  ICMJE
Principal Investigator: Vicente Martínez-Vizcaíno, PhD Health and Social Research Centre, University of Castilla-La Mancha, Cuenca, Spain
PRS Account University of Castilla-La Mancha
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP