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Effectiveness of a Physical Activity Intervention on the Obesity of Schoolchildren (Movi2)

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ClinicalTrials.gov Identifier: NCT01277224
Recruitment Status : Completed
First Posted : January 14, 2011
Last Update Posted : May 27, 2013
Sponsor:
Information provided by (Responsible Party):
FRANCISCO QUILES VICECHANCELLOR OF RESEARCH, University of Castilla-La Mancha

Study Description
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Brief Summary:
The purpose of this study is to evaluate the effectiveness of a recreational physical activity intervention (RPAI) for reducing the prevalence of overweight/obesity and other cardiovascular risk factors

Condition or disease Intervention/treatment Phase
Physical Activity Obesity Children Behavioral: Movi2 Program Not Applicable

Detailed Description:

The prevalence of overweight in Spanish children in the puberty age is among the highest in the world and increasing quickly. The investigators recently evaluated an after-school program of recreational physical activity to control obesity and other cardiovascular risk factors in primary school children in Cuenca. This program, known as the Movi program, reduced adiposity, increased serum apolipoprotein (apo) A-I concentration and reduced apo B concentration over one-year period.

Though the intervention MOVI had great acceptance between the children and his families, and it demonstrated to be effective opposite to the obesity, his results were relatively modest. For it, our hypothesis of work, which justifies this new project, is that a major intensity of the intervention, and a major weekly duration extending this one to the weekend, it might improve the efficiency on the obesity.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effectiveness of a Leisure Time Physical Activity Intervention on the Overweight and the Obesity in Schoolchildren. The Cuenca's Study
Study Start Date : September 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Movi2 Program Behavioral: Movi2 Program
In the Movi2 program we will perform a recreational physical activity intervention during one year that include standardized recreative and non competitive activities conducted by sports instructors. It consisted of two 90-min after school sessions per week on school days and one 150-minute session on Saturday morning.
No Intervention: Control


Outcome Measures
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Primary Outcome Measures :
  1. Skin-fold thickness [ Time Frame: 1 year ]
    Over 1 years, the Movi program will reduce the prevalence of excess weight in schoolchildren and improve other cardiovascular risk factors.


Secondary Outcome Measures :
  1. Physical activity, physical fitness, sleep, and quality of life [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   8 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
The Boards of Governors (community participatory organ in each school) and the children's parents will inform of the study's aims and methods, and give their written consent to the children's participation. Similarly, the study will present classroom-by-classroom to the children, and their oral consent will obtain. Participant children will be free of serious learning difficulties, or physical or mental disorders, that could impede participation in the scheduled physical activities.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01277224


Sponsors and Collaborators
University of Castilla-La Mancha
Investigators
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Principal Investigator: Vicente Martinez-Vizcaíno, PhD Health and Social Research Centre, Universidad de Castilla-La Mancha, Cuenca, Spain
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: FRANCISCO QUILES VICECHANCELLOR OF RESEARCH, Proffesor, University of Castilla-La Mancha
ClinicalTrials.gov Identifier: NCT01277224    
Other Study ID Numbers: PI081297
First Posted: January 14, 2011    Key Record Dates
Last Update Posted: May 27, 2013
Last Verified: May 2013
Keywords provided by FRANCISCO QUILES VICECHANCELLOR OF RESEARCH, University of Castilla-La Mancha:
physical activity
obesity
adiposity
children
 blood lipids
blood pressure
randomized controlled trials
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight