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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01277224
First Posted: January 14, 2011
Last Update Posted: May 27, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
FRANCISCO QUILES VICECHANCELLOR OF RESEARCH, University of Castilla-La Mancha
  Purpose
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 Intervention
Physical Activity Obesity Children Behavioral: Movi2 Program

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by FRANCISCO QUILES VICECHANCELLOR OF RESEARCH, University of Castilla-La Mancha:

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

Enrollment: 1200
Study Start Date: September 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

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
Principal Investigator: Vicente Martinez-Vizcaíno, PhD Health and Social Research Centre, Universidad de Castilla-La Mancha, Cuenca, Spain
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: FRANCISCO QUILES VICECHANCELLOR OF RESEARCH, Proffesor, University of Castilla-La Mancha
ClinicalTrials.gov Identifier: NCT01277224     History of Changes
Other Study ID Numbers: PI081297
First Submitted: January 12, 2011
First Posted: January 14, 2011
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:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms