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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
FRANCISCO QUILES VICECHANCELLOR OF RESEARCH, University of Castilla-La Mancha
ClinicalTrials.gov Identifier:
NCT01277224
First received: January 12, 2011
Last updated: May 24, 2013
Last verified: May 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 University of Castilla-La Mancha:

Primary Outcome Measures:
  • Skin-fold thickness [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   8 Years to 11 Years
Genders Eligible for Study:   Both
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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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University of Castilla-La Mancha

Additional 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
Study First Received: January 12, 2011
Last Updated: May 24, 2013
Health Authority: Spain: Ethics Committee
Spain: Ministry of Health and Consumption

Keywords provided by 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

ClinicalTrials.gov processed this record on September 14, 2014