Effectiveness of a Physical Activity Intervention on the Obesity of Schoolchildren

Obesity Clinical Trial

— Movi2  

Official title:

Effectiveness of a Leisure Time Physical Activity Intervention on the Overweight and the Obesity in Schoolchildren. The Cuenca's Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01277224
• Other study ID #: PI081297
• Status: Completed
• Phase: N/A
• First received: January 12, 2011
• Last updated: May 24, 2013
• Start date: September 2010
• Est. completion date: October 2011

Study information

• Verified date: May 2013
• Source: University of Castilla-La Mancha
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics CommitteeSpain: Ministry of Health and Consumption
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 11 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Children
• Obesity
• Physical Activity

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Castilla-La Mancha

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin-fold thickness	Over 1 years, the Movi program will reduce the prevalence of excess weight in schoolchildren and improve other cardiovascular risk factors.	1 year	No
Secondary	Physical activity, physical fitness, sleep, and quality of life		1 year	No