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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02214108
Other study ID # protwii2013
Secondary ID
Status Completed
Phase Phase 3
First received July 25, 2014
Last updated March 3, 2016
Start date November 2012
Est. completion date December 2015

Study information

Verified date March 2014
Source Centro Pediatrico Albina de Patino
Contact n/a
Is FDA regulated No
Health authority Bolivia: Ethics Commitee
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the effect of interactive video game in management of overweight in children. The investigators will evaluate the effect of product versus standard physical activity.


Description:

Background. Child Overweight and obesity are a world public health problem, in low income countries is more. One difficulty in the management is the poor adherence to physical activity, some studies show that active video games could improve this.

Objective: Establish the effect of the introduction of active video game (Nintendo Wii) on fitness, anthropometry and adherence to treatment, as part of an intervention program for the management of childhood obesity in children over 5 years of age with obesity Methodology: A clinical trial, randomized and controlled. children between 5-10 years with a diagnosis of overweight or obese, were divided into two groups. (Wii group), received 3 weekly sessions of one hour of physical activity by an active video game, the other group (control group) received 3 weekly sessions of one hour of physical activity by static exercises.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 2015
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender Both
Age group 5 Years to 10 Years
Eligibility Inclusion Criteria:

- children aged 5-10 years with a diagnosis of overweight or obese (according to WHO criteria)

Exclusion Criteria:

- overweight or obese due other disease.

Study Design

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


Related Conditions & MeSH terms


Intervention

Other:
Nintendo Wii
Tennis, box and bowling on Nintendo Wii, 3 hours per week.

Locations

Country Name City State
Bolivia Pediatric Center Albina Patino Cochabamba

Sponsors (2)

Lead Sponsor Collaborator
Centro Pediatrico Albina de Patino University of Chile

Country where clinical trial is conducted

Bolivia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Body Mass Index one month Yes
Secondary change in weight one month Yes
Secondary change in physical endurance one month Yes
Secondary variations in serum lipids Cholesterol, triglycerides. 1 month Yes
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