NCT02214108

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3 obesity

Timeline
Completed

Started Nov 2012

Typical duration for phase_3 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2014

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 12, 2014

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 4, 2016

Status Verified

March 1, 2014

Enrollment Period

1.7 years

First QC Date

July 25, 2014

Last Update Submit

March 3, 2016

Conditions

ObesityOverweight

Keywords

BMIObesityoverweightchildPhysical activity

Outcome Measures

Primary Outcomes (1)

  • Change in Body Mass Index

    one month

Secondary Outcomes (3)

  • change in weight

    one month

  • change in physical endurance

    one month

  • variations in serum lipids

    1 month

Study Arms (2)

Phisical activity with Nintendo Wii

EXPERIMENTAL

3 hours of weekly of physical activity, divided in 1 hour interday with Nintendo WII. games applied: Wii Boxing, Wii Tennis; Wii Bowling

Other: Nintendo Wii

phisical activity with phisiotherapist

NO INTERVENTION

3 hours of weekly physical activity, divided in 1 hour interday. applying cardiovascular and muscular endurance static exercises.

Interventions

Nintendo WiiOTHER

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

Also known as: active video games
Phisical activity with Nintendo Wii

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • overweight or obese due other disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Center Albina Patino

Cochabamba, Departamento de Cochabamba, 555, Bolivia

Location

MeSH Terms

Conditions

ObesityOverweightMotor Activity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Giuseppe Esteban Grandy Aranda, MSc

    Centro de Pediatria Albina Patino

    STUDY DIRECTOR

  • Alicia Ribero Nogales, MD

    Centro de Pediatria Albina Patino

    PRINCIPAL INVESTIGATOR

  • Gerardo Weisstaub, MSc

    Institute of Nutrition and Technology of Food.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical head of Nutrition Center Albina Patino

Study Record Dates

First Submitted

July 25, 2014

First Posted

August 12, 2014

Study Start

November 1, 2012

Primary Completion

August 1, 2014

Study Completion

December 1, 2015

Last Updated

March 4, 2016

Record last verified: 2014-03

Locations

BO(1)