NCT01374386

Brief Summary

The purpose of this study is to gather information on how much exercising with video games (ExerGaming) can increase the physical activity among overweight and youth. This study will try to see if participating in physical activity and exercising with video games at the same time can make overweight children move around more to better their own health. The hypothesis is that those in Exergaming arm will physiological changes and increase physical activity.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 16, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

November 13, 2017

Status Verified

November 1, 2017

Enrollment Period

2 years

First QC Date

June 14, 2011

Last Update Submit

November 8, 2017

Conditions

Keywords

adolescent obesity

Outcome Measures

Primary Outcomes (1)

  • Change in mean daily physical activity

    Change in mean daily physical activity from baseline (7-day activity log expressed as Kcal/day from relative MET intensity

    2 years

Secondary Outcomes (1)

  • Change in caloric expenditure, body composition, and BMI

    2 years

Study Arms (2)

Usual Physical Activity

NO INTERVENTION

Participants in this arm are do not have access to Exergames, only usual physical activity at the gym

Exergaming

EXPERIMENTAL

Participants in this arm will have access to usual physical activity at the gym as well as access to Exergaming equipment (video games that require physical activity)

Behavioral: Exergaming

Interventions

ExergamingBEHAVIORAL

Participants will have access to Exergaming equipment (video games that require physical activity)

Exergaming

Eligibility Criteria

Age12 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • male and female
  • aged 12-14 years
  • baseline BMI \> 25
  • gender- and age-specific 85th percentile cutoff points from the CDC growth chart
  • parental consent and subject assent

You may not qualify if:

  • Participants under the age of 12 are excluded from the study because Weingart YMCA has an age policy. Children under the age of 12 are not allowed to be at the facility alone. Therefore, the minimum age for the study is 12 years old so supervision is not a problem.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charles Drew University of Medicine and Science

Los Angeles, California, 90059, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Exergaming

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • David Martins, MD, Msc

    Charles Drew University of Medicine and Science

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

June 14, 2011

First Posted

June 16, 2011

Study Start

October 1, 2010

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

November 13, 2017

Record last verified: 2017-11

Locations