Back to resultsImpact of Exergaming on Adolescent Youth
Primary Purpose
Childhood Obesity
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exergaming
Sponsored by
About this trial
This is an interventional treatment trial for Childhood Obesity focused on measuring adolescent obesity
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- subjects not meeting the inclusion criteria or with physician-determined musculoskeletal, cardiopulmonary, metabolic, psychological, neuro-developmental or behavioral conditions that make mild-to-moderate physical activity potentially hazardous.
- 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.
Sites / Locations
- Charles Drew University of Medicine and Science
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Usual Physical Activity
Exergaming
Arm Description
Participants in this arm are do not have access to Exergames, only usual physical activity at the gym
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)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change in caloric expenditure, body composition, and BMI
(a) Total daily caloric expenditure, (b) change in body composition (total body estimates of fat mass, fat-free mass, and lean body mass), and (c) change in BMI z score from baseline.
Full Information
NCT ID
NCT01374386
First Posted
June 14, 2011
Last Updated
November 8, 2017
Sponsor
Charles Drew University of Medicine and Science
1. Study Identification
Unique Protocol Identification Number
NCT01374386
Brief Title
Impact of Exergaming on Adolescent Youth
Official Title
RCMI Clinical Research Infrastructure Initiative: Exergaming
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Withdrawn
Why Stopped
The study did not receive funding.
Study Start Date
October 2010 (undefined)
Primary Completion Date
October 2012 (Anticipated)
Study Completion Date
October 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charles Drew University of Medicine and Science
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
adolescent obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual Physical Activity
Arm Type
No Intervention
Arm Description
Participants in this arm are do not have access to Exergames, only usual physical activity at the gym
Arm Title
Exergaming
Arm Type
Experimental
Arm Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Exergaming
Intervention Description
Participants will have access to Exergaming equipment (video games that require physical activity)
Primary Outcome Measure Information:
Title
Change in mean daily physical activity
Description
Change in mean daily physical activity from baseline (7-day activity log expressed as Kcal/day from relative MET intensity
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Change in caloric expenditure, body composition, and BMI
Description
(a) Total daily caloric expenditure, (b) change in body composition (total body estimates of fat mass, fat-free mass, and lean body mass), and (c) change in BMI z score from baseline.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
subjects not meeting the inclusion criteria or with physician-determined musculoskeletal, cardiopulmonary, metabolic, psychological, neuro-developmental or behavioral conditions that make mild-to-moderate physical activity potentially hazardous.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Martins, MD, Msc
Organizational Affiliation
Charles Drew University of Medicine and Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charles Drew University of Medicine and Science
City
Los Angeles
State/Province
California
ZIP/Postal Code
90059
Country
United States
12. IPD Sharing Statement
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Impact of Exergaming on Adolescent Youth
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