- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01374386
Impact of Exergaming on Adolescent Youth
November 8, 2017 updated by: David Martins, Charles Drew University of Medicine and Science
RCMI Clinical Research Infrastructure Initiative: Exergaming
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.
Study Overview
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Los Angeles, California, United States, 90059
- Charles Drew University of Medicine and Science
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 14 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Usual Physical Activity
Participants in this arm are do not have access to Exergames, only usual physical activity at the gym
|
|
Experimental: Exergaming
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)
|
Participants will have access to Exergaming equipment (video games that require physical activity)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in mean daily physical activity
Time Frame: 2 years
|
Change in mean daily physical activity from baseline (7-day activity log expressed as Kcal/day from relative MET intensity
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in caloric expenditure, body composition, and BMI
Time Frame: 2 years
|
(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.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: David Martins, MD, Msc, Charles Drew University of Medicine and Science
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (Anticipated)
October 1, 2012
Study Completion (Anticipated)
October 1, 2012
Study Registration Dates
First Submitted
June 14, 2011
First Submitted That Met QC Criteria
June 15, 2011
First Posted (Estimate)
June 16, 2011
Study Record Updates
Last Update Posted (Actual)
November 13, 2017
Last Update Submitted That Met QC Criteria
November 8, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-10-2240-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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