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Effects of Interactive Video Game Cycling on Obese Adolescent Health

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ClinicalTrials.gov Identifier: NCT00983970
Recruitment Status : Completed
First Posted : September 24, 2009
Last Update Posted : September 24, 2009
Sponsor:
Collaborator:
Canadian Diabetes Association
Information provided by:
Children's Hospital of Eastern Ontario

Tracking Information
First Submitted Date  ICMJE September 23, 2009
First Posted Date  ICMJE September 24, 2009
Last Update Posted Date September 24, 2009
Study Start Date  ICMJE May 2007
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2009)
Energy Expenditure (kilocalories) [ Time Frame: baseline and 10-weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2009)
Aerobic fitness [ Time Frame: baseline and 10 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Interactive Video Game Cycling on Obese Adolescent Health
Official Title  ICMJE Effects of Interactive Video Game Cycling on Obese Adolescent Health
Brief Summary Exercise is an important component in the treatment of of child obesity and associated medical conditions. However, one of the strongest predictors of non-compliance from exercise programs in obese youth is lack of enjoyment, thus creating a more pleasurable environment, by using TV or video games as incentives, may be an effective way of increasing exercise in obese youth. The purpose of this study was to compare interactive video game stationary cycling (GameBike ®) with cycling to music on aerobic fitness, body composition, cardiovascular disease risk markers, and exercise behaviour as measured by attendance, energy expenditure, duration, intensity and distance pedaled in obese adolescents. Twenty six obese adolescents had an equal chance of being assigned to either interactive video game cycling (n=13) or cycling to music serving as controls (n=13). The 10-week program consisted of twice weekly sessions lasting a maximum of 60 minutes per session.
Detailed Description

Background: Energy expenditure through exercise is important for weight loss and reduction of medical morbidity associated with adolescent obesity. However, attrition from aerobic exercise programs is high in obese children as they do not tolerate it or enjoy it. Capitalizing on technology to use TV or video games as incentives to exercise may improve adherence to exercise and associated health benefits in obese adolescents.

Objective: The purpose of this study was to compare the efficacy of interactive video game stationary cycling (GameBike ®) with cycling to music on aerobic fitness, body composition, cardiovascular disease risk markers, and exercise behaviour as measured by attendance, energy expenditure, duration, intensity and distance pedaled in obese adolescents.

Method: Twenty six obese adolescents were stratified by gender and randomized to a either interactive video game cycling (n=13) or cycling to music serving as controls (n=13). The 10-week program consisted of twice weekly sessions lasting a maximum of 60 minutes per session.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Overweight With Comorbidity
  • Obesity
Intervention  ICMJE
  • Behavioral: Interactive video game cycling
    Participants were required to exercise on a Gamebike® (Cat Eye Electronics Ltd, Boulder Col.) interactive video gaming system that was interfaced with a Sony Play Station 2® (Sony computer Entertainment America Inc. Foster, City, CA) and a 42" flat screen television monitor. The Gamebike® has a handlebar mounted game controller allowing the participant to play most Sony Playstation 2- race-based video games. The Gamebike® reads the participant's speed by cycling cadence and the faster the individual pedalled, the faster they moved in the virtual world on screen. Participants were told that they could exercise at any intensity and duration they desired. Participants were asked to come to the lab for two sessions per week for 60 minutes for 10 weeks. Although participants were required to stay in the lab for 60 minutes, they could take breaks or stop when they wanted, and reading materials were available for those who did not or could not cycle for the full 60 minute session.
  • Behavioral: Cycling to Music
    Each participant exercised twice weekly for 10 weeks on the Gamebike® but the games and controls were turned off. The Gamebike® was used by both groups to control for any differences between two cycle ergometers such as comfort or usability. However, participants were allowed to listen to music of their choice via radio, CD or personal music device. We incorporated music into the control condition because most youth and young adults exercise to music and this provides a more stringent test of the Gamebike® while improving the ecological validity of the research design. We also wanted to minimize drop-out and felt that expecting overweight/obese adolescents, who often report disliking aerobic exercise, to bike in a lab with no form of distraction would create a less than desirable exercise environment and result in high drop-out rates.
Study Arms  ICMJE
  • Experimental: Interactive video cycling
    Interactive video cycling arm utilized the Gamebike that interfaced a Sony Play Station 2 with a stationary bicycle and a 42 inch flat screen TV. The Gamebike has a handle bar mounted game controller allowing the participant to play most Sony Play Station 2 raced-based video games. The Gamebike reads the participants' speed by cycling cadence and the faster the individual pedalled, the faster they moved in the virtual world on screen. Participants were asked to come to the lab for two sessions per week for 60 minutes for 10 weeks.Participants were told that they could exercise at any intensity or duration that they desired, and reading materials were provided for those who did not chose to exercise for the full 60 minute session.
    Intervention: Behavioral: Interactive video game cycling
  • Active Comparator: Cycling to Music
    Each participant exercised twice weekly for 10 weeks on the Gamebike® but the games and controls were turned off. The Gamebike® was used by both groups to control for any differences between two cycle ergometers such as comfort or usability. However, participants were allowed to listen to music of their choice via radio, CD or personal music device.
    Intervention: Behavioral: Cycling to Music
Publications * Thivel D, Chaput JP, Adamo KB, Goldfield GS. Is energy intake altered by a 10-week aerobic exercise intervention in obese adolescents? Physiol Behav. 2014 Aug;135:130-4. doi: 10.1016/j.physbeh.2014.06.013. Epub 2014 Jun 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 23, 2009)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • youth aged 12-17 years with BMI above 95th percentile for age and gender based on CDC growth chart data, OR
  • BMI > 85th percentile for age and gender with one of the following:
  • elevated fasting glucose or 2 hour OGTT (indicative of impaired glucose tolerance)
  • elevated fasting triglycerides, LDL-C, reduced HDL-C
  • total cholesterol/HDL-C ratio > 90th percentile
  • elevated fasting insulin
  • Blood pressure > 90th percentile
  • 1st degree relative with Type II diabetes or cardiovascular disease
  • Willingness to follow protocol and sign informed assent and consent

Exclusion Criteria:

  • Did not have a medical condition that altered intestinal absorption
  • Did not influence response to activity intervention or make vigorous exercise dangerous - such as
  • type 1 diabetes mellitus
  • inflammatory bowel disease,
  • severe arthritis/asthma,
  • congestive heart failure,
  • pulmonary disease,
  • systemic hypertension,
  • acute renal disease
  • other illness assessed by the study physician making participation inadvisable
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00983970
Other Study ID Numbers  ICMJE GA-2-06-2106-GG
CDA-GG-2-06-2106-GG
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Gary Goldfield, Senior Scientist, Children's Hospital of Eastern Ontario Research Institute
Study Sponsor  ICMJE Children's Hospital of Eastern Ontario
Collaborators  ICMJE Canadian Diabetes Association
Investigators  ICMJE
Principal Investigator: Gary S Goldfield, Ph.D. Children's Hospital of Eastern Ontario Research Institute
Principal Investigator: Kristi B Adamo, PhD. Children's Hospital of Eastern Ontario Research Institute
Study Director: Jane A Rutherford, MSc Children's Hospital of Eastern Ontario Research Institute
PRS Account Children's Hospital of Eastern Ontario
Verification Date September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP