Effects of Interactive Video Game Cycling on Obese Adolescent Health

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

Interactive video game cycling

Cycling to Music

About this trial

This is an interventional treatment trial for Overweight With Comorbidity focused on measuring Adolescents, Obesity, Exercise, Music, Virtual Reality

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Children's Hospital Of Eastern Ontario Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Interactive video cycling

Cycling to Music

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Energy Expenditure (kilocalories)

Secondary Outcome Measures

Aerobic fitness

Full Information

NCT ID

NCT00983970

First Posted

September 23, 2009

Last Updated

September 23, 2009

Sponsor

Children's Hospital of Eastern Ontario

Collaborators

Canadian Diabetes Association

1. Study Identification

Unique Protocol Identification Number

NCT00983970

Brief Title

Effects of Interactive Video Game Cycling on Obese Adolescent Health

Official Title

Effects of Interactive Video Game Cycling on Obese Adolescent Health

Study Type

Interventional

2. Study Status

Record Verification Date

September 2009

Overall Recruitment Status

Completed

Study Start Date

May 2007 (undefined)

Primary Completion Date

March 2009 (Actual)

Study Completion Date

March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Children's Hospital of Eastern Ontario

Collaborators

Canadian Diabetes Association

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight With Comorbidity, Obesity

Keywords

Adolescents, Obesity, Exercise, Music, Virtual Reality

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Interactive video cycling

Arm Type

Experimental

Arm Description

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.

Arm Title

Cycling to Music

Arm Type

Active Comparator

Arm Description

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 Type

Behavioral

Intervention Name(s)

Interactive video game cycling

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Cycling to Music

Intervention Description

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.

Primary Outcome Measure Information:

Title

Energy Expenditure (kilocalories)

Time Frame

baseline and 10-weeks

Secondary Outcome Measure Information:

Title

Aerobic fitness

Time Frame

baseline and 10 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gary S Goldfield, Ph.D.

Organizational Affiliation

Children's Hospital of Eastern Ontario Research Institute

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Kristi B Adamo, PhD.

Organizational Affiliation

Children's Hospital of Eastern Ontario Research Institute

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jane A Rutherford, MSc

Organizational Affiliation

Children's Hospital of Eastern Ontario Research Institute

Official's Role

Study Director

Facility Information:

Facility Name

Children's Hospital Of Eastern Ontario Research Institute

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L1

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

24952265

Citation

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.

Results Reference

derived

Overweight With Comorbidity, Obesity

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial