Overweight With ComorbidityPhase 4NCT00983970
Effects of Interactive Video Game Cycling on Obese Adolescent Health
A Phase 4 study testing Interactive video game cycling and Cycling to Music in people with Overweight With Comorbidity and Obesity, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Overweight With Comorbidity, Obesity
- What is being tested?
- Interactive video game cycling and Cycling to Music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- May 2007to Mar 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
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- Blood pressure > 90th percentile
- 1st degree relative with Type II diabetes or cardiovascular disease
- Willingness to follow protocol and sign informed assent and consent
Who cannot join
- 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,
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- pulmonary disease,
- systemic hypertension,
- acute renal disease
- other illness assessed by the study physician making participation inadvisable
Trial locations and contacts
1 site in 1 country.
Canada1 site
Children's Hospital Of Eastern Ontario Research Institute
Ottawa, Ontario, K1H 8L1
About this study
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.
Read the 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.
- Conditions
- Overweight With Comorbidity, Obesity
- Being tested
- Interactive video game cycling, Cycling to Music
- Keywords
- Adolescents, Obesity, Exercise, Music, Virtual Reality
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive video game cyclingBehavioural
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.
Cycling to MusicBehavioural
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 group | Role | What they receive |
|---|---|---|
| Interactive video cycling | Experimental | 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. Receives: Behavioral: Interactive video game cycling |
| Cycling to Music | Active comparator | 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. Receives: Behavioral: Cycling to Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy Expenditure (kilocalories)
Measured: baseline and 10-weeks
Secondary outcomes (1)
Aerobic fitness
Measured: baseline and 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2009 (estimated)
- Study startMay 2007
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight With ComorbidityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Eastern Ontario
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Diabetes Association
- Investigators
- Gary S Goldfield, Ph.D., Principal investigator, Children's Hospital of Eastern Ontario Research InstituteKristi B Adamo, PhD., Principal investigator, Children's Hospital of Eastern Ontario Research InstituteJane A Rutherford, MSc, Study director, Children's Hospital of Eastern Ontario Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00983970
- Sponsor's protocol ID
- GA-2-06-2106-GG
- Other IDs
- CDA-GG-2-06-2106-GG
- Status last verified
- Sep 2009
- First submitted
- 23 Sep 2009
- Last updated
- 24 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 24952265
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Interactive Video Game Cycling on Obese Adolescent Health
- ClinicalTrials.gov ID
- NCT00983970
- Acronym / sponsor ID
- GA-2-06-2106-GG
- Conditions
- Overweight With Comorbidity, Obesity
- Keywords
- Adolescents, Obesity, Exercise, Music, Virtual Reality
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Children's Hospital of Eastern OntarioUniversity, hospital or other
- Collaborators
- Canadian Diabetes Association
- Study start
- May 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 24 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interactive video cycling | Experimental | Behavioral: Interactive video game cyclingInteractive 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. |
| Cycling to Music | Active comparator | Behavioral: Cycling to MusicEach 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. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive video game cyclingParticipants 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. | Behavioural | Interactive video cycling |
| Cycling to MusicEach 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. | Behavioural | Cycling to Music |
Primary outcome
Energy Expenditure (kilocalories)
Time frame: baseline and 10-weeks
1 secondary outcome
Aerobic fitness
Time frame: baseline and 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2009.
- Derived from this study: PubMed 24952265Thivel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary S Goldfield, Ph.D. principal investigator
Children's Hospital of Eastern Ontario Research Institute
Kristi B Adamo, PhD. principal investigator
Children's Hospital of Eastern Ontario Research Institute
Jane A Rutherford, MSc study director
Children's Hospital of Eastern Ontario Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Interactive video game cycling and Cycling to Music in people with Overweight With Comorbidity and Obesity, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy Expenditure (kilocalories) (time frame: baseline and 10-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00983970, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2009.