ObesityNCT01523795
PRESENCE 2: Predicting Sedentary Entertainment Choices and Effects
A study testing Traditional video gaming and Television watching in people with Obesity and Physical Activity, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The purpose of this study is to determine whether playing motion-controlled video games produces low caloric intake and higher caloric expenditure than watching TV or playing traditional video games. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Physical Activity
- What is being tested?
- Traditional video gaming and Television watching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Feb 2011
- Phase
- Interventional
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the ages of 18 and 35 years old
Who cannot join
- Not at least a novice video game played (defined as having played games once or twice within the last year)
- Has pre-existing medical condition that precludes physical activity
- Is unable to find transportation to the study center
- Does not agree to be videotaped during the experiment
- Does not agree or is unable to fast for two hours prior to the experiment
- Is pregnant or nursing
- Weighs more than 300 pounds (required by one of the game controllers)
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27755
About this study
The purpose of this study is to determine whether playing motion-controlled video games produces low caloric intake and higher caloric expenditure than watching TV or playing traditional video games.
Read the detailed description
The purpose of this study is to investigate differences in behaviors and emotions during TV watching and video game playing. Participants will be randomized to either watch TV, play traditional button-based video games, or play motion-based video games for one hour while palatable snack foods and sugar-sweetened beverages are provided within easy reaching distance. Both energy intake as well as energy expenditure during a one-hour period will be measured. All three conditions will be optimized to resemble typical in-home conditions as much as possible.
An additional goal of this study is to provide insight into the possible pathways by which TV and video games differentially affect intake and expenditure. Distraction from the real world (also called presence or engagement) will be analyzed to determine if a) these variables differ across groups and b) if these variables explain differences in energy intake and/or expenditure. The TV group will watch TV shows using Netflix streaming service, which will allow them to choose from a variety of popular shows without viewing commercials. As the investigators are primarily interested in satiety and hand occupation effects, the lack of commercials will allow us to eliminate food advertisements as a causal factor.
Finally, the third major goal of the study is to investigate how young adults choose screen-based media. In the two video game arms, participants will be allowed to choose to play any of 10 provided games, and in the TV group, participants will be able to choose from hundreds of options. Choices of game/program, time spent on each game/program, and psychological reactions to each game will be measured and analyzed.
- Conditions
- Obesity, Physical Activity
- Being tested
- Motion-controlled video gaming, Traditional video gaming, Television watching
- Keywords
- Energy intake, Video games, Television, Physical activity, Obesity
- 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.
Motion-controlled video gamingOther
Play of motion-controlled video games for one hour
Traditional video gamingOther
Participants played traditional video games for one hour
Television watchingOther
Participants watched television for one hour
| Study group | Role | What they receive |
|---|---|---|
| Motion-controlled video gaming | Experimental | Participants played motion-controlled video games that involved at least throwing, hitting, or dancing motions using a Wii or Xbox 360 console for one hour Receives: Other: Motion-controlled video gaming |
| Traditional video gaming | Active comparator | Participants played traditional (handheld gamepad controller-based) video games using a Playstation 3 console for one hour Receives: Other: Traditional video gaming |
| Television watching | Active comparator | Participants watched television via Netflix instant streaming for one hour Receives: Other: Television watching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy intake
Energy intake was measured by weighing available food and beverage containers before and after one-hour period in which participants watched TV/played video games, then calculating the differences in weights
Measured: One-hour study period
Secondary outcomes (1)
Energy expenditure
Energy expenditure was measured using a Sense Wear Pro armband, which uses accelerometry and galvanic skin response to estimate metabolic equivalents
Measured: One-hour study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startOct 2010
- Primary completionFeb 2011
- Study completionFeb 2011
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 ObesityStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth J Lyons, PhD, MPH, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01523795
- Sponsor's protocol ID
- 10-1415
- Status last verified
- Jan 2012
- First submitted
- 27 Jan 2012
- Last updated
- 1 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Lyons EJ, Tate DF, Ward DS, Wang X. Energy intake and expenditure during sedentary screen time and motion-controlled video gaming. Am J Clin Nutr. 2012 Aug;96(2):234-9. doi: 10.3945/ajcn.111.028423. Epub 2012 Jul 3.
PubMed 22760571
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRESENCE 2: Predicting Sedentary Entertainment Choices and Effects
- ClinicalTrials.gov ID
- NCT01523795
- Acronym / sponsor ID
- 10-1415
- Conditions
- Obesity, Physical Activity
- Keywords
- Energy intake, Video games, Television, Physical activity, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 1 Feb 2012 (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.
The purpose of this study is to determine whether playing motion-controlled video games produces low caloric intake and higher caloric expenditure than watching TV or playing traditional video games.
Detailed description
The purpose of this study is to investigate differences in behaviors and emotions during TV watching and video game playing. Participants will be randomized to either watch TV, play traditional button-based video games, or play motion-based video games for one hour while palatable snack foods and sugar-sweetened beverages are provided within easy reaching distance. Both energy intake as well as energy expenditure during a one-hour period will be measured. All three conditions will be optimized to resemble typical in-home conditions as much as possible.
An additional goal of this study is to provide insight into the possible pathways by which TV and video games differentially affect intake and expenditure. Distraction from the real world (also called presence or engagement) will be analyzed to determine if a) these variables differ across groups and b) if these variables explain differences in energy intake and/or expenditure. The TV group will watch TV shows using Netflix streaming service, which will allow them to choose from a variety of popular shows without viewing commercials. As the investigators are primarily interested in satiety and hand occupation effects, the lack of commercials will allow us to eliminate food advertisements as a causal factor.
Finally, the third major goal of the study is to investigate how young adults choose screen-based media. In the two video game arms, participants will be allowed to choose to play any of 10 provided games, and in the TV group, participants will be able to choose from hundreds of options. Choices of game/program, time spent on each game/program, and psychological reactions to each game will be measured and analyzed.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Motion-controlled video gaming | Experimental | Other: Motion-controlled video gamingParticipants played motion-controlled video games that involved at least throwing, hitting, or dancing motions using a Wii or Xbox 360 console for one hour |
| Traditional video gaming | Active comparator | Other: Traditional video gamingParticipants played traditional (handheld gamepad controller-based) video games using a Playstation 3 console for one hour |
| Television watching | Active comparator | Other: Television watchingParticipants watched television via Netflix instant streaming for one hour |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Between the ages of 18 and 35 years old
Key exclusion criteria (7 listed)
- Not at least a novice video game played (defined as having played games once or twice within the last year)
- Has pre-existing medical condition that precludes physical activity
- Is unable to find transportation to the study center
- Does not agree to be videotaped during the experiment
- Does not agree or is unable to fast for two hours prior to the experiment
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 |
|---|---|---|
| Motion-controlled video gamingPlay of motion-controlled video games for one hour | Other | Motion-controlled video gaming |
| Traditional video gamingParticipants played traditional video games for one hour | Other | Traditional video gaming |
| Television watchingParticipants watched television for one hour | Other | Television watching |
Primary outcome
Energy intake
Time frame: One-hour study period
Energy intake was measured by weighing available food and beverage containers before and after one-hour period in which participants watched TV/played video games, then calculating the differences in weights
1 secondary outcome
Energy expenditure
Time frame: One-hour study period
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 1 Feb 2012.
- Derived from this study: PubMed 22760571Lyons EJ, Tate DF, Ward DS, Wang X. Energy intake and expenditure during sedentary screen time and motion-controlled video gaming. Am J Clin Nutr. 2012 Aug;96(2):234-9. doi: 10.3945/ajcn.111.028423. Epub 2012 Jul 3.
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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.
Elizabeth J Lyons, PhD, MPH principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional video gaming and Television watching in people with Obesity and Physical Activity, run by University of North Carolina, Chapel Hill at 1 site in United States.
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 1 inclusion and 7 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 1 Feb 2012. 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 United States. 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.
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 intake (time frame: One-hour study period). 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 NCT01523795, 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 1 Feb 2012.