PRESENCE 2: Predicting Sedentary Entertainment Choices and Effects

Obesity Clinical Trial

Official title:

PRESENCE 2: Predicting Sedentary Entertainment Choices and Effects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01523795
• Other study ID #: 10-1415
• Status: Completed
• Phase: N/A
• First received: January 27, 2012
• Last updated: January 31, 2012
• Start date: October 2010
• Est. completion date: February 2011

Study information

• Verified date: January 2012
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Between the ages of 18 and 35 years old

Exclusion Criteria:

• 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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Obesity
• Physical Activity

Intervention

Other:
• Motion-controlled video gaming
Play of motion-controlled video games for one hour
• Traditional video gaming
Participants played traditional video games for one hour
• Television watching
Participants watched television for one hour

Locations

Country	Name	City	State
United States	UNC Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	One-hour study period	No
Secondary	Energy expenditure	Energy expenditure was measured using a Sense Wear Pro armband, which uses accelerometry and galvanic skin response to estimate metabolic equivalents	One-hour study period	No