Ignite Creation Date:
2025-12-24 @ 1:43 PM
Ignite Modification Date:
2026-01-01 @ 8:36 PM
Study NCT ID:
NCT01523795
Status:
COMPLETED
Last Update Posted:
2012-02-01
First Post:
2012-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PRESENCE 2: Predicting Sedentary Entertainment Choices and Effects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-31', 'studyFirstSubmitDate': '2012-01-27', 'studyFirstSubmitQcDate': '2012-01-31', 'lastUpdatePostDateStruct': {'date': '2012-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Energy intake', 'timeFrame': 'One-hour study period', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Energy expenditure', 'timeFrame': 'One-hour study period', 'description': 'Energy expenditure was measured using a Sense Wear Pro armband, which uses accelerometry and galvanic skin response to estimate metabolic equivalents'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Energy intake', 'Video games', 'Television', 'Physical activity', 'Obesity'], 'conditions': ['Obesity', 'Physical Activity']}, 'referencesModule': {'references': [{'pmid': '22760571', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nAn 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.\n\nFinally, 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between the ages of 18 and 35 years old\n\nExclusion Criteria:\n\n* Not at least a novice video game played (defined as having played games once or twice within the last year)\n* Has pre-existing medical condition that precludes physical activity\n* Is unable to find transportation to the study center\n* Does not agree to be videotaped during the experiment\n* Does not agree or is unable to fast for two hours prior to the experiment\n* Is pregnant or nursing\n* Weighs more than 300 pounds (required by one of the game controllers)'}, 'identificationModule': {'nctId': 'NCT01523795', 'briefTitle': 'PRESENCE 2: Predicting Sedentary Entertainment Choices and Effects', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'PRESENCE 2: Predicting Sedentary Entertainment Choices and Effects', 'orgStudyIdInfo': {'id': '10-1415'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Motion-controlled video gaming', 'description': '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', 'interventionNames': ['Other: Motion-controlled video gaming']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional video gaming', 'description': 'Participants played traditional (handheld gamepad controller-based) video games using a Playstation 3 console for one hour', 'interventionNames': ['Other: Traditional video gaming']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Television watching', 'description': 'Participants watched television via Netflix instant streaming for one hour', 'interventionNames': ['Other: Television watching']}], 'interventions': [{'name': 'Motion-controlled video gaming', 'type': 'OTHER', 'description': 'Play of motion-controlled video games for one hour', 'armGroupLabels': ['Motion-controlled video gaming']}, {'name': 'Traditional video gaming', 'type': 'OTHER', 'description': 'Participants played traditional video games for one hour', 'armGroupLabels': ['Traditional video gaming']}, {'name': 'Television watching', 'type': 'OTHER', 'description': 'Participants watched television for one hour', 'armGroupLabels': ['Television watching']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27755', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'UNC Lineberger Comprehensive Cancer Center', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Elizabeth J Lyons, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}