Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-02-24 @ 3:16 PM
Study NCT ID:
NCT03722251
Status:
COMPLETED
Last Update Posted:
2018-10-29
First Post:
2018-10-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Active Video-game Playing and Food Intake in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001070', 'term': 'Appetitive Behavior'}], 'ancestors': [{'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Repeated measures cross-over design.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2015-05-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-25', 'studyFirstSubmitDate': '2018-10-25', 'studyFirstSubmitQcDate': '2018-10-25', 'lastUpdatePostDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-05-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Food Intake (kcal)', 'timeFrame': '30 minutes after treatment'}, {'measure': 'Subjective appetite (mm)', 'timeFrame': 'baseline and then 15, 30, and 60 minutes after preload consumption', 'description': 'subjective appetite assessed by motivation-to-eat visual analogue scale. The scale range is between 0 and 100 mm. Higher scores represent higher appetite'}], 'secondaryOutcomes': [{'measure': 'Subjective Mood (mm)', 'timeFrame': 'baseline and then 15, 30, and 60 minutes after preload consumption', 'description': 'Measured using visual analogue scale (mm). Each VAS is a 100 mm line where they will place a pencil mark to describe their feelings.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False}, 'conditionsModule': {'keywords': ['appetite, food intake, active gaming'], 'conditions': ['Appetitive Behavior']}, 'descriptionModule': {'briefSummary': 'The purpose of this experiment is to investigate the effect of active video game playing for 30 minutes on food intake and subjective appetite. The investigators hypothesize that video game playing will affect food intake in children. Food intake will be measured at 30 minutes following a glucose (50g glucose in 250ml of water) or sweetened non-caloric (150mg Sucralose® in 250ml of water) beverage with or without active video game playing. Subjective appetite will be measured at 0, 15, 30 and 60 minutes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '9 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nhealthy boys with no emotional, behavioral or learning problems\n\nExclusion Criteria:\n\n* Exclusion criteria are children with significant behavioral or emotional difficulties, those with dietary restrictions, or those taking medications.'}, 'identificationModule': {'nctId': 'NCT03722251', 'briefTitle': 'Active Video-game Playing and Food Intake in Children', 'organization': {'class': 'OTHER', 'fullName': 'Toronto Metropolitan University'}, 'officialTitle': 'Active Video-game Playing and a Glucose Preload on Food Intake Regulation in Children', 'orgStudyIdInfo': {'id': 'REB: 2012-120-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Glucose Beverage', 'description': '50 g of glucose in solution', 'interventionNames': ['Behavioral: Glucose beverage, control beverage, glucose beverage and active video game playing, control beverage and active video game playing']}, {'type': 'EXPERIMENTAL', 'label': 'Control Beverage', 'description': 'Sucralose in solution', 'interventionNames': ['Behavioral: Glucose beverage, control beverage, glucose beverage and active video game playing, control beverage and active video game playing']}, {'type': 'EXPERIMENTAL', 'label': 'Glucose beverage and active video game playing', 'description': '50 g of glucose in solution and 30 min of active video game playing', 'interventionNames': ['Behavioral: Glucose beverage, control beverage, glucose beverage and active video game playing, control beverage and active video game playing']}, {'type': 'EXPERIMENTAL', 'label': 'Control Beverage and active video game playing', 'description': 'Sucralose in solution and 30 min of active video game playing', 'interventionNames': ['Behavioral: Glucose beverage, control beverage, glucose beverage and active video game playing, control beverage and active video game playing']}], 'interventions': [{'name': 'Glucose beverage, control beverage, glucose beverage and active video game playing, control beverage and active video game playing', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Control Beverage', 'Control Beverage and active video game playing', 'Glucose Beverage', 'Glucose beverage and active video game playing']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5B 2K3', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'School of Nutrition, Ryerson University', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data will be shared upon request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Toronto Metropolitan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Nick Bellissimo', 'investigatorAffiliation': 'Toronto Metropolitan University'}}}}