Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2026-02-25 @ 9:44 PM
Study NCT ID:
NCT03693859
Status:
UNKNOWN
Last Update Posted:
2018-10-04
First Post:
2018-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Smart Gaming in Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-02', 'studyFirstSubmitDate': '2018-10-01', 'studyFirstSubmitQcDate': '2018-10-01', 'lastUpdatePostDateStruct': {'date': '2018-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight change', 'timeFrame': '52 weeks', 'description': 'Weight change maintenance of at least 5%'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'Obesity (Body Mass Index ≥ 30 kg/m2) is associated with diminished executive functioning. The primary objective of this randomized, controlled trial is to evaluate the efficacy of a behavioral weight loss program coupled with enhanced executive functioning training via serious gaming on weight loss and weight loss maintenance in adults with obesity and executive functioning deficits compared to adults undergoing standard behavioral treatment alone (N = 200). Serious gaming interventions that target the specific cognitive functions needed for weight-loss maintenance may improve long-term weight-loss success.', 'detailedDescription': 'This randomized, controlled study will evaluate the efficacy of a behavioral weight loss program coupled with enhanced executive functioning training via serious gaming (BWL+GAMING) on weight loss and maintenance in adults with obesity and executive functioning deficits compared to standard behavioral treatment alone (BWL) at two urban Philadelphia university-based clinics (PCOM \\[Philadelphia College of Osteopathic Medicine\\] and Temple University). Participants will be recruited from the community. All participants (N = 200) will complete 12 weeks of behavioral weight loss treatment. Intervention participants will also complete 30-minutes (5 days per week for 8 weeks) of a serious gaming program, which will feature online games developed specifically to enhance executive functions. The primary outcomes are weight change and weight change maintenance, which will be measured at 12 and 52 weeks, respectively. Neuropsychological testing will evaluate the proposed mechanism of action, changes in executive functioning, before and after treatment (12 and 52 weeks).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Obesity\n* Executive functioning deficits\n* Internet access\n\nExclusion Criteria:\n\n* Under 18 years of age\n* Over 65 years of age\n* Taking weight loss medication\n* Pregnant'}, 'identificationModule': {'nctId': 'NCT03693859', 'briefTitle': 'Smart Gaming in Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Philadelphia College of Osteopathic Medicine'}, 'officialTitle': 'Smart Gaming for Obesity: A Randomized Trial', 'orgStudyIdInfo': {'id': 'Lent1018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Behavioral Weight Loss + Gaming', 'description': 'Treatment will consist of 12-weekly, one-hour group sessions of approximately 15 participants per group. Participants will provide logs of serious gaming (intervention).', 'interventionNames': ['Behavioral: Cognitive enhancement program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Behavioral Weight Loss + Health Segments', 'description': 'Control participants will be asked to spend 30 minutes watching health segments online, five days per week, for 8 weeks. Participants will provide logs of video segment watching (control).', 'interventionNames': ['Behavioral: Behavioral Weight Loss + Health Segments']}], 'interventions': [{'name': 'Cognitive enhancement program', 'type': 'BEHAVIORAL', 'otherNames': ['Smart Gaming'], 'description': 'The cognitive enhancement condition (BWL+GAMING) will both teach the behavioral skills necessary for weight loss and strengthen the executive functions that underlie these skills.', 'armGroupLabels': ['Behavioral Weight Loss + Gaming']}, {'name': 'Behavioral Weight Loss + Health Segments', 'type': 'BEHAVIORAL', 'description': 'Control participants will be asked to spend 30 minutes watching health segments online, five days per week, for 8 weeks.', 'armGroupLabels': ['Behavioral Weight Loss + Health Segments']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philadelphia College of Osteopathic Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}