Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2026-02-26 @ 7:49 PM
Study NCT ID:
NCT04187066
Status:
COMPLETED
Last Update Posted:
2024-12-09
First Post:
2019-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Goal-directed and Cue-dependent Behavior in Severe Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D006184', 'term': 'Habits'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-04', 'studyFirstSubmitDate': '2019-11-26', 'studyFirstSubmitQcDate': '2019-12-02', 'lastUpdatePostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in food choice behavior due to substantial weight loss by bariatric surgery', 'timeFrame': 'pre bariatric surgery, 1 month after bariatric surgery, 6 months after bariatric surgery', 'description': 'changes in cue-dependent and goal-directed food choices assessed by the Pavlovian-to-instrumental transfer task'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Eating Behavior', 'Habits', 'Obesity']}, 'descriptionModule': {'briefSummary': 'The current proposal aims to investigate implicit and explicit priming paradigms for changing cue-dependent and goal-directed nutritional behavior in participants with severe obesity before and after bariatric surgery as well as in a control group with normal weight.', 'detailedDescription': 'Food choice and intake is a daily and throughout normal subject. However, for more and more people eating habits and the question of food choice are of increasing interest and in several cases even a problem. The prevalence of obesity has tripled in the last decades and it is even spoken of an obesity epidemic. Life style interventions to lose weight often fail on the long run, also because people fall back into former unhealthy eating habits. Bariatric surgery is a very effective procedure to reduce weight fundamentally.\n\nVarious factors influence our daily food choice, not all of which are apparent to ourselves. Thus, food choice might be goal-directed and therefore conscious and reflective, yet in other circumstances the choice to eat something specific might be based on cue dependent processes which are automatic and thus difficult to control. The aim of the current study is to investigate cue-dependent and goal-directed nutritional behavior as well as the effect of a health mindset induction in severe obesity as well as changes in such behaviors due to bariatric surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* experimental: severe obesity who might get a bariatric surgery\n* control: normal weight', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* experimental: severe obesity\n* control: normal weight\n\nExclusion Criteria:\n\n* impaired cognitive functions, which might conflict with the task\n* appropriate German'}, 'identificationModule': {'nctId': 'NCT04187066', 'acronym': 'PIT_BS', 'briefTitle': 'Goal-directed and Cue-dependent Behavior in Severe Obesity', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'Goal-directed and Cue-dependent Behavior in Severe Obesity', 'orgStudyIdInfo': {'id': 'PIT_BS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Obese', 'description': 'severe obesity', 'interventionNames': ['Behavioral: mindset induction']}, {'label': 'Control', 'description': 'Control group with normal weight', 'interventionNames': ['Behavioral: mindset induction']}], 'interventions': [{'name': 'mindset induction', 'type': 'BEHAVIORAL', 'description': 'induction of a health mindset to measure changes in cue-dependent and goal-directed behavior', 'armGroupLabels': ['Control', 'Obese']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'University Clinic of Tuebingen, fMEG Center', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Reserach Associate', 'investigatorFullName': 'Sabine Frank', 'investigatorAffiliation': 'University Hospital Tuebingen'}}}}