Ignite Creation Date:
2025-12-24 @ 9:50 PM
Ignite Modification Date:
2026-02-27 @ 8:27 AM
Study NCT ID:
NCT03735732
Status:
COMPLETED
Last Update Posted:
2024-12-05
First Post:
2018-07-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuronal Correlates of Priming on Goal-directed and Cue-dependent Behavior
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006184', 'term': 'Habits'}, {'id': 'D005247', 'term': 'Feeding Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001522', 'term': 'Behavior, Animal'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C035382', 'term': 'PRIME protocol'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-04', 'studyFirstSubmitDate': '2018-07-18', 'studyFirstSubmitQcDate': '2018-11-07', 'lastUpdatePostDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in neuronal correlates', 'timeFrame': 'before and 5 minutes after visually presented food items', 'description': 'Change of BOLD response measured by fMRI'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Functional Magnetic Resonance Imaging', 'Habits', 'Eating Behavior']}, 'descriptionModule': {'briefSummary': 'The current proposal aims to investigate neuronal correlates of implicit and explicit priming paradigms for changing cue-dependent and goal-directed nutritional behavior.', '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. Various 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. Since a change in eating-behavior and long-lasting weight loss is most problematic to achieve, the current proposal aims to investigate neuronal correlates of implicit and explicit priming paradigms for changing cue-dependent and goal-directed nutritional behavior.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'healthy lean and obese volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* experimental: participants with obesity\n* control: participants with normal-weight\n\nExclusion Criteria:\n\n* currently dieting\n* intolerance to provided food\n* cognitive impairment\n* contraindications for fMRI measurements'}, 'identificationModule': {'nctId': 'NCT03735732', 'briefTitle': 'Neuronal Correlates of Priming on Goal-directed and Cue-dependent Behavior', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'Neuronal Correlates of Priming on Goal-directed and Cue-dependent Behavior', 'orgStudyIdInfo': {'id': 'PIT_brain'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'weight status'}, {'label': 'mindset', 'interventionNames': ['Behavioral: prime']}], 'interventions': [{'name': 'prime', 'type': 'BEHAVIORAL', 'description': 'groups be confronted with health or palatability aspects of food items', 'armGroupLabels': ['mindset']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tübingen', 'country': 'Germany', 'facility': 'University of Tübingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Associate', 'investigatorFullName': 'Sabine Frank', 'investigatorAffiliation': 'University Hospital Tuebingen'}}}}