Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-02-19 @ 8:40 AM
Study NCT ID:
NCT02124993
Status:
COMPLETED
Last Update Posted:
2016-01-11
First Post:
2014-04-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Sleeve Gastrectomy on Food Preference
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-07', 'studyFirstSubmitDate': '2014-04-22', 'studyFirstSubmitQcDate': '2014-04-24', 'lastUpdatePostDateStruct': {'date': '2016-01-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participants food preferences before sleeve gastrectomy surgery and after surgery.', 'timeFrame': 'Change from Baseline in preferences after follow-up six weeks', 'description': 'A list of food items are on a questionnaire asking food preferences, Breads, Cereals, Grain products, Fruits and Juices, Fats and oils, Milk, etc. which allows the subjects to select their food preferences before and after the surgery.'}], 'secondaryOutcomes': [{'measure': 'Participants weight change before sleeve gastrectomy surgery and after surgery focusing on specific macronutrient.', 'timeFrame': 'Change from Baseline in weight after follow-up six weeks', 'description': 'A participant is weighted at baseline visit and follow-up visit 6 weeks after the surgery.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Gastrectomy'], 'conditions': ['Severe Obesity']}, 'descriptionModule': {'briefSummary': 'This is a questionnaire asking about the sleeve gastrectomy surgery and how has it altered food preferences before and after surgery.', 'detailedDescription': "Participants that will undergo the sleeve gastrectomy surgery by Dr. Drake Bellanger's, will be asked to participant in a questionnaire survey. Once given the consent to participate, a food preference questionnaire (FPQ) will be administered at a pre-operative visit and then a six-week follow up visit at Dr. Drake Bellanger's office."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Dr. Drake Bellanger sleeve gastrectomy surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or Female, 18 years or over, who will undergo a sleeve gastrectomy for obesity by Dr. Drake Bellanger.\n\nExclusion Criteria:\n\n* Women who are pregnant or nursing.'}, 'identificationModule': {'nctId': 'NCT02124993', 'acronym': 'FPQ', 'briefTitle': 'The Effect of Sleeve Gastrectomy on Food Preference', 'organization': {'class': 'OTHER', 'fullName': 'Pennington Biomedical Research Center'}, 'officialTitle': 'The Effect of Sleeve Gastrectomy on Food Preference', 'orgStudyIdInfo': {'id': 'PBRC 13029'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sleeve gastrectomy surgery Participants', 'description': 'Male or female who will undergo a sleeve gastrectomy for obesity by Dr. Drake Bellanger.', 'interventionNames': ['Other: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'otherNames': ['Food Preference questionnaire (FPQ)'], 'description': "Dr. Ballanger's office will administer a FPQ upon approval of an informed consent. Subjects will be asked to complete the questionnaire at a pre-operative visit and six weeks post-operatively.", 'armGroupLabels': ['Sleeve gastrectomy surgery Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70817', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Dr. Drake Bellanger', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}], 'overallOfficials': [{'name': 'Frank Greenway, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pennington Biomedical Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pennington Biomedical Research Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Frank Greenway', 'investigatorAffiliation': 'Pennington Biomedical Research Center'}}}}