Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2026-01-10 @ 8:57 PM
Study NCT ID:
NCT06480058
Status:
COMPLETED
Last Update Posted:
2024-06-28
First Post:
2024-06-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictors of Bariatric Surgery Weight Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D009767', 'term': 'Obesity, Morbid'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}], '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'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 376}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-26', 'studyFirstSubmitDate': '2024-06-19', 'studyFirstSubmitQcDate': '2024-06-26', 'lastUpdatePostDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Eating Disorder Screening', 'timeFrame': '1 Day', 'description': 'A validated SCOFF questionnaire will be self-administered to patients attending their first preoperative bariatric surgery appointment. The SCOFF questionnaire is a simple 5-question test developed to assess the possible presence of an eating disorder. The S in SCOFF stands for "sick" (to vomit). The O stands for "one stone" of weight (i.e., 6.35 kg). The letters C, F and F stand for "control", "fat" and "food" respectively. Although the SCOFF is not used for diagnostic purposes, a score of 2 or more positive answers raises the index of suspicion of eating disorders, highlighting the need for a more detailed psychological history .The SCOFF has been previously validated in Arab populations.'}], 'secondaryOutcomes': [{'measure': 'Anxiety', 'timeFrame': '1 Day', 'description': 'Kuwait University Anxiety Scale (KUAS)\n\nThe Kuwait University Anxiety Scale will be used to measure level of anxiety. The 20-item scale will capture cognitive/affective anxiety (9 items), subjective anxiety or nervousness (7 items), and somatic anxiety (4 items) \\[4\\]. Responses use a 4-point Likert scale ranging from 1=rare, 2=sometimes, 3= often, 4= always to measure the level of anxiety . The cut offs to indicate anxiety include 0 - 21 normal, 22 - 42 mild anxiety, 42 - 63 moderate anxiety, 64 - 84 severe anxiety.'}, {'measure': 'Depression', 'timeFrame': '1 Day', 'description': 'Beck Inventory\n\nPsychological screening and assessment for anxiety and depression will be carried by a clinical psychologist using a validated questionnaire. The Beck Depression inventory which includes a 21-item multiple choice self-report inventory will be used to measure depressive symptoms within the last week. Each question includes a set of 4 possible choices of how a participant may feel. Choices are scored from 0 to 3, increasing in intensity. The cut-offs to indicate depression include 0 - 9 minimal depression, 10 - 18 mild depression, 19 - 29 moderate depression, 30 - 63 severe depression.'}, {'measure': 'Obesity', 'timeFrame': '1 Day', 'description': "Height and weight will be measured using standard protocols by a qualified nurse during the patient's preoperative and post-operative appointments. Body Mass Index (BMI) will be calculated using WHO cut-off points to define obesity. Obese patients will be divided into different classes of obesity as the following: obese class I (BMI 30 - 34.9 kg/m2), obese class II (35 - 39.9 kg/m2) and obese class III (BMI \\> 40 kg/m2)."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obesity', 'Metabolic disease', 'Eating disorder', 'Mental health'], 'conditions': ['Obesity, Mild', 'Obesity, Morbid', 'Diabete Mellitus', 'Diabetes Mellitus, Type 2', 'Eating Disorders']}, 'descriptionModule': {'briefSummary': 'The aim of the observational cross-sectional study is to determine the prevalence and correlates of disordered eating among candidates for bariatric surgery in the BariPredict cohort.\n\nThe study aims to answer the following question on whether the prevalence of disordered eating is higher in individuals that are candidates of bariatric surgery compared to the general population with obesity.', 'detailedDescription': 'Participants referred to Jaber Al Ahmad Al Sabah Hospital, Hawalli, Kuwait, for bariatric surgery were consecutively screened for the study.\n\nA cross-sectional analysis was performed on a subgroup of this cohort with complete baseline data. The analysis investigates the influence of psychological factors associated with obesity before bariatric surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'A cohort of patients attending a bariatric clinic', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Obesity BMI \\> 30 kg/m2\n* 18 years and older\n\nExclusion Criteria:\n\n* BMI \\< 30 kg/m2'}, 'identificationModule': {'nctId': 'NCT06480058', 'acronym': 'BariPredict', 'briefTitle': 'Predictors of Bariatric Surgery Weight Loss', 'organization': {'class': 'OTHER', 'fullName': 'Kuwait University'}, 'officialTitle': 'Determinants of Eating Disorder Risk in Pre-intervention Bariatric Surgery Candidates.', 'orgStudyIdInfo': {'id': '2023/2323'}, 'secondaryIdInfos': [{'id': '2023/2323', 'type': 'OTHER', 'domain': 'Ministry of Health'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'P.O. Box 24923, Safa', 'city': 'Kuwait City', 'country': 'Kuwait', 'facility': 'Dana AlTarrah', 'geoPoint': {'lat': 29.367, 'lon': 47.97429}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kuwait University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dasman Diabetes Institute', 'class': 'OTHER'}, {'name': 'Jaber Al Ahmad Al Sabah Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Dana AlTarrah', 'investigatorAffiliation': 'Kuwait University'}}}}