Ignite Creation Date:
2025-12-24 @ 2:20 PM
Ignite Modification Date:
2026-03-07 @ 10:55 PM
Study NCT ID:
NCT02431195
Status:
COMPLETED
Last Update Posted:
2019-06-19
First Post:
2015-03-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of Changes in Eating Habits on Post Bariatric Surgery Patients and Their Family Members
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D005247', 'term': 'Feeding Behavior'}], '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': 'D001519', 'term': 'Behavior'}, {'id': 'D001522', 'term': 'Behavior, Animal'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-18', 'studyFirstSubmitDate': '2015-03-17', 'studyFirstSubmitQcDate': '2015-04-27', 'lastUpdatePostDateStruct': {'date': '2019-06-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes from baseline in different eating habits and culinary items in responses to questionnaires', 'timeFrame': 'At 3 month, 6 month and 12 month', 'description': "Changes from baseline in different eating habits and culinary items in responses to questionnaires at 3 months, 6 months and 1 year after bariatric surgery. It is expected that patient's feeding practice should be in accordance with the postsurgical dietary guidelines."}], 'secondaryOutcomes': [{'measure': 'Changes from baseline in different items about physical activity in responses to questionnaires', 'timeFrame': 'At 3 month, 6 month and 12 month', 'description': "Changes from baseline in different items about physical activity in responses to questionnaires at 3 months, 6 months and 1 year after bariatric surgery. It is expected that patient's physical activity practice should be in accordance with the postsurgical guidelines."}, {'measure': 'Quality of life measured by scores', 'timeFrame': 'At baseline, 3 month, 6 month and 12 month', 'description': 'Quality of life will be measured by scores at baseline, 3 month, 6 month and 12 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['obesity', 'bariatric surgery', 'physical activity', 'eating habits'], 'conditions': ['Obesity', 'Bariatric Surgery']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to identify changes in eating behaviors and physical activity in patients after bariatric surgery and their family members living in same household: children aged between 11-17 years, spouse, parents, cohabitee or partner in a civil union.', 'detailedDescription': 'As secondary objectives, the study aims to:\n\n* Describe the sociodemographic and clinical characteristics of post bariatric surgery patients.\n* Assess changes in quality of life of the post-surgery patients.\n* Explain changes of post-surgery in eating behavior and activity varied according to gender\n* Explain changes of post-surgery in eating behavior and activity varied according to socio-economic conditions\n* Explain changes of post-surgery in eating behavior and activity varied according to inter-generational relation\n* Have a overview on the surgery as a turning point in the life of patients\n* Estimate the relevant message of cares given to patients, in order to better adjust medical intervention, in conjunction with patients and their family members.\n\nThis is a prospective observational study. It will be performed in two university hospitals: CHU Ambroise Paré at Boulogne-Billancourt city and CHU Pitié Salpétrière at Paris, in nutrition department and metabolic surgery department. The study will involve collaboration of a team of social researchers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who will undergo bariatric surgery (bypass or sleeve) and live together with their families.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged ≥ 18 years\n* Eligible to undergo bariatric surgery\n* Post bariatric surgery follow-up visits will take place in the nutrition department\n* Living together with family member (children aged 11-17 years, parents, spouse, cohabitee or partner in civil union)\n* Informed consent signed\n\nExclusion Criteria:\n\n* Higher-order cognitive disorders\n* Language difficulties in understanding\n* Living alone or living without any family member'}, 'identificationModule': {'nctId': 'NCT02431195', 'acronym': 'SOCIOB', 'briefTitle': 'Analysis of Changes in Eating Habits on Post Bariatric Surgery Patients and Their Family Members', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Analysis of Changes in Eating Behaviors and Physical Activity on Post Bariatric Surgery Patients and Their Family Members : Comparison Between Men and Women', 'orgStudyIdInfo': {'id': '13SCW-SOCIOB'}}, 'contactsLocationsModule': {'locations': [{'zip': '92100', 'city': 'Boulogne-Billancourt', 'state': 'Hauts Des Seine', 'country': 'France', 'facility': 'Department of Nutrition, CHU Ambroise Paré', 'geoPoint': {'lat': 48.83545, 'lon': 2.24128}}], 'overallOfficials': [{'name': 'Sébastien Czernichow, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Ambroise Paré'}, {'name': 'Kàtia Lurbe-Puerto, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CHU Ambroise Paré'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}