Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:11 PM
Study NCT ID:
NCT01403558
Status:
COMPLETED
Last Update Posted:
2020-04-20
First Post:
2011-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Personality and Eating Behaviors in Morbidly Obese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D000342', 'term': 'Affective Symptoms'}], 'ancestors': [{'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-15', 'studyFirstSubmitDate': '2011-06-07', 'studyFirstSubmitQcDate': '2011-07-26', 'lastUpdatePostDateStruct': {'date': '2020-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Health related quality of life - impact of weight on quality of life (IWQOL-lite)', 'timeFrame': '1 and 4 years after surgery', 'description': 'Health related quality of life - impact of weight on quality of life (IWQOL-lite) is a 31-item questionnaire'}], 'primaryOutcomes': [{'measure': 'Change Eating behaviours', 'timeFrame': 'This co-primary outcome will be assessed, first, one week before the start of the 10 weeks intervention, and second, 1 week after the termination of the 10-weeks intervention. In addition a 1 and 4 year follow-up have been performed', 'description': 'Eating behaviors: We will assess emotional eating, uncontrolled eating and Primary outcomes will be scored on the subscales "emotional eating" and "uncontrolled eating" on the TFEQ-R21. The predetermined criterion for clinically important improvement at 12 weeks will be a decrease of 15% from baseline on the emotional eating and uncontrolled eating subscale (range 0 to 100)'}, {'measure': 'Change Affective symptoms', 'timeFrame': 'This co-primary outcome will be assessed, first, one week before the start of the 10 weeks intervention, and second, 1 week after the termination of the 10-weeks intervention. In addition a 1 and 4 year follow-up have been performed', 'description': 'Affective symptoms will be assessed With the HADS'}], 'secondaryOutcomes': [{'measure': 'Body weight - digital scale', 'timeFrame': 'As for primary outcome', 'description': 'Body weight - digital scale (Soehnle Professional 2755)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Eating Behaviors', 'Affective Symptoms']}, 'referencesModule': {'references': [{'pmid': '30112603', 'type': 'DERIVED', 'citation': 'Hjelmesaeth J, Rosenvinge JH, Gade H, Friborg O. Effects of Cognitive Behavioral Therapy on Eating Behaviors, Affective Symptoms, and Weight Loss After Bariatric Surgery: a Randomized Clinical Trial. Obes Surg. 2019 Jan;29(1):61-69. doi: 10.1007/s11695-018-3471-x.'}, {'pmid': '25893651', 'type': 'DERIVED', 'citation': 'Gade H, Friborg O, Rosenvinge JH, Smastuen MC, Hjelmesaeth J. The Impact of a Preoperative Cognitive Behavioural Therapy (CBT) on Dysfunctional Eating Behaviours, Affective Symptoms and Body Weight 1 Year after Bariatric Surgery: A Randomised Controlled Trial. Obes Surg. 2015 Nov;25(11):2112-9. doi: 10.1007/s11695-015-1673-z.'}, {'pmid': '25147733', 'type': 'DERIVED', 'citation': 'Gade H, Hjelmesaeth J, Rosenvinge JH, Friborg O. Effectiveness of a cognitive behavioral therapy for dysfunctional eating among patients admitted for bariatric surgery: a randomized controlled trial. J Obes. 2014;2014:127936. doi: 10.1155/2014/127936. Epub 2014 Jul 21.'}, {'pmid': '24685661', 'type': 'DERIVED', 'citation': 'Gade H, Rosenvinge JH, Hjelmesaeth J, Friborg O. Psychological correlates to dysfunctional eating patterns among morbidly obese patients accepted for bariatric surgery. Obes Facts. 2014;7(2):111-9. doi: 10.1159/000362257. Epub 2014 Mar 29.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this randomized controlled trial is assess the effect of a psychological based treatment model on eating behaviors and motivation for lifestyle changes in morbidly obese patients undergoing bariatric surgery.\n\nHypothesis: As compared with usual care, Cognitive Behavioral Therapy and Motivational interviewing-based (CBT/MI) intervention program will reduce dysfunctional eating behaviors and increase pre-surgical intrinsic motivation for lifestyle changes.', 'detailedDescription': 'Obesity is usually treated as a medical disease, prescribing interventions which adhere to the theoretically sound principles.The prevalence of obesity is increasing, and, accordingly, an increasing number of morbidly obese patients are eligible for Bariatric Surgery. This surgical procedure is highly effective and is often followed by resolution or remission of obesity related comorbidities (e.g. diabetes and obstructive sleep apnea). However, some individuals may have psychological and motivational problems that reduce these beneficial effects. Bariatric surgery represents a substantial part of total health care costs, and such costs may increase in the future. Another issue is that it is important to prevent post-surgical relapses. Hence, there is every reason to increase the effect and efficacy of both conservative treatments and bariatric surgery.\n\nClinically the investigators meet patients who regain their weight post-surgically, and the investigators have some experience that these patients may display more dysfunctional eating than those who are able to maintain a lower target weight. Given the expected outcome of the RCT, the autonomous motivation for lifestyle changes will be increased. Lowering dysfunctional eating, as well as increasing the probability of better success in preoperative weight loss, may help the patient to maintain a healthier weight after the surgical procedure. Moreover, developing a more tailored intervention for surgery patients may enable new evidence based treatments to be established for these patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have been accepted for bariatric surgery\n\nExclusion Criteria:\n\n* Patients suffering from drug and/or alcohol addiction.'}, 'identificationModule': {'nctId': 'NCT01403558', 'acronym': 'PSYMO', 'briefTitle': 'Personality and Eating Behaviors in Morbidly Obese Patients', 'organization': {'class': 'OTHER', 'fullName': 'Sykehuset i Vestfold HF'}, 'officialTitle': 'Personality and Eating Behaviors in Morbidly Obese Patients', 'orgStudyIdInfo': {'id': '2010/2071a'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive behavioral therapy', 'description': 'Ten weekly individual cognitive behavioral therapy sessions before bariatric surgery', 'interventionNames': ['Behavioral: Cognitive behavioral therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Usual preoperative care consisting of up to three voluntary sessions with nutritionist and physiotherapist before bariatric surgery'}], 'interventions': [{'name': 'Cognitive behavioral therapy', 'type': 'BEHAVIORAL', 'description': 'Cognitive behavioral therapy', 'armGroupLabels': ['Cognitive behavioral therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3103', 'city': 'Tønsberg', 'state': 'Vestfold', 'country': 'Norway', 'facility': 'Hege Gade', 'geoPoint': {'lat': 59.26754, 'lon': 10.40762}}, {'zip': '3103', 'city': 'Tønsberg', 'country': 'Norway', 'facility': 'Senter for sykelig overvekt i Helse Sør-Øst, Sykehuset i Vestfold', 'geoPoint': {'lat': 59.26754, 'lon': 10.40762}}], 'overallOfficials': [{'name': 'Jøran Hjelmesæth, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sykehuset i Vestfold HF', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Tromso', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD student', 'investigatorFullName': 'Hege Gade', 'investigatorAffiliation': 'Sykehuset i Vestfold HF'}}}}