Ignite Creation Date:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2026-03-04 @ 10:12 PM
Study NCT ID:
NCT00623792
Status:
COMPLETED
Last Update Posted:
2016-03-17
First Post:
2008-02-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Impact of Lifestyle Change and Weight Loss Before Bariatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}, {'id': 'D015431', 'term': 'Weight Loss'}], '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'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-15', 'studyFirstSubmitDate': '2008-02-14', 'studyFirstSubmitQcDate': '2008-02-25', 'lastUpdatePostDateStruct': {'date': '2016-03-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'weight and related outcomes (BMI, cardiovascular risk, quality of life)', 'timeFrame': 'pre and post intervention'}, {'measure': 'preparation for surgery (eating, activity and knowledge of surgery)', 'timeFrame': 'pre and post intervention'}, {'measure': 'compliance and eating problems (vomiting, dumping, plugging etc.)', 'timeFrame': '6- and 12-months post surgery'}, {'measure': 'surgical complications and outpatient visits', 'timeFrame': '6- and 12-months post surgery'}], 'secondaryOutcomes': [{'measure': 'Weight/BMI trajectory', 'timeFrame': 'pre- and post-intervention; 6-, 12 and 24 months postop'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Morbid obesity', 'Diet therapy', 'Bariatric Surgery', 'Gastric bypass', 'Behavior therapy', 'Randomized controlled trial', 'Weight loss'], 'conditions': ['Severe Obesity', 'Bariatric Surgery']}, 'referencesModule': {'references': [{'pmid': '25443069', 'type': 'DERIVED', 'citation': 'Kalarchian MA, Marcus MD, Courcoulas AP, Cheng Y, Levine MD. Self-report of gastrointestinal side effects after bariatric surgery. Surg Obes Relat Dis. 2014 Nov-Dec;10(6):1202-7. doi: 10.1016/j.soard.2014.08.007. Epub 2014 Aug 23.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the trial is to determine whether a preoperative lifestyle intervention (targeting diet, exercise, and preparation for surgery) will favorably impact obesity-related parameters prior to bariatric surgery and improve short-term postoperative outcomes.', 'detailedDescription': 'This is a randomized, controlled trial to evaluate the impact of a preoperative lifestyle intervention that targets diet, exercise, and preparation for surgery as an adjunct to the surgical treatment of obesity. Patients will be randomized to a 6-month lifestyle intervention (n = 100) or to usual care (n = 100) prior to undergoing bariatric surgery. We aim to evaluate the effect of the intervention on select pre- and postoperative outcomes. We hypothesize that patients who participate in the preoperative intervention will exhibit greater improvements in weight and related outcomes and better preparation for surgery than those who receive usual care. After operation, we hypothesize that patients who participate in the intervention will exhibit better compliance and fewer behavior-related eating problems, as well as a lower rate of complications and fewer outpatient visits with surgery-related conditions than those who received usual preoperative care. Our secondary aim is to determine whether the intervention affects weight/BMI trajectory through 24 months after operation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any candidate for weight loss surgery who is at least 18 years old \\[At the University of Pittsburgh Medical Center, bariatric surgery is recommended as a treatment for individuals with Class III obesity (BMI \\> 40), or Class II obesity (BMI 35- 40) and serious obesity-related health problems\\]\n\nExclusion Criteria:\n\n* Mental retardation or psychosis\n* Previously diagnosed genetic obesity syndrome\n* Participation in a structured weight management program in the 6 months prior to study enrollment\n* Uncontrolled psychiatric symptomatology sufficiently severe to require immediate treatment\n* Pregnant or lactating in the previous 6 months\n* Taking a medication known to affect body weight such as oral steroids in the previous 6 months\n* Any previous surgery for weight loss\n* Deemed high risk surgical candidate.'}, 'identificationModule': {'nctId': 'NCT00623792', 'acronym': 'PREP', 'briefTitle': 'Study on Impact of Lifestyle Change and Weight Loss Before Bariatric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Duquesne University'}, 'officialTitle': 'Preoperative Lifestyle Intervention in Bariatric Surgery', 'orgStudyIdInfo': {'id': 'R01DK077102-01A1', 'link': 'https://reporter.nih.gov/quickSearch/R01DK077102-01A1', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01DK077102', 'link': 'https://reporter.nih.gov/quickSearch/R01DK077102', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': '1', 'description': 'Usual preoperative care'}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Preoperative Lifestyle Intervention', 'interventionNames': ['Behavioral: Preoperative lifestyle Intervention']}], 'interventions': [{'name': 'Preoperative lifestyle Intervention', 'type': 'BEHAVIORAL', 'description': '6 month individual intervention consisting of weekly face-to-face and telephone sessions addressing diet, activity and preparation for surgery, followed by 3 "booster" telephone calls after surgery', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15282', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Duquesne University', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Melissa A Kalarchian, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duquesne University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duquesne University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Melissa Kalarchian', 'investigatorAffiliation': 'Duquesne University'}}}}