Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2025-12-29 @ 7:57 AM
Study NCT ID:
NCT00294268
Status:
COMPLETED
Last Update Posted:
2008-07-03
First Post:
2006-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Behavioural Therapy for Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], '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'}]}, '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-07', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-07-01', 'studyFirstSubmitDate': '2006-02-16', 'studyFirstSubmitQcDate': '2006-02-16', 'lastUpdatePostDateStruct': {'date': '2008-07-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight', 'timeFrame': 'baseline, post-treatment, one-year follow-up'}], 'secondaryOutcomes': [{'measure': 'obesity-specific quality of life, mood disturbance, eating disturbance, cognitive disturbance', 'timeFrame': 'baseline, post-treatment, one-year follow-up'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['obesity', 'CBT', 'motivational enhancement therapy', 'weight loss maintenance'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effectiveness of a cognitive behavioural treatment (CBT) designed to help obese patients lose weight and to maintain their weight losses over time. It is hypothesized that CBT will result in greater sustained weight loss.', 'detailedDescription': 'The primary aim of the present study is to improve the maintenance of weight loss, and hence the physical, psychological and social well-being, of obese patients who have sought weight loss treatment. To do so, it will implement a cognitive-behavioural treatment (CBT) with motivational enhancement strategies specifically designed to target weight maintenance. It is hypothesized that the maintenance-oriented CBT approach will result in sustained weight loss, as well as improved physical, psychological and social well-being.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The participants will be recruited from among patients referred to the Metabolism and Obesity Service of Royal Prince Alfred Hospital.\n* The inclusion criteria include: 18-65 years of age and a body mass index (BMI: kg/m2) between 30-45.\n\nExclusion Criteria:\n\n* psychiatric conditions (i.e., current psychosis, severe depression, mental retardation, and drug or alcohol abuse)\n* or physical conditions (i.e., significant hepatic or renal dysfunction and significant cardiovascular disease such as heart failure, stroke and transient ischaemic attacks) that would preclude full participation in the study;\n* current treatment for obesity;\n* current treatments known to affect eating or weight (e.g., medications);\n* pregnancy.'}, 'identificationModule': {'nctId': 'NCT00294268', 'briefTitle': 'Cognitive Behavioural Therapy for Obesity', 'organization': {'class': 'OTHER', 'fullName': 'University of Sydney'}, 'officialTitle': 'A Maintenance-Oriented Cognitive Behavioural Therapy in the Treatment of Obesity', 'orgStudyIdInfo': {'id': 'erie8202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'description': '20 weekly sessions of CBT integrated with motivational enhancement strategies', 'interventionNames': ['Behavioral: cognitive behavioural therapy']}], 'interventions': [{'name': 'cognitive behavioural therapy', 'type': 'BEHAVIORAL', 'description': '20 weekly sessions of CBT integrated with motivational enhancement strategies', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2050', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Metabolism and Obesity Services, Royal Prince Alfred Hospital', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}], 'overallOfficials': [{'name': 'Elizabeth Rieger, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sydney'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sydney', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr Elizabeth Rieger', 'oldOrganization': 'University of Sydney'}}}}