Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-29 @ 11:05 PM
Study NCT ID:
NCT01606904
Status:
COMPLETED
Last Update Posted:
2018-05-11
First Post:
2012-05-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of CBT- Based Weight Loss Program on Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D006937', 'term': 'Hypercholesterolemia'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D059445', 'term': 'Anhedonia'}], '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': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-04', 'studyFirstSubmitDate': '2012-05-21', 'studyFirstSubmitQcDate': '2012-05-23', 'lastUpdatePostDateStruct': {'date': '2018-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-05-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in weight', 'timeFrame': 'baseline, 9 months, 1,2 and 3 years', 'description': 'kilograms'}], 'secondaryOutcomes': [{'measure': 'change in eating behavior', 'timeFrame': 'baseline, 9 months, 1,2 and 3 years', 'description': 'emotional eating, uncontrolled eating, cognitive restraint, binge eating symptoms'}, {'measure': 'change in total cholesterol,HDL, LDL,Trigly and glucose', 'timeFrame': 'baseline, 1,2 and 3 years', 'description': 'change in laboratory values'}, {'measure': 'DNA', 'timeFrame': 'baseline', 'description': 'for genetic analyses'}, {'measure': 'change in incretins', 'timeFrame': 'baseline, 12, 24 and 36 months', 'description': 'change in incretins'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obesity', 'Hypercholesterolemia', 'Diabetes Mellitus, Type 2', 'Anhedonia']}, 'referencesModule': {'references': [{'pmid': '19406146', 'type': 'BACKGROUND', 'citation': 'Keranen AM, Savolainen MJ, Reponen AH, Kujari ML, Lindeman SM, Bloigu RS, Laitinen JH. The effect of eating behavior on weight loss and maintenance during a lifestyle intervention. Prev Med. 2009 Aug;49(1):32-8. doi: 10.1016/j.ypmed.2009.04.011. Epub 2009 May 4.'}, {'pmid': '20955744', 'type': 'BACKGROUND', 'citation': 'Keranen AM, Strengell K, Savolainen MJ, Laitinen JH. Effect of weight loss intervention on the association between eating behaviour measured by TFEQ-18 and dietary intake in adults. Appetite. 2011 Feb;56(1):156-62. doi: 10.1016/j.appet.2010.10.004. Epub 2010 Oct 16.'}, {'pmid': '20801180', 'type': 'BACKGROUND', 'citation': 'Keranen AM, Rasinaho E, Hakko H, Savolainen M, Lindeman S. Eating behavior in obese and overweight persons with and without anhedonia. Appetite. 2010 Dec;55(3):726-9. doi: 10.1016/j.appet.2010.08.012. Epub 2010 Aug 27.'}]}, 'descriptionModule': {'briefSummary': 'The investigators purpose is to study how CBT (cognitive behavioral therapy)-based weight loss program affects on eating behavior, weight loss and risk factors for CHD (coronary heart diseases)and type 2 diabetes. Moreover, the investigators aim is to recognize subjects suffering from anhedonia (one of the core symptoms of depression, lack of pleasure) and follow how they benefit from the program in order to achieve maintained weight loss. Also, the associations between weight loss, physical activity and musculoskeletal disorders are studied.', 'detailedDescription': 'Obesity is an increasing problem and effective weight loss methods are needed. The study is randomized follow-up study with 9 months intervention and three (3) years follow-up period. The study is organized in Oulu University Hospital, Department of Internal Medicine. Eighty (80)obese, 20-65 years, study subjects will be randomized into intervention or control group.\n\nThe hypothesis of the CognObe study is: CBT (cognitive behavioral therapy)-based weight loss program is successful in sustained and favourable change in eating behavior and weight as well as decreased risk for coronary heart diseases or type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\> 30\n\nExclusion Criteria:\n\n* other concurrent weight loss programs\n* disease which prevents weight loss\n* medication which affects on weight loss'}, 'identificationModule': {'nctId': 'NCT01606904', 'acronym': 'CognObe', 'briefTitle': 'The Effect of CBT- Based Weight Loss Program on Obesity', 'organization': {'class': 'OTHER', 'fullName': 'University of Oulu'}, 'officialTitle': 'The Effect of CBT- Based Weight Loss Program on Eating Behavior, Weight Loss Result and Risk for Coronary Heart Diseases and Type 2 Diabetes', 'orgStudyIdInfo': {'id': '58/2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Weight loss counseling', 'description': 'Cognitive behavioral therapy - based weight loss program', 'interventionNames': ['Behavioral: Cognitive behavioral therapy -based weight loss program']}, {'type': 'OTHER', 'label': 'Control', 'description': 'Short term weight loss counseling, control group', 'interventionNames': ['Behavioral: Cognitive behavioral therapy -based weight loss program']}], 'interventions': [{'name': 'Cognitive behavioral therapy -based weight loss program', 'type': 'BEHAVIORAL', 'description': 'CBT-based program includes 20 group visits', 'armGroupLabels': ['Control', 'Weight loss counseling']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Oulu', 'country': 'Finland', 'facility': 'Deparment of Internal Medicine, Oulu University Hospital', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}], 'overallOfficials': [{'name': 'Anna-Maria Teeriniemi (nee Keränen)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oulun University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oulu', 'class': 'OTHER'}, 'collaborators': [{'name': 'Juho Vainio Foundation', 'class': 'OTHER'}, {'name': 'Yrjo Jahnsson Foundation', 'class': 'OTHER'}, {'name': 'Oulu University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'P.h.D, clinical nutritionist', 'investigatorFullName': 'Anna-Maria Keränen', 'investigatorAffiliation': 'University of Oulu'}}}}