Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-01-28 @ 3:27 PM
Study NCT ID:
NCT02978105
Status:
COMPLETED
Last Update Posted:
2018-01-24
First Post:
2016-11-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Self-conditioning Techniques in Promoting Weight Loss in Patients With Obesity. A Randomized Controlled Trial
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': 'D059039', 'term': 'Standard of Care'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D001521', 'term': 'Behavior Therapy'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-22', 'studyFirstSubmitDate': '2016-11-26', 'studyFirstSubmitQcDate': '2016-11-29', 'lastUpdatePostDateStruct': {'date': '2018-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'weight loss', 'timeFrame': '12 months after randomization'}], 'secondaryOutcomes': [{'measure': 'Change in body fat percentage', 'timeFrame': '12 months after randomization', 'description': 'Dual Energy X-Ray Absorptiometry (DEXA)'}, {'measure': 'Change in fasting glucose', 'timeFrame': '12 months after randomization'}, {'measure': 'Change in insulin circulating values', 'timeFrame': '12 months after randomization'}, {'measure': 'Change in quality of life', 'timeFrame': '12 months after randomization', 'description': 'EuroQol (EQ)-5D \\[Index and Visual Analog Scale (VAS)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '30226009', 'type': 'DERIVED', 'citation': 'Bo S, Rahimi F, Goitre I, Properzi B, Ponzo V, Regaldo G, Boschetti S, Fadda M, Ciccone G, Abbate Daga G, Mengozzi G, Evangelista A, De Francesco A, Belcastro S, Broglio F. Effects of Self-Conditioning Techniques (Self-Hypnosis) in Promoting Weight Loss in Patients with Severe Obesity: A Randomized Controlled Trial. Obesity (Silver Spring). 2018 Sep;26(9):1422-1429. doi: 10.1002/oby.22262.'}]}, 'descriptionModule': {'briefSummary': 'The investigators hypothesized that hypnosis is an alternative technique that could be applied to help patients with obesity to lose weight.\n\nThe possibility that a self-conditioning technique (self-hypnosis) added to traditional approach (diet, exercise and behavioral recommendations) will be effective in determining weight loss with respect to the traditional approach in subjects with a body mass index (BMI) between 35 and 50 kg/m2 will be studied.', 'detailedDescription': 'Obesity is a serious health concern. Most lifestyle interventions fail over time; indeed, overeating often involves loss of control and compulsive behaviors.\n\nHypnosis could increase the ability to control emotional impulses. Self-conditioning techniques borrowed from hypnosis (self-hypnosis) increase self-control and self-management of emotions. Recent hypnosis techniques with a rapid-induction phase allow the trained patients to go into self-hypnosis in a few minutes and to repeat the experience in complete autonomy, employing a short time of the day only.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to give written informed consent\n* BMI between 35 and 50 kg/m2\n* Age 20-70 years\n\nExclusion Criteria:\n\n* Current or previous mental disorders and/or on any psychotropic drug\n* Insulin treatment\n* Candidates for bariatric surgery\n* Current (or discontinued for less than 6 months) treatment with anti-obesity drugs\n* Patients at risk of heart failure, edema, ascites (heart diseases, chronic liver diseases, nephrotic syndrome, renal failure)\n* Patients with untreated or uncompensated thyroid diseases'}, 'identificationModule': {'nctId': 'NCT02978105', 'briefTitle': 'Effects of Self-conditioning Techniques in Promoting Weight Loss in Patients With Obesity. A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Turin, Italy'}, 'officialTitle': 'Effects of Self-conditioning Techniques in Promoting Weight Loss in Patients With Severe Obesity. A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'sbo2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'self-conditioning techniques plus standard care', 'interventionNames': ['Other: self-conditioning techniques', 'Other: standard care (diet, exercise and behavioral therapy)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Standard care: dietary recommendations, exercise recommendations, and behavioral recommendations', 'interventionNames': ['Other: standard care (diet, exercise and behavioral therapy)']}], 'interventions': [{'name': 'self-conditioning techniques', 'type': 'OTHER', 'description': 'Self-hypnosis to increase self-control before meals and every food compulsion episode', 'armGroupLabels': ['Experimental']}, {'name': 'standard care (diet, exercise and behavioral therapy)', 'type': 'OTHER', 'description': 'dietary recommendations, exercise recommendations, and behavioral recommendations', 'armGroupLabels': ['Control', 'Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10126', 'city': 'Turin', 'country': 'Italy', 'facility': 'Città della Salute e della Scienza di Torino', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}], 'overallOfficials': [{'name': 'Simona Bo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Turin, Italy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Turin, Italy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Simona Bo', 'investigatorAffiliation': 'University of Turin, Italy'}}}}