Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2025-12-27 @ 3:57 AM
Study NCT ID:
NCT01202292
Status:
UNKNOWN
Last Update Posted:
2010-10-01
First Post:
2010-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Group Motivational Intervention in Overweight/Obese Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'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': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-09-30', 'studyFirstSubmitDate': '2010-05-31', 'studyFirstSubmitQcDate': '2010-09-14', 'lastUpdatePostDateStruct': {'date': '2010-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine whether a group motivational intervention, is more efficient than the latter in the treatment of overweight and obesity, for initial weight loss and essentially to achieve sustained normalisation of the weight achieved.', 'timeFrame': '26 months'}], 'secondaryOutcomes': [{'measure': 'Observe whether this intervention is more effective for reducing cardiovascular risk factors associated to overweight and obesity, and in the overall cardiovascular risk in these patients.', 'timeFrame': '26 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['overweight', 'obesity', 'motivational intervention'], 'conditions': ['Overweight', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '20298557', 'type': 'BACKGROUND', 'citation': 'Rodriguez Cristobal JJ, Panisello Royo JM, Alonso-Villaverde Grote C, Perez Santos JM, Munoz Lloret A, Rodriguez Cortes F, Trave Mercade P, Benavides Marquez F, Marti de la Morena P, Gonzalez Burgillos MJ, Delclos Baulies M, Bleda Fernandez D, Quillama Torres E; IMOAP Group. Group motivational intervention in overweight/obese patients in primary prevention of cardiovascular disease in the primary healthcare area. BMC Fam Pract. 2010 Mar 18;11:23. doi: 10.1186/1471-2296-11-23.'}]}, 'descriptionModule': {'briefSummary': "The overall goal of IMOAP study is to assess whether the efficacy of the healthcare professionals' usual practices, together with a motivational group intervention (delivered by a nurse trained by an expert psychologist), is more effective than an isolated traditional intervention on weight loss and its maintenance in overweight and obese patients. Furthermore, the study will evaluate whether this result has a positive impact on quality of life, changes in eating habits, and a reduction in the associated cardiovascular risk factors and overall cardiovascular risk.", 'detailedDescription': 'The global mortality caused by cardiovascular disease increases with weight. The Framingham study showed that obesity is a cardiovascular risk factor independent of other risks such as type 2 diabetes mellitus, dyslipidemia and smoking. Moreover, the main problem in the management of weight-loss is its maintenance, if it is achieved. We have designed a study in two geographically separated groups, one of which would receive the group motivational intervention, and the other one would receive the usual follow up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Overweight (BMI\\>25) and obese (BMI\\>30) patients of both sexes, registered in the medical history (MH) or newly diagnosed.\n2. Aged between 30 and 70 years\n3. Agreement to participate in the study\n\nExclusion Criteria:\n\n1. Patients with severe clinical pathology (bedridden, dementia, advanced neoplasia, etc.)\n2. Patients with secondary obesity (hypothyroidism, Cushing's disease, etc)\n3. Patients with severe sensorial disorders capable of interfering with the motivational intervention (severe, uncorrected deafness, severe visual deficit, etc).\n4. Patients with serious psychiatric disorders"}, 'identificationModule': {'nctId': 'NCT01202292', 'acronym': 'IMOAP', 'briefTitle': 'Group Motivational Intervention in Overweight/Obese Patients.', 'organization': {'class': 'OTHER', 'fullName': "Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina"}, 'officialTitle': 'Group Motivational Intervention in Overweight/Obese Patients in Primary Prevention of Cardiovascular Disease in the Primary Healthcare Area.', 'orgStudyIdInfo': {'id': 'PI 070087'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lifestyle counseling', 'interventionNames': ['Behavioral: Behavioral (e.g., Psychotherapy, Lifestyle Counseling)']}], 'interventions': [{'name': 'Behavioral (e.g., Psychotherapy, Lifestyle Counseling)', 'type': 'BEHAVIORAL', 'otherNames': ['Control group receives the usual follow up: diet, exercise'], 'description': 'Group motivational intervention consist in expert psychologist 32 monthly sessions (group intervention) on top of the diet plus exercise', 'armGroupLabels': ['Lifestyle counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08095', 'city': "L'Hospitalet Del Llobregat", 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Juan José Rodriguez-Cristóbal, Dr', 'role': 'CONTACT', 'email': '21002jrc@comb.es', 'phone': '934471080'}, {'name': 'Juan José Rodriguez Cristóbal, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'ABS Florida Sud'}], 'centralContacts': [{'name': 'Juan Jose Rodriguez-Cristóbal, Dr', 'role': 'CONTACT', 'email': '21002jrc@comb.es', 'phone': '0034934471080'}], 'overallOfficials': [{'name': 'Juan José Roodriguez-Cristóbal, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Catalan Institute of Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina", 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Juan José Rodriguez Cristóbal', 'oldOrganization': 'ABS FLORIDA SUR'}}}}