Ignite Creation Date:
2025-12-24 @ 12:07 PM
Ignite Modification Date:
2026-01-02 @ 1:29 PM
Study NCT ID:
NCT02102061
Status:
UNKNOWN
Last Update Posted:
2016-05-04
First Post:
2014-03-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Health and Wellness in Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'lastUpdateSubmitDate': '2016-05-02', 'studyFirstSubmitDate': '2014-03-28', 'studyFirstSubmitQcDate': '2014-04-01', 'lastUpdatePostDateStruct': {'date': '2016-05-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'quality of life', 'timeFrame': '12 months', 'description': 'will be assessed by quantitative and qualitative research methods'}], 'secondaryOutcomes': [{'measure': 'physical capacity', 'timeFrame': '12 months', 'description': 'will be assessed by an incremental maximal test'}, {'measure': 'body composition', 'timeFrame': '12 months'}, {'measure': 'food pattern and intake', 'timeFrame': '12 months', 'description': 'will be assessed by quantitative and qualitative research methods'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['overweight', 'exercise', 'nutrition', 'philosophy'], 'conditions': ['Obesity', 'Overweight']}, 'referencesModule': {'references': [{'pmid': '30940423', 'type': 'DERIVED', 'citation': 'Sabatini F, Ulian MD, Perez I, Pinto AJ, Vessoni A, Aburad L, Benatti FB, Lopes de Campos-Ferraz P, Coelho D, de Morais Sato P, Roble OJ, Unsain RF, Schuster RC, Gualano B, Scagliusi FB. Eating Pleasure in a Sample of Obese Brazilian Women: A Qualitative Report of an Interdisciplinary Intervention Based on the Health at Every Size Approach. J Acad Nutr Diet. 2019 Sep;119(9):1470-1482. doi: 10.1016/j.jand.2019.01.006. Epub 2019 Mar 30.'}, {'pmid': '29214922', 'type': 'DERIVED', 'citation': 'Ulian MD, Gualano B, Benatti FB, de Campos-Ferraz PL, Coelho D, Roble OJ, Sabatini F, Perez I, Aburad L, Pinto AJ, Vessoni A, Victor JC, Lima VK, Unsain RF, de Morais Sato P, Rogero MM, Toporcov TN, Scagliusi FB. The design and rationale of an interdisciplinary, non-prescriptive, and Health at Every Size(R)-based clinical trial: The "Health and Wellness in Obesity" study. Nutr Health. 2017 Dec;23(4):261-270. doi: 10.1177/0260106017731260.'}, {'pmid': '26579524', 'type': 'DERIVED', 'citation': 'Ulian MD, Benatti FB, de Campos-Ferraz PL, Roble OJ, Unsain RF, de Morais Sato P, Brito BC, Murakawa KA, Modesto BT, Aburad L, Bertuzzi R, Lancha AH Jr, Gualano B, Scagliusi FB. The Effects of a "Health at Every Size((R))"-Based Approach in Obese Women: A Pilot-Trial of the "Health and Wellness in Obesity" Study. Front Nutr. 2015 Oct 27;2:34. doi: 10.3389/fnut.2015.00034. eCollection 2015.'}]}, 'descriptionModule': {'briefSummary': 'The present study aims to explore the effects of a novel multidisciplinary non-pharmacological intervention designed to improve health parameters and well-being in overweight and obese women. The proposed program is health- and quality of life-oriented, without a focus on weight loss, following the philosophical principles from "Health at Every Size", and may provide an alternative mode of intervention to the traditional one, which is focused on the concept of "weight loss at any cost". To evaluate the efficacy of the intervention, a mixed-method design combining both qualitative and quantitative assessments will be applied.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* overweight (BMI \\> 25 kg/m²)\n* without using "anti-obesity" drugs\n* not engaged in other interventions to control weight\n\nExclusion Criteria:\n\n* BMI \\< 25 kg/m²\n* under pharmacological treatment\n* under any type of intervention to control weight\n* inability to exercise'}, 'identificationModule': {'nctId': 'NCT02102061', 'briefTitle': 'Health and Wellness in Obesity', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Health and Wellness in Obesity: Exploring the Efficacy of a New Multidisciplinary Intervention', 'orgStudyIdInfo': {'id': 'Health and Wellness in Obesity'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'multidisciplinary intervention', 'interventionNames': ['Other: multidisciplinary intervention']}, {'type': 'NO_INTERVENTION', 'label': 'control'}], 'interventions': [{'name': 'multidisciplinary intervention', 'type': 'OTHER', 'description': 'a health- and quality of life-oriented program comprising exercise, nutrition advices, and philosophy meetings, without a focus on weight loss, following the philosophical principles from "Health at Every Size".', 'armGroupLabels': ['multidisciplinary intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05508030', 'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Rosângela Osório', 'role': 'CONTACT', 'email': 'roosorio@usp.br', 'phone': '551130912121'}, {'name': 'Bruno Gualano, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'School of Physical Education and Sport - USP', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Rosângela Osório', 'role': 'CONTACT', 'email': 'roosorio@usp.br', 'phone': '551130912121'}], 'overallOfficials': [{'name': 'Bruno Gualano, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universidade de Campinas', 'class': 'UNKNOWN'}, {'name': 'Universidad Nacional de Buenos Aires', 'class': 'UNKNOWN'}, {'name': 'Federal University of São Paulo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Bruno Gualano', 'investigatorAffiliation': 'University of Sao Paulo'}}}}