Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2026-03-14 @ 6:35 AM
Study NCT ID:
NCT07229027
Status:
RECRUITING
Last Update Posted:
2025-11-14
First Post:
2025-11-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Global Overweight and oBesE (GLOBE) Patient Registry, Development and Implementation of Disease-specific: Severity, Quality of Life and Cost Instruments.
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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-10-22', 'size': 282869, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-11-13T12:21', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '60 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-13', 'studyFirstSubmitDate': '2025-11-13', 'studyFirstSubmitQcDate': '2025-11-13', 'lastUpdatePostDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cost Implications of Obesity', 'timeFrame': '2 months'}], 'primaryOutcomes': [{'measure': 'Development of a Disease-Specific Questionnaire', 'timeFrame': '2 months'}], 'secondaryOutcomes': [{'measure': 'Quality of Life Instrument', 'timeFrame': '2 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overweight (BMI > 25)', 'Obesity & Overweight']}, 'descriptionModule': {'briefSummary': 'We are conducting this study to develop a disease-specific instrument, a quality of life instrument and a comprehensive list of costs associated with overweight and obesity.', 'detailedDescription': 'Despite evidence on the burden of BMI \\>25, few disease-specific instruments comprehensively capture its multidimensional impact. Existing frameworks often target obesity (BMI ≥30) or patients on pharmacological or surgical therapy. Overweight and extremely obese populations are underrepresented, and economic and psychosocial dimensions are rarely integrated into severity staging.\n\nThis study, therefore, aims to systematically evaluate symptoms, comorbidities, HRQoL, and costs across the full spectrum of individuals with BMI \\>25, excluding those on GLP-1 therapy. Integrating clinician and patient perspectives will support the development of more inclusive severity measures and inform early intervention strategies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with BMI over 25 Healthcare professionals treating patients.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient group\n\n 1. Patient is aged ≥18 years at the time of survey completion.\n 2. Patient has a BMI over 25 (self-reported)\n 3. Patient is willing to participate in all study activities.\n 4. Patient is able to read, write, and converse in English.\n* Healthcare professional participant must meet the following criteria for inclusion in the study:\n\n 1. HCP is aged ≥18 years at the time of survey completion.\n 2. HCP is suitably qualified and involved in the healthcare management of patients with a BMI over 25\n 3. HCP is willing to participate in all study activities.\n 4. HCP is able to read, write, and converse in English.\n\n Exclusion Criteria:\n\nA participant who meets any of the following criteria will be excluded from the study:\n\n1. Participants do not have the cognitive capacity to provide informed consent.\n2. Participants with severe co-morbidity that might affect study participation.'}, 'identificationModule': {'nctId': 'NCT07229027', 'acronym': 'GLOBE', 'briefTitle': 'Global Overweight and oBesE (GLOBE) Patient Registry, Development and Implementation of Disease-specific: Severity, Quality of Life and Cost Instruments.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medialis Ltd.'}, 'officialTitle': 'Global Overweight and oBesE (GLOBE) Patient Registry, Development and Implementation of Disease-specific: Severity, Quality of Life and Cost Instruments.', 'orgStudyIdInfo': {'id': 'MED 63'}}, 'contactsLocationsModule': {'locations': [{'zip': 'MK12 5NW', 'city': 'Milton Keynes', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Omolade Allen', 'role': 'CONTACT', 'email': 'omolade@medialis.co.uk', 'phone': '+447502228066'}], 'facility': 'Online recruitment', 'geoPoint': {'lat': 52.04172, 'lon': -0.75583}}], 'centralContacts': [{'name': 'Omolade Allen, PhD', 'role': 'CONTACT', 'email': 'omolade@medialis.co.uk', 'phone': '+447502228066'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medialis Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Ravi Jandhyala', 'investigatorAffiliation': 'Medialis Ltd.'}}}}