Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2026-01-02 @ 10:29 AM
Study NCT ID:
NCT04130932
Status:
WITHDRAWN
Last Update Posted:
2021-10-29
First Post:
2019-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Flooring on Office Workers' Health and Behaviors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'lack of funding', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-24', 'studyFirstSubmitDate': '2019-10-16', 'studyFirstSubmitQcDate': '2019-10-16', 'lastUpdatePostDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sickness, absence, presenteeism', 'timeFrame': '9 weeks', 'description': 'Work Limitations Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': "Researchers are trying to better understand how offices and workspaces influence people's performance, behavior and health during the course of weeks and over long periods of time."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Ability to provide informed consent\n* Must be adults between the ages of 18 and 60\n* Ability to relocate to the Well Living Lab for 9 consecutive weeks\n* Full-time Mayo Clinic employees (35+ hours per week)\n* Report working a sedentary job (e.g., sit for \\>= 50% of their work time).\n* Have a working mobile phone that can receive text messages\n* Must be present for 80% of the study (minimum of 4 days per week)\n\nExclusion Criteria:\n\n* Individuals who are shift-workers\n* Individuals diagnosed with vascular diseases (i.e., Raynaud's disease, peripheral artery disease, etc.)\n* Individuals with diagnosed neurological and psychiatric disorders that may have physical limitations\n* Drug (illegal or prescription narcotic), nicotine, or alcohol dependency\n* Women who are lactating, pregnant or intend to become pregnant during the duration of the study\n* Individuals who are taking medications (either prescribed or over-the-counter) which may affect comfort levels (e.g., opiate based medications)\n* Working in occupation requiring standing/stepping \\>50% of work time\n* Report \\< 1 year at current job\n* Hospitalization from either a physical or mental disorder in the past six months\n* History of cardiovascular, pulmonary, metabolic, neurological, or orthopedic limitations that would prohibit occupational physical activity (e.g., standing, stepping, etc.)"}, 'identificationModule': {'nctId': 'NCT04130932', 'briefTitle': "The Effect of Flooring on Office Workers' Health and Behaviors", 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': "The Effect of Flooring on Office Workers' Health and Behaviors", 'orgStudyIdInfo': {'id': '19-006733'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Normal flooring', 'description': 'standard office flooring'}, {'type': 'EXPERIMENTAL', 'label': 'Ergonomic flooring', 'description': 'Ergonomically designed flooring', 'interventionNames': ['Other: Ergonomic flooring']}], 'interventions': [{'name': 'Ergonomic flooring', 'type': 'OTHER', 'description': 'Specially designed flooring system to optimize ergonomics of participants', 'armGroupLabels': ['Ergonomic flooring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Brent Bauer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Brent A. Bauer', 'investigatorAffiliation': 'Mayo Clinic'}}}}