Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-02-25 @ 12:25 AM
Study NCT ID:
NCT02071420
Status:
COMPLETED
Last Update Posted:
2017-10-23
First Post:
2014-02-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy of a Combined Ergonomic Health Promotion Intervention on Employee Health
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057185', 'term': 'Sedentary Behavior'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lucas-carr@uiowa.edu', 'phone': '319-353-5432', 'title': 'Lucas Carr, PhD', 'organization': 'University of Iowa'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected for 16 weeks during the intervention.', 'eventGroups': [{'id': 'EG000', 'title': 'Experimental Group', 'description': "This group will receive the seated active workstation intervention, the ergonomic intervention and the email intervention for 16 weeks.\n\nActive Workstation Intervention: Participants in the experimental group will receive a seated active workstation at their work setting for 16 weeks.\n\nErgonomic Intervention: Participants of both arms will receive a face to face ergonomic workstation optimization intervention. This consultation will take 30 minutes to complete and will be performed at the participant's actual work station.\n\nEmail Intervention: Participants of both arms will receive three emails per week for 16 weeks. Messages will be consistent with what they hear in the ergonomic intervention (e.g., encourage taking breaks from sitting at work and adjusting posture to be in line with ergonomic principles).\n\nBluetooth enabled device (Wahoo Fitness Blue SC sensor) and accompanying iPod application.", 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Active Control', 'description': "This group will receive the ergonomic intervention and email intervention only for 16 weeks. This group will not receive a seated active workstation.\n\nErgonomic Intervention: Participants of both arms will receive a face to face ergonomic workstation optimization intervention. This consultation will take 30 minutes to complete and will be performed at the participant's actual work station.\n\nEmail Intervention: Participants of both arms will receive three emails per week for 16 weeks. Messages will be consistent with what they hear in the ergonomic intervention (e.g., encourage taking breaks from sitting at work and adjusting posture to be in line with ergonomic principles).\n\nBluetooth enabled device (Wahoo Fitness Blue SC sensor) and accompanying iPod application.", 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Occupational Physical Activity From Baseline to 16 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group', 'description': "This group will receive the seated active workstation intervention, the ergonomic intervention and the email intervention for 16 weeks.\n\nActive Workstation Intervention: Participants in the experimental group will receive a seated active workstation at their work setting for 16 weeks.\n\nErgonomic Intervention: Participants of both arms will receive a face to face ergonomic workstation optimization intervention. This consultation will take 30 minutes to complete and will be performed at the participant's actual work station.\n\nEmail Intervention: Participants of both arms will receive three emails per week for 16 weeks. Messages will be consistent with what they hear in the ergonomic intervention (e.g., encourage taking breaks from sitting at work and adjusting posture to be in line with ergonomic principles).\n\nBluetooth enabled device (Wahoo Fitness Blue SC sensor) and accompanying iPod application."}, {'id': 'OG001', 'title': 'Active Control', 'description': "This group will receive the ergonomic intervention and email intervention only for 16 weeks. This group will not receive a seated active workstation.\n\nErgonomic Intervention: Participants of both arms will receive a face to face ergonomic workstation optimization intervention. This consultation will take 30 minutes to complete and will be performed at the participant's actual work station.\n\nEmail Intervention: Participants of both arms will receive three emails per week for 16 weeks. Messages will be consistent with what they hear in the ergonomic intervention (e.g., encourage taking breaks from sitting at work and adjusting posture to be in line with ergonomic principles).\n\nBluetooth enabled device (Wahoo Fitness Blue SC sensor) and accompanying iPod application."}], 'classes': [{'categories': [{'measurements': [{'value': '9752', 'groupId': 'OG000', 'lowerLimit': '1067', 'upperLimit': '18463'}, {'value': '-142', 'groupId': 'OG001', 'lowerLimit': '-10623', 'upperLimit': '10339'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 16 weeks', 'description': 'Occupational physical activity (primary outcome) will be measured objectively with the GENEActiv physical activity monitor. The monitor will be worn on the right ankle and will be worn for 5 working days during all non-bathing hours. The outcome measure will be change in occupational activity (average counts/work day) from baseline to 16 weeks. The measure will be calculated as follows: 16 weeks value - baseline value.', 'unitOfMeasure': 'Average counts/work day', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Experimental Group', 'description': "This group will receive the seated active workstation intervention, the ergonomic intervention and the email intervention for 16 weeks.\n\nActive Workstation Intervention: Participants in the experimental group will receive a seated active workstation at their work setting for 16 weeks.\n\nErgonomic Intervention: Participants of both arms will receive a face to face ergonomic workstation optimization intervention. This consultation will take 30 minutes to complete and will be performed at the participant's actual work station.\n\nEmail Intervention: Participants of both arms will receive three emails per week for 16 weeks. Messages will be consistent with what they hear in the ergonomic intervention (e.g., encourage taking breaks from sitting at work and adjusting posture to be in line with ergonomic principles).\n\nBluetooth enabled device (Wahoo Fitness Blue SC sensor) and accompanying iPod application."}, {'id': 'FG001', 'title': 'Active Control', 'description': "This group will receive the ergonomic intervention and email intervention only for 16 weeks. This group will not receive a seated active workstation.\n\nErgonomic Intervention: Participants of both arms will receive a face to face ergonomic workstation optimization intervention. This consultation will take 30 minutes to complete and will be performed at the participant's actual work station.\n\nEmail Intervention: Participants of both arms will receive three emails per week for 16 weeks. Messages will be consistent with what they hear in the ergonomic intervention (e.g., encourage taking breaks from sitting at work and adjusting posture to be in line with ergonomic principles).\n\nBluetooth enabled device (Wahoo Fitness Blue SC sensor) and accompanying iPod application."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Experimental Group', 'description': "This group will receive the seated active workstation intervention, the ergonomic intervention and the email intervention for 16 weeks.\n\nActive Workstation Intervention: Participants in the experimental group will receive a seated active workstation at their work setting for 16 weeks.\n\nErgonomic Intervention: Participants of both arms will receive a face to face ergonomic workstation optimization intervention. This consultation will take 30 minutes to complete and will be performed at the participant's actual work station.\n\nEmail Intervention: Participants of both arms will receive three emails per week for 16 weeks. Messages will be consistent with what they hear in the ergonomic intervention (e.g., encourage taking breaks from sitting at work and adjusting posture to be in line with ergonomic principles).\n\nBluetooth enabled device (Wahoo Fitness Blue SC sensor) and accompanying iPod application."}, {'id': 'BG001', 'title': 'Active Control', 'description': "This group will receive the ergonomic intervention and email intervention only for 16 weeks. This group will not receive a seated active workstation.\n\nErgonomic Intervention: Participants of both arms will receive a face to face ergonomic workstation optimization intervention. This consultation will take 30 minutes to complete and will be performed at the participant's actual work station.\n\nEmail Intervention: Participants of both arms will receive three emails per week for 16 weeks. Messages will be consistent with what they hear in the ergonomic intervention (e.g., encourage taking breaks from sitting at work and adjusting posture to be in line with ergonomic principles).\n\nBluetooth enabled device (Wahoo Fitness Blue SC sensor) and accompanying iPod application."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.2', 'spread': '10.9', 'groupId': 'BG000'}, {'value': '45.0', 'spread': '10.7', 'groupId': 'BG001'}, {'value': '45.1', 'spread': '10.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-20', 'studyFirstSubmitDate': '2014-02-21', 'resultsFirstSubmitDate': '2015-08-24', 'studyFirstSubmitQcDate': '2014-02-24', 'lastUpdatePostDateStruct': {'date': '2017-10-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-09-20', 'studyFirstPostDateStruct': {'date': '2014-02-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Occupational Physical Activity From Baseline to 16 Weeks', 'timeFrame': 'Baseline and 16 weeks', 'description': 'Occupational physical activity (primary outcome) will be measured objectively with the GENEActiv physical activity monitor. The monitor will be worn on the right ankle and will be worn for 5 working days during all non-bathing hours. The outcome measure will be change in occupational activity (average counts/work day) from baseline to 16 weeks. The measure will be calculated as follows: 16 weeks value - baseline value.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sedentary', 'Overweight']}, 'referencesModule': {'references': [{'pmid': '26260492', 'type': 'DERIVED', 'citation': 'Carr LJ, Leonhard C, Tucker S, Fethke N, Benzo R, Gerr F. Total Worker Health Intervention Increases Activity of Sedentary Workers. Am J Prev Med. 2016 Jan;50(1):9-17. doi: 10.1016/j.amepre.2015.06.022. Epub 2015 Aug 7.'}]}, 'descriptionModule': {'briefSummary': "Our objective in this pilot study is to test the combined effect of a) replacing office workers' sedentary workstations with active workstations (LifeBalance Station) and b) optimizing computer workstation ergonomics on daily occupational sedentary time, cardiometabolic risk factors, musculoskeletal symptom health outcomes and work productivity.", 'detailedDescription': 'Primary Aim: To compare the effects of providing sedentary employees with seated active workstations in combination with an ergonomic intervention and regular motivational emails (experimental group) against the ergonomic intervention and regular emails only (active control group) on occupational sedentary behavior over 16 weeks.\n\nHypothesis: The addition of a seated active workstation will result in significant reductions in daily occupational sedentary time compared to the active control group.\n\nSecondary Aims: To compare the effects of the experimental group against the active control group on secondary measures of cardiometabolic disease risk factors, musculoskeletal discomfort, cognitive function and work productivity.\n\nHypothesis 1: The experimental group will result in reduced cardiometabolic disease risk, musculoskeletal discomfort and work limitations compared to the active control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* We will recruit overweight/obese (body mass index 25.0-40.0 kg/m2) adults (18-65 years) working in full-time (minimum 35 hours/week), sedentary (self-report sitting \\>75% work time) occupations at an independent work site.\n\nExclusion Criteria:\n\n* Working in an office that will not meet the space or electrical requirements of the active workstation, acute or chronic illness not under treatment of a provider, orthopedic limitations that prohibit physical activity, current or planned pregnancy, hospitalization from a physical or mental disorder in the past six months and/or taking medication that may impair physical activity'}, 'identificationModule': {'nctId': 'NCT02071420', 'briefTitle': 'Efficacy of a Combined Ergonomic Health Promotion Intervention on Employee Health', 'organization': {'class': 'OTHER', 'fullName': 'University of Iowa'}, 'officialTitle': 'Efficacy of a Combined Ergonomic Health Promotion Intervention on Employee Health', 'orgStudyIdInfo': {'id': '201306711'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'This group will receive the seated active workstation intervention, the ergonomic intervention and the email intervention for 16 weeks.', 'interventionNames': ['Behavioral: Active Workstation Intervention', 'Behavioral: Ergonomic Intervention', 'Behavioral: Email Intervention', 'Device: Bluetooth enabled device (Wahoo Fitness Blue SC sensor) and accompanying iPod application.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Control', 'description': 'This group will receive the ergonomic intervention and email intervention only for 16 weeks. This group will not receive a seated active workstation.', 'interventionNames': ['Behavioral: Ergonomic Intervention', 'Behavioral: Email Intervention', 'Device: Bluetooth enabled device (Wahoo Fitness Blue SC sensor) and accompanying iPod application.']}], 'interventions': [{'name': 'Active Workstation Intervention', 'type': 'BEHAVIORAL', 'description': 'Participants in the experimental group will receive a seated active workstation at their work setting for 16 weeks.', 'armGroupLabels': ['Experimental Group']}, {'name': 'Ergonomic Intervention', 'type': 'BEHAVIORAL', 'description': "Participants of both arms will receive a face to face ergonomic workstation optimization intervention. This consultation will take 30 minutes to complete and will be performed at the participant's actual work station.", 'armGroupLabels': ['Active Control', 'Experimental Group']}, {'name': 'Email Intervention', 'type': 'BEHAVIORAL', 'description': 'Participants of both arms will receive three emails per week for 16 weeks. Messages will be consistent with what they hear in the ergonomic intervention (e.g., encourage taking breaks from sitting at work and adjusting posture to be in line with ergonomic principles).', 'armGroupLabels': ['Active Control', 'Experimental Group']}, {'name': 'Bluetooth enabled device (Wahoo Fitness Blue SC sensor) and accompanying iPod application.', 'type': 'DEVICE', 'armGroupLabels': ['Active Control', 'Experimental Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}], 'overallOfficials': [{'name': 'Lucas Carr, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Iowa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Iowa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Lucas Carr', 'investigatorAffiliation': 'University of Iowa'}}}}