Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-03-02 @ 4:02 PM
Study NCT ID:
NCT03274635
Status:
COMPLETED
Last Update Posted:
2020-10-19
First Post:
2017-09-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Penn State Hershey Sitting and Health Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-14', 'studyFirstSubmitDate': '2017-09-01', 'studyFirstSubmitQcDate': '2017-09-05', 'lastUpdatePostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Worker Productivity', 'timeFrame': 'Baseline (1 month period prior to program start) and post-program (immediately after program ends)', 'description': 'Self-report assessments of worker productivity. The assessments will ask about work productivity in the prior 4-week period.'}, {'measure': 'Elliptical Device Pedaling Quantity', 'timeFrame': '1 month (4 weeks) during pedaling program', 'description': 'Objectively-measured pedaling quantity from elliptical device'}], 'secondaryOutcomes': [{'measure': 'User satisfaction, process evaluations', 'timeFrame': 'Post-program (immediately after program ends)', 'description': 'Satisfaction with intervention condition'}, {'measure': 'General (non-desk pedaling) physical activity', 'timeFrame': 'Baseline (1 month period prior to program start) and post-program (immediately after program ends)', 'description': 'Self-reported physical activity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Physical Activity']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to: (a) evaluate if a desk-based elliptical device can help employees to increase their daily physical activity without compromising work productivity; and (b) evaluate the effects of different types of incentives for pedaling the desk-based elliptical device on employees' pedaling quantity over a one-month intervention period. The study will involve placing a compact elliptical device (provided at no cost by the research team) under employees' desk at Penn State Hershey Medical Center/College of Medicine. Data evaluating the effects of the elliptical device on work productivity will be obtained from both employees and the employees' supervisors."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Full time employee, employed at least 35 hours per week at Penn State Hershey\n* Able to provide documented approval from supervisor to participate\n* Age 18-70 years\n* Overweight or obese (BMI between 25-55)\n* Sit at desk at least 5 hours per day\n* Have regular working hours between 6 am and 6 pm on weekdays\n* Ability to understand written and spoken English\n* Own a smartphone (Android or iPhone) with Internet access\n* Willing to download cycling app on smartphone during one month study period\n\nExclusion Criteria:\n\n* Not present in Penn State Hershey office during study period due to personal circumstances such as travel/extended vacation or leave, relocation, or health-related circumstances\n* Advised to only do physical activity recommended by a physician\n* Chest pain during physical activity or during prior month\n* Currently has a desk-based pedaling device or treadmill workstation already installed at desk'}, 'identificationModule': {'nctId': 'NCT03274635', 'briefTitle': 'Penn State Hershey Sitting and Health Study', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'Desk-Compatible Elliptical Device: Feasibility Evaluation', 'orgStudyIdInfo': {'id': '1R21HL118453', 'link': 'https://reporter.nih.gov/quickSearch/1R21HL118453', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Delayed Compensation, Money', 'description': 'Will receive delayed monetary compensation with Amazon gift card, non performance-contingent.', 'interventionNames': ['Behavioral: Desk-based pedaling device and pedaling incentives provided']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Delayed Compensation, Food', 'description': 'Will receive delayed compensation with food-based gift card, non performance-contingent.', 'interventionNames': ['Behavioral: Desk-based pedaling device and pedaling incentives provided']}, {'type': 'EXPERIMENTAL', 'label': 'Individual Immediate Contingent Reward, Money', 'description': 'Will receive daily performance-contingent monetary compensation with Amazon gift card.', 'interventionNames': ['Behavioral: Desk-based pedaling device and pedaling incentives provided']}, {'type': 'EXPERIMENTAL', 'label': 'Individual Immediate Contingent Reward, Food', 'description': 'Will receive daily performance-contingent food-based gift card.', 'interventionNames': ['Behavioral: Desk-based pedaling device and pedaling incentives provided']}, {'type': 'EXPERIMENTAL', 'label': 'Joint Immediate Contingent Reward, Money', 'description': 'Will receive daily performance-contingent monetary compensation with Amazon gift card, with additional compensation contingent on pedaling activity of co-worker participant.', 'interventionNames': ['Behavioral: Desk-based pedaling device and pedaling incentives provided']}, {'type': 'EXPERIMENTAL', 'label': 'Joint Immediate Contingent Reward, Food', 'description': 'Will receive daily performance-contingent monetary compensation with food gift card, with additional compensation contingent on pedaling activity of co-worker participant.', 'interventionNames': ['Behavioral: Desk-based pedaling device and pedaling incentives provided']}], 'interventions': [{'name': 'Desk-based pedaling device and pedaling incentives provided', 'type': 'BEHAVIORAL', 'description': 'Varying types of incentives, equivalent in monetary value, will be randomly assigned across the 6 arms to promote regular desk-based pedaling. A free desk-based pedaling device will be provided. Effects on amount of desk-based pedaling and work productivity will be evaluated.', 'armGroupLabels': ['Individual Immediate Contingent Reward, Food', 'Individual Immediate Contingent Reward, Money', 'Joint Immediate Contingent Reward, Food', 'Joint Immediate Contingent Reward, Money', 'Usual Delayed Compensation, Food', 'Usual Delayed Compensation, Money']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Liza Rovniak', 'investigatorAffiliation': 'Milton S. Hershey Medical Center'}}}}