Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-01-04 @ 4:07 PM
Study NCT ID:
NCT02109432
Status:
TERMINATED
Last Update Posted:
2019-03-29
First Post:
2014-03-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Short-term Behavior Change With Pedal Desk Installation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'corby.martin@pbrc.edu', 'phone': '225-763-2585', 'title': 'Corby Martin, Associate Professor', 'organization': 'Pennington Biomedical Research Center'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': "The study's progress was hindered by technical problems with the pedaldesk's software that limited the ability of participants and staff members to view pedaldesk data. This hindered deployment of the anticipated 3 levels of support."}}, 'adverseEventsModule': {'timeFrame': '6 weeks of study participation', 'description': 'adverse event collection was completed at clinic visits. The standard clinical trials definition of AEs was used.', 'eventGroups': [{'id': 'EG000', 'title': 'Pedal Desk', 'description': 'Participants will complete three 2-week pedal desk conditions in the following order:\n\n1. Self-directed Pedal Desk\n2. Facilitated Pedal Desk\n3. Facilitated Pedal Desk with Pedometer', 'otherNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Weight Change (kg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pedal Desk', 'description': 'Three 2-week pedal desk conditions (Self-directed, Facilitated and Facilitated Pedal Desk with Pedometer)'}], 'classes': [{'categories': [{'measurements': [{'value': '-.98', 'spread': '1.09', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 6 weeks', 'description': 'KG weight change from Baseline to 6 weeks', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pedal Desk', 'description': 'Three 2-week pedal desk conditions (Self-directed, Facilitated and Facilitated Pedal Desk with Pedometer)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Pedal Desk', 'description': 'Participants will complete three 2-week pedal desk conditions in the following order:\n\n1. Self-directed Pedal Desk\n2. Facilitated Pedal Desk\n3. Facilitated Pedal Desk with Pedometer'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'whyStopped': 'Continued development of technology', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-28', 'studyFirstSubmitDate': '2014-03-12', 'resultsFirstSubmitDate': '2018-03-07', 'studyFirstSubmitQcDate': '2014-04-04', 'lastUpdatePostDateStruct': {'date': '2019-03-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-28', 'studyFirstPostDateStruct': {'date': '2014-04-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight Change (kg)', 'timeFrame': 'Baseline to 6 weeks', 'description': 'KG weight change from Baseline to 6 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pedal Desk', 'Physical Activity', 'Workplace', 'Energy Expenditure'], 'conditions': ['Physical Activity in the Workplace']}, 'descriptionModule': {'briefSummary': 'The purpose of this investigation is to evaluate participant use of a dedicated office pedal desk with and without behavioral support.', 'detailedDescription': 'For this pilot study the investigators will identify and recruit up to 20 full time Pennington Biomedical staff members employed in sedentary jobs (i.e., report mostly sitting during working hours). The sample size is limited by the number of pedal desks being built for this pilot study and the need for timely data generation. Although the investigators can stagger starts as needed, all participants must intend to be on campus for the subsequent 6 weeks after they start the intervention. Two cohorts of 10 participants will complete the three 2-week conditions in the following order: 1) SELF-DIRECTED use where participants have access to their daily recorded data but will not have any other form of feedback or goal-setting; 2) FACILITATED use where participants are provided with their daily recorded pedal desk data and additional daily behavioral support from an interventionist (e.g., feedback and goal-setting) to increase their use of the pedal desk by an individually negotiated and agreed upon amount; 3) FACILITATED use with PEDOMETER where participants will be provided with their daily recorded pedal desk and step count data and additional daily behavioral support from an interventionist (e.g., feedback and goal-setting) to increase their use of the pedal desk by an individually negotiated and agreed upon amount and increase their step count by 3,000 steps/day compared to baseline. Participants will be asked to pedal at a sustainable and self-selected pace while using the pedal desk.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be a full-time employee at Pennington Biomedical Research Center\n* Be between 21 and 65 years of age\n* Primarily sit while at work\n* Work from a private office/cubicle\n\nExclusion Criteria:\n\n* Weigh more than 250 pounds\n* Have physical limitations that prevent performance of pedaling motions\n* Plan to be away from work for the 6 weeks of the intervention\n* Be pregnant\n* Have a pace maker and/or metal joint replacement\n* Plan to be away from work for the 6 weeks of the intervention'}, 'identificationModule': {'nctId': 'NCT02109432', 'acronym': 'PD-ST', 'briefTitle': 'Short-term Behavior Change With Pedal Desk Installation', 'organization': {'class': 'OTHER', 'fullName': 'Pennington Biomedical Research Center'}, 'officialTitle': 'Short-term Behavior Change With Pedal Desk Installation', 'orgStudyIdInfo': {'id': 'PBRC 2013-051'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Pedal Desk', 'description': 'Participants will complete three 2-week conditions in the following order:\n\n1. Self-directed Pedal Desk\n2. Facilitated Pedal Desk\n3. Facilitated Pedal Desk with Pedometer', 'interventionNames': ['Behavioral: Self-Directed Pedal Desk', 'Behavioral: Facilitated Pedal Desk', 'Behavioral: Facilitated Pedal Desk with Pedometer']}], 'interventions': [{'name': 'Self-Directed Pedal Desk', 'type': 'BEHAVIORAL', 'description': 'participants will have a pedal desk installed in their office and will have access to their daily recorded data but will not have any other form of feedback or goal-setting', 'armGroupLabels': ['Pedal Desk']}, {'name': 'Facilitated Pedal Desk', 'type': 'BEHAVIORAL', 'description': 'participants are provided with their daily recorded pedal desk data and additional daily behavioral support from an interventionist (e.g., feedback and goal-setting) to increase their use of the pedal desk by an individually negotiated and agreed upon amount', 'armGroupLabels': ['Pedal Desk']}, {'name': 'Facilitated Pedal Desk with Pedometer', 'type': 'BEHAVIORAL', 'description': 'participants will be provided with their daily recorded pedal desk and step count data and additional daily behavioral support from an interventionist (e.g., feedback and goal-setting) to increase their use of the pedal desk by an individually negotiated and agreed upon amount and increase their step count by 3,000 steps/day compared to baseline.', 'armGroupLabels': ['Pedal Desk']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Pennington Biomedical Research Center', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}], 'overallOfficials': [{'name': 'Corby K Martin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pennington Biomedical Research Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Yes'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pennington Biomedical Research Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Corby K. Martin', 'investigatorAffiliation': 'Pennington Biomedical Research Center'}}}}