Ignite Creation Date:
2025-12-24 @ 12:50 PM
Ignite Modification Date:
2026-01-07 @ 5:37 PM
Study NCT ID:
NCT01842061
Status:
COMPLETED
Last Update Posted:
2021-10-14
First Post:
2013-04-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Everyday Activity Supports You (EASY) Pilot Study
Sponsor:
Organization:
Raw JSON
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Specifically, they will be given an EASY Program Manual with strategies to break up sitting time during the day and increase utilitarian activity; this will include a section on how to set, monitor and maintain achievable goals. They will also be offered a pedometer program, group education sessions and encouraged to use public transport by providing free bus tickets.\n\nActive Living Program', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Education', 'description': 'Control group participants will be offered monthly drop-in sessions that target information on general health and well-being unrelated to physical activity.\n\nEducation', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Feasibility of Study Recruitment and Retention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Living Program', 'description': 'Participants in the intervention group will receive a self-management program designed to reduce sedentary behaviour and increase physical activity. Specifically, they will be given an EASY Program Manual with strategies to break up sitting time during the day and increase utilitarian activity; this will include a section on how to set, monitor and maintain achievable goals. They will also be offered a pedometer program, group education sessions and encouraged to use public transport by providing free bus tickets.\n\nActive Living Program'}, {'id': 'OG001', 'title': 'Education', 'description': 'Control group participants will be offered monthly drop-in sessions that target information on general health and well-being unrelated to physical activity.\n\nEducation'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'The number of study participants recruited and finish the 6 month study (and final assessment).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sedentary Time (Measured by Average Daily Percent)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Living Program', 'description': 'Participants in the intervention group will receive a self-management program designed to reduce sedentary behaviour and increase physical activity. Specifically, they will be given an EASY Program Manual with strategies to break up sitting time during the day and increase utilitarian activity; this will include a section on how to set, monitor and maintain achievable goals. They will also be offered a pedometer program, group education sessions and encouraged to use public transport by providing free bus tickets.\n\nActive Living Program'}, {'id': 'OG001', 'title': 'Education', 'description': 'Control group participants will be offered monthly drop-in sessions that target information on general health and well-being unrelated to physical activity.\n\nEducation'}], 'classes': [{'categories': [{'measurements': [{'value': '66.17', 'spread': '7.06', 'groupId': 'OG000'}, {'value': '67.23', 'spread': '4.68', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'sedentary time (measured by average daily percent) as measured by accelerometry', 'unitOfMeasure': 'percentage of day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Physical Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Living Program', 'description': 'Participants in the intervention group will receive a self-management program designed to reduce sedentary behaviour and increase physical activity. Specifically, they will be given an EASY Program Manual with strategies to break up sitting time during the day and increase utilitarian activity; this will include a section on how to set, monitor and maintain achievable goals. They will also be offered a pedometer program, group education sessions and encouraged to use public transport by providing free bus tickets.\n\nActive Living Program'}, {'id': 'OG001', 'title': 'Education', 'description': 'Control group participants will be offered monthly drop-in sessions that target information on general health and well-being unrelated to physical activity.\n\nEducation'}], 'classes': [{'categories': [{'measurements': [{'value': '7606', 'spread': '3917', 'groupId': 'OG000'}, {'value': '4593', 'spread': '663', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'steps counts as measured by accelerometry', 'unitOfMeasure': 'steps/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Body Composition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Living Program', 'description': 'Participants in the intervention group will receive a self-management program designed to reduce sedentary behaviour and increase physical activity. Specifically, they will be given an EASY Program Manual with strategies to break up sitting time during the day and increase utilitarian activity; this will include a section on how to set, monitor and maintain achievable goals. They will also be offered a pedometer program, group education sessions and encouraged to use public transport by providing free bus tickets.\n\nActive Living Program'}, {'id': 'OG001', 'title': 'Education', 'description': 'Control group participants will be offered monthly drop-in sessions that target information on general health and well-being unrelated to physical activity.\n\nEducation'}], 'classes': [{'categories': [{'measurements': [{'value': '67.33', 'spread': '18.57', 'groupId': 'OG000'}, {'value': '91.6', 'spread': '19.04', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'body weight measured in kilograms', 'unitOfMeasure': 'kgs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Active Transportation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Living Program', 'description': 'Participants in the intervention group will receive a self-management program designed to reduce sedentary behaviour and increase physical activity. Specifically, they will be given an EASY Program Manual with strategies to break up sitting time during the day and increase utilitarian activity; this will include a section on how to set, monitor and maintain achievable goals. They will also be offered a pedometer program, group education sessions and encouraged to use public transport by providing free bus tickets.\n\nActive Living Program'}, {'id': 'OG001', 'title': 'Education', 'description': 'Control group participants will be offered monthly drop-in sessions that target information on general health and well-being unrelated to physical activity.\n\nEducation'}], 'classes': [{'categories': [{'measurements': [{'value': '396', 'groupId': 'OG000', 'lowerLimit': '231', 'upperLimit': '841.5'}, {'value': '272.3', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '321.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'Self reported description of minutes/week of active transportation (e.g., walking, cycling, etc.)', 'unitOfMeasure': 'mins/week', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active Living Program', 'description': 'Participants in the intervention group will receive a self-management program designed to reduce sedentary behaviour and increase physical activity. Specifically, they will be given an EASY Program Manual with strategies to break up sitting time during the day and increase utilitarian activity; this will include a section on how to set, monitor and maintain achievable goals. They will also be offered a pedometer program, group education sessions and encouraged to use public transport by providing free bus tickets.\n\nActive Living Program'}, {'id': 'FG001', 'title': 'Education', 'description': 'Control group participants will be offered monthly drop-in sessions that target information on general health and well-being unrelated to physical activity.\n\nEducation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Active Living Program', 'description': 'Participants in the intervention group will receive a self-management program designed to reduce sedentary behaviour and increase physical activity. Specifically, they will be given an EASY Program Manual with strategies to break up sitting time during the day and increase utilitarian activity; this will include a section on how to set, monitor and maintain achievable goals. They will also be offered a pedometer program, group education sessions and encouraged to use public transport by providing free bus tickets.\n\nActive Living Program'}, {'id': 'BG001', 'title': 'Education', 'description': 'Control group participants will be offered monthly drop-in sessions that target information on general health and well-being unrelated to physical activity.\n\nEducation'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'aged 55-70 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '1 participant in the intervention group did not complete the study, and 4 participants in the control group did not complete the study.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'populationDescription': '1 participant from the intervention and 4 participants in the control group did not complete the study.'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-18', 'studyFirstSubmitDate': '2013-04-17', 'resultsFirstSubmitDate': '2021-06-22', 'studyFirstSubmitQcDate': '2013-04-24', 'lastUpdatePostDateStruct': {'date': '2021-10-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-09-18', 'studyFirstPostDateStruct': {'date': '2013-04-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of Study Recruitment and Retention', 'timeFrame': '6 months', 'description': 'The number of study participants recruited and finish the 6 month study (and final assessment).'}], 'secondaryOutcomes': [{'measure': 'Sedentary Time (Measured by Average Daily Percent)', 'timeFrame': '6 months', 'description': 'sedentary time (measured by average daily percent) as measured by accelerometry'}, {'measure': 'Physical Activity', 'timeFrame': '6 months', 'description': 'steps counts as measured by accelerometry'}, {'measure': 'Body Composition', 'timeFrame': '6 months', 'description': 'body weight measured in kilograms'}, {'measure': 'Active Transportation', 'timeFrame': '6 months', 'description': 'Self reported description of minutes/week of active transportation (e.g., walking, cycling, etc.)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['active living', 'retirement'], 'conditions': ['Lifestyle']}, 'referencesModule': {'references': [{'pmid': '27175291', 'type': 'BACKGROUND', 'citation': 'Ashe MC, Winters M, Hoppmann CA, Dawes MG, Gardiner PA, Giangregorio LM, Madden KM, McAllister MM, Wong G, Puyat JH, Singer J, Sims-Gould J, McKay HA. "Not just another walking program": Everyday Activity Supports You (EASY) model-a randomized pilot study for a parallel randomized controlled trial. Pilot Feasibility Stud. 2015;1:4. doi: 10.1186/2055-5784-1-4. Epub 2015 Jan 12.'}, {'pmid': '29570005', 'type': 'DERIVED', 'citation': 'Gray SM, Chen P, Fleig L, Gardiner PA, McAllister MM, Puyat JH, Sims-Gould J, McKay HA, Winters M, Ashe MC. Can a Lifestyle Intervention Increase Active Transportation in Women Aged 55-70 years? Secondary Outcomes From a Pilot Randomized Controlled Trial. J Phys Act Health. 2018 Jun 1;15(6):411-416. doi: 10.1123/jpah.2016-0348. Epub 2018 Mar 23.'}]}, 'descriptionModule': {'briefSummary': 'The investigators propose a 6-month, parallel, single-blind randomized controlled trial (RCT) feasibility study of a self-management program to reduce sedentary time and increase physical activity (Sit Less to Move More) in women aged 55-70 years. The primary aim is to determine feasibility and acceptability of the intervention; and the secondary aim is to test the effect of the intervention on the primary health outcome, physical activity (mean daily step count by accelerometry) at 6 months. The investigators will also conduct an economic evaluation and a process evaluation to guide a future larger study and to inform a scaled-up implementation plan.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy community-dwelling women aged 55-70 years who (via self-report) are not currently engaging (or in the previous 3 months) in any strength training, or \\<30 minutes brisk walking or moderate exercise/week\n* are able to climb stairs and walk 400 meters (e.g., do not have a mobility disability).\n\nExclusion Criteria:\n\n* Participants who receive treatment for medical conditions that preclude participation in a walking program'}, 'identificationModule': {'nctId': 'NCT01842061', 'acronym': 'EASY-Pilot', 'briefTitle': 'Everyday Activity Supports You (EASY) Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Everyday Activity Supports You (EASY) Pilot Study', 'orgStudyIdInfo': {'id': 'H13-00518'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Living Program', 'description': 'Participants in the intervention group will receive a self-management program designed to reduce sedentary behaviour and increase physical activity. Specifically, they will be given an EASY Program Manual with strategies to break up sitting time during the day and increase utilitarian activity; this will include a section on how to set, monitor and maintain achievable goals. They will also be offered a pedometer program, group education sessions and encouraged to use public transport by providing free bus tickets.', 'interventionNames': ['Behavioral: Active Living Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Education', 'description': 'Control group participants will be offered monthly drop-in sessions that target information on general health and well-being unrelated to physical activity.', 'interventionNames': ['Behavioral: Education']}], 'interventions': [{'name': 'Active Living Program', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Active Living Program']}, {'name': 'Education', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Education']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Centre for Hip Health and Mobility', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Maureen C Ashe, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Maureen C. Ashe', 'investigatorAffiliation': 'University of British Columbia'}}}}