Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2026-04-13 @ 12:34 AM
Study NCT ID:
NCT02786394
Status:
COMPLETED
Last Update Posted:
2023-05-10
First Post:
2016-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Return to Everyday Activities in the Community and Home
Sponsor:
Organization:
Raw JSON
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We will ask participants to provide feedback after each session, and in two to three 30 minutes recorded interviews (in-person or over the telephone) at the end of the study.\n\nREACH: REACH is a lifestyle intervention program which aims to reduce sedentary behaviour, increase physical activity, and increase strength and balance. The REACH program is comprised of six sessions which include evidence-based education, behaviour change theory, and activity instruction. REACH also teaches goal setting techniques, mindfulness, and encourages active community engagement. 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We will ask participants to provide feedback after each session, and in two to three 30 minutes recorded interviews (in-person or over the telephone) at the end of the study.\n\nREACH: REACH is a lifestyle intervention program which aims to reduce sedentary behaviour, increase physical activity, and increase strength and balance. The REACH program is comprised of six sessions which include evidence-based education, behaviour change theory, and activity instruction. REACH also teaches goal setting techniques, mindfulness, and encourages active community engagement. In this study we are running the REACH program for women aged 55 and older alongside a supplementary optional walking program run by SportMedBC.'}], 'classes': [{'categories': [{'measurements': [{'value': '7954', 'groupId': 'OG000', 'lowerLimit': '6861', 'upperLimit': '11,401'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'weekly for 6 weeks', 'description': 'We will request participants to record their daily step count data from activity monitors.', 'unitOfMeasure': 'steps/day', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of REACH Sessions Attended', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}, {'units': 'Sessions', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'REACH Participant Course', 'description': 'This study will run twice a week over 6 weeks with 6 REACH sessions optional walking program sessions. The optional walking program will be run by SportMedBC and may consist of one or more educational sessions (e.g., nutrition). Each REACH session introduces new topics, strength and balance activities and home practices which progressively build on each other. We will ask participants to provide feedback after each session, and in two to three 30 minutes recorded interviews (in-person or over the telephone) at the end of the study.\n\nREACH: REACH is a lifestyle intervention program which aims to reduce sedentary behaviour, increase physical activity, and increase strength and balance. The REACH program is comprised of six sessions which include evidence-based education, behaviour change theory, and activity instruction. REACH also teaches goal setting techniques, mindfulness, and encourages active community engagement. 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Each REACH session introduces new topics, strength and balance activities and home practices which progressively build on each other. We will ask participants to provide feedback after each session, and in two to three 30 minutes recorded interviews (in-person or over the telephone) at the end of the study.\n\nREACH: REACH is a lifestyle intervention program which aims to reduce sedentary behaviour, increase physical activity, and increase strength and balance. The REACH program is comprised of six sessions which include evidence-based education, behaviour change theory, and activity instruction. REACH also teaches goal setting techniques, mindfulness, and encourages active community engagement. In this study we are running the REACH program for women aged 55 and older alongside a supplementary optional walking program run by SportMedBC.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'REACH Participant Course', 'description': 'This study will run twice a week over 6 weeks with 6 REACH sessions and optional walking program sessions. The optional walking program will be run by SportMedBC and may consist of one or more educational sessions (e.g., nutrition). Each REACH session introduces new topics, strength and balance activities and home practices which progressively build on each other. We will ask participants to provide feedback after each session, and in two to three 30 minutes recorded interviews (in-person or over the telephone) at the end of the study.\n\nREACH: REACH is a lifestyle intervention program which aims to reduce sedentary behaviour, increase physical activity, and increase strength and balance. The REACH program is comprised of six sessions which include evidence-based education, behaviour change theory, and activity instruction. REACH also teaches goal setting techniques, mindfulness, and encourages active community engagement. In this study we are running the REACH program for women aged 55 and older alongside a supplementary optional walking program run by SportMedBC.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000', 'lowerLimit': '57.5', 'upperLimit': '71'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-08', 'studyFirstSubmitDate': '2016-05-18', 'resultsFirstSubmitDate': '2021-06-22', 'studyFirstSubmitQcDate': '2016-05-25', 'lastUpdatePostDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-04-19', 'studyFirstPostDateStruct': {'date': '2016-06-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'REACH Session Feedback', 'timeFrame': '6 weeks', 'description': "We will ask participants to report feedback and experience following each REACH session. As this was a pilot study we wanted to capture participants' perceptions of the program. When appropriate, we adjusted the content/delivery in consultation with participants. We also asked participants to rate their overall experience with REACH \\[1 (low) - 7 (high)\\]."}], 'secondaryOutcomes': [{'measure': 'Physical Activity Identity', 'timeFrame': '6 weeks', 'description': 'A questionnaire will be administered at the beginning and end of the REACH sessions to determine how the participant identifies themselves with regard to physical activity. The minimum score is 9 and the maximal score is 63; the higher the score the better.'}, {'measure': 'Grit Score', 'timeFrame': '6 weeks', 'description': 'A questionnaire will be used to determine how the participant perceives their ability to stick with (follow through on) projects or goals. The higher the score the better. Scores range from 1 (not like me to) to 5 (very much like me).'}, {'measure': 'Automaticity Subscale of the Self-Report Habit Index', 'timeFrame': '6 weeks', 'description': 'A questionnaire will be administered to determine the participant\'s level of automaticity for physical activity. Scores are based on a 7-point Likert scale (1=strongly disagree- 7=strongly agree). In other words, participants rate how "automatic" their behavior is for physical activity.'}, {'measure': 'Sedentary Behaviour', 'timeFrame': 'weekly for 6 weeks', 'description': 'We will request participants record their sedentary behaviour data from activity monitors.'}, {'measure': 'Hourly Activity', 'timeFrame': 'weekly for 6 weeks', 'description': 'We will request participants to record their hourly activity (number of hours active per day) data from activity monitors.'}, {'measure': 'Step Count', 'timeFrame': 'weekly for 6 weeks', 'description': 'We will request participants to record their daily step count data from activity monitors.'}, {'measure': 'Number of REACH Sessions Attended', 'timeFrame': 'weekly for 6 weeks', 'description': 'Number of REACH sessions attended during the project.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Aging', 'Activity', 'Lifestyle']}, 'referencesModule': {'references': [{'pmid': '31297236', 'type': 'BACKGROUND', 'citation': 'Ashe MC, Edwards NY, Taylor A, Burnett L, Giangregorio L, Milne K, Clemson L, Fleig L. Return to Everyday Activity in the Community and Home: a feasibility study for a lifestyle intervention to sit less, move more, and be strong. Pilot Feasibility Stud. 2019 Jun 28;5:84. doi: 10.1186/s40814-019-0467-9. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test feasibility for the delivery and perceptions of a lifestyle model for middle-aged and older adults by involving participants in its development. The goal of the program is to reduce sedentary behaviour, increase physical activity, and increase strength and balance. An optional walking program will be run in parallel to emphasize the importance of moving more. Participants will be asked to fill out questionnaires on course delivery, content and effect throughout the program and 2-3 recorded interviews throughout the study. We will collect measurements of physical performance before and after the program.', 'detailedDescription': 'This study aims to describe the delivery of a lifestyle model for older adults. Return to Everyday Activities in the Community and Home (REACH) is a health promotion program aimed at middle-aged and older adults. The goal of REACH is to reduce sedentary behaviour, increase physical activity, and increase strength and balance. The REACH program is comprised of six sessions which include evidence-based education, behaviour change theory, and activity instruction. REACH also teaches goal setting techniques, mindfulness, and encourages active community engagement. In this study we are running the REACH program for women aged 55 and older alongside a supplementary optional walking program run by SportMedBC. We will gather pre- and post-intervention measures of program perceptions, delivery psychological variables and physical performance outcomes. We will also collect participant feedback about course delivery, content and effect throughout the program. This study will allow us to describe the delivery strategies of REACH and involve the participants in the development of the REACH program. The optional walking program will emphasize the importance of increasing daily physical activity.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '105 Years', 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants included will be women aged 55 and older.\n* Participants must speak English.\n* Participants must be able to walk a minimum of four city blocks, climb a flight of stairs and take part in a physical activity and walking program.\n* Participants must be cleared by a health care professional to participate using the Physical Activity Readiness Questionnaire for Everyone (Par-Q+) assessment to determine if they are physically able to take part in the activity program.\n\nExclusion Criteria:\n\n* Individuals will be excluded if they are men, under the age of 55 and/or do not speak English.'}, 'identificationModule': {'nctId': 'NCT02786394', 'acronym': 'REACH', 'briefTitle': 'Return to Everyday Activities in the Community and Home', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'REACH Lifestyle Program for Older Adults', 'orgStudyIdInfo': {'id': 'H16-00670'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'REACH Participant Course', 'description': 'This study will run twice a week over 6 weeks with 6 REACH sessions optional walking program sessions. The optional walking program will be run by SportMedBC and may consist of one or more educational sessions (e.g., nutrition). Each REACH session introduces new topics, strength and balance activities and home practices which progressively build on each other. We will ask participants to provide feedback after each session, and in two to three 30 minutes recorded interviews (in-person or over the telephone) at the end of the study.', 'interventionNames': ['Behavioral: REACH']}], 'interventions': [{'name': 'REACH', 'type': 'BEHAVIORAL', 'description': 'REACH is a lifestyle intervention program which aims to reduce sedentary behaviour, increase physical activity, and increase strength and balance. The REACH program is comprised of six sessions which include evidence-based education, behaviour change theory, and activity instruction. REACH also teaches goal setting techniques, mindfulness, and encourages active community engagement. In this study we are running the REACH program for women aged 55 and older alongside a supplementary optional walking program run by SportMedBC.', 'armGroupLabels': ['REACH Participant Course']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z 1M9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Centre for Hip Health and Mobility', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Maureen Ashe, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Colubia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Maureen C. Ashe', 'investigatorAffiliation': 'University of British Columbia'}}}}