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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Living Program | Experimental | 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. |
|
| Education | Active Comparator | Control group participants will be offered monthly drop-in sessions that target information on general health and well-being unrelated to physical activity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Living Program | Behavioral |
| ||
| Education |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Study Recruitment and Retention | The number of study participants recruited and finish the 6 month study (and final assessment). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sedentary Time (Measured by Average Daily Percent) | sedentary time (measured by average daily percent) as measured by accelerometry | 6 months |
| Physical Activity | steps counts as measured by accelerometry |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maureen C Ashe, PhD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Hip Health and Mobility | Vancouver | British Columbia | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27175291 | Background | 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. | |
| 29570005 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Living Program | 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. Active Living Program |
| FG001 | Education | Control group participants will be offered monthly drop-in sessions that target information on general health and well-being unrelated to physical activity. Education |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Living Program | 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. Active Living Program |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of Study Recruitment and Retention | The number of study participants recruited and finish the 6 month study (and final assessment). | Posted | Count of Participants | Participants | 6 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Living Program | 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. Active Living Program |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Professor MC Ashe | The University Of British Columbia | 604-675-2574 | maureen.ashe@ubc.ca |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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|
| 6 months |
| Body Composition | body weight measured in kilograms | 6 months |
| Active Transportation | Self reported description of minutes/week of active transportation (e.g., walking, cycling, etc.) | 6 months |
| Derived |
| 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. |
| BG001 | Education | Control group participants will be offered monthly drop-in sessions that target information on general health and well-being unrelated to physical activity. Education |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | 1 participant in the intervention group did not complete the study, and 4 participants in the control group did not complete the study. | Count of Participants | Participants |
|
| Region of Enrollment | 1 participant from the intervention and 4 participants in the control group did not complete the study. | Number | participants |
|
Control group participants will be offered monthly drop-in sessions that target information on general health and well-being unrelated to physical activity. Education |
|
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| Secondary | Sedentary Time (Measured by Average Daily Percent) | sedentary time (measured by average daily percent) as measured by accelerometry | Posted | Mean | Standard Deviation | percentage of day | 6 months |
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| Secondary | Physical Activity | steps counts as measured by accelerometry | Posted | Mean | Standard Deviation | steps/day | 6 months |
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| Secondary | Body Composition | body weight measured in kilograms | Posted | Mean | Standard Deviation | kgs | 6 months |
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| Secondary | Active Transportation | Self reported description of minutes/week of active transportation (e.g., walking, cycling, etc.) | Posted | Median | Inter-Quartile Range | mins/week | 6 months |
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| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Education | Control group participants will be offered monthly drop-in sessions that target information on general health and well-being unrelated to physical activity. Education | 0 | 12 | 0 | 12 | 0 | 12 |
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