Lifestyle Clinical Trial
— EASY-PilotOfficial title:
Everyday Activity Supports You (EASY) Pilot Study
NCT number | NCT01842061 |
Other study ID # | H13-00518 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2013 |
Est. completion date | December 2013 |
Verified date | September 2021 |
Source | University of British Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 55 Years to 70 Years |
Eligibility | Inclusion Criteria: - 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 - are able to climb stairs and walk 400 meters (e.g., do not have a mobility disability). Exclusion Criteria: - Participants who receive treatment for medical conditions that preclude participation in a walking program |
Country | Name | City | State |
---|---|---|---|
Canada | Centre for Hip Health and Mobility | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia | Canadian Institutes of Health Research (CIHR) |
Canada,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of Study Recruitment and Retention | The number of study participants recruited and finish the 6 month study (and final assessment). | 6 months | |
Secondary | Sedentary Time (Measured by Average Daily Percent) | sedentary time (measured by average daily percent) as measured by accelerometry | 6 months | |
Secondary | Physical Activity | steps counts as measured by accelerometry | 6 months | |
Secondary | Body Composition | body weight measured in kilograms | 6 months | |
Secondary | Active Transportation | Self reported description of minutes/week of active transportation (e.g., walking, cycling, etc.) | 6 months |
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