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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date September 2021
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Active Living Program

Education


Locations

Country Name City State
Canada Centre for Hip Health and Mobility Vancouver British Columbia

Sponsors (2)

Lead Sponsor Collaborator
University of British Columbia Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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

Outcome

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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