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Everyday Activity Supports You (EASY) Pilot Study (EASY-Pilot)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01842061
Recruitment Status : Completed
First Posted : April 29, 2013
Last Update Posted : May 16, 2017
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Maureen C. Ashe, University of British Columbia

Tracking Information
First Submitted Date  ICMJE April 17, 2013
First Posted Date  ICMJE April 29, 2013
Last Update Posted Date May 16, 2017
Study Start Date  ICMJE May 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2013)
Feasibility of study recruitment and retention [ Time Frame: 6 months ]
The number of study participants recruited and finish the 6 month study (and final assessment).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01842061 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2013)
  • Sedentary time (measured by average daily percent) [ Time Frame: 6 months ]
    sedentary time (measured by average daily percent) as measured by accelerometry
  • Physical activity (measured by average daily step count) [ Time Frame: 6 months ]
    steps counts as measured by accelerometry
  • Executive Function (Stroop and Trail B) [ Time Frame: 6 months ]
  • Health-related Quality of Life (EQ5D-5L) [ Time Frame: 6 months ]
  • Quality of Life (ICECAP-O) [ Time Frame: 6 months ]
  • Health Resource Utilization [ Time Frame: 6 months ]
  • Body Composition (BMI and waist circumference, hip to waist ratio) [ Time Frame: 6 months ]
  • Acceptability of program to participants [ Time Frame: 6 months ]
    qualitative interviews
  • Travel patterns (number of trips/week) [ Time Frame: 6 months ]
  • Falls [ Time Frame: 6 months ]
    monthly falls diaries
  • Social Support (Medical Outcomes Study: Social Support Survey Instrument) [ Time Frame: 6 months ]
  • Exercise Self-Efficacy Scale [ Time Frame: 6 months ]
  • Physical Activity (Self-report IPAQ) [ Time Frame: 6 months ]
  • Gait speed and variability [ Time Frame: 6 months ]
  • Perceived Neighbourhood Walkability (NEWS) [ Time Frame: 6 months ]
  • Behavioural Intentions for Physical Activity Questionnaire [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2013)
  • Sedentary time (measured by average daily percent) [ Time Frame: 6 months ]
    sedentary time (measured by average daily percent) as measured by accelerometry (7 days)
  • Physical activity (measured by average daily step count) [ Time Frame: 6 months ]
    steps counts as measured by accelerometry (7 days)
  • Executive Function (Stroop and Trail B) [ Time Frame: 6 months ]
  • Health-related Quality of Life (EQ5D-5L) [ Time Frame: 6 months ]
  • Quality of Life (ICECAP-O) [ Time Frame: 6 months ]
  • Health research utilization [ Time Frame: 6 months ]
  • Body Composition (BMI and waist circumference, hip to waist ratio) [ Time Frame: 6 months ]
  • Acceptability of program to participants [ Time Frame: 6 months ]
    qualitative interviews
  • Travel patterns (number of trips/week) [ Time Frame: 6 months ]
  • Falls [ Time Frame: 6 months ]
    falls diary
  • Social Support (perceived support/assistance from other people on a scale 0-100) [ Time Frame: 6 months ]
  • Exercise Self-Efficacy Scale [ Time Frame: 6 months ]
Current Other Outcome Measures  ICMJE
 (submitted: May 27, 2013)
  • DNA methylation [ Time Frame: 6 months ]
  • inflammation (C-reactive protein) [ Time Frame: 6 months ]
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Everyday Activity Supports You (EASY) Pilot Study
Official Title  ICMJE Everyday Activity Supports You (EASY) Pilot Study
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Lifestyle
Intervention  ICMJE
  • Behavioral: Active Living Program
  • Behavioral: Education
Study Arms
  • Experimental: 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.
    Intervention: Behavioral: Active Living Program
  • Active Comparator: Education
    Control group participants will be offered monthly drop-in sessions that target information on general health and well-being unrelated to physical activity.
    Intervention: Behavioral: Education
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 2, 2014)
25
Original Estimated Enrollment  ICMJE
 (submitted: April 24, 2013)
36
Actual Study Completion Date December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: Female
Ages 55 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01842061
Other Study ID Numbers  ICMJE H13-00518
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Maureen C. Ashe, University of British Columbia
Study Sponsor  ICMJE University of British Columbia
Collaborators  ICMJE Canadian Institutes of Health Research (CIHR)
Investigators  ICMJE
Principal Investigator: Maureen C Ashe, PhD University of British Columbia
PRS Account University of British Columbia
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP