ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.

Condition or disease Intervention/treatment Phase
Lifestyle Behavioral: Active Living Program Behavioral: Education Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Everyday Activity Supports You (EASY) Pilot Study
Study Start Date : May 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Arm Intervention/treatment
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.
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.
Behavioral: Education



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Sedentary time (measured by average daily percent) [ Time Frame: 6 months ]
    sedentary time (measured by average daily percent) as measured by accelerometry

  2. Physical activity (measured by average daily step count) [ Time Frame: 6 months ]
    steps counts as measured by accelerometry

  3. Executive Function (Stroop and Trail B) [ Time Frame: 6 months ]
  4. Health-related Quality of Life (EQ5D-5L) [ Time Frame: 6 months ]
  5. Quality of Life (ICECAP-O) [ Time Frame: 6 months ]
  6. Health Resource Utilization [ Time Frame: 6 months ]
  7. Body Composition (BMI and waist circumference, hip to waist ratio) [ Time Frame: 6 months ]
  8. Acceptability of program to participants [ Time Frame: 6 months ]
    qualitative interviews

  9. Travel patterns (number of trips/week) [ Time Frame: 6 months ]
  10. Falls [ Time Frame: 6 months ]
    monthly falls diaries

  11. Social Support (Medical Outcomes Study: Social Support Survey Instrument) [ Time Frame: 6 months ]
  12. Exercise Self-Efficacy Scale [ Time Frame: 6 months ]
  13. Physical Activity (Self-report IPAQ) [ Time Frame: 6 months ]
  14. Gait speed and variability [ Time Frame: 6 months ]
  15. Perceived Neighbourhood Walkability (NEWS) [ Time Frame: 6 months ]
  16. Behavioural Intentions for Physical Activity Questionnaire [ Time Frame: 6 months ]

Other Outcome Measures:
  1. DNA methylation [ Time Frame: 6 months ]
  2. inflammation (C-reactive protein) [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   55 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01842061


Locations
Canada, British Columbia
Centre for Hip Health and Mobility
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Maureen C Ashe, PhD University of British Columbia

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maureen C. Ashe, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT01842061     History of Changes
Other Study ID Numbers: H13-00518
First Posted: April 29, 2013    Key Record Dates
Last Update Posted: May 16, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Maureen C. Ashe, University of British Columbia:
active living
retirement