NCT01842061

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 29, 2013

Completed
2 days until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
7.9 years until next milestone

Results Posted

Study results publicly available

October 14, 2021

Completed
Last Updated

October 14, 2021

Status Verified

September 1, 2021

Enrollment Period

7 months

First QC Date

April 17, 2013

Results QC Date

June 22, 2021

Last Update Submit

September 18, 2021

Conditions

Keywords

active livingretirement

Outcome Measures

Primary Outcomes (1)

  • Feasibility of Study Recruitment and Retention

    The number of study participants recruited and finish the 6 month study (and final assessment).

    6 months

Secondary Outcomes (4)

  • Sedentary Time (Measured by Average Daily Percent)

    6 months

  • Physical Activity

    6 months

  • Body Composition

    6 months

  • Active Transportation

    6 months

Study Arms (2)

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.

Behavioral: Active Living Program

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.

Behavioral: Education

Interventions

Active Living Program
EducationBEHAVIORAL
Education

Eligibility Criteria

Age55 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • Participants who receive treatment for medical conditions that preclude participation in a walking program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Hip Health and Mobility

Vancouver, British Columbia, Canada

Location

Related Publications (2)

  • 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.

    PMID: 27175291BACKGROUND
  • 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.

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Results Point of Contact

Title
Associate Professor MC Ashe
Organization
The University Of British Columbia

Study Officials

  • Maureen C Ashe, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 17, 2013

First Posted

April 29, 2013

Study Start

May 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

October 14, 2021

Results First Posted

October 14, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations