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

• Sponsor: University of British Columbia (Other)
• Overall Status: Completed
• CT.gov ID: NCT01842061
• Collaborator: Canadian Institutes of Health Research (CIHR) (Other)
• Enrollment: 25
• Location: 1
• Arms: 2
• Duration (Months): 7
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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 1, 2013
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Feasibility of Study Recruitment and Retention [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) [6 months]

   sedentary time (measured by average daily percent) as measured by accelerometry

2. Physical Activity [6 months]

   steps counts as measured by accelerometry

3. Body Composition [6 months]

   body weight measured in kilograms

4. Active Transportation [6 months]

   Self reported description of minutes/week of active transportation (e.g., walking, cycling, etc.)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Maureen C. Ashe, Principal Investigator, University of British Columbia
• ClinicalTrials.gov Identifier: NCT01842061
• Other Study ID Numbers: H13-00518
• First Posted: Apr 29, 2013
• Last Update Posted: Oct 14, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Maureen C. Ashe, Principal Investigator, University of British Columbia: active living; retirement

Study Results

Participant Flow

Arm/Group Title	Active Living Program	Education
Arm/Group Description	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. Active Living Program	Control group participants will be offered monthly drop-in sessions that target information on general health and well-being unrelated to physical activity. Education
Period Title: Overall Study
STARTED	13	12
COMPLETED	12	8
NOT COMPLETED	1	4

Baseline Characteristics

Arm/Group Title	Active Living Program	Education	Total
Arm/Group Description	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. Active Living Program	Control group participants will be offered monthly drop-in sessions that target information on general health and well-being unrelated to physical activity. Education	Total of all reporting groups
Overall Participants	13	12	25
Age, Customized (Count of Participants)
aged 55-70 years	13 100%	12 100%	25 100%
Sex: Female, Male (Count of Participants)
Female	12 92.3%	8 66.7%	20 80%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Canada	12 92.3%	8 66.7%	20 80%

Outcome Measures

1. Primary Outcome

Title	Feasibility of Study Recruitment and Retention
Description	The number of study participants recruited and finish the 6 month study (and final assessment).
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active Living Program	Education
Arm/Group Description	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. Active Living Program	Control group participants will be offered monthly drop-in sessions that target information on general health and well-being unrelated to physical activity. Education
Measure Participants	12	8
Count of Participants [Participants]	12 92.3%	8 66.7%

2. Secondary Outcome

Title	Sedentary Time (Measured by Average Daily Percent)
Description	sedentary time (measured by average daily percent) as measured by accelerometry
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active Living Program	Education
Arm/Group Description	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. Active Living Program	Control group participants will be offered monthly drop-in sessions that target information on general health and well-being unrelated to physical activity. Education
Measure Participants	12	7
Mean (Standard Deviation) [percentage of day]	66.17 (7.06)	67.23 (4.68)

3. Secondary Outcome

Title	Physical Activity
Description	steps counts as measured by accelerometry
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active Living Program	Education
Arm/Group Description	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. Active Living Program	Control group participants will be offered monthly drop-in sessions that target information on general health and well-being unrelated to physical activity. Education
Measure Participants	12	7
Mean (Standard Deviation) [steps/day]	7606 (3917)	4593 (663)

4. Secondary Outcome

Title	Body Composition
Description	body weight measured in kilograms
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active Living Program	Education
Arm/Group Description	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. Active Living Program	Control group participants will be offered monthly drop-in sessions that target information on general health and well-being unrelated to physical activity. Education
Measure Participants	12	8
Mean (Standard Deviation) [kgs]	67.33 (18.57)	91.6 (19.04)

5. Secondary Outcome

Title	Active Transportation
Description	Self reported description of minutes/week of active transportation (e.g., walking, cycling, etc.)
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active Living Program	Education
Arm/Group Description	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. Active Living Program	Control group participants will be offered monthly drop-in sessions that target information on general health and well-being unrelated to physical activity. Education
Measure Participants	12	8
Median (Inter-Quartile Range) [mins/week]	396	272.3

Adverse Events

Arm/Group Title	Active Living Program		Education
Arm/Group Description	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. Active Living Program		Control group participants will be offered monthly drop-in sessions that target information on general health and well-being unrelated to physical activity. Education
All Cause Mortality
	Active Living Program		Education
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/12 (0%)
Serious Adverse Events
	Active Living Program		Education
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	Active Living Program		Education
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/12 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.