Trial Outcomes & Findings for Everyday Activity Supports You (EASY) Pilot Study (NCT NCT01842061)
NCT ID: NCT01842061
Last Updated: 2021-10-14
Results Overview
The number of study participants recruited and finish the 6 month study (and final assessment).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
6 months
Results posted on
2021-10-14
Participant Flow
Participant milestones
| Measure |
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.
Active Living Program
|
Education
Control group participants will be offered monthly drop-in sessions that target information on general health and well-being unrelated to physical activity.
Education
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
12
|
|
Overall Study
COMPLETED
|
12
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
1 participant in the intervention group did not complete the study, and 4 participants in the control group did not complete the study.
Baseline characteristics by cohort
| Measure |
Active Living Program
n=13 Participants
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
|
Education
n=12 Participants
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
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
aged 55-70 years
|
13 Participants
n=13 Participants
|
12 Participants
n=12 Participants
|
25 Participants
n=25 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=12 Participants • 1 participant in the intervention group did not complete the study, and 4 participants in the control group did not complete the study.
|
8 Participants
n=8 Participants • 1 participant in the intervention group did not complete the study, and 4 participants in the control group did not complete the study.
|
20 Participants
n=20 Participants • 1 participant in the intervention group did not complete the study, and 4 participants in the control group did not complete the study.
|
|
Sex: Female, Male
Male
|
0 Participants
n=12 Participants • 1 participant in the intervention group did not complete the study, and 4 participants in the control group did not complete the study.
|
0 Participants
n=8 Participants • 1 participant in the intervention group did not complete the study, and 4 participants in the control group did not complete the study.
|
0 Participants
n=20 Participants • 1 participant in the intervention group did not complete the study, and 4 participants in the control group did not complete the study.
|
|
Region of Enrollment
Canada
|
12 participants
n=12 Participants • 1 participant from the intervention and 4 participants in the control group did not complete the study.
|
8 participants
n=8 Participants • 1 participant from the intervention and 4 participants in the control group did not complete the study.
|
20 participants
n=20 Participants • 1 participant from the intervention and 4 participants in the control group did not complete the study.
|
PRIMARY outcome
Timeframe: 6 monthsThe number of study participants recruited and finish the 6 month study (and final assessment).
Outcome measures
| Measure |
Active Living Program
n=12 Participants
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
|
Education
n=8 Participants
Control group participants will be offered monthly drop-in sessions that target information on general health and well-being unrelated to physical activity.
Education
|
|---|---|---|
|
Feasibility of Study Recruitment and Retention
|
12 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 6 monthssedentary time (measured by average daily percent) as measured by accelerometry
Outcome measures
| Measure |
Active Living Program
n=12 Participants
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
|
Education
n=7 Participants
Control group participants will be offered monthly drop-in sessions that target information on general health and well-being unrelated to physical activity.
Education
|
|---|---|---|
|
Sedentary Time (Measured by Average Daily Percent)
|
66.17 percentage of day
Standard Deviation 7.06
|
67.23 percentage of day
Standard Deviation 4.68
|
SECONDARY outcome
Timeframe: 6 monthssteps counts as measured by accelerometry
Outcome measures
| Measure |
Active Living Program
n=12 Participants
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
|
Education
n=7 Participants
Control group participants will be offered monthly drop-in sessions that target information on general health and well-being unrelated to physical activity.
Education
|
|---|---|---|
|
Physical Activity
|
7606 steps/day
Standard Deviation 3917
|
4593 steps/day
Standard Deviation 663
|
SECONDARY outcome
Timeframe: 6 monthsbody weight measured in kilograms
Outcome measures
| Measure |
Active Living Program
n=12 Participants
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
|
Education
n=8 Participants
Control group participants will be offered monthly drop-in sessions that target information on general health and well-being unrelated to physical activity.
Education
|
|---|---|---|
|
Body Composition
|
67.33 kgs
Standard Deviation 18.57
|
91.6 kgs
Standard Deviation 19.04
|
SECONDARY outcome
Timeframe: 6 monthsSelf reported description of minutes/week of active transportation (e.g., walking, cycling, etc.)
Outcome measures
| Measure |
Active Living Program
n=12 Participants
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
|
Education
n=8 Participants
Control group participants will be offered monthly drop-in sessions that target information on general health and well-being unrelated to physical activity.
Education
|
|---|---|---|
|
Active Transportation
|
396 mins/week
Interval 231.0 to 841.5
|
272.3 mins/week
Interval 0.0 to 321.8
|
Adverse Events
Active Living Program
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Associate Professor MC Ashe
The University Of British Columbia
Phone: 604-675-2574
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place