Lifestyle
Conditions
Keywords
active living, retirement
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.
Interventions
BEHAVIORALActive Living Program
BEHAVIORALEducation
Sponsors
Canadian Institutes of Health Research (CIHR)
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
55 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Study Recruitment and Retention | 6 months | The number of study participants recruited and finish the 6 month study (and final assessment). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sedentary Time (Measured by Average Daily Percent) | 6 months | sedentary time (measured by average daily percent) as measured by accelerometry |
| Physical Activity | 6 months | steps counts as measured by accelerometry |
| Body Composition | 6 months | body weight measured in kilograms |
| Active Transportation | 6 months | Self reported description of minutes/week of active transportation (e.g., walking, cycling, etc.) |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 13 |
| 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 | 12 |
| Total | 25 |
Baseline characteristics
| Characteristic | Active Living Program | Education | Total |
|---|---|---|---|
| Age, Customized aged 55-70 years | 13 Participants | 12 Participants | 25 Participants |
| Region of Enrollment Canada | 12 participants | 8 participants | 20 participants |
| Sex: Female, Male Female | 12 Participants | 8 Participants | 20 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 12 |
| other Total, other adverse events | 0 / 13 | 0 / 12 |
| serious Total, serious adverse events | 0 / 13 | 0 / 12 |
Outcome results
Primary
Feasibility of Study Recruitment and Retention
The number of study participants recruited and finish the 6 month study (and final assessment).
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Living Program | Feasibility of Study Recruitment and Retention | 12 Participants |
| Education | Feasibility of Study Recruitment and Retention | 8 Participants |
Secondary
Active Transportation
Self reported description of minutes/week of active transportation (e.g., walking, cycling, etc.)
Time frame: 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Active Living Program | Active Transportation | 396 mins/week |
| Education | Active Transportation | 272.3 mins/week |
Secondary
Body Composition
body weight measured in kilograms
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Living Program | Body Composition | 67.33 kgs | Standard Deviation 18.57 |
| Education | Body Composition | 91.6 kgs | Standard Deviation 19.04 |
Secondary
Physical Activity
steps counts as measured by accelerometry
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Living Program | Physical Activity | 7606 steps/day | Standard Deviation 3917 |
| Education | Physical Activity | 4593 steps/day | Standard Deviation 663 |
Secondary
Sedentary Time (Measured by Average Daily Percent)
sedentary time (measured by average daily percent) as measured by accelerometry
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Living Program | Sedentary Time (Measured by Average Daily Percent) | 66.17 percentage of day | Standard Deviation 7.06 |
| Education | Sedentary Time (Measured by Average Daily Percent) | 67.23 percentage of day | Standard Deviation 4.68 |