- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03403270
A Mobile Health App to Reduce Sedentary Time in Inactive Employees
Testing the Efficacy of the ENCOURAGE App in Decreasing Sedentary Behaviour: A Time Series Quasi-Experimental Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Sixty percent of Canadian adults are accessible through the workplace. Thus, workplace wellness programs that include physical activity components provide a viable option to encourage employees to reduce sedentary time. Moving forward with the ENCOURAGE health promotion model, we will use mobile health technology to support employees to reduce sitting and become more physically active, while offering employers a solution that can be easily implemented in a variety of contexts.
The public release of the ENCOURAGE App will involve two phases:
- The recruitment of up to 300 individuals through the App. Any user will be able to download the ENCOURAGE App through the iTunes Store or Google Play. Note that when participants download the App, they are not automatically enrolled in the study. Participants will be prompted, after downloading the App, with a brief description of the study, as well as a pre-screening tool that will be used to determine eligibility. Users will be asked via a pop-up to determine if they wish to participate in a research project. Users will be asked to participate in a time series quasi-experimental study to determine if the ENCOURAGE App can support participants to increase the number of breaks in sedentary time taken throughout the day, over a 6-month time period. The App can be customized by the users to set prompts at intervals that fit into their schedule. For example, these activities can range from a stretching activity (e.g., a neck stretch), a standing activity (e.g., stand and read), or a physical activity (e.g., fill up the printer with paper, do a squat). Additionally, the App will use Behaviour Change Techniques as a strategy to support participants as they reduce their sedentary behaviour and increase their physical activity levels.
- The recruitment of a sub-sample of 60 participants who live in Winnipeg, MB which will be drawn from the larger sample. In addition to completing all the components of the larger research study, the sub-sample will be also asked to wear a physical activity monitor, called an accelerometer.
The objectives of this study are to determine if the final product ENCOURAGE App:
- Reduces the number of breaks from sitting;
- Reduces total sedentary time;
- Increases physical activity levels; and,
- Improves self-efficacy for reducing sedentary behaviour.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R2H 2A6
- St-Boniface Hospital Albrechtsen Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
-Specific to sub-sample of 60 participants; live in Winnipeg, MB
Exclusion Criteria:
- Individuals who do not own a personal mobile phone
- Any physical limitations that would not allow individual to engage in physical activity
- Any cognitive limitations that would not allow individual to consent for study
- Specific to sub-sample of 60 participants; live outside Winnipeg, MB
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: ENCOURAGE App Intervention
Users will download the ENCOURAGE mobile app.
The App uses a time management technique (i.e.
Pomodoro technique) as a strategy to provide prompts for users to engage in an activity.
The App can be customized by the users to set prompts at intervals that fit into their schedule.
For example, these activities can range from a stretching activity (e.g., a neck stretch), a standing activity (e.g., stand and read), or a physical activity (e.g., fill up the printer with paper, do a squat).
Additionally, the App will use Behaviour Change Techniques as a strategy to support participants as they reduce their sedentary behaviour and improve their physical activity levels.
The App uses a series of Behavior Change Techniques shown to be effective in promoting a more active lifestyle.
|
Users will have an opportunity to engage with the app as described for the duration of the study period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of breaks from sitting
Time Frame: Change from baseline number of breaks from sitting at 1-month
|
This outcome will be assessed by self-report using the Workplace Sitting Breaks Questionnaire.
|
Change from baseline number of breaks from sitting at 1-month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of breaks from sitting
Time Frame: Change from baseline number of breaks from sitting at 1-week, 2-months, 3-months, 4-months, 5-months, and 6-months
|
This outcome will be assessed by self-report using the Workplace Sitting Breaks Questionnaire in a typical work day
|
Change from baseline number of breaks from sitting at 1-week, 2-months, 3-months, 4-months, 5-months, and 6-months
|
|
Duration of breaks from sitting
Time Frame: Change from baseline duration of breaks from sitting at 1-week, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
|
This outcome will be assessed by self-report using the Workplace Sitting Breaks in a typical work day.
|
Change from baseline duration of breaks from sitting at 1-week, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
|
|
Percent time spent sitting at work
Time Frame: Change from baseline percent time spent sitting at work at 1-week, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
|
This outcome will be assessed by the Occupational Sitting and Physical Activity Questionnaire over the last 7 days
|
Change from baseline percent time spent sitting at work at 1-week, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
|
|
Percent time spent standing at work
Time Frame: Change from baseline percent time spent standing at work at 1-week, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
|
This outcome will be assessed by the Occupational Sitting and Physical Activity Questionnaire over the last 7 days
|
Change from baseline percent time spent standing at work at 1-week, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
|
|
Percent time spent walking at work
Time Frame: Change from baseline percent time spent walking at work at 1-week, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
|
This outcome will be assessed by the Occupational Sitting and Physical Activity Questionnaire over the last 7 days
|
Change from baseline percent time spent walking at work at 1-week, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
|
|
Percent time spent participating in heavy labour at work
Time Frame: Change from baseline percent time spent participating in heavy labour at work at 1-week, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
|
This outcome will be assessed by the Occupational Sitting and Physical Activity over the last 7 days
|
Change from baseline percent time spent participating in heavy labour at work at 1-week, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
|
|
Mild physical activity
Time Frame: Change from baseline minutes per week in mild physical activity at 1-week, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
|
This outcome will be assessed by the Godin Leisure-Time Exercise Questionnaire in minutes per week
|
Change from baseline minutes per week in mild physical activity at 1-week, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
|
|
Moderate physical activity
Time Frame: Change from baseline minutes per week in moderate physical activity at 1-week, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
|
This outcome will be assessed by the Godin Leisure-Time Exercise Questionnaire in minutes per week
|
Change from baseline minutes per week in moderate physical activity at 1-week, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
|
|
Strenuous physical activity
Time Frame: Change from baseline minutes per week in strenuous physical activity at 1-week, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
|
This outcome will be assessed by the Godin Leisure-Time Exercise Questionnaire in minutes per week
|
Change from baseline minutes per week in strenuous physical activity at 1-week, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
|
|
Degree of confidence to break up sitting time
Time Frame: Change from baseline degree of confidence to break up sitting time at 1-week, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
|
This outcome will be assessed by the Task Self-Efficacy for Sedentary Behaviour Questionnaire using a scale from 0 (i.e.
not at all confident) to 10 (i.e.
completely confident)
|
Change from baseline degree of confidence to break up sitting time at 1-week, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
|
|
Degree of confidence for engaging in self-regulatory actions that would help them reduce their sedentary time
Time Frame: Change from baseline degree of confidence for engaging in self-regulatory actions that would help them reduce their sedentary time at 1-week, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
|
This outcome will be assessed by the Self-Regulatory Efficacy for Sedentary Behaviour Questionnaire using a scale from 0 (i.e.
not at all confident) to 10 (i.e.
completely confident)
|
Change from baseline degree of confidence for engaging in self-regulatory actions that would help them reduce their sedentary time at 1-week, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
|
|
Degree of confidence for reducing their sedentary behaviours even when faced with feeling tired at work
Time Frame: Change from baseline for reducing their sedentary behaviours even when faced with feeling tired at work at 1-week, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
|
This outcome will be assessed by the Self-Regulatory Efficacy for Managing Barriers Questionnaire using a scale from 10 (i.e.
not at all confident) to 100 (i.e.
completely confident)
|
Change from baseline for reducing their sedentary behaviours even when faced with feeling tired at work at 1-week, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
|
|
Degree of confidence for reducing their sedentary behaviours even when faced with feeling comfortable in their seated position at work
Time Frame: Change from baseline for reducing their sedentary behaviours even when faced with feeling comfortable in their seated position at work at 1-week, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
|
This outcome will be assessed by the Self-Regulatory Efficacy for Managing Barriers Questionnaire using a scale from 10 (i.e.
not at all confident) to 100 (i.e.
completely confident)
|
Change from baseline for reducing their sedentary behaviours even when faced with feeling comfortable in their seated position at work at 1-week, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
|
|
Degree of confidence for reducing their sedentary behaviours even when having important tasks to do while seated at work
Time Frame: Change from baseline for reducing their sedentary behaviours even when having important tasks to do while seated at work at 1-week, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
|
This outcome will be assessed by the Self-Regulatory Efficacy for Managing Barriers Questionnaire using a scale from 10 (i.e.
not at all confident) to 100 (i.e.
completely confident)
|
Change from baseline for reducing their sedentary behaviours even when having important tasks to do while seated at work at 1-week, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
|
|
Degree of confidence for reducing their sedentary behaviours even when feeling as if they deserve to sit at work
Time Frame: Change from baseline for reducing their sedentary behaviours even when feeling as if they deserve to sit at work at 1-week, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
|
This outcome will be assessed by the Self-Regulatory Efficacy for Managing Barriers Questionnaire using a scale from 10 (i.e.
not at all confident) to 100 (i.e.
completely confident)
|
Change from baseline for reducing their sedentary behaviours even when feeling as if they deserve to sit at work at 1-week, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
|
|
Degree of confidence for reducing their sedentary behaviours even when feeling stressed at work
Time Frame: Change from baseline for reducing their sedentary behaviours even when feeling stressed at work at 1-week, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
|
This outcome will be assessed by the Self-Regulatory Efficacy for Managing Barriers Questionnaire using a scale from 10 (i.e.
not at all confident) to 100 (i.e.
completely confident)
|
Change from baseline for reducing their sedentary behaviours even when feeling stressed at work at 1-week, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
|
|
Degree of confidence for reducing their sedentary behaviours even when feeling down or depressed at work
Time Frame: Change from baseline for reducing their sedentary behaviours even when feeling down or depressed at work at 1-week, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
|
This outcome will be assessed by the Self-Regulatory Efficacy for Managing Barriers Questionnaire using a scale from 10 (i.e.
not at all confident) to 100 (i.e.
completely confident)
|
Change from baseline for reducing their sedentary behaviours even when feeling down or depressed at work at 1-week, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
|
|
Total sedentary time
Time Frame: Change from baseline total sedentary time at 1-week, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
|
Sub-sample of 60 individuals will wear an accelerometer to measure their total sedentary time (hours per day)
|
Change from baseline total sedentary time at 1-week, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
|
|
Prolonged bouts of sedentary time lasting at least 30 minutes
Time Frame: Change from baseline prolonged bouts of sedentary time lasting at least 30 minutes at 1-week, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
|
Sub-sample of 60 individuals will wear an accelerometer to measure their prolonged bouts of sedentary time lasting at least 30 minutes (number per day)
|
Change from baseline prolonged bouts of sedentary time lasting at least 30 minutes at 1-week, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
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Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- H2016:228
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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