Clinical trial NCT03403270: A Mobile Health App to Reduce Sedentary Time in Inactive Employees
Official title: Testing the Efficacy of the ENCOURAGE App in Decreasing Sedentary Behaviour: A Time Series Quasi-Experimental Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Physical Activity
Sedentary Lifestyle
Keywords: Mobile App
Sedentary Behaviour
Workplace Wellness
Sitting Time
Lead sponsor: St. Boniface Hospital
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation Manitoba
name: Tactica Interactive Winnipeg
First posted: 2018-01-18
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Time Series Quasi-Experiment
Primary purpose: PREVENTION

Brief summary: The ENCOURAGE App will use mobile health technology to support employees to reduce their sedentary time and become more physically active. The mobile app has been developed using time management techniques (i.e. Pomodoro technique) as a strategy to provide prompts to encourage users to engage in an activity and break up bouts of prolonged sitting.

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:

1. 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.
2. 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:

1. Reduces the number of breaks from sitting;
2. Reduces total sedentary time;
3. Increases physical activity levels; and,
4. Improves self-efficacy for reducing sedentary behaviour.

Eligibility criteria: 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

Primary outcomes:
measure: Number of breaks from sitting
timeFrame: Change from baseline number of breaks from sitting at 1-month
Secondary outcomes:
measure: Number of breaks from sitting
timeFrame: Change from baseline number of breaks from sitting at 1-week, 2-months, 3-months, 4-months, 5-months, and 6-months
measure: Duration of breaks from sitting
timeFrame: Change from baseline duration of breaks from sitting at 1-week, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
measure: Percent time spent sitting at work
timeFrame: Change from baseline percent time spent sitting at work at 1-week, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
measure: Percent time spent standing at work
timeFrame: Change from baseline percent time spent standing at work at 1-week, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
measure: Percent time spent walking at work
timeFrame: Change from baseline percent time spent walking at work at 1-week, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
measure: Percent time spent participating in heavy labour at work
timeFrame: 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
measure: Mild physical activity
timeFrame: 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
measure: Moderate physical activity
timeFrame: 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
measure: Strenuous physical activity
timeFrame: 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
measure: Degree of confidence to break up sitting time
timeFrame: 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
measure: Degree of confidence for engaging in self-regulatory actions that would help them reduce their sedentary time
timeFrame: 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
measure: Degree of confidence for reducing their sedentary behaviours even when faced with feeling tired at work
timeFrame: 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
measure: Degree of confidence for reducing their sedentary behaviours even when faced with feeling comfortable in their seated position at work
timeFrame: 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
measure: Degree of confidence for reducing their sedentary behaviours even when having important tasks to do while seated at work
timeFrame: 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
measure: Degree of confidence for reducing their sedentary behaviours even when feeling as if they deserve to sit at work
timeFrame: 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
measure: Degree of confidence for reducing their sedentary behaviours even when feeling stressed at work
timeFrame: 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
measure: Degree of confidence for reducing their sedentary behaviours even when feeling down or depressed at work
timeFrame: 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
measure: Total sedentary time
timeFrame: Change from baseline total sedentary time at 1-week, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
measure: Prolonged bouts of sedentary time lasting at least 30 minutes
timeFrame: 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
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: St-Boniface Hospital Albrechtsen Research Center
state: Manitoba
Study officials:
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