A Mobile Health App to Reduce Sedentary Time in Inactive Employees

Physical Activity Clinical Trial

Official title:

Testing the Efficacy of the ENCOURAGE App in Decreasing Sedentary Behaviour: A Time Series Quasi-Experimental Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03403270
• Other study ID #: H2016:228
• Status: Not yet recruiting
• Phase: N/A
• First received: October 12, 2017
• Last updated: January 10, 2018
• Start date: January 31, 2018
• Est. completion date: January 1, 2019

Study information

• Verified date: January 2018
• Source: St. Boniface General Hospital Research Centre
• Contact: Todd A Duhamel, Ph.D.
• Phone: (204) 474-8922
• Email: TDuhamel[@]sbrc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: January 1, 2019
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Physical Activity
• Sedentary Lifestyle

Intervention

Other:
• ENCOURAGE App
Users will have an opportunity to engage with the app as described for the duration of the study period.

Locations

Country	Name	City	State
Canada	St-Boniface Hospital Albrechtsen Research Center	Winnipeg	Manitoba

Sponsors (3)

Lead Sponsor	Collaborator
St. Boniface General Hospital Research Centre	Heart and Stroke Foundation Manitoba, Tactica Interactive Winnipeg

Country where clinical trial is conducted

Canada, 

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* Note: There are 40 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of breaks from sitting	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	Number of breaks from sitting	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
Secondary	Duration of breaks from sitting	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
Secondary	Percent time spent sitting at work	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
Secondary	Percent time spent standing at work	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
Secondary	Percent time spent walking at work	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
Secondary	Percent time spent participating in heavy labour at work	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
Secondary	Mild physical activity	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
Secondary	Moderate physical activity	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
Secondary	Strenuous physical activity	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
Secondary	Degree of confidence to break up sitting time	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
Secondary	Degree of confidence for engaging in self-regulatory actions that would help them reduce their sedentary time	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
Secondary	Degree of confidence for reducing their sedentary behaviours even when faced with feeling tired at work	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
Secondary	Degree of confidence for reducing their sedentary behaviours even when faced with feeling comfortable in their seated position at work	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
Secondary	Degree of confidence for reducing their sedentary behaviours even when having important tasks to do while seated at work	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
Secondary	Degree of confidence for reducing their sedentary behaviours even when feeling as if they deserve to sit at work	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
Secondary	Degree of confidence for reducing their sedentary behaviours even when feeling stressed at work	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
Secondary	Degree of confidence for reducing their sedentary behaviours even when feeling down or depressed at work	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
Secondary	Total sedentary time	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
Secondary	Prolonged bouts of sedentary time lasting at least 30 minutes	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