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A Mobile Health App to Reduce Sedentary Time in Inactive Employees

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ClinicalTrials.gov Identifier: NCT03403270
Recruitment Status : Not yet recruiting
First Posted : January 18, 2018
Last Update Posted : January 18, 2018
Sponsor:
Collaborators:
Heart and Stroke Foundation Manitoba
Tactica Interactive Winnipeg
Information provided by (Responsible Party):
St. Boniface General Hospital Research Centre

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.

Condition or disease Intervention/treatment Phase
Physical Activity Sedentary Lifestyle Other: ENCOURAGE App Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Time Series Quasi-Experiment
Masking: None (Open Label)
Masking Description: Outcome Assessors will not be aware of previous research data collected. As this is a single group study, all participants will receive the intervention as described.
Primary Purpose: Prevention
Official Title: Testing the Efficacy of the ENCOURAGE App in Decreasing Sedentary Behaviour: A Time Series Quasi-Experimental Study
Estimated Study Start Date : January 31, 2018
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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)

  11. 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)

  12. 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)

  13. 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)

  14. 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)

  15. 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)

  16. 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)

  17. 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)

  18. 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)

  19. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03403270


Contacts
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Contact: Todd A Duhamel, Ph.D. (204) 474-8922 TDuhamel@sbrc.ca

Locations
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Canada, Manitoba
St-Boniface Hospital Albrechtsen Research Center Not yet recruiting
Winnipeg, Manitoba, Canada, R2H 2A6
Contact: Karen Swanson    204-235-3206    kswanson@sbrc.ca   
Principal Investigator: Todd A Duhamel         
Sponsors and Collaborators
St. Boniface General Hospital Research Centre
Heart and Stroke Foundation Manitoba
Tactica Interactive Winnipeg
  Study Documents (Full-Text)

Documents provided by St. Boniface General Hospital Research Centre:
Statistical Analysis Plan  [PDF] November 6, 2017
Study Protocol  [PDF] March 1, 2017


Publications:

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Responsible Party: St. Boniface General Hospital Research Centre
ClinicalTrials.gov Identifier: NCT03403270     History of Changes
Other Study ID Numbers: H2016:228
First Posted: January 18, 2018    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not intend to share individual participant data with researchers outside of the principal and co-investigators.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by St. Boniface General Hospital Research Centre:
Mobile App
Sedentary Behaviour
Workplace Wellness
Sitting Time