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Physical ActivityNCT03403270

A Mobile Health App to Reduce Sedentary Time in Inactive Employees

A study testing ENCOURAGE App in people with Physical Activity and Sedentary Lifestyle, run by St. Boniface Hospital at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Physical Activity, Sedentary Lifestyle
What is being tested?
ENCOURAGE App
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteCanada
Study dates
31 Jan 2018to 1 Jan 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • -Specific to sub-sample of 60 participants; live in Winnipeg, MB

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Todd A Duhamel, Ph.D. contact

(204) 474-8922

TDuhamel@sbrc.ca

Canada1 site
  • St-Boniface Hospital Albrechtsen Research Center

    Winnipeg, Manitoba, R2H 2A6

    Karen Swanson, 204-235-3206, kswanson@sbrc.ca

    Todd A Duhamel

Other trials in Canada

About this study

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

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.

Read the 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.
Being tested
ENCOURAGE App
Keywords
Mobile App, Sedentary Behaviour, Workplace Wellness, Sitting Time
Medical subject headings
Motor Activity, Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ENCOURAGE AppOther

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

Study groups in NCT03403270
Study groupRoleWhat they receive
ENCOURAGE App InterventionExperimentalUsers 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.
Receives: Other: ENCOURAGE App

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of breaks from sitting

    This outcome will be assessed by self-report using the Workplace Sitting Breaks Questionnaire.

    Measured: Change from baseline number of breaks from sitting at 1-month

Secondary outcomes (19)
  1. Number of breaks from sitting

    This outcome will be assessed by self-report using the Workplace Sitting Breaks Questionnaire in a typical work day

    Measured: Change from baseline number of breaks from sitting at 1-week, 2-months, 3-months, 4-months, 5-months, and 6-months

  2. Duration of breaks from sitting

    This outcome will be assessed by self-report using the Workplace Sitting Breaks in a typical work day.

    Measured: Change from baseline duration of breaks from sitting at 1-week, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month

  3. Percent time spent sitting at work

    This outcome will be assessed by the Occupational Sitting and Physical Activity Questionnaire over the last 7 days

    Measured: Change from baseline percent time spent sitting at work at 1-week, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month

  4. Percent time spent standing at work

    This outcome will be assessed by the Occupational Sitting and Physical Activity Questionnaire over the last 7 days

    Measured: Change from baseline percent time spent standing at work at 1-week, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month

  5. Percent time spent walking at work

    This outcome will be assessed by the Occupational Sitting and Physical Activity Questionnaire over the last 7 days

    Measured: Change from baseline percent time spent walking at work at 1-week, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month

  6. 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

    Measured: 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

  7. Mild physical activity

    This outcome will be assessed by the Godin Leisure-Time Exercise Questionnaire in minutes per week

    Measured: 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

  8. Moderate physical activity

    This outcome will be assessed by the Godin Leisure-Time Exercise Questionnaire in minutes per week

    Measured: 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

  9. Strenuous physical activity

    This outcome will be assessed by the Godin Leisure-Time Exercise Questionnaire in minutes per week

    Measured: 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

  10. 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)

    Measured: 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

  11. 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)

    Measured: 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

  12. 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)

    Measured: 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

  13. 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)

    Measured: 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

  14. 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)

    Measured: 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

  15. 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)

    Measured: 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

  16. 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)

    Measured: 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

  17. 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)

    Measured: 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

  18. Total sedentary time

    Sub-sample of 60 individuals will wear an accelerometer to measure their total sedentary time (hours per day)

    Measured: Change from baseline total sedentary time at 1-week, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month

  19. 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)

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2018
  2. Study start31 Jan 2018 (estimated)
  3. Primary completion1 Sep 2018 (estimated)
  4. Study completion1 Jan 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
Time Series Quasi-Experiment
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03403270
Sponsor's protocol ID
H2016:228
Status last verified
Jan 2018
First submitted
12 Oct 2017
Last updated
18 Jan 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: We do not intend to share individual participant data with researchers outside of the principal and co-investigators.

Publications

  • Stamatakis E, Hamer M, Dunstan DW. Screen-based entertainment time, all-cause mortality, and cardiovascular events: population-based study with ongoing mortality and hospital events follow-up. J Am Coll Cardiol. 2011 Jan 18;57(3):292-9. doi: 10.1016/j.jacc.2010.05.065.

    PubMed 21232666
  • Dunstan DW, Barr EL, Healy GN, Salmon J, Shaw JE, Balkau B, Magliano DJ, Cameron AJ, Zimmet PZ, Owen N. Television viewing time and mortality: the Australian Diabetes, Obesity and Lifestyle Study (AusDiab). Circulation. 2010 Jan 26;121(3):384-91. doi: 10.1161/CIRCULATIONAHA.109.894824. Epub 2010 Jan 11.

    PubMed 20065160
  • Wilmot EG, Edwardson CL, Achana FA, Davies MJ, Gorely T, Gray LJ, Khunti K, Yates T, Biddle SJ. Sedentary time in adults and the association with diabetes, cardiovascular disease and death: systematic review and meta-analysis. Diabetologia. 2012 Nov;55(11):2895-905. doi: 10.1007/s00125-012-2677-z. Epub 2012 Aug 14.

    PubMed 22890825
  • Thorp AA, Owen N, Neuhaus M, Dunstan DW. Sedentary behaviors and subsequent health outcomes in adults a systematic review of longitudinal studies, 1996-2011. Am J Prev Med. 2011 Aug;41(2):207-15. doi: 10.1016/j.amepre.2011.05.004.

    PubMed 21767729
  • Proper KI, Singh AS, van Mechelen W, Chinapaw MJ. Sedentary behaviors and health outcomes among adults: a systematic review of prospective studies. Am J Prev Med. 2011 Feb;40(2):174-82. doi: 10.1016/j.amepre.2010.10.015.

    PubMed 21238866
  • van Uffelen JG, Wong J, Chau JY, van der Ploeg HP, Riphagen I, Gilson ND, Burton NW, Healy GN, Thorp AA, Clark BK, Gardiner PA, Dunstan DW, Bauman A, Owen N, Brown WJ. Occupational sitting and health risks: a systematic review. Am J Prev Med. 2010 Oct;39(4):379-88. doi: 10.1016/j.amepre.2010.05.024.

    PubMed 20837291
  • Colley RC, Garriguet D, Janssen I, Craig CL, Clarke J, Tremblay MS. Physical activity of Canadian adults: accelerometer results from the 2007 to 2009 Canadian Health Measures Survey. Health Rep. 2011 Mar;22(1):7-14.

    PubMed 21510585
  • Thorp AA, Healy GN, Winkler E, Clark BK, Gardiner PA, Owen N, Dunstan DW. Prolonged sedentary time and physical activity in workplace and non-work contexts: a cross-sectional study of office, customer service and call centre employees. Int J Behav Nutr Phys Act. 2012 Oct 26;9:128. doi: 10.1186/1479-5868-9-128.

    PubMed 23101767
  • Tew GA, Posso MC, Arundel CE, McDaid CM. Systematic review: height-adjustable workstations to reduce sedentary behaviour in office-based workers. Occup Med (Lond). 2015 Jul;65(5):357-66. doi: 10.1093/occmed/kqv044. Epub 2015 May 1.

    PubMed 25934982
  • Neuhaus M, Healy GN, Dunstan DW, Owen N, Eakin EG. Workplace sitting and height-adjustable workstations: a randomized controlled trial. Am J Prev Med. 2014 Jan;46(1):30-40. doi: 10.1016/j.amepre.2013.09.009.

    PubMed 24355669
  • Evans RE, Fawole HO, Sheriff SA, Dall PM, Grant PM, Ryan CG. Point-of-choice prompts to reduce sitting time at work: a randomized trial. Am J Prev Med. 2012 Sep;43(3):293-7. doi: 10.1016/j.amepre.2012.05.010.

    PubMed 22898122
  • Shrestha N, Kukkonen-Harjula KT, Verbeek JH, Ijaz S, Hermans V, Bhaumik S. Workplace interventions for reducing sitting at work. Cochrane Database Syst Rev. 2016 Mar 17;3(3):CD010912. doi: 10.1002/14651858.CD010912.pub3.

    PubMed 26984326
  • Verweij LM, Proper KI, Weel AN, Hulshof CT, van Mechelen W. The application of an occupational health guideline reduces sedentary behaviour and increases fruit intake at work: results from an RCT. Occup Environ Med. 2012 Jul;69(7):500-7. doi: 10.1136/oemed-2011-100377. Epub 2012 Mar 1.

    PubMed 22383591
  • Allen JC, Lewis JB, Tagliaferro AR. Cost-effectiveness of health risk reduction after lifestyle education in the small workplace. Prev Chronic Dis. 2012;9:E96. doi: 10.5888/pcd9.110169. Epub 2012 May 10.

    PubMed 22575081
  • Free C, Phillips G, Galli L, Watson L, Felix L, Edwards P, Patel V, Haines A. The effectiveness of mobile-health technology-based health behaviour change or disease management interventions for health care consumers: a systematic review. PLoS Med. 2013;10(1):e1001362. doi: 10.1371/journal.pmed.1001362. Epub 2013 Jan 15.

    PubMed 23349621

Questions about this trial

What is this clinical trial studying?

A study testing ENCOURAGE App in people with Physical Activity and Sedentary Lifestyle, run by St. Boniface Hospital at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Todd A Duhamel, Ph.D. ((204) 474-8922, TDuhamel@sbrc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of breaks from sitting (time frame: Change from baseline number of breaks from sitting at 1-month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03403270, which also lists 40 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2018.

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