A Mobile Health App to Reduce Sedentary Time in Inactive Employees

NCT ID: NCT03403270

Last Updated: 2018-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-31

Study Completion Date

2019-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Physical Activity Sedentary Lifestyle

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Time Series Quasi-Experiment
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

ENCOURAGE App

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ENCOURAGE App

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Heart and Stroke Foundation Manitoba

UNKNOWN

Sponsor Role collaborator

Tactica Interactive Winnipeg

UNKNOWN

Sponsor Role collaborator

St. Boniface Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

St-Boniface Hospital Albrechtsen Research Center

Winnipeg, Manitoba, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Todd A Duhamel, Ph.D.

Role: CONTACT

(204) 474-8922

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Karen Swanson

Role: primary

204-235-3206

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 21232666 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20065160 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22890825 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21767729 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21238866 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20837291 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21510585 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23101767 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25934982 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24355669 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22898122 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26984326 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22383591 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22575081 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23349621 (View on PubMed)

Hurling R, Catt M, Boni MD, Fairley BW, Hurst T, Murray P, Richardson A, Sodhi JS. Using internet and mobile phone technology to deliver an automated physical activity program: randomized controlled trial. J Med Internet Res. 2007 Apr 27;9(2):e7. doi: 10.2196/jmir.9.2.e7.

Reference Type BACKGROUND
PMID: 17478409 (View on PubMed)

Stephens J, Allen J. Mobile phone interventions to increase physical activity and reduce weight: a systematic review. J Cardiovasc Nurs. 2013 Jul-Aug;28(4):320-9. doi: 10.1097/JCN.0b013e318250a3e7.

Reference Type BACKGROUND
PMID: 22635061 (View on PubMed)

Fanning J, Mullen SP, McAuley E. Increasing physical activity with mobile devices: a meta-analysis. J Med Internet Res. 2012 Nov 21;14(6):e161. doi: 10.2196/jmir.2171.

Reference Type BACKGROUND
PMID: 23171838 (View on PubMed)

Abraham C, Michie S. A taxonomy of behavior change techniques used in interventions. Health Psychol. 2008 May;27(3):379-87. doi: 10.1037/0278-6133.27.3.379.

Reference Type BACKGROUND
PMID: 18624603 (View on PubMed)

Michie S, Richardson M, Johnston M, Abraham C, Francis J, Hardeman W, Eccles MP, Cane J, Wood CE. The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann Behav Med. 2013 Aug;46(1):81-95. doi: 10.1007/s12160-013-9486-6.

Reference Type BACKGROUND
PMID: 23512568 (View on PubMed)

Mohr DC, Cheung K, Schueller SM, Hendricks Brown C, Duan N. Continuous evaluation of evolving behavioral intervention technologies. Am J Prev Med. 2013 Oct;45(4):517-23. doi: 10.1016/j.amepre.2013.06.006.

Reference Type BACKGROUND
PMID: 24050429 (View on PubMed)

Collins LM, Murphy SA, Strecher V. The multiphase optimization strategy (MOST) and the sequential multiple assignment randomized trial (SMART): new methods for more potent eHealth interventions. Am J Prev Med. 2007 May;32(5 Suppl):S112-8. doi: 10.1016/j.amepre.2007.01.022.

Reference Type BACKGROUND
PMID: 17466815 (View on PubMed)

Kumar S, Nilsen WJ, Abernethy A, Atienza A, Patrick K, Pavel M, Riley WT, Shar A, Spring B, Spruijt-Metz D, Hedeker D, Honavar V, Kravitz R, Lefebvre RC, Mohr DC, Murphy SA, Quinn C, Shusterman V, Swendeman D. Mobile health technology evaluation: the mHealth evidence workshop. Am J Prev Med. 2013 Aug;45(2):228-36. doi: 10.1016/j.amepre.2013.03.017.

Reference Type BACKGROUND
PMID: 23867031 (View on PubMed)

Williams SL, French DP. What are the most effective intervention techniques for changing physical activity self-efficacy and physical activity behaviour--and are they the same? Health Educ Res. 2011 Apr;26(2):308-22. doi: 10.1093/her/cyr005. Epub 2011 Feb 14.

Reference Type BACKGROUND
PMID: 21321008 (View on PubMed)

Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583.

Reference Type BACKGROUND
PMID: 23295957 (View on PubMed)

Eysenbach G; CONSORT-EHEALTH Group. CONSORT-EHEALTH: improving and standardizing evaluation reports of Web-based and mobile health interventions. J Med Internet Res. 2011 Dec 31;13(4):e126. doi: 10.2196/jmir.1923.

Reference Type BACKGROUND
PMID: 22209829 (View on PubMed)

Prochaska JO, DiClemente CC. Stages and processes of self-change of smoking: toward an integrative model of change. J Consult Clin Psychol. 1983 Jun;51(3):390-5. doi: 10.1037//0022-006x.51.3.390. No abstract available.

Reference Type BACKGROUND
PMID: 6863699 (View on PubMed)

Michie S, Ashford S, Sniehotta FF, Dombrowski SU, Bishop A, French DP. A refined taxonomy of behaviour change techniques to help people change their physical activity and healthy eating behaviours: the CALO-RE taxonomy. Psychol Health. 2011 Nov;26(11):1479-98. doi: 10.1080/08870446.2010.540664. Epub 2011 Jun 28.

Reference Type BACKGROUND
PMID: 21678185 (View on PubMed)

Pedisic Z, Bennie JA, Timperio AF, Crawford DA, Dunstan DW, Bauman AE, Salmon J. Workplace Sitting Breaks Questionnaire (SITBRQ): an assessment of concurrent validity and test-retest reliability. BMC Public Health. 2014 Dec 5;14:1249. doi: 10.1186/1471-2458-14-1249.

Reference Type BACKGROUND
PMID: 25476788 (View on PubMed)

Maclagan LC, Park J, Sanmartin C, Mathur KR, Roth D, Manuel DG, Gershon A, Booth GL, Bhatia S, Atzema CL, Tu JV. The CANHEART health index: a tool for monitoring the cardiovascular health of the Canadian population. CMAJ. 2014 Feb 18;186(3):180-7. doi: 10.1503/cmaj.131358. Epub 2013 Dec 23.

Reference Type BACKGROUND
PMID: 24366893 (View on PubMed)

Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

Reference Type BACKGROUND
PMID: 11556941 (View on PubMed)

Blumenthal JA. Depression and coronary heart disease: association and implications for treatment. Cleve Clin J Med. 2008 Mar;75 Suppl 2:S48-53. doi: 10.3949/ccjm.75.suppl_2.s48.

Reference Type BACKGROUND
PMID: 18540147 (View on PubMed)

Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.

Reference Type BACKGROUND
PMID: 4053261 (View on PubMed)

Chau JY, Van Der Ploeg HP, Dunn S, Kurko J, Bauman AE. Validity of the occupational sitting and physical activity questionnaire. Med Sci Sports Exerc. 2012 Jan;44(1):118-25. doi: 10.1249/MSS.0b013e3182251060.

Reference Type BACKGROUND
PMID: 21659903 (View on PubMed)

Rothney MP, Schaefer EV, Neumann MM, Choi L, Chen KY. Validity of physical activity intensity predictions by ActiGraph, Actical, and RT3 accelerometers. Obesity (Silver Spring). 2008 Aug;16(8):1946-52. doi: 10.1038/oby.2008.279. Epub 2008 May 29.

Reference Type BACKGROUND
PMID: 18535553 (View on PubMed)

Colley RC, Tremblay MS. Moderate and vigorous physical activity intensity cut-points for the Actical accelerometer. J Sports Sci. 2011 May;29(8):783-9. doi: 10.1080/02640414.2011.557744.

Reference Type BACKGROUND
PMID: 21424979 (View on PubMed)

Welk GJ, Schaben JA, Morrow JR Jr. Reliability of accelerometry-based activity monitors: a generalizability study. Med Sci Sports Exerc. 2004 Sep;36(9):1637-45.

Reference Type BACKGROUND
PMID: 15354049 (View on PubMed)

Holmen H, Torbjornsen A, Wahl AK, Jenum AK, Smastuen MC, Arsand E, Ribu L. A Mobile Health Intervention for Self-Management and Lifestyle Change for Persons With Type 2 Diabetes, Part 2: One-Year Results From the Norwegian Randomized Controlled Trial RENEWING HEALTH. JMIR Mhealth Uhealth. 2014 Dec 11;2(4):e57. doi: 10.2196/mhealth.3882.

Reference Type BACKGROUND
PMID: 25499872 (View on PubMed)

Kannisto KA, Korhonen J, Adams CE, Koivunen MH, Vahlberg T, Valimaki MA. Factors Associated With Dropout During Recruitment and Follow-Up Periods of a mHealth-Based Randomized Controlled Trial for Mobile.Net to Encourage Treatment Adherence for People With Serious Mental Health Problems. J Med Internet Res. 2017 Feb 21;19(2):e46. doi: 10.2196/jmir.6417.

Reference Type BACKGROUND
PMID: 28223262 (View on PubMed)

Fukuoka Y, Gay C, Haskell W, Arai S, Vittinghoff E. Identifying Factors Associated With Dropout During Prerandomization Run-in Period From an mHealth Physical Activity Education Study: The mPED Trial. JMIR Mhealth Uhealth. 2015 Apr 13;3(2):e34. doi: 10.2196/mhealth.3928.

Reference Type BACKGROUND
PMID: 25872754 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H2016:228

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

MapTrek for Sedentary Workers
NCT03109535 COMPLETED NA
Enduring Exercise Habits
NCT03634423 COMPLETED NA