Physically Inactive Hospital EmployeesNCT02638675
Financial Health Incentives to Promote Physical Activity Among Hospital Employees: A Randomized Control Trial
A study testing Wellness program, Accelerometer and Incentive in people with Physically Inactive Hospital Employees, run by University of Toronto at 1 site in Canada.
Trial summary
The objective of this randomized control trial is to examine whether incentives-for-steps (i.e. $1 per day step count goals are reached) increase daily step counts among physically inactive hospital employees. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physically Inactive Hospital Employees
- What is being tested?
- Wellness program, Accelerometer and Incentive
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteCanada
- Study dates
- 6 Feb 2017to 30 Nov 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over the age of 18 years
- English speaking
Who cannot join
- Existing medical condition, which could be exacerbated by physical activity as measured by the Physical Activity Readiness Questionnaire.
- Note. Participants cannot enrol in the study without Internet access
Trial locations and contacts
1 site in 1 country.
Canada1 site
Faculty of Kinesiology and Physical Education, University of Toronto
Toronto, Ontario, M5S 2W6
About this study
Official title: Examining Financial Health Incentives to Promote Physical Activity Among Inactive Hospital Employees: A Web-based Randomized Control Trial
The objective of this randomized control trial is to examine whether incentives-for-steps (i.e. $1 per day step count goals are reached) increase daily step counts among physically inactive hospital employees.
Read the detailed description
A 24-week, parallel arm, randomized control trial will be employed to examine the impact of incentives on physical activity among physically inactive Hamilton Health Science Corporation employees. Participants will be randomly allocated (1:1) into control (i.e. wellness program and accelerometer) or intervention groups (i.e. wellness program, accelerometer, incentives), where only intervention participants will receive reward points for completing daily step count goals.
After randomization, a baseline 'run-in' assessment phase will occur one week prior to the study intervention (T0). During this 'run-in' period, participants will wear a Bluetooth enabled StepsCount Piezo accelerometer, which will track participants' daily steps and moderate to vigorous physical activity (MVPA), and synchronize their accelerometer (i.e. upload information) to the Change4Life program for seven days. Participants will also be asked to complete the Behavioural Regulation to Exercise Questionnaire (BREQ-3) and the Self-Efficacy for Exercise Scale.
Throughout the 24-week study, all participants will be asked to wear the accelerometer and synchronize it to the Change4Life program daily. Date, steps per day, and bout minutes of MVPA per day (bouts include 10 or more continuous minutes of MVPA) will be collected when the accelerometer is synchronized. Daily synchronization from the accelerometer to the Change4Life program must be completed by 10 am the next morning. Participants will be instructed to increase their daily step counts by 1,000 and 2,000 steps above baseline (T0) over the course of the first six weeks of the study. On week 7, participants will be asked to increase daily steps per day to 3,000 over baseline, and maintain that level of activity for the duration of the study.
Outcome measures will be assessed at baseline (T0), intervention end point (T2), and follow up (T3).
- Conditions
- Physically Inactive Hospital Employees
- Being tested
- Wellness program, Accelerometer, Incentive
- Keywords
- financial health incentives, physical activity, behavioral economics, randomized control trial, workplace health
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wellness programBehavioural
All participants have access to Change4Life, a web-based health education and behaviour change program. Individuals are rewarded with very modest incentives (uncertain chance; less than 1 in 100 chance of earning) when they complete learning modules or health tasks.
AccelerometerDevice
All participants will be asked to wear the StepsCount Piezo accelerometer, which tracks steps and bout minutes of MVPA per day, synchronize the device to the Change4Life program, and reach daily step count goals for 24 weeks.
IncentiveBehavioural
During the first 12 weeks, participants will be eligible to earn $1 in vouchers (e.g., grocery, cinema) when daily goals are reached. The total amount available over the 3-month intervention period will be $90 (9,000 points). During weeks 13 to 24, participants will not receive daily reward points for completing step count goals.
| Study group | Role | What they receive |
|---|---|---|
| Wellness program, accelerometer, incentives | Experimental | During the intervention period (weeks 1 to 12), intervention participants will be eligible to earn daily reward points contingent on step count goal achievement. Intervention participants will earn 100 reward points (i.e. $1) for each day that specific step count goals are reached. During weeks 13 to 24, participants will no longer receive daily reward points for completing specific step count goals. Receives: Behavioral: Wellness program; Device: Accelerometer; Behavioral: Incentive |
| Wellness program and accelerometer | Active comparator | During the 24 week trial, control participants will receive no additional incentives when step count goals are reached. Receives: Behavioral: Wellness program; Device: Accelerometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steps
Steps per day will be objectively assessed using the Bluetooth enabled, medical grade, StepsCount Piezo accelerometer
Measured: Daily for 24 weeks
Secondary outcomes (4)
10 Minute Bouts of Moderate to Vigorous Physical Activity
10 minutes bouts of moderate to vigorous physical activity per day will be objectively assessed using the Bluetooth enabled, medical grade, StepsCount Piezo accelerometer.
Measured: Daily for 24 weeks
Motivation to Exercise - Behavioural Regulation to Exercise Questionnaire; BREQ-3
Participants will be asked to complete the Behavioural Regulation to Exercise Questionnaire (BREQ-3; Markland \& Tobin, 2004; Wilson et al., 2006), a 24-item questionnaire designed to measure self-determined motivation to exercise. This questionnaire will be administered online at baseline (T0; week 0), intervention end point (T2; week 12), and follow up assessments (T3; week 24).
Measured: Baseline (T0; week 0), intervention end point (T2; week 12), and follow up assessments (T3; week 24).
Walking Self-Efficacy - Self-Efficacy for Exercise Scale; SEE Scale
Participants will be asked to complete a modified version of the Self-efficacy for Exercise (SEE) Scale (Resnick \& Jenkins, 2000), a 9-item questionnaire designed to measure self-reported confidence to exercise (i.e. walk). This questionnaire will be administered online at baseline (T0; week 0), intervention end point (T2; week 12), and follow up assessments (T3; week 24).
Measured: Baseline (T0; week 0), intervention end point (T2; week 12), and follow up assessments (T3; week 24).
10 Minute Bouts of Moderate to Vigorous Physical Activity
Participants will also be asked to complete a modified version of the International Physical Activity Questionnaire - Short Form (IPAQ-SF), a six-item questionnaire designed to measure moderate and vigorous physical activity, as well as time spent walking (Booth, 2000; Craig et al., 2003). This questionnaire will be administered online at intervention end point (T2; week 12), and follow up assessments (T3; week 24).
Measured: Intervention end point (T2; week 12), and follow up assessments (T3; week 24).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2015 (estimated)
- Study start6 Feb 2017
- Primary completion30 Nov 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Physically Inactive Hospital EmployeesStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Green Shield Canada Inc., Cookson James Loyalty Inc., Hamilton Health Sciences Corporation
- Responsible party
- Principal investigator, Guy Faulkner, University of Toronto
- Investigators
- Guy Faulkner, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02638675
- Sponsor's protocol ID
- C4L-01
- Status last verified
- May 2018
- First submitted
- 16 Dec 2015
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available
Publications
Resnick B, Jenkins LS. Testing the reliability and validity of the Self-Efficacy for Exercise scale. Nurs Res. 2000 May-Jun;49(3):154-9. doi: 10.1097/00006199-200005000-00007.
PubMed 10882320Markland D, Tobin V. A modification of the Behavioral Regulation in Exercise Questionnaire to include an assessment of amotivation. Journal of Sport and Exercise Psychology 26: 191-196, 2004.
Wilson PM, Rodgers WM, Loitz CC, Scime G. "It's who I am…really!" The importance of integrated regulation in exercise contexts. Journal of Biobehavioral Research 11: 79-104, 2006.
Booth M. Assessment of physical activity: an international perspective. Res Q Exerc Sport. 2000 Jun;71(2 Suppl):S114-20. No abstract available.
PubMed 10925833Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
PubMed 12900694Mitchell M, White L, Oh P, Kwan M, Gove P, Leahey T, Faulkner G. Examining Incentives to Promote Physical Activity Maintenance Among Hospital Employees Not Achieving 10,000 Daily Steps: A Web-Based Randomized Controlled Trial Protocol. JMIR Res Protoc. 2016 Dec 12;5(4):e231. doi: 10.2196/resprot.6285.
PubMed 27956377
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Financial Health Incentives to Promote Physical Activity Among Inactive Hospital Employees: A Web-based Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02638675
- Acronym / sponsor ID
- C4L-01
- Conditions
- Physically Inactive Hospital Employees
- Keywords
- financial health incentives, physical activity, behavioral economics, randomized control trial, workplace health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Green Shield Canada Inc., Cookson James Loyalty Inc., Hamilton Health Sciences Corporation
- Study start
- 6 Feb 2017 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 23 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this randomized control trial is to examine whether incentives-for-steps (i.e. $1 per day step count goals are reached) increase daily step counts among physically inactive hospital employees.
Detailed description
A 24-week, parallel arm, randomized control trial will be employed to examine the impact of incentives on physical activity among physically inactive Hamilton Health Science Corporation employees. Participants will be randomly allocated (1:1) into control (i.e. wellness program and accelerometer) or intervention groups (i.e. wellness program, accelerometer, incentives), where only intervention participants will receive reward points for completing daily step count goals.
After randomization, a baseline 'run-in' assessment phase will occur one week prior to the study intervention (T0). During this 'run-in' period, participants will wear a Bluetooth enabled StepsCount Piezo accelerometer, which will track participants' daily steps and moderate to vigorous physical activity (MVPA), and synchronize their accelerometer (i.e. upload information) to the Change4Life program for seven days. Participants will also be asked to complete the Behavioural Regulation to Exercise Questionnaire (BREQ-3) and the Self-Efficacy for Exercise Scale.
Throughout the 24-week study, all participants will be asked to wear the accelerometer and synchronize it to the Change4Life program daily. Date, steps per day, and bout minutes of MVPA per day (bouts include 10 or more continuous minutes of MVPA) will be collected when the accelerometer is synchronized. Daily synchronization from the accelerometer to the Change4Life program must be completed by 10 am the next morning. Participants will be instructed to increase their daily step counts by 1,000 and 2,000 steps above baseline (T0) over the course of the first six weeks of the study. On week 7, participants will be asked to increase daily steps per day to 3,000 over baseline, and maintain that level of activity for the duration of the study.
Outcome measures will be assessed at baseline (T0), intervention end point (T2), and follow up (T3).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wellness program, accelerometer, incentives | Experimental | Behavioral: Wellness program, Device: Accelerometer, Behavioral: IncentiveDuring the intervention period (weeks 1 to 12), intervention participants will be eligible to earn daily reward points contingent on step count goal achievement. Intervention participants will earn 100 reward points (i.e. $1) for each day that specific step count goals are reached. During weeks 13 to 24, participants will no longer receive daily reward points for completing specific step count goals. |
| Wellness program and accelerometer | Active comparator | Behavioral: Wellness program, Device: AccelerometerDuring the 24 week trial, control participants will receive no additional incentives when step count goals are reached. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Over the age of 18 years
- English speaking
Key exclusion criteria (2 listed)
- Existing medical condition, which could be exacerbated by physical activity as measured by the Physical Activity Readiness Questionnaire.
- Note. Participants cannot enrol in the study without Internet access
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wellness programAll participants have access to Change4Life, a web-based health education and behaviour change program. Individuals are rewarded with very modest incentives (uncertain chance; less than 1 in 100 chance of earning) when they complete learning modules or health tasks. | Behavioural | Wellness program and accelerometer, Wellness program, accelerometer, incentives |
| AccelerometerAll participants will be asked to wear the StepsCount Piezo accelerometer, which tracks steps and bout minutes of MVPA per day, synchronize the device to the Change4Life program, and reach daily step count goals for 24 weeks. | Device | Wellness program and accelerometer, Wellness program, accelerometer, incentives |
| IncentiveDuring the first 12 weeks, participants will be eligible to earn $1 in vouchers (e.g., grocery, cinema) when daily goals are reached. The total amount available over the 3-month intervention period will be $90 (9,000 points). During weeks 13 to 24, participants will not receive daily reward points for completing step count goals. | Behavioural | Wellness program, accelerometer, incentives |
Primary outcome
Steps
Time frame: Daily for 24 weeks
Steps per day will be objectively assessed using the Bluetooth enabled, medical grade, StepsCount Piezo accelerometer
4 secondary outcomes
10 Minute Bouts of Moderate to Vigorous Physical Activity
Time frame: Daily for 24 weeks
Motivation to Exercise - Behavioural Regulation to Exercise Questionnaire; BREQ-3
Time frame: Baseline (T0; week 0), intervention end point (T2; week 12), and follow up assessments (T3; week 24).
Walking Self-Efficacy - Self-Efficacy for Exercise Scale; SEE Scale
Time frame: Baseline (T0; week 0), intervention end point (T2; week 12), and follow up assessments (T3; week 24).
10 Minute Bouts of Moderate to Vigorous Physical Activity
Time frame: Intervention end point (T2; week 12), and follow up assessments (T3; week 24).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Background: PubMed 10882320Resnick B, Jenkins LS. Testing the reliability and validity of the Self-Efficacy for Exercise scale. Nurs Res. 2000 May-Jun;49(3):154-9. doi: 10.1097/00006199-200005000-00007.
- BackgroundMarkland D, Tobin V. A modification of the Behavioral Regulation in Exercise Questionnaire to include an assessment of amotivation. Journal of Sport and Exercise Psychology 26: 191-196, 2004.
- BackgroundWilson PM, Rodgers WM, Loitz CC, Scime G. "It's who I am…really!" The importance of integrated regulation in exercise contexts. Journal of Biobehavioral Research 11: 79-104, 2006.
- Background: PubMed 10925833Booth M. Assessment of physical activity: an international perspective. Res Q Exerc Sport. 2000 Jun;71(2 Suppl):S114-20. No abstract available.
- Background: PubMed 12900694Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
- Derived from this study: PubMed 27956377Mitchell M, White L, Oh P, Kwan M, Gove P, Leahey T, Faulkner G. Examining Incentives to Promote Physical Activity Maintenance Among Hospital Employees Not Achieving 10,000 Daily Steps: A Web-Based Randomized Controlled Trial Protocol. JMIR Res Protoc. 2016 Dec 12;5(4):e231. doi: 10.2196/resprot.6285.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guy Faulkner, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wellness program, Accelerometer and Incentive in people with Physically Inactive Hospital Employees, run by University of Toronto 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 11 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Steps (time frame: Daily for 24 weeks). 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 NCT02638675, which also lists 6 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 11 May 2018; AzTrials last refreshed its copy on 8 Nov 2026.