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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02638675
Other study ID # C4L-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 6, 2017
Est. completion date November 30, 2017

Study information

Verified date May 2018
Source University of Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 99
Est. completion date November 30, 2017
Est. primary completion date November 30, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Over the age of 18 years

- English speaking

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms

  • Physically Inactive Hospital Employees

Intervention

Behavioral:
Wellness program
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.
Device:
Accelerometer
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.
Behavioral:
Incentive
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.

Locations

Country Name City State
Canada Faculty of Kinesiology and Physical Education, University of Toronto Toronto Ontario

Sponsors (4)

Lead Sponsor Collaborator
University of Toronto Cookson James Loyalty Inc., Green Shield Canada Inc., Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

References & Publications (5)

Booth M. Assessment of physical activity: an international perspective. Res Q Exerc Sport. 2000 Jun;71(2 Suppl):S114-20. — View Citation

Craig CL, Marshall AL, Sjöström 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. — View Citation

Markland 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.

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. — View Citation

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.

Outcome

Type Measure Description Time frame Safety issue
Primary Steps Steps per day will be objectively assessed using the Bluetooth enabled, medical grade, StepsCount Piezo accelerometer Daily for 24 weeks
Secondary 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. Daily for 24 weeks
Secondary 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). Baseline (T0; week 0), intervention end point (T2; week 12), and follow up assessments (T3; week 24).
Secondary 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). Baseline (T0; week 0), intervention end point (T2; week 12), and follow up assessments (T3; week 24).
Secondary 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). Intervention end point (T2; week 12), and follow up assessments (T3; week 24).