A Randomized Trial of Economic Incentives to Promote Walking Among Full Time Employees
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ClinicalTrials.gov Identifier: NCT01855776 |
Recruitment Status :
Completed
First Posted : May 16, 2013
Last Update Posted : January 5, 2016
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Tracking Information | ||||
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First Submitted Date ICMJE | August 8, 2012 | |||
First Posted Date ICMJE | May 16, 2013 | |||
Last Update Posted Date | January 5, 2016 | |||
Study Start Date ICMJE | May 2013 | |||
Actual Primary Completion Date | August 2015 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Changes in MVPA (Moderate-to-Vigorous Physical Activity) bouts of participants from baseline to months 6 and 12 [ Time Frame: Baseline, 6 and 12 months ] MVPA bouts are defined as the total number of minutes during each 1-week assessment period in which moderate or vigorous activity of at least 8 of 10 consecutive minutes are reached. This will be assessed via the Actigraph GT3XE-Plus Triaxial Activity Monitor.
We will measure "MVPA bouts" at baseline, 6, and 12 months. We hypothesize that participants in the Programme Only, and Incentive groups record more "MVPA bouts" at 6 months compared to baseline. Furthermore, participants in the Incentive groups will record more "MVPA bouts" at 6 months compared to the Control and Programme only groups.
We also measure "MVPA bouts" for all participants at 12 months. We do so to test if the "MVPA bouts" measured at month 6, can be sustained at month 12 when incentives are no longer being provided.
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
Change in VO2Max of participants from baseline to months 6, and 12. [ Time Frame: Baseline, 6 and 12 months ] VO2Max is one of the major parameters to evaluate health and fitness of the cardiovascular system and is widely used for health promotion purposes. VO2Max will also be assessed via the Non Exercise Fitness Test (NEFT); NEFT predicts VO2max based on age, gender, BMI, resting heart rate and self-reported physical activities.
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Randomized Trial of Economic Incentives to Promote Walking Among Full Time Employees | |||
Official Title ICMJE | A Randomized Trial of Economic Incentives to Promote Walking Among Full Time Employees | |||
Brief Summary | This study aims to assess the uptake, effectiveness, and cost-effectiveness of a scalable walking programme for full-time employees both with and without incentives. | |||
Detailed Description | The first part of this study comprises an in-home face-to-face survey with 950 full-time employees in Singapore. The survey aims to identify what an optimal programme might look like and to quantify the potential uptake of the programme, if offered. Stated preference conjoint analysis, which assesses individual preferences for attributes of specific programmes, will be used. The second part of this study is a Randomised Controlled Trial (RCT) of a 12-month walking programme. Up to 800 full-time employees will be recruited and allocated to one of four research arms: Control Group, Programme Only Group, Cash Incentive Group and Charitable Incentive Group. Participants in the intervention arms will be asked to track their physical activities using Fitbit Zip, a wireless pedometer, which automatically uploads the data to a custom website. Those in the incentive arms will earn money or raise money for charities if they meet weekly exercise targets. Those in the control and Programme Only groups with receive a weekly payment for participation. Incentives and participation payment will be provided from months 1 - 6, after which they will be withdrawn. The key outcome variable of the RCT is defined as bouts (in minutes) of moderate to vigorous physical activity ("MVPA bouts") as measured via accelerometry. Data will be collected at baseline and month 6 and 12 assessments. Findings from the RCT will also be used to determine the cost to employers of implementing each programme and the incremental cost-effectiveness of the incentive programmes compared to the basic programme without incentives. The primary hypotheses are that the basic programme will have lower costs per person than the cash or charity programmes, but that the incentive programmes will be more cost-effective relative to the less expensive and less effective basic programme. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Factorial Assignment Masking: None (Open Label) |
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Condition ICMJE | Physical Activity | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
800 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | August 2015 | |||
Actual Primary Completion Date | August 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 21 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Singapore | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01855776 | |||
Other Study ID Numbers ICMJE | HSRG10NOV002 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Eric A. Finkelstein, Duke-NUS Graduate Medical School | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Duke-NUS Graduate Medical School | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Health Promotion Board, Singapore | |||
Investigators ICMJE |
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PRS Account | Duke-NUS Graduate Medical School | |||
Verification Date | January 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |