Ignite Creation Date:
2024-05-06 @ 3:04 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04518943
Status:
COMPLETED
Last Update Posted:
2024-01-09
First Post:
2020-08-14
Brief Title:
Multiphase Optimization Trial of Incentives for Veterans to Encourage Walking
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Multiphase Optimization Trial of Incentives for Veterans to Encourage Walking
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Regular physical activity PA is essential to healthy aging Unfortunately only 5 of US adults meet guideline of 150 minutes of moderate exercise Veterans and non-Veterans have similar levels of PA A patient incentive program for PA may help Behavioral economics suggests that the chronic inability to start and maintain a PA routine may be the result of present bias which is a tendency to value immediate rewards over rewards in the future With present bias it is always better to exercise tomorrow because the immediate gratification of watching television or surfing the internet is a more powerful motivator than the intangible and delayed benefit of future health Patient incentives may overcome present bias by moving the rewards for exercise forward in time
Recent randomized trials suggest that incentives for PA can be effective but substantial gaps in knowledge prevent the implementation of a PA incentive program in Veterans Affairs VA First incentive designs vary considerably They vary by the size of the incentive the type of incentive cash or non-financial the probability of earning an incentive an assured payment for effort or a lottery-based incentive or whether the incentive is earned after the effort is given a gain-framed incentive or awarded up-front and lost if the effort is not given a loss-framed incentive The optimal combination of these components for a Veteran population is unknown Second the evidence about the effective components of incentives comes from studies conducted in populations that were overwhelmingly female often employees at large companies with high levels of education and income VA users in contrast are mostly male and lower income and most are not employed This is important because the investigators have theoretical reasons to believe that the effects of components of incentives are likely to vary by income and gender Finally few studies have managed to design an incentive such that the physical activity was maintained after the incentive was removed Indeed a common theme in incentivizing health behavior change is the difficulty in sustaining behavior change once the incentives are removed
Recent randomized trials suggest that incentives for PA can be effective but substantial gaps in knowledge prevent the implementation of a PA incentive program in Veterans Affairs VA First incentive designs vary considerably They vary by the size of the incentive the type of incentive cash or non-financial the probability of earning an incentive an assured payment for effort or a lottery-based incentive or whether the incentive is earned after the effort is given a gain-framed incentive or awarded up-front and lost if the effort is not given a loss-framed incentive The optimal combination of these components for a Veteran population is unknown Second the evidence about the effective components of incentives comes from studies conducted in populations that were overwhelmingly female often employees at large companies with high levels of education and income VA users in contrast are mostly male and lower income and most are not employed This is important because the investigators have theoretical reasons to believe that the effects of components of incentives are likely to vary by income and gender Finally few studies have managed to design an incentive such that the physical activity was maintained after the incentive was removed Indeed a common theme in incentivizing health behavior change is the difficulty in sustaining behavior change once the incentives are removed
Detailed Description:
The investigators propose to fill the research gaps through a Multiphase Optimization Strategy MOST trial of incentives for walking A MOST trial is ideally suited for situations in which a proposed intervention has many potential intervention components A MOST trial consists of three phases A screening phase trial is used to efficiently identify-through a factorial designed randomized trial-the effective components of a complex intervention like incentives A refining phase trial tests the optimal dose size or duration of the incentives A confirmatory phase trial tests the optimal components and dose against a usual care control The goal of the proposed study is to conduct the screening phase trial in 128 Veterans to identify the optimal components of incentives for increasing walking among physically inactive Veterans All Veterans in this phase will be given various components of incentives for increasing average steps per day to 7000 steps over a 12-week habit-building period and then maintaining the increase through a 12-week habit maintenance period The specific aims are
Aim 1 Conduct a 24 factorial designed screening-phase trial of incentives for increasing average steps per day to 7000 steps over 12 weeks among physically inactive Veterans Every patient in the trial will be given a Fitbit Inspire activity monitor and assigned to a group that receives different components of incentives The investigators will test four different incentive factors 1 lottery vs loss framed incentives 2 financial vs non-financial incentives 3 a pre-commitment postcard reminder of a Veterans stated intrinsic reason for commitment to PA vs no pre-commitment postcard and 4 a request for PA advice from a Veteran on staying active vs no request The first factor has never been tested in a population like the VA Factors 2-4 are designed specifically to sustain the effects of incentives after the incentive is removed Factor 4 is a novel hypothesis that has never been tested outside of educational research specifically that asking for advice from a Veteran is more motivating than giving advice to them even if that Veteran is struggling with low physical activity themselves The primary outcome is change in steps per week from baseline to week 24
Aim 2 Conduct cost analyses and qualitative interviews The cost of administering each component and qualitative assessments of the acceptability of each component to trial participants will inform the decision of which components to retain for the subsequent refining and confirmatory phase trials
Aim 3 Convene an expert panel to choose components for the next phases of the MOST trial The panel will weigh each component in terms of its effect on step counts Aim 1 administrative costs and participant-reported qualitative assessments Aim 2 and the strength of the theoretical basis for the components effect on physical activity
Aim 1 Conduct a 24 factorial designed screening-phase trial of incentives for increasing average steps per day to 7000 steps over 12 weeks among physically inactive Veterans Every patient in the trial will be given a Fitbit Inspire activity monitor and assigned to a group that receives different components of incentives The investigators will test four different incentive factors 1 lottery vs loss framed incentives 2 financial vs non-financial incentives 3 a pre-commitment postcard reminder of a Veterans stated intrinsic reason for commitment to PA vs no pre-commitment postcard and 4 a request for PA advice from a Veteran on staying active vs no request The first factor has never been tested in a population like the VA Factors 2-4 are designed specifically to sustain the effects of incentives after the incentive is removed Factor 4 is a novel hypothesis that has never been tested outside of educational research specifically that asking for advice from a Veteran is more motivating than giving advice to them even if that Veteran is struggling with low physical activity themselves The primary outcome is change in steps per week from baseline to week 24
Aim 2 Conduct cost analyses and qualitative interviews The cost of administering each component and qualitative assessments of the acceptability of each component to trial participants will inform the decision of which components to retain for the subsequent refining and confirmatory phase trials
Aim 3 Convene an expert panel to choose components for the next phases of the MOST trial The panel will weigh each component in terms of its effect on step counts Aim 1 administrative costs and participant-reported qualitative assessments Aim 2 and the strength of the theoretical basis for the components effect on physical activity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None