Last reviewed · How we verify
Multiphase Optimization Trial of Incentives for Veterans to Encourage Walking
NA trial testing Walking in Sedentary Behavior in 102 participants. Completed in 31 July 2024.
| Lead sponsor | VA Office of Research and Development |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | factorial |
| Masking | single |
| Primary purpose | health services research |
| Enrollment | 102 |
| Start date | 17 March 2022 |
| Primary completion | 30 November 2023 |
| Estimated completion | 31 July 2024 |
| Sites | 1 location across United States |
VA Office of Research and Development — full company profile →
Adults 50 to 69, any sex, with Sedentary Behavior or Exercise. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The change in average steps per day from the baseline week to week 12.
| Group | Value | 95% CI |
|---|---|---|
| F1M1P1R1 | 4224 | ± 719 |
| N1M1P1R1 | 4786 | ± 6843 |
| N1M1P1R0 | 3654 | ± 3272 |
| N1M1P0R0 | 2626 | ± 0 |
| N1M1P0R1 | 3740 | ± 2248 |
| N1L1P1R1 | 4493 | ± 6036 |
| N1L1P1R0 | 3680 | ± 96 |
| N1L1P0R1 | 4577 | ± 97 |
| F1M1P1R0 | 1110 | ± 1390 |
| F1M1P0R0 | 2176 | ± 1467 |
| F1M1P0R1 | 3216 | ± 3366 |
| F1L1P1R1 | 7002 | ± 456 |
Measured using the Exercise Self-Efficacy Scale at baseline, week 12 and week 24 (McAuley E 1993). This scale measures self-efficacy on nine different measures from not confident (0 rating) to very confident (10 rating).The range is 0 to 10. A higher rating indicates that the respondent is more confident they will be able to overcome barriers to physical activity.
| Group | Value | 95% CI |
|---|---|---|
| F1M1P1R1 | 5.1 | ± 1.4 |
| N1M1P1R1 | 5.7 | ± 1.5 |
| N1M1P1R0 | 5.9 | ± 1.4 |
| N1M1P0R0 | 2.1 | ± 0 |
| N1M1P0R1 | 5.6 | ± 3.7 |
| N1L1P1R1 | 5.0 | ± 2.0 |
| N1L1P1R0 | 9.5 | ± 0.7 |
| N1L1P0R1 | 6.4 | ± 0.5 |
| F1M1P1R0 | 5.6 | ± 2.9 |
| F1M1P0R0 | 5.0 | ± 3.3 |
| F1M1P0R1 | 6.9 | ± 1.9 |
| F1L1P1R1 | 5.9 | ± 2.3 |
| Group | Value | 95% CI |
|---|---|---|
| F1M1P1R1 | 5.9 | ± 1.1 |
| N1M1P1R1 | 6.4 | ± 2.1 |
| N1M1P1R0 | 5.0 | ± 2.1 |
| N1M1P0R0 | 2.1 | ± 0 |
| N1M1P0R1 | 5.0 | ± 1.6 |
| N1L1P1R1 | 5.6 | ± 1.4 |
| N1L1P1R0 | 5.8 | ± 3.1 |
| N1L1P0R1 | 6.6 | ± 1.8 |
| F1M1P1R0 | 5.0 | ± 1.1 |
| F1M1P0R0 | 3.2 | ± 1.9 |
| F1M1P0R1 | 5.5 | ± 1.0 |
| F1L1P1R1 | 6.0 | ± 1.3 |
| Group | Value | 95% CI |
|---|---|---|
| F1M1P1R1 | 4.3 | ± 0.2 |
| N1M1P1R1 | 6.7 | ± 1.9 |
| N1M1P1R0 | 6.8 | ± 2.4 |
| N1M1P0R0 | 1.3 | ± 0 |
| N1M1P0R1 | 5.0 | ± 1.8 |
| N1L1P1R1 | 7.1 | ± 2.1 |
| N1L1P1R0 | 8.2 | ± 1.7 |
| N1L1P0R1 | 4.9 | ± 1.3 |
| F1M1P1R0 | 5.6 | ± 1.9 |
| F1M1P0R0 | 5.0 | ± 2.8 |
| F1M1P0R1 | 5.4 | ± 1.5 |
| F1L1P1R1 | 6.0 | ± 0.2 |
Measured using the Motivation for Physical Activity Measurement (MPAM) at baseline, week 12 and week 24 (Frederick CM 1993). This scale measures reasons and motivations for participating in physical activity having respondents indicate why they exercise. The scale ranges from 1=very true for me, 2= somewhat true for me, 3=neither true nor untrue for me, 4=somewhat untrue for me, 5= very untrue for me. The minimum score is 1 and the maximum is 5. Higher scores means more intrinsic motivation to exercise.
| Group | Value | 95% CI |
|---|---|---|
| F1M1P1R1 | 2.1 | ± 0.7 |
| N1M1P1R1 | 2.7 | ± 0.6 |
| N1M1P1R0 | 2.5 | ± 0.3 |
| N1M1P0R0 | 2.8 | ± 0 |
| N1M1P0R1 | 2.2 | ± 0.8 |
| N1L1P1R1 | 2.6 | ± 0.9 |
| N1L1P1R0 | 1.0 | ± 0 |
| N1L1P0R1 | 2.0 | ± 0.2 |
| F1M1P1R0 | 2.7 | ± 0.4 |
| F1M1P0R0 | 1.8 | ± 0.4 |
| F1M1P0R1 | 1.8 | ± 0.3 |
| F1L1P1R1 | 2.1 | ± 0.1 |
| Group | Value | 95% CI |
|---|---|---|
| F1M1P1R1 | 2.2 | ± 0.3 |
| N1M1P1R1 | 2.8 | ± 1.2 |
| N1M1P1R0 | 2.4 | ± 0.6 |
| N1M1P0R0 | 3.0 | ± 0 |
| N1M1P0R1 | 2.4 | ± 0.6 |
| N1L1P1R1 | 2.1 | ± 1.6 |
| N1L1P1R0 | 1.8 | ± 0.1 |
| N1L1P0R1 | 1.8 | ± 0.2 |
| F1M1P1R0 | 2.8 | ± 0.7 |
| F1M1P0R0 | 2.0 | ± 0.7 |
| F1M1P0R1 | 2.0 | ± 0.4 |
| F1L1P1R1 | 2.3 | ± 0.3 |
| Group | Value | 95% CI |
|---|---|---|
| F1M1P1R1 | 1.8 | ± 0.5 |
| N1M1P1R1 | 2.5 | ± 1.2 |
| N1M1P1R0 | 2.7 | ± 0.5 |
| N1M1P0R0 | 3.0 | ± 0 |
| N1M1P0R1 | 2.6 | ± 0.5 |
| N1L1P1R1 | 2.4 | ± 1.2 |
| N1L1P1R0 | 1.2 | ± 0.2 |
| N1L1P0R1 | 2.3 | ± 0 |
| F1M1P1R0 | 2.7 | ± 0.8 |
| F1M1P0R0 | 1.7 | ± 0.6 |
| F1M1P0R1 | 2.2 | ± 0.5 |
| F1L1P1R1 | 2.1 | ± 0.3 |
Measured using the PHQ-8 depression scale at baseline, week 12 and week 24. This assessment measures depressive symptoms over the past 2 weeks. Respondents indicate how bothered they were by the following problems on a scale from 0 (not at all) to 3 (nearly every day). The minimum and maximum score are zero and 24, respectively. A lower score indicates fewer depressive symptoms.
| Group | Value | 95% CI |
|---|---|---|
| F1M1P1R1 | 4.3 | ± 0.6 |
| N1M1P1R1 | 6.0 | ± 6.2 |
| N1M1P1R0 | 12.7 | ± 4.7 |
| N1M1P0R0 | 10.0 | ± 0 |
| N1M1P0R1 | 8.3 | ± 2.5 |
| N1L1P1R1 | 6.0 | ± 5.3 |
| N1L1P1R0 | 4.0 | ± 5.7 |
| N1L1P0R1 | 3.0 | ± 1.4 |
| F1M1P1R0 | 4.4 | ± 4.6 |
| F1M1P0R0 | 1.0 | ± 1.4 |
| F1M1P0R1 | 4.8 | ± 4.4 |
| F1L1P1R1 | 7.3 | ± 7.0 |
| Group | Value | 95% CI |
|---|---|---|
| F1M1P1R1 | 2.0 | ± 1.0 |
| N1M1P1R1 | 5.0 | ± 6.7 |
| N1M1P1R0 | 15.5 | ± 2.1 |
| N1M1P0R0 | 10.0 | ± 0 |
| N1M1P0R1 | 5.8 | ± 4.6 |
| N1L1P1R1 | 3.0 | ± 0 |
| N1L1P1R0 | 9.0 | ± 0 |
| N1L1P0R1 | 2.8 | ± 2.5 |
| F1M1P1R0 | 6.6 | ± 5.8 |
| F1M1P0R0 | 3.3 | ± 2.1 |
| F1M1P0R1 | 5.3 | ± 3.6 |
| F1L1P1R1 | 7.0 | ± 7.2 |
| Group | Value | 95% CI |
|---|---|---|
| F1M1P1R1 | 2.0 | ± 0 |
| N1M1P1R1 | 5.3 | ± 5.3 |
| N1M1P1R0 | 7.5 | ± 3.5 |
| N1M1P0R0 | 11 | ± 0 |
| N1M1P0R1 | 3.3 | ± 2.5 |
| N1L1P1R1 | 9.7 | ± 7.4 |
| N1L1P1R0 | 7.0 | ± 1.4 |
| N1L1P0R1 | 2.0 | ± 2.8 |
| F1M1P1R0 | 6.0 | ± 9.0 |
| F1M1P0R0 | 4.0 | ± 4.0 |
| F1M1P0R1 | 7.2 | ± 4.5 |
| F1L1P1R1 | 4.7 | ± 6.4 |
The change in average steps per day from the baseline week to week 24
| Group | Value | 95% CI |
|---|---|---|
| F1M1P1R1 | 5237 | ± 0 |
| N1M1P1R1 | 4631 | ± 3513 |
| N1M1P1R0 | 4074 | ± 2361 |
| N1M1P0R0 | 3804 | ± 0 |
| N1M1P0R1 | 6414 | ± 0 |
| N1L1P1R1 | 3844 | ± 4122 |
| N1L1P1R0 | 2487 | ± 3072 |
| N1L1P0R1 | 6531 | ± 2683 |
| F1M1P1R0 | 614 | ± 928 |
| F1M1P0R0 | 3165 | ± 2961 |
| F1M1P0R1 | 1312 | ± 3845 |
| F1L1P1R1 | 5939 | ± 0 |
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
Trials testing the same drug.
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04518943.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing