Sedentary BehaviorNCT04518943

Multiphase Optimization Trial of Incentives for Veterans to Encourage Walking

A study testing Walking in people with Sedentary Behavior and Exercise, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 50 to 69 years
Conditions the study is for: Sedentary Behavior, Exercise, Walking
What is being tested?: Walking
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 102 participants
Where: 1 siteUnited States
Study dates: 17 Mar 2022to 31 Jul 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 50 to 69 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Veteran that receives healthcare at VA Puget Sound Health Care System
Age 50-69
Diagnosis of hypertension, depression or a BMI between 25-40.
Physically inactive according to self-report. .
2,000-5,000 steps per day during the screening week
Have and be able to use a smart phone.

Who cannot join

MOVE participation in the past 4 months
Blind
<2,000 steps per day
Inability to walk 20 minutes without stopping (self-report).
Eating disorder.
Dementia/ cognitive impairment

Show all 14Show fewer

Metastatic cancer, end state renal disease, hospice, palliative care, heart failure, undergoing chemotherapy, radiation or hemodialysis, have had or are on the list for an organ transplant.
Implanted cardiovascular device such as defibrillator or ventricular device
Active psychosis/mania/behavioral flag
Pregnant women
Homeless or housing insecure
Has a paid caregiver that provides >50% of daily living activities, lives in a nursing home, assisted living facility or group home.
Individuals that exhibit threatening, violent or inappropriate behavior during the screening phone call.
Foot Ulcer

Trial locations and contacts

1 site in 1 country.

United States1 site

VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108-1532

Other trials in United States

About this study

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.

Read the 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 7,000 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 7,000 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 Veteran's 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 component's effect on physical activity.

Conditions: Sedentary Behavior, Exercise, Walking, Motivation, Hypertension, Depression
Being tested: Walking
Keywords: sedentary behavior, walking, motivation
Medical subject headings: Sedentary Behavior, Motor Activity, Hypertension, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

WalkingBehavioural
Inactive Veterans will be encouraged to increase their step count to 7,000 steps per day by the end of the 12-week intervention period. Weekly the step goal will increase 15% if they were successful in reaching their goal the previous week.

Study groups in NCT04518943
Study group	Role	What they receive
F1M1P1R1	Experimental	Financial Reward, mixed lottery, pre-commitment postcard reminders, request physical activity advice Receives: Behavioral: Walking
N1M1P1R1	Experimental	Non-financial reward, mixed lottery, pre-commitment postcard reminders, request physical activity advice Receives: Behavioral: Walking
N1M1P1R0	Experimental	Non-financial reward, mixed lottery, pre-commitment postcard reminders, no request physical activity advice Receives: Behavioral: Walking
N1M1P0R0	Experimental	Non-financial reward, mixed lottery, no pre-commitment postcard reminders, no request physical activity advice Receives: Behavioral: Walking
N1M1P0R1	Experimental	Non-financial reward, mixed lottery, no pre-commitment postcard reminders, request physical activity advice Receives: Behavioral: Walking
N1L1P1R1	Experimental	Non-financial reward, loss incentive, pre-commitment postcard reminders, request physical activity advice Receives: Behavioral: Walking
N1L1P1R0	Experimental	Non-financial reward, loss incentive, pre-commitment postcard reminders, no request physical activity advice Receives: Behavioral: Walking
N1L1P0R0	Experimental	Non-financial reward, loss incentive, no pre-commitment postcard reminders, no request physical activity advice Receives: Behavioral: Walking
N1L1P0R1	Experimental	Non-financial reward, loss incentive, no pre-commitment postcard reminders, request physical activity advice Receives: Behavioral: Walking
F1M1P1R0	Experimental	Financial Reward, mixed lottery, pre-commitment postcard reminders, no request physical activity advice Receives: Behavioral: Walking
F1M1P0R0	Experimental	Financial Reward, mixed lottery, no pre-commitment postcard reminders, no request physical activity advice Receives: Behavioral: Walking
F1M1P0R1	Experimental	Financial Reward, mixed lottery, no pre-commitment postcard reminders, request physical activity advice Receives: Behavioral: Walking
F1L1P1R1	Experimental	Financial Reward, loss incentive, pre-commitment postcard reminders, request physical activity advice Receives: Behavioral: Walking
F1L1P1R0	Experimental	Financial Reward, loss incentive, pre-commitment postcard reminders, no request physical activity advice Receives: Behavioral: Walking
F1L1P0R0	Experimental	Financial Reward, loss incentive, no pre-commitment postcard reminders, no request physical activity advice Receives: Behavioral: Walking
F1L1P0R1	Experimental	Financial Reward, loss incentive, no pre-commitment postcard reminders, request physical activity advice Receives: Behavioral: Walking

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Average Steps Per Day From Baseline Week to Week 12
The change in average steps per day from the baseline week to week 12.
Measured: baseline to week 12
Change in Average Steps Per Day From Baseline Week to Week 24
The change in average steps per day from the baseline week to week 24
Measured: baseline to week 24

Secondary outcomes (3)

Self-efficacy
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.
Measured: Measured at baseline, week 12 and 24
Intrinsic/Extrinsic Motivation
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.
Measured: Measured at baseline, week 12 and 24
Mental Health
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.
Measured: Measured at baseline, week 12 and 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Mar 202231 Jul 2024

First posted19 Aug 2020
Study start17 Mar 2022
Primary completion30 Nov 2023
Study completion31 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Sedentary BehaviorStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe 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: Health services research
Allocation: Randomised
Intervention model: Factorial
Model description: The MOST trial design involves optimizing an intervention before it is tested against a usual control. It is optimized in that the various components of the intervention are tested against one another in a screening phase to assess which components add value to the intervention, and then only the valuable components are included in the final intervention. It is especially useful when an intervention has many potential combinations of components, as is the case with incentives. In a traditional trial, researchers would use theory or evidence from prior studies to choose an incentive design and test this package against usual care. Even if this package outperforms usual care in a randomized trial, the investigators cannot tell whether it was optimal. Some components could have provided no benefit or delivered in too small a dose to be effective. Other components could have been detrimental to subjects. There is no way to know if the components are all tested as a single package.
Masking: Single blind
Who is masked: Investigator
Enrolment: 102 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04518943
Sponsor's protocol ID: IIR 19-450
Status last verified: Apr 2025
First submitted: 14 Aug 2020
Last updated: 30 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Recruiting
Yoga vs. Stretching-Strengthening: Physical Fitness in Sedentary Young Adults
Sedentary Lifestlye, Exercise
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Recruiting
Scalable TELeheaLth Cancer CARe: The STELLAR Program to Treat Cancer Risk Behaviors
Obesity, Smoking Cessation
Not yet recruiting
Be Well at Work-Plus: A Depression and Physical Activity Intervention for Hospital Service Workers (Aim 3)
Depression, Physical Inactivity

All Sedentary Behavior trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multiphase Optimization Trial of Incentives for Veterans to Encourage Walking
ClinicalTrials.gov ID: NCT04518943
Acronym / sponsor ID: IIR 19-450
Conditions: Sedentary Behavior, Exercise, Walking, Motivation, Hypertension, Depression
Keywords: sedentary behavior, walking, motivation
Study type: Interventional
Recruitment status: Completed
Enrolment: 102 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 17 Mar 2022 (actual)
Primary completion: 30 Nov 2023 (actual)
Study completion: 31 Jul 2024 (actual)
First posted: 19 Aug 2020 (actual)
Results: Posted 30 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (investigator)
Number of arms: 16
Model description: The MOST trial design involves optimizing an intervention before it is tested against a usual control. It is optimized in that the various components of the intervention are tested against one another in a screening phase to assess which components add value to the intervention, and then only the valuable components are included in the final intervention. It is especially useful when an intervention has many potential combinations of components, as is the case with incentives. In a traditional trial, researchers would use theory or evidence from prior studies to choose an incentive design and test this package against usual care. Even if this package outperforms usual care in a randomized trial, the investigators cannot tell whether it was optimal. Some components could have provided no benefit or delivered in too small a dose to be effective. Other components could have been detrimental to subjects. There is no way to know if the components are all tested as a single package.

Arm	Type	Receives
F1M1P1R1	Experimental	Behavioral: WalkingFinancial Reward, mixed lottery, pre-commitment postcard reminders, request physical activity advice
N1M1P1R1	Experimental	Behavioral: WalkingNon-financial reward, mixed lottery, pre-commitment postcard reminders, request physical activity advice
N1M1P1R0	Experimental	Behavioral: WalkingNon-financial reward, mixed lottery, pre-commitment postcard reminders, no request physical activity advice
N1M1P0R0	Experimental	Behavioral: WalkingNon-financial reward, mixed lottery, no pre-commitment postcard reminders, no request physical activity advice
N1M1P0R1	Experimental	Behavioral: WalkingNon-financial reward, mixed lottery, no pre-commitment postcard reminders, request physical activity advice
N1L1P1R1	Experimental	Behavioral: WalkingNon-financial reward, loss incentive, pre-commitment postcard reminders, request physical activity advice
N1L1P1R0	Experimental	Behavioral: WalkingNon-financial reward, loss incentive, pre-commitment postcard reminders, no request physical activity advice
N1L1P0R0	Experimental	Behavioral: WalkingNon-financial reward, loss incentive, no pre-commitment postcard reminders, no request physical activity advice
N1L1P0R1	Experimental	Behavioral: WalkingNon-financial reward, loss incentive, no pre-commitment postcard reminders, request physical activity advice
F1M1P1R0	Experimental	Behavioral: WalkingFinancial Reward, mixed lottery, pre-commitment postcard reminders, no request physical activity advice
F1M1P0R0	Experimental	Behavioral: WalkingFinancial Reward, mixed lottery, no pre-commitment postcard reminders, no request physical activity advice
F1M1P0R1	Experimental	Behavioral: WalkingFinancial Reward, mixed lottery, no pre-commitment postcard reminders, request physical activity advice
F1L1P1R1	Experimental	Behavioral: WalkingFinancial Reward, loss incentive, pre-commitment postcard reminders, request physical activity advice
F1L1P1R0	Experimental	Behavioral: WalkingFinancial Reward, loss incentive, pre-commitment postcard reminders, no request physical activity advice
F1L1P0R0	Experimental	Behavioral: WalkingFinancial Reward, loss incentive, no pre-commitment postcard reminders, no request physical activity advice
F1L1P0R1	Experimental	Behavioral: WalkingFinancial Reward, loss incentive, no pre-commitment postcard reminders, request physical activity advice

Who may qualify

Ages: 50 to 69 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Veteran that receives healthcare at VA Puget Sound Health Care System
Age 50-69
Diagnosis of hypertension, depression or a BMI between 25-40.
Physically inactive according to self-report. .
2,000-5,000 steps per day during the screening week

Key exclusion criteria (14 listed)

MOVE participation in the past 4 months
Blind
<2,000 steps per day
Inability to walk 20 minutes without stopping (self-report).
Eating disorder.

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
WalkingInactive Veterans will be encouraged to increase their step count to 7,000 steps per day by the end of the 12-week intervention period. Weekly the step goal will increase 15% if they were successful in reaching their goal the previous week.	Behavioural	F1L1P0R0, F1L1P0R1, F1L1P1R0, F1L1P1R1, F1M1P0R0, F1M1P0R1, F1M1P1R0, F1M1P1R1, N1L1P0R0, N1L1P0R1, N1L1P1R0, N1L1P1R1, N1M1P0R0, N1M1P0R1, N1M1P1R0, N1M1P1R1

Primary outcome

Change in Average Steps Per Day From Baseline Week to Week 12
Time frame: baseline to week 12
The change in average steps per day from the baseline week to week 12.
Change in Average Steps Per Day From Baseline Week to Week 24
Time frame: baseline to week 24
The change in average steps per day from the baseline week to week 24

3 secondary outcomes

Self-efficacy
Time frame: Measured at baseline, week 12 and 24
Intrinsic/Extrinsic Motivation
Time frame: Measured at baseline, week 12 and 24
Mental Health
Time frame: Measured at baseline, week 12 and 24

Results and safety

Results posted to the registry on 30 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
F1M1P1R1	6	3
N1M1P1R1	6	5
N1M1P1R0	7	3
N1M1P0R0	6	1
N1M1P0R1	6	3
N1L1P1R1	7	4
N1L1P1R0	6	2
N1L1P0R0	7	0
N1L1P0R1	6	2
F1M1P1R0	6	5
F1M1P0R0	6	3
F1M1P0R1	7	6
F1L1P1R1	7	3
F1L1P1R0	7	2
F1L1P0R0	6	2
F1L1P0R1	6	2

Primary outcome: Change in Average Steps Per Day From Baseline Week to Week 12

Time frame: baseline to week 12. Mean (Standard Deviation). Unit: steps/day

Measure	F1M1P1R1 n = 3	N1M1P1R1 n = 4	N1M1P1R0 n = 3	N1M1P0R0 n = 1	N1M1P0R1 n = 3	N1L1P1R1 n = 3	N1L1P1R0 n = 2	N1L1P0R1 n = 2	F1M1P1R0 n = 5	F1M1P0R0 n = 3	F1M1P0R1 n = 6	F1L1P1R1 n = 3	F1L1P1R0 n = 2	F1L1P0R0 n = 2	F1L1P0R1 n = 2
Value	4224 (719)	4786 (6843)	3654 (3272)	2626 (0)	3740 (2248)	4493 (6036)	3680 (96)	4577 (97)	1110 (1390)	2176 (1467)	3216 (3366)	7002 (456)	8158 (4016)	3599 (226)	2728 (0)

F1M1P1R1 vs N1M1P1R1 vs N1M1P1R0 vs N1M1P0R0 vs N1M1P0R1 vs N1L1P1R1 vs N1L1P1R0 vs N1L1P0R1 vs F1M1P1R0 vs F1M1P0R0 vs F1M1P0R1 vs F1L1P1R1 vs F1L1P1R0 vs F1L1P0R0 vs F1L1P0R1: Mean Difference (Net): -634 (90% CI -1924 to 655), p = 0.418, linear mixed model
F1M1P1R1 vs N1M1P1R1 vs N1M1P1R0 vs N1M1P0R0 vs N1M1P0R1 vs N1L1P1R1 vs N1L1P1R0 vs N1L1P0R1 vs F1M1P1R0 vs F1M1P0R0 vs F1M1P0R1 vs F1L1P1R1 vs F1L1P1R0 vs F1L1P0R0 vs F1L1P0R1: Mean Difference (Net): -1697 (90% CI -3000 to -385), p = 0.033, Mixed Models Analysis
F1M1P1R1 vs N1M1P1R1 vs N1M1P1R0 vs N1M1P0R0 vs N1M1P0R1 vs N1L1P1R1 vs N1L1P1R0 vs N1L1P0R1 vs F1M1P1R0 vs F1M1P0R0 vs F1M1P0R1 vs F1L1P1R1 vs F1L1P1R0 vs F1L1P0R0 vs F1L1P0R1: Mean Difference (Net): 820 (90% CI -347 to 1988), p = 0.248, Mixed Models Analysis

Population analysed: The participants in the N1L1P0R0 group were not assessed because they either walked too many or to few steps at the baseline period

Primary outcome: Change in Average Steps Per Day From Baseline Week to Week 24

Time frame: baseline to week 24. Mean (Standard Deviation). Unit: steps/day

Measure	F1M1P1R1 n = 1	N1M1P1R1 n = 2	N1M1P1R0 n = 2	N1M1P0R0 n = 1	N1M1P0R1 n = 1	N1L1P1R1 n = 3	N1L1P1R0 n = 2	N1L1P0R1 n = 2	F1M1P1R0 n = 4	F1M1P0R0 n = 3	F1M1P0R1 n = 6	F1L1P1R1 n = 2	F1L1P1R0 n = 1	F1L1P0R0 n = 1	F1L1P0R1 n = 1
Value	5237 (0)	4631 (3513)	4074 (2361)	3804 (0)	6414 (0)	3844 (4122)	2487 (3072)	6531 (2683)	614 (928)	3165 (2961)	1312 (3845)	5939 (0)	10675	4382	3406

F1M1P1R1 vs N1M1P1R1 vs N1M1P1R0 vs N1M1P0R0 vs N1M1P0R1 vs N1L1P1R1 vs N1L1P1R0 vs N1L1P0R1 vs F1M1P1R0 vs F1M1P0R0 vs F1M1P0R1 vs F1L1P1R1 vs F1L1P1R0 vs F1L1P0R0 vs F1L1P0R1: Mean Difference (Net): -35 (90% CI -1685 to 1616), p = 0.972, Mixed Models Analysis
F1M1P1R1 vs N1M1P1R1 vs N1M1P1R0 vs N1M1P0R0 vs N1M1P0R1 vs N1L1P1R1 vs N1L1P1R0 vs N1L1P0R1 vs F1M1P1R0 vs F1M1P0R0 vs F1M1P0R1 vs F1L1P1R1 vs F1L1P1R0 vs F1L1P0R0 vs F1L1P0R1: Mean Difference (Net): -2428 (90% CI -4134 to -722), p = 0.019, Mixed Models Analysis
F1M1P1R1 vs N1M1P1R1 vs N1M1P1R0 vs N1M1P0R0 vs N1M1P0R1 vs N1L1P1R1 vs N1L1P1R0 vs N1L1P0R1 vs F1M1P1R0 vs F1M1P0R0 vs F1M1P0R1 vs F1L1P1R1 vs F1L1P1R0 vs F1L1P0R1: Mean Difference (Net): 418 (90% CI -999 to 1836), p = 0.627, Mixed Models Analysis

Population analysed: The participants in the N1L1P0R0 group were not assessed because they either walked too many or to few steps at the baseline period

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: For 24 Weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
F1M1P1R1	0 of 6 (0%)	0 of 6 (0%)	0 of 6
N1M1P1R1	0 of 6 (0%)	0 of 6 (0%)	0 of 6
N1M1P1R0	0 of 7 (0%)	0 of 7 (0%)	0 of 7
N1M1P0R0	0 of 6 (0%)	0 of 6 (0%)	0 of 6
N1M1P0R1	0 of 6 (0%)	0 of 6 (0%)	0 of 6
N1L1P1R1	0 of 7 (0%)	0 of 7 (0%)	0 of 7
N1L1P1R0	0 of 6 (0%)	0 of 6 (0%)	0 of 6
N1L1P0R0	0 of 7 (0%)	0 of 7 (0%)	0 of 7
N1L1P0R1	0 of 6 (0%)	0 of 6 (0%)	0 of 6
F1M1P1R0	0 of 6 (0%)	0 of 6 (0%)	0 of 6
F1M1P0R0	0 of 6 (0%)	0 of 6 (0%)	0 of 6
F1M1P0R1	0 of 7 (0%)	0 of 7 (0%)	0 of 7
F1L1P1R1	0 of 7 (0%)	0 of 7 (0%)	0 of 7
F1L1P1R0	0 of 7 (0%)	0 of 7 (0%)	0 of 7
F1L1P0R0	0 of 6 (0%)	0 of 6 (0%)	0 of 6
F1L1P0R1	0 of 6 (0%)	0 of 6 (0%)	0 of 6

Limitations and caveats (from the sponsor): The COVID-19 pandemic forced IRB-approved changes to recruitment procedures to obviate in-person recruitment. Recruitment was slowed dramatically and we missed our target enrollment. All statistical tests are underpowered. Because of slow delivery of mailed study material, we received IRB approval to randomize patients at consent rather than after the week-long baseline period. This resulted in random imbalance in assignment to treatment arms.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Sedentary Behavior

Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Recruiting
Yoga vs. Stretching-Strengthening: Physical Fitness in Sedentary Young Adults
Sedentary Lifestlye, Exercise
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Recruiting
Scalable TELeheaLth Cancer CARe: The STELLAR Program to Treat Cancer Risk Behaviors
Obesity, Smoking Cessation
Not yet recruiting
Be Well at Work-Plus: A Depression and Physical Activity Intervention for Hospital Service Workers (Aim 3)
Depression, Physical Inactivity

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.

Paul L. Hebert, PhD BA principal investigator

VA Puget Sound Health Care System Seattle Division, Seattle, WA

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Walking in people with Sedentary Behavior and Exercise, run by VA Office of Research and Development at 1 site in United States.

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 6 inclusion and 14 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 30 Apr 2025. 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 United States. 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?

Yes. Results are posted in the registry (first posted 30 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Average Steps Per Day From Baseline Week to Week 12 (time frame: baseline to week 12). The study lists 2 primary outcomes in all. 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 NCT04518943.

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 30 Apr 2025.