Multiphase Optimization Trial of Incentives for Veterans to Encourage Walking

NCT04518943 | Completed Results

• 1 other identifier: IIR 19-450
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedentary Behavior; Exercise; Walking; Motivation; Hypertension; Depression; Body Mass Index

Keywords

sedentary behavior; walking; motivation

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  baseline to week 24

Secondary Outcomes (3)

• Self-efficacy

  Measured at baseline, week 12 and 24

• Intrinsic/Extrinsic Motivation

  Measured at baseline, week 12 and 24

• Mental Health

  Measured at baseline, week 12 and 24

Study Arms (16)

F1M1P1R1

EXPERIMENTAL

Financial Reward, mixed lottery, pre-commitment postcard reminders, request physical activity advice

Behavioral: Walking

N1M1P1R1

EXPERIMENTAL

Non-financial reward, mixed lottery, pre-commitment postcard reminders, request physical activity advice

Behavioral: Walking

N1M1P1R0

EXPERIMENTAL

Non-financial reward, mixed lottery, pre-commitment postcard reminders, no request physical activity advice

Behavioral: Walking

N1M1P0R0

EXPERIMENTAL

Non-financial reward, mixed lottery, no pre-commitment postcard reminders, no request physical activity advice

Behavioral: Walking

N1M1P0R1

EXPERIMENTAL

Non-financial reward, mixed lottery, no pre-commitment postcard reminders, request physical activity advice

Behavioral: Walking

N1L1P1R1

EXPERIMENTAL

Non-financial reward, loss incentive, pre-commitment postcard reminders, request physical activity advice

Behavioral: Walking

N1L1P1R0

EXPERIMENTAL

Non-financial reward, loss incentive, pre-commitment postcard reminders, no request physical activity advice

Behavioral: Walking

N1L1P0R0

EXPERIMENTAL

Non-financial reward, loss incentive, no pre-commitment postcard reminders, no request physical activity advice

Behavioral: Walking

N1L1P0R1

EXPERIMENTAL

Non-financial reward, loss incentive, no pre-commitment postcard reminders, request physical activity advice

Behavioral: Walking

F1M1P1R0

EXPERIMENTAL

Financial Reward, mixed lottery, pre-commitment postcard reminders, no request physical activity advice

Behavioral: Walking

F1M1P0R0

EXPERIMENTAL

Financial Reward, mixed lottery, no pre-commitment postcard reminders, no request physical activity advice

Behavioral: Walking

F1M1P0R1

EXPERIMENTAL

Financial Reward, mixed lottery, no pre-commitment postcard reminders, request physical activity advice

Behavioral: Walking

F1L1P1R1

EXPERIMENTAL

Financial Reward, loss incentive, pre-commitment postcard reminders, request physical activity advice

Behavioral: Walking

F1L1P1R0

EXPERIMENTAL

Financial Reward, loss incentive, pre-commitment postcard reminders, no request physical activity advice

Behavioral: Walking

F1L1P0R0

EXPERIMENTAL

Financial Reward, loss incentive, no pre-commitment postcard reminders, no request physical activity advice

Behavioral: Walking

F1L1P0R1

EXPERIMENTAL

Financial Reward, loss incentive, no pre-commitment postcard reminders, request physical activity advice

Behavioral: Walking

Interventions

Walking BEHAVIORAL

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.

F1L1P0R0; F1L1P0R1; F1L1P1R0; F1L1P1R1; F1M1P0R0; F1M1P0R1; F1M1P1R0; F1M1P1R1; N1L1P0R0; N1L1P0R1; N1L1P1R0; N1L1P1R1; N1M1P0R0; N1M1P0R1; N1M1P1R0; N1M1P1R1

Eligibility Criteria

• Age: 50 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. .
• ,000-5,000 steps per day during the screening week
• Have and be able to use a smart phone.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

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

Seattle, Washington, 98108-1532, United States

Location

MeSH Terms

Conditions

Sedentary Behavior; Motor Activity; Hypertension; Depression

Interventions

Walking

Condition Hierarchy (Ancestors)

Behavior; Vascular Diseases; Cardiovascular Diseases; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Paul Hebert
• Organization: VA Puget Sound Health Care System

paul.hebert2@va.gov

(206) 277-4165

Study Officials

• Paul L. Hebert, PhD BA

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Data will be masked to the principal investigator.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 14, 2020
• First Posted: August 19, 2020
• Study Start: March 17, 2022
• Primary Completion: November 30, 2023
• Study Completion: July 31, 2024
• Last Updated: April 30, 2025
• Results First Posted: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)