Recruiting

Motivational Interviewing & Financial Incentives

Sponsor:

Brigham and Women's Hospital

Code:

NCT07825480

Conditions

Spinal Surgery for Lumbar Spinal Stenosis (LSS)

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Wrist based activity tracker wear

Basic Study Activities

Telephonic Active Coaching (Motivational Interviewing) + Financial Incentives

Study Details

Brief summary:

Back pain can be disabling, limiting the ability to walk and to engage in physical activity. For patients with degenerative lumbar spinal stenosis, decompressive surgery often provides substantial pain relief and improved mobility. However, research has shown that even after successful surgery, most patients do not increase physical activity or walking. This is important because regular physical activity can help older adults prevent and manage chronic disease, delay functional decline, and maintain independence.

The goal of our study, called the Activity post Spinal Surgery Engagement Trial (ASSET), is to test whether a behavioral program can help patients become more physically active after spine surgery. The investigators have evaluated strategies to help people improve their physical activity after knee replacement surgery and would now like to understand whether these interventions are effective for patients undergoing spine surgery.

The intervention combines two approaches designed to motivate behavior change. Motivational interviewing invokes internal motivation, where patients work with a trained coach to recognize the importance of walking habits, prepare for change, and develop and implement an effective walking plan. External motivation is based on financial incentives, where patients receive small but concrete rewards for obtaining their physical activity goals.

The investigators want to test whether this intervention is better than simply providing patients with an activity tracker, so the study will randomly assign interested participants to one of two groups: the motivational interviewing and financial incentive intervention, or a control arm. All participants will receive a Fitbit activity monitor, and patients in the intervention group will also receive coaching sessions and financial incentives. This pilot study will help determine whether the program is acceptable to patients and whether it shows promise for improving physical activity after spine surgery.

Conditions

Spinal Surgery for Lumbar Spinal Stenosis (LSS)

Study ID

NCT07825480

Start date

Oct 19, 2026

Status verified date

Sep, 2026

Completion date

Sep 1, 2028

Anticipated

Primary completion date

Mar 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age: 40-85 years
  • Scheduled to undergo a decompressive lumbar laminectomy with or without concomitant lumbar fusion
  • LSS is principal diagnosis for lumbar decompression surgery
  • Passes the Physical Activity Readiness Questionnaire (PAR-Q)
  • Agrees to all study technology requirements
  • Able to wear the ActiGraph for ≥ 4/7 days for ≥ 10 hours per day during pre-screening
  • Average baseline steps/day < 6,000 during pre-screening assessment period

Exclusion Criteria:

  • Lives in a nursing home
  • Non-English speaking
  • Uses a wheelchair for all ambulation
  • Has a physical condition resulting in inability to walk or makes walking -unstable
  • Diagnosis of dementia, epilepsy, Parkinson's Disease, or peripheral neuropathy with documented gait or balance disturbance of falls related to the condition
  • Has psychological issues that preclude participation
  • Surgeon-documented other reason for study exclusion
  • Primary indication for surgery is not lumbar spinal stenosis (this could include primary or metastatic tumor, spine infection, or sagittal deformity issues)
  • Has an inpatient or musculoskeletal surgery scheduled within the 6 months following lumbar decompression surgery
  • Has a history of past spine surgery within one year of date of pre-screen
  • Has a history of more than one spine surgery in the zone of proposed surgery

Study Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Wrist-based activity tracker

Participants in this arm receive usual post-operative care, complete all basic study activities, and receive a wrist-based activity tracker intervention.

experimental: Wrist-based activity tracker + TAC(MI)+FI

Participants in this arm receive usual post-operative care, complete all basic study activities (as described in arm 1), receive wrist-based activity tracker intervention, and receive the TAC(MI)+FI.

Interventions

Wrist based activity tracker wear

Activity tracking data will be collected on a weekly basis. Participants who receive this intervention are eligible to receive $5 for every week they wear their wrist-based activity tracker >10 hours for >4/7 days a week, beginning 6-weeks after surgery from weeks 6-31 ($130 maximum total).

Basic Study Activities

Basic study activities begin approximately two-weeks before LDS and end approximately 24-months after LDS. Basic study activities include: two in-person visits at the clinic site (2 weeks before LDS and 32-weeks after LDS), having check-in calls with study staff weekly from weeks 1-13 after surgery and every other week for weeks 14-31, completing 4 surveys, and wearing an ActiGraph activity tracker (waist-worn) for three one-week periods throughout the study (2-weeks before-LDS, 32-weeks post-LDS, and one-year post-LDS). All participants will be eligible to receive up to $155 for completing these activities over the course of one year.

Telephonic Active Coaching (Motivational Interviewing) + Financial Incentives

As part of TAC(MI)+FI, participants speak with a health coach at Brigham and Women's Hospital once a week via telephone for weeks 6-13 following surgery, and once every other week for weeks 14-31 after surgery. Participants in this arm can receive financial rewards for achieving weekly step goals, as well as bonus rewards for achieving goals multiple weeks in a row. Over the course of this 6-month long TAC(MI)+FI intervention period, these participants are able to receive up to $380 for meeting step goals, and up to $110 in bonus rewards for sustaining step goals.

Primary outcome measure

  • Feasibility: Proportion of eligible participants who consent [ Time Frame: Baseline ]
  • Change in average daily step count [ Time Frame: 2 weeks pre-LDS to 32 Weeks post-LDS ]
  • Feasibility: Retention rate [ Time Frame: 52 Weeks post-LDS ]
  • Feasibility: Satisfaction [ Time Frame: 52 Weeks post-LDS ]

Central Contacts and Locations

Locations

Mass General Brigham

Recruiting

Boston, Massachusetts, United States, 02139

Contacts

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Oct 22, 2026

Last verified

Sep, 2026

Keywords

  • Physical Activity
  • lumbar spinal stenosis (LSS)
  • spinal stenosis decompression surgery
  • Musculoskeletal Diseases
  • Motivational Interviewing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-10-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.