200 Participants Needed

Mobile Intervention for Osteoarthritis

(MORPH-III Trial)

JF
DO
Overseen ByDeja O Dobson, MS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The experience of chronic pain powerfully and negatively affects quality of life and functional independence in aging. Unfortunately, while as many as three in four older adults experience chronic pain, few have access to effective non-pharmacological pain management strategies. Participating in regular physical activity, avoiding sustained sitting, and maintaining a healthy weight are important and interrelated lifestyle inputs to chronic pain, and socially rich behavioral interventions informed by contemporary theories of behavior change appear important for engaging in activity and healthy eating in the long term. Our group has demonstrated in a series of Stage I trials that a group-mediated behavioral intervention combining dietary behavior change and a physical activity program focused on moving often throughout the day contributes to meaningful weight loss, and lasting weight maintenance, with pilot data suggesting this may contribute to improved pain, physical function, and health-related quality of life among older adults with chronic pain. As these were NIH Stage I trials, there are several important gaps to be addressed in the present trial: (1) both studies of chronic pain recruited small samples and were 12 weeks in duration, limiting our ability to establish efficacy and the durability of changes to activity, HRQOL, and pain outcomes; (2) participants included anyone with chronic pain, regardless of pain type, a likely contributor to heterogeneous pain intensity and interference findings; and (3) the investigators have yet to examine behavioral maintenance.The overarching goal of the proposed Stage II "mobile intervention to reduce pain and improve health-III (MORPH-III)" is to establish the efficacy of the intervention for enhancing physical activity via steps (primary), and for reducing pain interference and body weight while enhancing physical function (secondary) among older adults with chronic knee or hip osteoarthritic (OA) pain. The investigators will recruit 200 older adults with knee or hip osteoarthritic pain to engage in a 6-month remotely delivered intervention comprising weekly group or individual intervention meetings plus brief individual goal-setting coaching calls. This will be followed by a 12-month no-contact maintenance period, where participants will attempt to sustain behavioral goals on their own.The Specific Aims are:Specific Aim 1: To examine the impact of MORPH on ActivPAL-assessed daily steps relative to an enhanced usual care control. Hypotheses: MORPH will significantly increase steps relative to control at month 6.Specific Aim 2: To examine the impact of MORPH on pain interference, change in body weight, and physical function relative to the enhanced usual care control. Hypotheses: MORPH will result in significant reductions in pain interference and body weight and improvement in physical function relative to control at month 6.Exploratory Aims: Aim 1: To investigate the impact of the MORPH intervention on steps, weight change, pain interference, and physical function at month 18. Aim 2: If the MORPH intervention results in reduced pain interference at 6 and/or 18 months, the investigators will examine the extent to which 6-month change in steps, weight, pain self-efficacy, and catastrophizing mediate change in interference at 6 and/or 18 months.

Who Is on the Research Team?

JF

Jason Fanning, PhD

Principal Investigator

Wake Forest University

AB

Amber Brooks, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for older adults aged 65+ with knee or hip osteoarthritis, a BMI of 30-45 kg/m2, and a stable weight in the past 6 months. Participants should be living independently, not very active (little to no regular exercise), able to safely engage in physical activity, not on weight loss meds, and willing to consent to study procedures.

Inclusion Criteria

I have not been regularly exercising more than 20 minutes a day, twice a week in the last 3 months.
My BMI is between 30 and 45.
My weight has been stable, not changing more than 5% in the last 6 months.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 6-month remotely delivered intervention comprising weekly group or individual intervention meetings plus brief individual goal-setting coaching calls

6 months
Weekly group or individual sessions

Maintenance

Participants attempt to sustain behavioral goals on their own during a no-contact period

12 months

Follow-up

Participants are monitored for changes in steps, weight, pain interference, and physical function

18 months

What Are the Treatments Tested in This Trial?

Interventions

  • MORPH
Trial Overview The MORPH intervention aims to increase daily steps using mobile technology and reduce pain interference among those with chronic knee or hip pain due to osteoarthritis. It includes weekly group or individual meetings plus coaching calls over six months followed by a year of self-maintained behavior.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: MORPHExperimental Treatment1 Intervention
MORPH participants will attend one weekly group-mediated session alongside a group of their peers plus individual coaching calls. Participants will aim to increase daily steps by moving often throughout the day, using an activity monitor and mHealth app to view feedback and set goals. Participants will also aim to weight via healthy eating while reducing daily calories by \~400kcal/day below weight maintenance needs to achieve approximately 6% weight loss in 6 months and 10% over 18 months.
Group II: Measurement OnlyActive Control1 Intervention
Measurement-only participants will receive an activity monitor and wireless weight scale to account for the effect of these self-monitoring technologies and activity behavior.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University

Lead Sponsor

Trials
193
Recruited
151,000+

Duke University

Collaborator

Trials
2,495
Recruited
5,912,000+

Wake Forest University Health Sciences

Collaborator

Trials
1,432
Recruited
2,506,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of ServiceยทPrivacy PolicyยทCookiesยทSecurity