NCT06623669: MORPH-III

A Mobile Intervention to Reduce Pain and Improve Health-III

Recruiting now Phase 2 Last updated 20 February 2026

What this trial tests

Phase 2 trial testing MORPH in Chronic Pain in 200 participants. Currently enrolling.

Timeline

14 August 2025

Primary endpoint
15 June 2029

31 August 2029

Quick facts

Lead sponsor	Wake Forest University
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	200
Start date	14 August 2025
Primary completion	15 June 2029
Estimated completion	31 August 2029
Sites	1 location across United States

Drugs / interventions tested

• MORPH
• Measurement Only

Conditions studied

• Chronic Pain — all drugs for Chronic Pain →
• Osteoarthritis — all drugs for Osteoarthritis →
• Obesity and Overweight — all drugs for Obesity and Overweight →
• Inactivity — all drugs for Inactivity →

Sponsor

Wake Forest University

Who can join

65 and older, any sex, with Chronic Pain or Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A mobile intervention to reduce pain and improve health-III: protocol for a remotely delivered randomized controlled trial of physical activity for pain management in older adults with obesity and knee or hip osteoarthritis.
   Fanning J, Dobson DO, Ford SA, Bennett M, et al · · 2026 · PMID 42255285 · DOI 10.3389/fdgth.2026.1739501