Mobile Intervention for Osteoarthritis

(MORPH-III Trial)

Recruiting at 1 trial location

Overseen By Deja O Dobson, MS

Age: 65+

Sex: Any

Trial Phase: Phase 2

Sponsor: Wake Forest University

Must not be taking: Weight loss medications

Disqualifiers: Severe arthritis, Cognitive impairment, Uncontrolled hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new mobile-based intervention called MORPH, designed to help older adults with knee or hip osteoarthritis manage pain and increase physical activity. Participants will follow a program that encourages more daily steps and healthier eating habits to lose weight and reduce pain. The trial will compare this approach with a usual care group to determine its effectiveness in enhancing daily activity and reducing pain. It suits older adults with knee or hip osteoarthritis pain who are not currently involved in regular exercise programs. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to valuable insights on managing osteoarthritis pain.

Do I need to stop my current medications to join the trial?

The trial does not specify whether you need to stop taking your current medications. However, you cannot participate if you are currently using a weight loss medication.

What prior data suggests that this intervention is safe for older adults with osteoarthritic pain?

Research has shown that mobile app-based programs, such as MORPH, are generally safe for people with osteoarthritis. In past studies, these digital tools have been used safely to help manage pain and improve health. The MORPH program, adapted from an existing one, is designed for home use with smartphones. It helps participants become more active and manage their weight, which can reduce pain and improve physical function. No serious side effects have been reported so far, indicating that participants tolerate the treatment well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MORPH approach for osteoarthritis because it combines physical activity and weight management in a unique way. Unlike typical treatments that focus on medications or surgery, MORPH encourages participants to increase their daily steps using an activity monitor and a mobile health app, which provides real-time feedback and goal-setting. Additionally, it emphasizes healthy eating with a structured calorie reduction plan aimed at significant weight loss over time. This holistic approach addresses both physical activity and diet, which could lead to improved outcomes for osteoarthritis patients beyond what current treatments offer.

What evidence suggests that this mobile intervention is effective for osteoarthritis?

Research has shown that the MORPH program, which participants in this trial may receive, might help older adults with osteoarthritis by reducing pain and improving physical function. In earlier studies, participants reported better pain management and increased physical activity. A small trial found that people who followed the MORPH program attended most sessions, lost weight, and felt less pain. Digital programs like this one have slightly reduced pain and disability. Overall, the MORPH program encourages more daily movement and healthy eating, potentially leading to less pain and a better quality of life. ^{4 6 7 8 9}

Who Is on the Research Team?

Jason Fanning, PhD

Principal Investigator

Wake Forest University

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.

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?

Group I: MORPH Experimental Treatment 1 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 Only Active Control 1 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.

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06623669

A Mobile Intervention to Reduce Pain and Improve Health-III 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 ...

2. withpower.com withpower.com/trial/phase-2-osteoarthritis-2025-365fd

Mobile Intervention for Osteoarthritis (MORPH-III Trial) Hypotheses: MORPH will result in significant reductions in pain interference and body weight and improvement in physical function relative to control at month 6 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9666366/

Results of the MORPH-II randomized pilot trial - PubMed Central Participants in the MORPH intervention condition attended 82.5% of sessions on average. There was one individual in the intervention condition ...

4. sciencedirect.com sciencedirect.com/org/science/article/pii/S2561760523000257

Older Adults' Pain Outcomes After mHealth Interventions The purpose of this scoping review is to examine the characteristics of mHealth interventions and their efficacy on pain outcomes in older adults with ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12484128/

Effectiveness of digital pain management for older adults ... Our results suggest that digital interventions may reduce pain intensity and pain disability slightly at post-intervention and compared to other interventions ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12454192/

The Effect and Safety of App-Based Interventions for ... This study showed that app-based interventions were safe and effective for patients with OA, which might provide a cost-effective option, ...

7. frontiersin.org frontiersin.org/journals/digital-health/articles/10.3389/fdgth.2020.598456/full

A Mobile Health Behavior Intervention to Reduce Pain and ... The MORPH study first adapted and iteratively refined an evidence-based group-mediated intervention for delivery in the home via mHealth tools (a smartphone app ...

8. trials.arthritis.org trials.arthritis.org/trials/NCT06623669

A Mobile Intervention to Reduce Pain and Improve Health-III Hypotheses: MORPH will result in significant reductions in pain interference and body weight and improvement in physical function relative to control at month 6 ...

9. mhealth.jmir.org mhealth.jmir.org/2023/1/e40844

mHealth Intervention for Improving Pain, Quality of Life, and ... Interventions were mHealth systems based on mobile apps (smartphone or tablet) used for monitoring pain and health-related outcomes, for pain ...