Mobile Intervention for Pain and Obesity

(MORPH-II Trial)

Overseen By Charlotte Crotts, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University

Must not be taking: Growth hormones, oral steroids

Disqualifiers: Severe heart disease, uncontrolled hypertension, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a mobile intervention, called MORPH, can assist older adults with chronic pain and obesity. It aims to reduce pain, increase daily movement, and promote weight loss through remote coaching and a custom smartphone app. Participants receive a wearable activity monitor and engage in virtual meetings and coaching sessions. Ideal candidates are aged 55-85, are low-active, have a BMI of 30-45, and experience pain in multiple areas such as the back, neck, or knees. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance quality of life for many.

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

The trial protocol does not specify whether you need to stop taking your current medications. However, if you regularly use growth hormones, oral steroids, or prescription osteoporosis medications, you may not be eligible to participate.

What prior data suggests that this mobile intervention is safe for older adults with chronic pain and obesity?

Research has shown that the MORPH program might be safe for people. In a previous study, this mobile health program helped older, overweight adults with long-term pain by encouraging weight loss, less sitting, and more physical activity. Participants used a smartphone app and received coaching to reach these goals.

However, the available information does not provide detailed safety data specifically for the MORPH program. The absence of reported negative effects suggests that the program might be well-tolerated. Additionally, the study is at a stage where major safety issues would likely have been addressed in earlier testing.

It's important to note that MORPH uses non-drug methods, like coaching and movement, which generally have fewer risks compared to medication. Participants in earlier studies managed the program without major problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about MORPH because it takes a fresh approach to managing pain and obesity with the help of technology. Unlike traditional treatments that might focus on medication or surgery, MORPH combines personalized coaching with the use of a smartphone app, smart scale, and activity monitor to encourage daily physical activity and calorie control. This method empowers participants to take control of their health by integrating healthy habits into their everyday lives, with the added flexibility of virtual meetings. By leveraging technology and personalized support, MORPH aims to create sustainable lifestyle changes, which could offer a more engaging and accessible option for people dealing with pain and obesity.

What evidence suggests that the MORPH intervention could be effective for pain and obesity?

Research has shown that the MORPH program, available to participants in this trial, can reduce pain and improve physical function in older, overweight adults with chronic pain. One study found that individuals in the program lost weight, sat less, walked more, and experienced less pain compared to non-participants. The program employs phone coaching and a mobile app to promote increased movement and healthier eating. Most participants increased their activity through walking, which helped reduce stiffness and pain. Overall, MORPH appears promising for managing pain and enhancing health in this group. ^{1 3 6 7 8}

Who Is on the Research Team?

Jason Fanning, PhD

Principal Investigator

Wake Forest University

Are You a Good Fit for This Trial?

This trial is for older adults aged 55-85 with obesity (BMI of 30-45), chronic pain in multiple areas, and a sedentary lifestyle. They must have stable weight, data coverage at home, agree to the study's procedures, and own a smartphone.

Inclusion Criteria

Agree to all study procedures and assessments

Owns an Android or Apple smartphone

Has data coverage in the home

Exclusion Criteria

Participation in regular resistance training and/or > 20 mins on 2+ d/w of aerobic exercise in past 6 months

I need a cane or walker to walk short distances.

Vision insufficient to read a smartphone screen, unable to read

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in 12 weeks of group and 1-on-1 coaching to promote physical activity and caloric restriction, using a custom smartphone application, smart scale, and physical activity monitor.

12 weeks

Remote sessions via video conference

Follow-up

Participants transition to a 12-week no-contact follow-up to observe whether behavior change sustains following completion of the focused intervention.

12 weeks

Maintenance

Participants are provided with tools to continue meeting virtually on their own if desired, and will be followed for an additional 12-week maintenance phase.

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MORPH

Trial Overview MORPH II tests a fully remote intervention aimed at reducing pain and promoting movement throughout the day using high-contact coaching via tablet computers. It compares this approach against standard control over 12 weeks to see if it improves pain, physical function, activity levels, and reduces sitting time.

How Is the Trial Designed?

Group I: MORPH Experimental Treatment 1 Intervention

Participants engage in 12 weeks of group and 1-on-1 coaching meant to promote physical activity throughout the day and caloric restriction. Participants engage with a custom smartphone application, use a smart scale and physical activity monitor, and meet using video conference software. At the end of 12 weeks, participants are provided with tools to continue meeting virtually on their own if desired, and will be followed for an additional 12-week maintenance phase.

Group II: Control Active Control 1 Intervention

This condition receives the wearable activity monitor and simply asked to use it and continue in their daily lives for 24 weeks.

Who Is Running the Clinical Trial?

Wake Forest University

Lead Sponsor

Trials

193

Recruited

151,000+

Published Research Related to This Trial

A technology-based weight loss intervention for 18 urban, low-income mothers resulted in a significant weight loss of -2.9 kg over 14 weeks, compared to only 0.5 kg in the usual care group, indicating its efficacy.

One-third of the mothers in the intervention group lost more than 5% of their initial body weight, highlighting the potential of technology to support weight loss in postpartum women from disadvantaged backgrounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using technology to promote postpartum weight loss in urban, low-income mothers: a pilot randomized controlled trial. Herring, SJ., Cruice, JF., Bennett, GG., et al.[2022]

A pilot study involving 50 obese black women tested a 6-month text messaging intervention for weight loss, showing that participants in the intervention group lost an average of 1.27 kg, while the control group gained weight, indicating potential efficacy of the text messaging approach.

The study found that 85% of participants engaged with the self-monitoring prompts at least twice a week, and many reported that the daily texting was easy and helpful, suggesting that text messaging could be a feasible tool for weight management in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily text messaging for weight control among racial and ethnic minority women: randomized controlled pilot study. Steinberg, DM., Levine, EL., Askew, S., et al.[2021]

A study involving 22 participants from a weight management clinic in Singapore identified key features that weight loss apps should include for a multi-ethnic population with overweight and obesity, such as comprehensive calorie counters and individualized behavior change recommendations.

Participants emphasized the importance of flexibility in food logging and the need for apps to provide just-in-time reminders about the consequences of their choices, suggesting that future apps could benefit from artificial intelligence to offer personalized support for weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Essential elements of weight loss apps for a multi-ethnic population with high BMI: a qualitative study with practical recommendations. Chew, HSJ., Lim, SL., Kim, G., et al.[2023]

In a pilot study involving 68 obese adults over six months, those receiving intensive counseling combined with smartphone self-monitoring lost an average of 5.4 kg, indicating that this approach may enhance weight loss efforts.

The study suggests that smartphone technology can be a feasible and acceptable tool for supporting behavioral interventions in weight loss, particularly when combined with counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled pilot study testing use of smartphone technology for obesity treatment. Allen, JK., Stephens, J., Dennison Himmelfarb, CR., et al.[2022]

Inpatient rehabilitation for obesity should involve a multidisciplinary team, including various health professionals, to effectively improve weight loss and address related health issues.

Internet-based and mobile health (mHealth) technologies can enhance long-term obesity rehabilitation by improving treatment compliance and engagement, suggesting a promising direction for future research in this field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obesity and outpatient rehabilitation using mobile technologies: the potential mHealth approach. Castelnuovo, G., Manzoni, GM., Pietrabissa, G., et al.[2022]

A study involving 66-118 patients who underwent weight loss surgery showed that post-operative weeks were linked to decreased daily steps, less time spent walking, and improved sleep metrics, indicating significant lifestyle changes after surgery.

The research highlights the effectiveness of consumer-grade wearable devices, like Fitbits, in monitoring behavioral and physiological changes during recovery, suggesting they could be valuable tools for tracking patient progress in a convenient and continuous manner.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous Digital Assessment for Weight Loss Surgery Patients. Ramirez, E., Marinsek, N., Bradshaw, B., et al.[2020]

In a study involving 24 veterans, it was found that while most participants believed mHealth interventions for weight management were appropriate, many did not complete the registration process, indicating that initial adoption requires more than just a single invitation.

Key barriers to mHealth adoption included preferences for in-person care and challenges with self-monitoring, suggesting that successful implementation should consider user preferences and provide multiple options for engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adoption and Appropriateness of mHealth for Weight Management in the Real World: A Qualitative Investigation of Patient Perspectives. Breland, JY., Agha, K., Mohankumar, R.[2022]

The ENGAGED study involves 96 obese adults and compares three weight loss methods over 12 months, aiming for a 7% weight loss goal through dietary changes and increased physical activity.

The study hypothesizes that the technology-supported behavioral weight loss program (TECH) will lead to greater weight loss than standard methods (STND) and self-guided approaches (SELF) due to better adherence and goal achievement, utilizing a smartphone app for monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A smartphone-supported weight loss program: design of the ENGAGED randomized controlled trial. Pellegrini, CA., Duncan, JM., Moller, AC., et al.[2021]

Current mobile health (mHealth) technologies have the potential to significantly enhance real-time interventions for obesity-related behaviors, but most efforts still rely on basic SMS interventions instead of utilizing advanced real-time sensing capabilities.

The paper highlights five studies that explore innovative uses of new technologies for monitoring diet, physical activity, and sleep, while also addressing the challenges that mHealth obesity research must overcome to fully leverage these advancements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovations in the Use of Interactive Technology to Support Weight Management. Spruijt-Metz, D., Wen, CK., O'Reilly, G., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03377634

A Mobile Intervention to Reduce Pain and Improve Health ... The purpose of this study is to develop and test a novel, patient-centered intervention to reduce pain and improve physical function in older, obese adults.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5972205/

A Mobile Health Intervention to Reduce Pain and Improve ... The MORPH Companion provides immersive intervention content designed to prompt daily movement and to enhance social connections, outcome ...

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

A Mobile Health Behavior Intervention to Reduce Pain and ... Regarding phase 2, we hypothesized that participation in MORPH was feasible for older adults with chronic pain and that it would result in reductions in self- ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11079154/

Successes and lessons learned from a mobile health ... This paper describes qualitative analyses of interview data collected in conjunction with a novel treatment for chronic pain in older adults ...

5. researchprotocols.org researchprotocols.org/2021/7/e29013/

Building on Lessons Learned in a Mobile Intervention to ... A mobile health behavior intervention to reduce pain and improve health in older adults with obesity and chronic pain: the MORPH pilot trial.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8329761/

Protocol for the MORPH-II Trial - PMC - PubMed Central The MORPH-II study is an iteration on MORPH designed to pilot a refined framework, enhance scalability through fully remote delivery, and increase uptake of ...

7. withpower.com withpower.com/trial/phase-2021-1015d

Mobile Intervention for Pain and Obesity (MORPH-II Trial) Is the mobile intervention for pain and obesity safe for humans? The research articles do not provide specific safety data for the mobile intervention for pain ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8018691/

A Mobile Health Behavior Intervention to Reduce Pain and ... A Mobile Health Behavior Intervention to Reduce Pain and Improve Health in Older Adults With Obesity and Chronic Pain: The MORPH Pilot Trial. Jason Fanning ...