Mobile Intervention for Pain and Obesity
(MORPH-II Trial)
Trial Summary
What is the purpose of this trial?
Chronic pain is a pervasive and costly health condition among older adults that is associated with wide-ranging adverse health outcomes including falls, declining mobility, and increasing functional disability. Obesity exacerbates many of these health issues, contributing to a higher frequency of intractable pain episodes, increased pain severity, multi-site pain, and the use of stronger opioid medications compared to normal weight individuals with chronic pain. In addition, older adults who suffer from chronic pain are significantly more sedentary than those without chronic pain. Despite evidence relating increased sedentary behavior to pain, non-pharmacological treatments have largely focused on structured moderate-to-vigorous physical activity (MVPA) by way of conventional forms of exercise. Recent evidence from an intervention designed to decreased sedentary behavior (SB) demonstrated the approach is effective in preventing weight regain following weight loss. A subsequent study-a mobile intervention to reduce pain and improve health (MORPH: Wake Forest Baptist Health institutional review board \[IRB\] 00046364)-demonstrated that a primarily home-delivered intervention (9 of 12 delivered in home; 3 of 12 delivered in a research center) supported by technology can produce significant weight loss, reductions in sedentary time, increases in daily steps, less pain intensity, and better physical function compared with a waitlist control. MORPH included a focus on dietary weight loss plus movement across the day through a combination of group telecoaching and a custom mobile health (mHealth) application, but results indicated that participants did not internalize the day-long movement intervention. Instead, they appeared to achieve a greater number of steps through conventional walking exercise, allowing for high levels of sitting, stiffness, and pain. MORPH concluded with a two-group randomized controlled pilot trial (RCT) in obese (BMI=30-45 kg/m2), low-active, older (55-85 years) adults with chronic pain who were randomized to either 12-weeks of active intervention or a wait-list control. This study represents an extension of MORPH-hereafter MORPH II-with the intention of immediately addressing limitations in the original MORPH study. Participants will be randomize 30 older, low-active, obese adults to the active intervention or to a standard control for 12 weeks. To build upon the last phase of MORPH, the research team will deliver this intervention fully remotely, providing cellular data-equipped tablet computers to protect participant safety and reduce technical issues that may arise due to lack of face-to-face orientation appointments. Given the current COVID-19 climate, the investigators have chosen to deliver the entire intervention remotely. The investigators are implementing intensive individual coaching throughout the program and greater emphasis on frequent movement to drive better uptake of a day-long movement program and will transition participants to a 12-week no-contact follow-up to observe whether behavior change sustains following completion of the focused intervention. This study is couched within a contemporary engineering-inspired design framework-the multiphase optimization strategy (MOST)-which emphasizes rapid identification of successful intervention components and the removal or redesign of components that are either ineffective or perceived as a nuisance. To this end, the study team will carry momentum from MORPH into MORPH II wherein the team will assess the impact of a fully remote MORPH intervention with the addition of high-contact coaching on pain ratings, physical function, levels of physical activity and sedentary behavior, and body weight. This is particularly timely given limited access to center-based resources for many during the COVID-19 pandemic, and especially those who are high-risk, including older adults with chronic pain. Aims and Hypotheses Specific Aim 1: To conduct a pilot RCT to provide initial evidence for the effect size associated with the proposed intervention on pain, sitting time, and daily steps. Investigators will also explore the impact of this program on social connection (i.e., relatedness) and physical function. Hypothesis 1: It is expected that the provision of the in-home application to contribute to clinically meaningful improvements in pain ratings and steps and a reduction in daily sedentary time compared to the control condition. Specific Aim 2: To examine whether a socially mediated, home-delivered health intervention produces lasting behavior change over a 12-week no-contact period. Hypothesis 2: It is expected that levels of physical activity at week 24 will remain meaningfully improved over baseline in the intervention condition relative to the control.
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 data supports the effectiveness of the treatment MORPH for pain and obesity?
Research shows that using mobile technology for weight loss can be effective, as seen in studies where smartphone apps helped people lose weight by providing personalized recommendations and reminders. These findings suggest that mobile interventions like MORPH could be beneficial for managing obesity.12345
Is the mobile intervention for pain and obesity safe for humans?
How is the MORPH treatment for pain and obesity different from other treatments?
Research Team
Jason Fanning, PhD
Principal Investigator
Wake Forest University
Eligibility Criteria
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
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.
Follow-up
Participants transition to a 12-week no-contact follow-up to observe whether behavior change sustains following completion of the focused intervention.
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.
Treatment Details
Interventions
- MORPH
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University
Lead Sponsor