Building on Lessons Learned in a Mobile Intervention to Reduce Pain and Improve Health (MORPH): Protocol for the MORPH-II Trial.

ABSTRACT

BACKGROUND: Engaging in sufficient levels of physical activity, guarding against sustained sitting, and maintaining a healthy body weight represent important lifestyle strategies for managing older adults' chronic pain. Our first Mobile Health Intervention to Reduce Pain and Improve Health (MORPH) randomized pilot study demonstrated that a partially remote group-mediated diet and daylong activity intervention (ie, a focus on moving often throughout the day) can lead to improved physical function, weight loss, less pain intensity, and fewer minutes of sedentary time. We also identified unique delivery challenges that limited the program's scalability and potential efficacy. OBJECTIVE: The purpose of the MORPH-II randomized pilot study is to refine the MORPH intervention package based on feedback from MORPH and evaluate the feasibility, acceptability, and preliminary efficacy of this revised package prior to conducting a larger clinical trial. METHODS: 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 the daylong movement protocol through revised education content and additional personalized remote coaching. Older, obese, and low-active adults with chronic multisite pain (n=30) will be randomly assigned to receive a 12-week remote group-mediated physical activity and dietary weight loss intervention followed by a 12-week maintenance period or a control condition. Those in the intervention condition will partake in weekly social cognitive theory-based group meetings via teleconference software plus one-on-one support calls on a tapered schedule. They will also engage with a tablet application paired with a wearable activity monitor and smart scale designed to provide ongoing social and behavioral support throughout the week. Those in the control group will receive only the self-monitoring tools. RESULTS: Recruitment is ongoing as of January 2021. CONCLUSIONS: Findings from MORPH-II will help guide other researchers working to intervene on sedentary behavior through frequent movement in older adults with chronic pain. TRIAL REGISTRATION ClinicalTrials.gov NCT04655001; https//clinicaltrials.gov/ct2/show/NCT04655001. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) PRR1-10.2196/29013.