Clinical trial NCT03377634: A Mobile Intervention to Reduce Pain and Improve Health (MORPH)
Official title: A Mobile Intervention to Reduce Pain and Improve Health (MORPH) in Obese Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Obesity
Sedentary Lifestyle
Keywords: Older Adults
Physical Activity
MORPH
Telecoaching
mHealth
Weight Loss
Sedentary Behavior
Pain
Design
RCT
Randomized Controlled Trial
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2017-12-19
Enrollment: 33
Sex: ALL
Minimum age (years): 65
Maximum age (years): 79
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic pain contributes to declining health and function in older adults; effects that are intensified by obesity and sedentary (sitting) behavior. 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. The study will utilize a combination of telephone based coaching and smartphone tools to deliver this novel intervention to decrease both body weight and sitting behavior. The long-term goals of this project are to test the efficacy of the intervention and to develop it as a tool for clinicians to provide outside-of-clinic patient-centered support for overweight/obese older adults with chronic pain.

Detailed description: Chronic pain has emerged as an urgent age-related health issue that significantly effects physical functioning and quality of life, with the unfavorable effects worsened by both obesity and sedentary behavior. The annual cost of pain in the United States is nearly 30% higher than the combined costs of cancer and diabetes. In 2016, the NIH called for a National Pain Strategy to: 1) expand non-pharmacological treatment options in older adults, who are particularly susceptible to the side effects of opioid and other pain medications; 2) develop accessible treatments that are tailored to individuals; and 3) increase the development of self-management programs for chronic pain. The purpose of this R-21 is to develop and test the feasibility and acceptability of a novel, patient-centered intervention to reduce chronic pain and improve physical functioning in older adults, leveraging the combination of telecoaching and individually-adaptive mHealth tools to decrease both body mass and sedentary behavior. A pilot randomized controlled trial will be conducted to provide initial evidence for effect sizes (pain and physical function) associated with the proposed intervention, and to estimate the sample size needed for a full scale randomized controlled trial design that compares the effects of the intervention versus usual care on pain ratings and physical function in overweight/obese older adults with chronic pain.

Eligibility criteria: Inclusion Criteria:

* Own smartphone
* Pain in 2 of 5 areas (i.e., back, neck, shoulders, hips, knees) on most days during the previous 3 months
* No contraindication for participation in exercise with approval for participation by their physician
* Obese (BMI=30-45 kg/m2)
* Weight-stable (i.e., no weight loss or gain \> 5% in the past 6 months)
* Low-active (i.e., engaging in less than 2 days/week of structured physical activity for at least 20 minutes).
* Approved for participation by LMC Pain Center Director and Dr. Brooks
* Willingness to provide consent; Agree to all study procedures and assessments; Able to provide own transportation to study visits
* Access to home Wi-Fi and smartphone device

Exclusion Criteria:

* Dependent on cane or walker
* \>1 fall (injurious or non-injurious) in past year
* Vision insufficient to read a smartphone screen, unable to read
* Participation in regular resistance training and/or \> 20 mins/d of aerobic exercise in past 6 months
* No contraindication to exercise
* Unable to walk without assistive devices
* Cognitive impairment as indicated by a Montreal Cognitive Assessment score \< 22
* Uncontrolled hypertension (\>160/90 mmHg);
* Current or recent past (within 1 year) severe symptomatic heart disease, uncontrolled angina, stroke, chronic respiratory disease requiring oxygen, neurological or hematological disease; cancer requiring treatment in past yr, except non-melanoma skin cancers
* Regular use of: growth hormones, oral steroids, or prescription osteoporosis medications
* Current participation in other research study targeting pain, physical activity, or weight loss

Primary outcomes:
measure: Change in PROMIS Pain Intensity Scale
timeFrame: Baseline to 12 weeks
measure: Change in PROMIS Pain Interference Scale
timeFrame: Baseline to 12 weeks
measure: Change in Short Physical Performance Battery
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Change in Weight
timeFrame: Baseline to 12 weeks
measure: Activity Minutes
timeFrame: Baseline and Week 12
measure: Sitting Time
timeFrame: Week 12
measure: Sit to Stand Transitions
timeFrame: Baseline and Week 13
measure: Participant Retention
timeFrame: Baseline to 12 weeks
measure: Utilization of Study Application
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center Pain Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Amber K Brooks, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fanning J, Brooks AK, Ip E, Nicklas BJ, Rejeski WJ, Nesbit B, Ford S. A Mobile Health Behavior Intervention to Reduce Pain and Improve Health in Older Adults With Obesity and Chronic Pain: The MORPH Pilot Trial. Front Digit Health. 2020 Dec;2:598456. doi: 10.3389/fdgth.2020.598456. Epub 2020 Dec 18.
citation: Fanning J, Brooks AK, Ip E, Nicklas BJ, Rejeski WJ. A Mobile Health Intervention to Reduce Pain and Improve Health (MORPH) in Older Adults With Obesity: Protocol for the MORPH Trial. JMIR Res Protoc. 2018 May 14;7(5):e128. doi: 10.2196/resprot.9712.