N/A
N=5
A Mobile Intervention to Reduce Pain and Improve Health (MORPH)
Chronic Pain · Obesity · Sedentary Lifestyle
Bottom Line
View on ClinicalTrials.gov: NCT03377634 ↗Enrolled (actual)
5
Serious AEs
3.6%
Results posted
Jan 2021
Primary outcome: Primary: Change in PROMIS Pain Intensity Scale — -8.08; -1.92 units on a scale — p=0.11
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MORPH (Behavioral)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in PROMIS Pain Intensity Scale |
-8.08; -1.92 | 0.11 |
| PRIMARY Change in PROMIS Pain Interference Scale |
2.76; 3.11 | .99 |
| PRIMARY Change in Short Physical Performance Battery |
0.67; 0.00 | .14 |
| SECONDARY Change in Weight |
-2.27; -0.18 | .11 |
| SECONDARY Activity Minutes |
53; 73.35; 51; 62.70 | .65 |
| SECONDARY Sitting Time |
698.48; 642.12; 682.26; 684.86 | .41 |
| SECONDARY Sit to Stand Transitions |
31.33; 36.44; 29.22; 37.44 | .28 |
| SECONDARY Participant Retention |
80; 100 | — |
| SECONDARY Utilization of Study Application |
10.84 | — |
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.
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 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
Data sourced from ClinicalTrials.gov (NCT03377634). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.