A Mobile Intervention to Reduce Pain and Improve Health (MORPH)

Obesity Clinical Trial

Official title:

A Mobile Intervention to Reduce Pain and Improve Health (MORPH) in Obese Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03377634
• Other study ID #: IRB00046364
• Secondary ID: 1R21AG058249-01
• Status: Completed
• Phase: N/A
• Start date: August 7, 2018
• Est. completion date: February 28, 2020

Study information

• Verified date: November 2020
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: February 28, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Obesity
• Sedentary Lifestyle

Intervention

Behavioral:
• MORPH
Participants will engage in 12 weekly group coaching sessions discussion behavioral approaches to pain management, weight loss, and daily physical activity. The first three sessions (i.e., weeks 1 - 3) will occur in-person, and the remaining 9 will take place via telephone. All intervention participants will receive access to an activity monitor, smart scale, and smartphone app that aims to provide support for daily physical activity and weight loss.

Locations

Country	Name	City	State
United States	Wake Forest Baptist Medical Center Pain Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in PROMIS Pain Intensity Scale	The Pain Intensity Scale tasks participants with rating how much they hurt on a scale of 1 (had no pain) to 5 (very severe). Final scores are given as T-scores, with higher scores representing worse intensity. PROMIS scores are a t-score representing relationships with an estimated population average collected on a general US sample of adults as well as clinical samples. On this t distribution, 50 represents the population average with a standard deviation of 10. Thus, a score of 55 represents a score that is a half-standard deviation about the US national average, and a 40 represents a score that is 1 standard deviation below the national average. Scores were computed using the HealthMeasures.org scoring service as recommended for PROMIS measures.	Baseline to 12 weeks
Primary	Change in PROMIS Pain Interference Scale	The Pain Interference Scale captures the impact of pain on valued areas of an individual's life (e.g., how much did pain interfere with your day to day activities) on a scale of 1 (not at all) to 5 (very much). Final scores are given as T-scores, with higher scores representing worse interference. PROMIS scores are a t-score representing relationships with an estimated population average collected on a general US sample of adults as well as clinical samples. On this t distribution, 50 represents the population average with a standard deviation of 10. Thus, a score of 55 represents a score that is a half-standard deviation about the US national average, and a 40 represents a score that is 1 standard deviation below the national average. Scores were computed using the HealthMeasures.org scoring service as recommended for PROMIS measures.	Baseline to 12 weeks
Primary	Change in Short Physical Performance Battery	This test of lower-extremity function consists of 4-m walk at usual pace, a timed repeated chair stand, and 3 increasingly difficult standing balance tests. Each measure is assigned a categorical score ranging from 0 (inability to complete the test) to 4 (best performance) resulting in a final score of 0-12. Higher scores denotes better outcomes.	Baseline to 12 weeks
Secondary	Change in Weight	Weight will be assessed weekly.	Baseline to 12 weeks
Secondary	Activity Minutes	Activity Minutes will be assessed using ActivPal activity monitors (PAL Technologies Ltd, Glasgow, UK) worn at the thigh for 7 consecutive days. We will assess (a) number of daily minutes spent in light-intensity physical activity as reported by the ActivPal (range: 0-1440, more minutes of light activity are favorable); (b) number of daily minutes spent in moderate-intensity physical activity as reported by the ActivPal (range: 0-1440, more minutes of moderate activity are favorable).	Baseline and Week 12
Secondary	Sitting Time	daily minutes of sedentary time as recorded on the ActivPALTM 4 device	Week 12
Secondary	Sit to Stand Transitions	Transitions will be assessed using ActivPal activity monitors (PAL Technologies Ltd, Glasgow, UK) worn at the thigh for 7 consecutive days. We will assess number of daily transitions from sitting to non-sitting behavior, captured via the ActivPal inclinometer (range: 0 - infinity; a higher number of transitions are favorable).	Baseline and Week 13
Secondary	Participant Retention	The extent to which participants were retained in the study (minimum retention goal of 80%). The number of participants that complete the study over the number that were enrolled.	Baseline to 12 weeks
Secondary	Utilization of Study Application	The extent to which participants utilize the study application, as defined by an average weekly use of 7 application accesses per week for the duration of the study period.	Baseline to 12 weeks