Chronic Pain, Obesity, Sedentary Lifestyle
Conditions
Keywords
Older Adults, Physical Activity, MORPH, Telecoaching, mHealth, Weight Loss, Sedentary Behavior, Pain, Design, RCT, Randomized Controlled Trial
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.
Interventions
BEHAVIORALMORPH
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.
Sponsors
National Institute on Aging (NIA)
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in PROMIS Pain Intensity Scale | Baseline to 12 weeks | 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. |
| Change in PROMIS Pain Interference Scale | Baseline to 12 weeks | 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. |
| Change in Short Physical Performance Battery | Baseline to 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sit to Stand Transitions | Baseline and Week 13 | 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). |
| Sitting Time | Week 12 | daily minutes of sedentary time as recorded on the ActivPALTM 4 device |
| Utilization of Study Application | Baseline to 12 weeks | 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. |
| Participant Retention | Baseline to 12 weeks | 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. |
| Change in Weight | Baseline to 12 weeks | Weight will be assessed weekly. |
| Activity Minutes | Baseline and Week 12 | 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). |
Countries
United States
Participant flow
Pre-assignment details
Five participants were assigned to an usability testing period. For the duration of this period, intervention staff kept detailed notation of software and usability challenges, and iterations were made according to information gathered from this period. Notably, these iterations do not affect the overarching structure of the intervention, but will ensure all components of the program are maximally usability for the older adult with chronic pain.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Participants receive the MORPH intervention.
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. | 15 |
| Control The wait list control participants receive usual care and are offered intervention materials on completion of the study. | 13 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Study Period | Adverse Event | 1 | 0 |
| Study Period | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Intervention | Total | Control |
|---|---|---|---|
| Age, Continuous | 70.12 years STANDARD_DEVIATION 5.43 | 70.21 years STANDARD_DEVIATION 5.22 | 70.32 years STANDARD_DEVIATION 5.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 27 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 23 Participants | 11 Participants |
| Region of Enrollment United States | 15 participants | 28 participants | 13 participants |
| Sex: Female, Male Female | 13 Participants | 22 Participants | 9 Participants |
| Sex: Female, Male Male | 2 Participants | 6 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 13 |
| other Total, other adverse events | 6 / 15 | 2 / 13 |
| serious Total, serious adverse events | 0 / 15 | 1 / 13 |
Outcome results
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.
Time frame: Baseline to 12 weeks
Population: Three subjects did not do follow up visits in the intervention arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change in PROMIS Pain Intensity Scale | -8.08 units on a scale | Standard Deviation 9 |
| Control | Change in PROMIS Pain Intensity Scale | -1.92 units on a scale | Standard Deviation 5.71 |
p-value: 0.11ANCOVA
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.
Time frame: Baseline to 12 weeks
Population: Three subjects did not do follow up visits in the intervention arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change in PROMIS Pain Interference Scale | 2.76 units on a scale | Standard Deviation 10.54 |
| Control | Change in PROMIS Pain Interference Scale | 3.11 units on a scale | Standard Deviation 5.97 |
p-value: 0.99ANCOVA
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.
Time frame: Baseline to 12 weeks
Population: Three subjects did not do follow up visits in the intervention arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change in Short Physical Performance Battery | 0.67 score on a scale | Standard Deviation 1.5 |
| Control | Change in Short Physical Performance Battery | 0.00 score on a scale | Standard Deviation 1 |
p-value: 0.14ANCOVA
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).
Time frame: Baseline and Week 12
Population: Only 9 in each arm with 2+ days of valid data at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Activity Minutes | Week 12 | 51 minutes per day | Standard Deviation 27.08 |
| Intervention | Activity Minutes | Baseline | 53 minutes per day | Standard Deviation 23.57 |
| Control | Activity Minutes | Week 12 | 62.70 minutes per day | Standard Deviation 35.53 |
| Control | Activity Minutes | Baseline | 73.35 minutes per day | Standard Deviation 46.42 |
p-value: 0.65ANCOVA
Secondary
Change in Weight
Weight will be assessed weekly.
Time frame: Baseline to 12 weeks
Population: One subject did not do follow up visits in the intervention arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change in Weight | -2.27 kg | Standard Deviation 4.34 |
| Control | Change in Weight | -0.18 kg | Standard Deviation 1.55 |
p-value: 0.11ANCOVA
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.
Time frame: Baseline to 12 weeks
Population: Three lost to follow-up from intervention arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Participant Retention | 80 percentage of subjects completing |
| Control | Participant Retention | 100 percentage of subjects completing |
Secondary
Sitting Time
daily minutes of sedentary time as recorded on the ActivPALTM 4 device
Time frame: Week 12
Population: Only 9 subjects had 2+ days of valid data at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Sitting Time | baseline | 698.48 minutes per day | Standard Deviation 123.29 |
| Intervention | Sitting Time | Week 12 | 682.26 minutes per day | Standard Deviation 182.49 |
| Control | Sitting Time | baseline | 642.12 minutes per day | Standard Deviation 176.48 |
| Control | Sitting Time | Week 12 | 684.86 minutes per day | Standard Deviation 154.92 |
p-value: 0.41ANCOVA
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).
Time frame: Baseline and Week 13
Population: Only 9 subjects in each arm with 2+ days of valid data at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Sit to Stand Transitions | Week 12 | 29.22 number of transitions per day | Standard Deviation 11.33 |
| Intervention | Sit to Stand Transitions | baseline | 31.33 number of transitions per day | Standard Deviation 10.2 |
| Control | Sit to Stand Transitions | baseline | 36.44 number of transitions per day | Standard Deviation 9.72 |
| Control | Sit to Stand Transitions | Week 12 | 37.44 number of transitions per day | Standard Deviation 10.55 |
p-value: 0.28ANCOVA
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.
Time frame: Baseline to 12 weeks
Population: This outcome only pertains to the intervention arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Utilization of Study Application | 10.84 number of times accessing per week | Standard Deviation 9.64 |