An interventional study of MORPH in Chronic Pain, Obesity and Sedentary Lifestyle, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 65 Years to 79 Years. Per ClinicalTrials.gov, last updated 2021-01-22.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Treatment
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.
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.
3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.
This study's enrollment of 33 is below the median of 60 across 2,388 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive the MORPH intervention.
Behavioral: MORPH
The wait list control participants receive usual care and are offered intervention materials on completion of the study.
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.
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
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
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
Change in Weight
Weight will be assessed weekly.
Time frame: Baseline to 12 weeks
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
Sitting Time
daily minutes of sedentary time as recorded on the ActivPALTM 4 device
Time frame: Week 12
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
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
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
| Milestone | Intervention | Control |
|---|---|---|
| Started | 5 | 0 |
| Completed | 5 | 0 |
| Not completed | 0 | 0 |
| Milestone | Intervention | Control |
|---|---|---|
| Started | 15 | 13 |
| Completed | 13 | 13 |
| Not completed | 2 | 0 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
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.
| units on a scale | Intervention | Control |
|---|---|---|
| Change in PROMIS Pain Intensity Scale | -8.08 ± 9.00 | -1.92 ± 5.71 |
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.
| units on a scale | Intervention | Control |
|---|---|---|
| Change in PROMIS Pain Interference Scale | 2.76 ± 10.54 | 3.11 ± 5.97 |
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.
| score on a scale | Intervention | Control |
|---|---|---|
| Change in Short Physical Performance Battery | 0.67 ± 1.50 | 0.00 ± 1.0 |
Weight will be assessed weekly.
| kg | Intervention | Control |
|---|---|---|
| Change in Weight | -2.27 ± 4.34 | -0.18 ± 1.55 |
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).
| minutes per day | Intervention | Control |
|---|---|---|
| Baseline | 53 ± 23.57 | 73.35 ± 46.42 |
| Week 12 | 51 ± 27.08 | 62.70 ± 35.53 |
daily minutes of sedentary time as recorded on the ActivPALTM 4 device
| minutes per day | Intervention | Control |
|---|---|---|
| baseline | 698.48 ± 123.29 | 642.12 ± 176.48 |
| Week 12 | 682.26 ± 182.49 | 684.86 ± 154.92 |
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).
| number of transitions per day | Intervention | Control |
|---|---|---|
| baseline | 31.33 ± 10.20 | 36.44 ± 9.72 |
| Week 12 | 29.22 ± 11.33 | 37.44 ± 10.55 |
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.
| percentage of subjects completing | Intervention | Control |
|---|---|---|
| Participant Retention | 80 | 100 |
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.
| number of times accessing per week | Intervention | Control |
|---|---|---|
| Utilization of Study Application | 10.84 ± 9.64 | — |
Collected over Baseline through Week 12. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | 0/15 (0%) | 0/15 (0%) | 6/15 (40%) |
| Control | 0/13 (0%) | 1/13 (7.7%) | 2/13 (15.4%) |
| Event | Intervention | Control |
|---|---|---|
| small intestinal bleedGastrointestinal disorders | 0/15 | 1/13 |
| Event | Intervention | Control |
|---|---|---|
| Upper Respiratory InfectionRespiratory, thoracic and mediastinal disorders | 2/15 | 0/13 |
| Atrial fibrillationCardiac disorders | 0/15 | 1/13 |
| SinusitisInfections and infestations | 1/15 | 1/13 |
| Strep ThroatInfections and infestations | 1/15 | 0/13 |
| BronchitisRespiratory, thoracic and mediastinal disorders | 1/15 | 0/13 |
| myasthenia gravisNervous system disorders | 1/15 | 0/13 |
| Age, Continuous(years) | Intervention | Control | Total |
|---|---|---|---|
| Mean | 70.12 ± 5.43 | 70.32 ± 5.20 | 70.21 ± 5.22 |
| Sex: Female, Male(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Female | 13 | 9 | 22 |
| Male | 2 | 4 | 6 |
| Ethnicity (NIH/OMB)(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 |
| Not Hispanic or Latino | 15 | 12 | 27 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Intervention | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 2 | 5 |
| White | 12 | 11 | 23 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Intervention | Control | Total |
|---|---|---|---|
| United States | 15 | 13 | 28 |
PDFs hosted by the registry, ClinicalTrials.gov.
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