Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01AG082777 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Wake Forest University Health Sciences | OTHER |
| Duke University | OTHER |
| National Institute on Aging (NIA) | NIH |
Not provided
Not provided
Not provided
Not provided
The experience of chronic pain powerfully and negatively affects quality of life and functional independence in aging. Unfortunately, while as many as three in four older adults experience chronic pain, few have access to effective non-pharmacological pain management strategies. Participating in regular physical activity, avoiding sustained sitting, and maintaining a healthy weight are important and interrelated lifestyle inputs to chronic pain, and socially rich behavioral interventions informed by contemporary theories of behavior change appear important for engaging in activity and healthy eating in the long term. Our group has demonstrated in a series of Stage I trials that a group-mediated behavioral intervention combining dietary behavior change and a physical activity program focused on moving often throughout the day contributes to meaningful weight loss, and lasting weight maintenance, with pilot data suggesting this may contribute to improved pain, physical function, and health-related quality of life among older adults with chronic pain. As these were NIH Stage I trials, there are several important gaps to be addressed in the present trial: (1) both studies of chronic pain recruited small samples and were 12 weeks in duration, limiting our ability to establish efficacy and the durability of changes to activity, HRQOL, and pain outcomes; (2) participants included anyone with chronic pain, regardless of pain type, a likely contributor to heterogeneous pain intensity and interference findings; and (3) the investigators have yet to examine behavioral maintenance.
The overarching goal of the proposed Stage II "mobile intervention to reduce pain and improve health-III (MORPH-III)" is to establish the efficacy of the intervention for enhancing physical activity via steps (primary), and for reducing pain interference and body weight while enhancing physical function (secondary) among older adults with chronic knee or hip osteoarthritic (OA) pain. The investigators will recruit 200 older adults with knee or hip osteoarthritic pain to engage in a 6-month remotely delivered intervention comprising weekly group or individual intervention meetings plus brief individual goal-setting coaching calls. This will be followed by a 12-month no-contact maintenance period, where participants will attempt to sustain behavioral goals on their own.
The Specific Aims are:
Specific Aim 1: To examine the impact of MORPH on ActivPAL-assessed daily steps relative to an enhanced usual care control. Hypotheses: MORPH will significantly increase steps relative to control at month 6.
Specific Aim 2: To examine the impact of MORPH on pain interference, change in body weight, and physical function relative to the enhanced usual care control. Hypotheses: MORPH will result in significant reductions in pain interference and body weight and improvement in physical function relative to control at month 6.
Exploratory Aims: Aim 1: To investigate the impact of the MORPH intervention on steps, weight change, pain interference, and physical function at month 18. Aim 2: If the MORPH intervention results in reduced pain interference at 6 and/or 18 months, the investigators will examine the extent to which 6-month change in steps, weight, pain self-efficacy, and catastrophizing mediate change in interference at 6 and/or 18 months.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MORPH | Experimental | MORPH participants will attend one weekly group-mediated session alongside a group of their peers plus individual coaching calls. Participants will aim to increase daily steps by moving often throughout the day, using an activity monitor and mHealth app to view feedback and set goals. Participants will also aim to weight via healthy eating while reducing daily calories by ~400kcal/day below weight maintenance needs to achieve approximately 6% weight loss in 6 months and 10% over 18 months. |
|
| Measurement Only | Active Comparator | Measurement-only participants will receive an activity monitor and wireless weight scale to account for the effect of these self-monitoring technologies and activity behavior. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MORPH | Behavioral | A remote behavioral intervention combining coaching and digital health tools to improve diet and activity behaviors. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Daily steps | Daily steps measured over one week via the ActivPAL accelerometer | Baseline, after 6 months of intervention, after 18 months of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Interference | Measured via questionnaire: the Patient-Reported Outcomes Measurement Information System (PROMIS) 8-item pain interference scale, which produces a t-score such that the population mean is a 50 with a standard deviation of 10; higher scores indicate higher interference. | Baseline, after 6 months of intervention, after 18 months of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Physical activity behavior | Directly measured using the ActivPAL 4 accelerometer | Collected over one week at baseline, after 6 months of intervention, after 18 months of intervention |
| Adverse Events | Assessed via assessor query and spontaneous report |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deja O Dobson, MS | Contact | 3367585042 | dobsondo@wfu.edu | |
| Jason Fanning, PhD | Contact | 3367585042 | fanninjt@wfu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jason Fanning, PhD | Wake Forest University | Principal Investigator |
| Amber Brooks, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University | Recruiting | Winston-Salem | North Carolina | 27109 | United States |
De-identified data will be made available via the Wake Forest Pepper Center Study Registry for the outcome measures described in the Outcome Measures section.
The research community will have access to the data at the end of the performance period or the time of an associated publication (whichever is earlier). Data will be made available within the Pepper Study Registry in perpetuity.
Data will be available for investigators providing an Institutional Review Board (IRB)/Ethics approval or certification of exemption from IRB/Ethics review and agreeing to the terms and conditions of a data use agreement. To request access to the data, researchers will use the standard processes for the repository where the data are deposited. This involves user registration, which includes a requirement to review and agree to Terms of Service, ensuring that study data will be used for scholarly scientific research, that data will not be shared with others outside of those listed on a given project proposal, that the data will be presented in aggregate, that researchers will not attempt to present individual data or attempt to identify individuals, and that any potential identification is immediately disclosed.
Not provided
Not provided
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D010003 | Osteoarthritis |
| D009765 | Obesity |
| D050177 | Overweight |
| D057185 | Sedentary Behavior |
| D009043 | Motor Activity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measurement Only | Behavioral | This intervention entails receipt of a body weight scale and wearable activity monitor. |
|
| Body weight | Measured via the BodyTrace wireless body weight scale | From the start of the intervention through month 18. |
| 30-second chair stand | Measured via in-home chair stand task. | Baseline, after 6 months of intervention, after 18 months of intervention |
| Gait speed | Measured via in-home test: 4-meter habitual gait speed | Baseline, after 6 months of intervention, after 18 months of intervention |
| Baseline, after 6 months of intervention, after 18 months of intervention |
| Participant Feedback | Assessed via semi-structured interview | After 6 months of intervention |
| Medication usage | Assessed via assessor query | Baseline, after 6 months of intervention, after 18 months of intervention |
| Sleep behavior | Assessed via wearable activity monitor | Nightly over the 18-month intervention |
| Pain intensity | Self-reported using the 3-item Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Scale, which produces a t-score such that the population mean is a 50 with a standard deviation of 10; higher scores indicate higher interference. | Baseline, after 6 months of intervention, after 18 months of intervention |
| Perceived physical function | Self-Reported via the Pepper Assessment Tool for Disability. The scale produces a total score and subscales capturing basic activities of daily living, mobility, and instrumental activities of daily living. Scores range from 1-6 with lower scores representing less disability. | Baseline, after 6 months of intervention, after 18 months of intervention. |
| Pain Catastrophizing | Self-reported using the Pain Catastrophizing Scale. The scale produces a total score (range 0 - 52) and subscales including rumination (range 0 - 16), magnification (range 0 - 12), and helplessness (range 0 - 24). Higher scores represent greater catastrophizing. | Baseline, after 6 months of intervention, after 18 months of intervention |
| Self-determinative needs | Self-reported using the Basic Psychological Need Satisfaction and Frustration Scales. Produces six subscale scores: autonomy satisfaction and frustration, relatedness satisfaction and frustration, and competence satisfaction and frustration. Scores for each subscale range from 4 - 20 such that higher scores represent greater satisfaction or frustration. | Baseline, after 6 months of intervention, after 18 months of intervention |
| Affect | Self-reported using the Positive and Negative Affect Schedule. The scale produces a positive affect score and a negative affect score, which each range from 10 - 50 whereby higher scores indicate greater positive or negative affect. | Baseline, after 6 months of intervention, after 18 months of intervention |
| Stress | Self-reported using the 10-item perceived stress scale. Scores range from 0 - 40 with higher scores indicating greater stress. | Baseline, after 6 months of intervention, after 18 months of intervention |
| Exercise Self-Efficacy | Self-reported using the Exercise Self-Efficacy Scale as well as by a modified version of the scale to capture accumulated physical activities. Final scores range from 0 - 100 with higher scores reflecting greater self-efficacy. | Baseline, after 6 months of intervention, after 18 months of intervention |
| Outcome Expectencies related to Eating Behavior | Self-reported using the Outcome Expectations for Nutrition Scale. The scale produces subscales for physical, social, and self-evaluative outcome expectancies with scores range from 5-25. Higher scores reflect more positive expectations in each domain. | Baseline, after 6 months of intervention, after 18 months of intervention |
| Outcome Expectencies related to Activity Behavior | Self-reported using the Outcome Expectations for Exercise Scale, modified to capture all daily physical activities. The scale produces subscales for physical, social, and self-evaluative outcome expectancies with scores range from 5-25. Higher scores reflect more positive expectations in each domain. | Baseline, after 6 months of intervention, after 18 months of intervention |
| Self-regulation | Self-reported using the Self-Regulation Strategy Usage for Nutrition and Activity. The scales produce scores for nutrition and activity behaviors, which each range from 10-50 such that higher scores reflect greater self-regulation strategy usage. | Baseline, after 6 months of intervention, after 18 months of intervention |
| Barriers | Self-reported using the Perceived Barriers for Physical Activity and Eating. The scales produce scores for eating and activity behaviors, with each ranging from 1 - 5 such that higher scores indicate more barriers. | Baseline, after 6 months of intervention, after 18 months of intervention |
| Health-related quality of life | Self-reported using the 36-item Short Form Health Survey (SF36). Scores are generated for 8 subdomains (physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, general health). Scores for each subscale range from 0 - 100; higher scores are better. | Baseline, after 6 months of intervention, after 18 months of intervention |
| Perceived Sleep | Self-reported using the Pittsburgh Sleep Quality Index. The scale yields a total score of 0 - 21 such that 0 represents no sleep difficulty and 21 represents severe difficulty. | Baseline, after 6 months of intervention, after 18 months of intervention |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D001519 | Behavior |
| D001836 | Body Weight Changes |