Wake Forest University
Winston-Salem, North Carolina, 27109, United States
Location status: Recruiting
NCT Number: NCT06623669
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.
Interested in participating?
Request Info65 year and older
All sexes
Interventional
Phase 2
Winston-Salem, North Carolina, 27109, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A remote behavioral intervention combining coaching and digital health tools to improve diet and activity behaviors.
This intervention entails receipt of a body weight scale and wearable activity monitor.
Time frame: Baseline, after 6 months of intervention, after 18 months of intervention
Daily steps measured over one week via the ActivPAL accelerometer
Time frame: Baseline, after 6 months of intervention, after 18 months of intervention
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.
Time frame: From the start of the intervention through month 18.
Measured via the BodyTrace wireless body weight scale
Time frame: Baseline, after 6 months of intervention, after 18 months of intervention
Measured via in-home chair stand task.
Time frame: Baseline, after 6 months of intervention, after 18 months of intervention
Measured via in-home test: 4-meter habitual gait speed
Time frame: Collected over one week at baseline, after 6 months of intervention, after 18 months of intervention
Directly measured using the ActivPAL 4 accelerometer
Time frame: Baseline, after 6 months of intervention, after 18 months of intervention
Assessed via assessor query and spontaneous report
Time frame: After 6 months of intervention
Assessed via semi-structured interview
Time frame: Baseline, after 6 months of intervention, after 18 months of intervention
Assessed via assessor query
Time frame: Nightly over the 18-month intervention
Assessed via wearable activity monitor
Time frame: Baseline, after 6 months of intervention, after 18 months of intervention
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.
Time frame: Baseline, after 6 months of intervention, after 18 months of intervention.
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.
Time frame: Baseline, after 6 months of intervention, after 18 months of intervention
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.
Time frame: Baseline, after 6 months of intervention, after 18 months of intervention
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.
Time frame: Baseline, after 6 months of intervention, after 18 months of intervention
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.
Time frame: Baseline, after 6 months of intervention, after 18 months of intervention
Self-reported using the 10-item perceived stress scale. Scores range from 0 - 40 with higher scores indicating greater stress.
Time frame: Baseline, after 6 months of intervention, after 18 months of intervention
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.
Time frame: Baseline, after 6 months of intervention, after 18 months of intervention
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.
Time frame: Baseline, after 6 months of intervention, after 18 months of intervention
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.
Time frame: Baseline, after 6 months of intervention, after 18 months of intervention
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.
Time frame: Baseline, after 6 months of intervention, after 18 months of intervention
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.
Time frame: Baseline, after 6 months of intervention, after 18 months of intervention
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.
Time frame: Baseline, after 6 months of intervention, after 18 months of intervention
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.
Contact information is provided by the study sponsor or research team.
Deja O Dobson, MS
CONTACT
Jason Fanning, PhD
CONTACT
Wake Forest University
Other
Acronym: MORPH-III
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