A Phase 2 interventional study of MORPH and Measurement Only in Chronic Pain, Osteoarthritis and Obesity and Overweight, sponsored by Wake Forest University. Recruiting at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-02-20.
Sponsored by Wake Forest University · Phase 2, Interventional, and Treatment
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.
3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.
This study's planned enrollment of 200 is above the median of 60 across 2,388 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Wake Forest University is the lead sponsor of 118 studies on the registry; 7 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 27 (87%) 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.
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.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
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.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: MORPH
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.
Behavioral: Measurement Only
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.
Daily steps
Daily steps measured over one week via the ActivPAL accelerometer
Time frame: Baseline, after 6 months of intervention, after 18 months of intervention
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.
Time frame: Baseline, after 6 months of intervention, after 18 months of intervention
Body weight
Measured via the BodyTrace wireless body weight scale
Time frame: From the start of the intervention through month 18.
30-second chair stand
Measured via in-home chair stand task.
Time frame: Baseline, after 6 months of intervention, after 18 months of intervention
Gait speed
Measured via in-home test: 4-meter habitual gait speed
Time frame: Baseline, after 6 months of intervention, after 18 months of intervention
Physical activity behavior
Directly measured using the ActivPAL 4 accelerometer
Time frame: 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
Time frame: Baseline, after 6 months of intervention, after 18 months of intervention
Participant Feedback
Assessed via semi-structured interview
Time frame: After 6 months of intervention
Medication usage
Assessed via assessor query
Time frame: Baseline, after 6 months of intervention, after 18 months of intervention
Sleep behavior
Assessed via wearable activity monitor
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, after 6 months of intervention, after 18 months of intervention
Plan to share: Yes — 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.
Supporting information: Study protocol
Time frame: 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.
Access criteria: 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.
No publications or documents are linked to this record.
Started Aug 2025 (actual). Primary completion is estimated for Jun 2029, 46 months after the start.
Of 48 non-industry phase 2 interventional studies under Chronic Pain, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 52. This study's planned 46 months is close to that.
Counting every sponsor, half of 61 studies reached it within 37 months; a quarter within 21 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.