Chronic PainPhase 2MORPH-IIINCT06623669
A Mobile Intervention to Reduce Pain and Improve Health-III
A Phase 2 study testing MORPH and Measurement Only in people with Chronic Pain and Osteoarthritis, run by Wake Forest University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Chronic Pain, Osteoarthritis, Obesity and Overweight
- What is being tested?
- MORPH and Measurement Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2025to 31 Aug 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged 65+ years
- Body mass index of 30-45 kg/m2 or >45 kg/m2 with physician's approval
- No loss or gain of more than 5% body mass in previous 6 months
- Presence of knee or hip osteoarthritis as ascertained via the Roux questionnaire
- Independently living
- Low active (i.e., not participating in regular resistance training and/or >20 mins/day of aerobic exercise on more than 2 days/week in past 3 months as ascertained via a modified CHAMPS questionnaire)
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- Have no contraindication for safe and optimal participation in exercise based on EASY screening (pertaining to chest pain and discomfort during physical activity, dizziness or light headedness, or frequent falls and use of assistive devices)
- Not currently using a weight loss medication (medications for diabetes management are permitted if weight stable)
- Approved for participation by medical director
- Willing to provide informed consent and agree to all study procedures and assessments.
Who cannot join
- Reside in skilled nursing facility, rehab or assisted living environment
- History of pharmacologic treatment for a psychiatric disorder other than depression/anxiety within past year
- Current untreated and/or unstable clinical depression or anxiety (Patient Health Questionnaire (PHQ-9) >15)
- Hospitalization for psychiatric event within past year prior to screening
- History of mild cognitive impairment or dementia
- Cognitive impairment (<32) on Modified Telephone Interview for Cognitive Status survey (TICS-M)
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- Hearing or visual impairment that would preclude use of the videoconferencing software
- Severe arthritis or other musculoskeletal disorder that is a contraindication for safe walking
- Presently undergoing treatment for orthopedic fracture
- Currently using a weight loss medication (medications for diabetes management are permitted if weight stable)
- Contraindication based on EASY screening (pertaining to chest pain and discomfort during physical activity, dizziness or light headedness, or frequent falls and use of assistive devices) without physician approval
- Joint replacement or other orthopedic surgery in past 6 months
- Joint replacement or other orthopedic surgery planned in next 18 months
- Have a diagnosis of uncontrolled hypertension; current or recent past (within 1 year) severe symptomatic heart disease, uncontrolled angina, stroke, chronic respiratory disease other than asthma or COPD, any disease requiring oxygen use, neurological or hematological disease; cancer requiring current treatment, except non-melanoma skin cancers; kidney failure requiring dialysis; have a Katz ADL disability; or engage in heavy alcohol use >14 drinks/week.
- Current participation in other research study with a prospective intervention
- Unable/unwilling to commit to study protocol, including random assignment and use of technology tools
- Unable/unwilling to attend three virtual testing appointments
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wake Forest University
Winston-Salem, North Carolina, 27109
Deja Dobson, 336-758-6677, MORPH@wfu.edu
About this study
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.
Read more
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.
- Conditions
- Chronic Pain, Osteoarthritis, Obesity and Overweight, Inactivity
- Being tested
- MORPH, Measurement Only
- Keywords
- Digital health, Randomized Trial, Physical Activity, Weight Loss, Aging
- Medical subject headings
- Chronic Pain, Osteoarthritis, Obesity, Overweight, Sedentary Behavior, Motor Activity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MORPHBehavioural
A remote behavioral intervention combining coaching and digital health tools to improve diet and activity behaviors.
Measurement OnlyBehavioural
This intervention entails receipt of a body weight scale and wearable activity monitor.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: MORPH |
| 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. Receives: Behavioral: Measurement Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily steps
Daily steps measured over one week via the ActivPAL accelerometer
Measured: Baseline, after 6 months of intervention, after 18 months of intervention
Secondary outcomes (4)
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.
Measured: Baseline, after 6 months of intervention, after 18 months of intervention
Body weight
Measured via the BodyTrace wireless body weight scale
Measured: From the start of the intervention through month 18.
30-second chair stand
Measured via in-home chair stand task.
Measured: Baseline, after 6 months of intervention, after 18 months of intervention
Gait speed
Measured via in-home test: 4-meter habitual gait speed
Measured: Baseline, after 6 months of intervention, after 18 months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start14 Aug 2025
- Primary completion15 Jun 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Collaborators
- Wake Forest University Health Sciences, Duke University, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Jason Fanning, Wake Forest University
- Investigators
- Jason Fanning, PhD, Principal investigator, Wake Forest UniversityAmber Brooks, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06623669
- Sponsor's protocol ID
- IRB00025649
- Other IDs
- R01AG082777
- Acronym
- MORPH-III
- Status last verified
- Feb 2026
- First submitted
- 30 Sep 2024
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile Intervention to Reduce Pain and Improve Health-III
- ClinicalTrials.gov ID
- NCT06623669
- Acronym / sponsor ID
- MORPH-III / IRB00025649
- Conditions
- Chronic Pain, Osteoarthritis, Obesity and Overweight, Inactivity
- Keywords
- Digital health, Randomized Trial, Physical Activity, Weight Loss, Aging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Collaborators
- Wake Forest University Health Sciences, Duke University, National Institute on Aging (NIA)
- Study start
- 14 Aug 2025 (actual)
- Primary completion
- 15 Jun 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MORPH | Experimental | Behavioral: MORPHMORPH 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 | Behavioral: Measurement OnlyMeasurement-only participants will receive an activity monitor and wireless weight scale to account for the effect of these self-monitoring technologies and activity behavior. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- Aged 65+ years
- Body mass index of 30-45 kg/m2 or >45 kg/m2 with physician's approval
- No loss or gain of more than 5% body mass in previous 6 months
- Presence of knee or hip osteoarthritis as ascertained via the Roux questionnaire
- Independently living
Key exclusion criteria (17 listed)
- Reside in skilled nursing facility, rehab or assisted living environment
- History of pharmacologic treatment for a psychiatric disorder other than depression/anxiety within past year
- Current untreated and/or unstable clinical depression or anxiety (Patient Health Questionnaire (PHQ-9) >15)
- Hospitalization for psychiatric event within past year prior to screening
- History of mild cognitive impairment or dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MORPHA remote behavioral intervention combining coaching and digital health tools to improve diet and activity behaviors. | Behavioural | MORPH |
| Measurement OnlyThis intervention entails receipt of a body weight scale and wearable activity monitor. | Behavioural | Measurement Only |
Primary outcome
Daily steps
Time frame: Baseline, after 6 months of intervention, after 18 months of intervention
Daily steps measured over one week via the ActivPAL accelerometer
4 secondary outcomes
Pain Interference
Time frame: Baseline, after 6 months of intervention, after 18 months of intervention
Body weight
Time frame: From the start of the intervention through month 18.
30-second chair stand
Time frame: Baseline, after 6 months of intervention, after 18 months of intervention
Gait speed
Time frame: Baseline, after 6 months of intervention, after 18 months of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jason Fanning, PhD principal investigator
Wake Forest University
Amber Brooks, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MORPH and Measurement Only in people with Chronic Pain and Osteoarthritis, run by Wake Forest University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deja O Dobson, MS (3367585042, dobsondo@wfu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily steps (time frame: Baseline, after 6 months of intervention, after 18 months of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.