PainMORPH-IINCT04655001
Revisiting A Mobile Intervention to Reduce Pain and Improve Health
A study testing MORPH in people with Pain and Obesity, run by Wake Forest University at 1 site in United States.
Trial summary
Chronic pain is a pervasive and costly health condition among older adults that is associated with wide-ranging adverse health outcomes including falls, declining mobility, and increasing functional disability. Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Obesity, Sedentary Behavior
- What is being tested?
- MORPH
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to Oct 2025
- Phase
- Interventional
- 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 55 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 55-85 years;
- Corrected (based on phone self-reported height and weight) BMI=30-45 kg/m2;
- Has data coverage in the home;
- Weight stable-reporting no loss or gain (±5%) in past 6 months;
- Willing to provide informed consent;
- Agree to all study procedures and assessments;
- Owns an Android or Apple smartphone;
- Self-reported pain in 2 or more of the following sites on most days for the previous 3 months: back, neck, shoulders, hips and/or knees
Who cannot join
- Dependent on cane or walker to walk a short distance; >1 fall (injurious or non-injurious) in past year (does not include falls where participant was pushed/pulled by another object and was not injured)
- Vision insufficient to read a smartphone screen, unable to read
- Participation in regular resistance training and/or > 20 mins on 2+ d/w of aerobic exercise in past 6 months
- No contraindication to exercise
- TICS-M score ≤ 31
- Uncontrolled hypertension (>160/90 mmHg);
Show all 11Show fewer
- Current or recent past (within 1 year) severe symptomatic heart disease, uncontrolled angina, stroke, osteoporosis, chronic respiratory disease requiring oxygen, neurological or hematological disease; cancer requiring treatment in past yr, except non-melanoma skin cancers
- Regular use of: growth hormones, oral steroids, or prescription osteoporosis medications
- Current participation in other research study targeting pain, physical activity, or weight loss.
- Previous participation in MORPH I- phase 1 or 2
- Joint replacement or orthopedic surgery within previous 6 months or planning to have orthopedic surgery in the next 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University
Winston-Salem, North Carolina, 27109
About this study
Official title: MORPH II: Revisiting A Mobile Intervention to Reduce Pain and Improve Health (MORPH)
Chronic pain is a pervasive and costly health condition among older adults that is associated with wide-ranging adverse health outcomes including falls, declining mobility, and increasing functional disability. Obesity exacerbates many of these health issues, contributing to a higher frequency of intractable pain episodes, increased pain severity, multi-site pain, and the use of stronger opioid medications compared to normal weight individuals with chronic pain. In addition, older adults who suffer from chronic pain are significantly more sedentary than those without chronic pain. Despite evidence relating increased sedentary behavior to pain, non-pharmacological treatments have largely focused on structured moderate-to-vigorous physical activity (MVPA) by way of conventional forms of exercise.
Recent evidence from an intervention designed to decreased sedentary behavior (SB) demonstrated the approach is effective in preventing weight regain following weight loss. A subsequent study-a mobile intervention to reduce pain and improve health (MORPH: Wake Forest Baptist Health institutional review board [IRB] 00046364)-demonstrated that a primarily home-delivered intervention (9 of 12 delivered in home; 3 of 12 delivered in a research center) supported by technology can produce significant weight loss, reductions in sedentary time, increases in daily steps, less pain intensity, and better physical function compared with a waitlist control. MORPH included a focus on dietary weight loss plus movement across the day through a combination of group telecoaching and a custom mobile health (mHealth) application, but results indicated that participants did not internalize the day-long movement intervention. Instead, they appeared to achieve a greater number of steps through conventional walking exercise, allowing for high levels of sitting, stiffness, and pain.
Read more
MORPH concluded with a two-group randomized controlled pilot trial (RCT) in obese (BMI=30-45 kg/m2), low-active, older (55-85 years) adults with chronic pain who were randomized to either 12-weeks of active intervention or a wait-list control. This study represents an extension of MORPH-hereafter MORPH II-with the intention of immediately addressing limitations in the original MORPH study. Participants will be randomize 30 older, low-active, obese adults to the active intervention or to a standard control for 12 weeks. To build upon the last phase of MORPH, the research team will deliver this intervention fully remotely, providing cellular data-equipped tablet computers to protect participant safety and reduce technical issues that may arise due to lack of face-to-face orientation appointments. Given the current COVID-19 climate, the investigators have chosen to deliver the entire intervention remotely. The investigators are implementing intensive individual coaching throughout the program and greater emphasis on frequent movement to drive better uptake of a day-long movement program and will transition participants to a 12-week no-contact follow-up to observe whether behavior change sustains following completion of the focused intervention.
This study is couched within a contemporary engineering-inspired design framework-the multiphase optimization strategy (MOST)-which emphasizes rapid identification of successful intervention components and the removal or redesign of components that are either ineffective or perceived as a nuisance. To this end, the study team will carry momentum from MORPH into MORPH II wherein the team will assess the impact of a fully remote MORPH intervention with the addition of high-contact coaching on pain ratings, physical function, levels of physical activity and sedentary behavior, and body weight. This is particularly timely given limited access to center-based resources for many during the COVID-19 pandemic, and especially those who are high-risk, including older adults with chronic pain.
Aims and Hypotheses Specific Aim 1: To conduct a pilot RCT to provide initial evidence for the effect size associated with the proposed intervention on pain, sitting time, and daily steps. Investigators will also explore the impact of this program on social connection (i.e., relatedness) and physical function.
Hypothesis 1: It is expected that the provision of the in-home application to contribute to clinically meaningful improvements in pain ratings and steps and a reduction in daily sedentary time compared to the control condition.
Specific Aim 2: To examine whether a socially mediated, home-delivered health intervention produces lasting behavior change over a 12-week no-contact period.
Hypothesis 2: It is expected that levels of physical activity at week 24 will remain meaningfully improved over baseline in the intervention condition relative to the control.
- Conditions
- Pain, Obesity, Sedentary Behavior
- Being tested
- MORPH
- Keywords
- Telehealth, Aging, mHealth, Wearable
- Medical subject headings
- Pain, Obesity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MORPHBehavioural
A 12-week movement and caloric restriction intervention meant to reduce pain and body weight.
| Study group | Role | What they receive |
|---|---|---|
| MORPH | Experimental | Participants engage in 12 weeks of group and 1-on-1 coaching meant to promote physical activity throughout the day and caloric restriction. Participants engage with a custom smartphone application, use a smart scale and physical activity monitor, and meet using video conference software. At the end of 12 weeks, participants are provided with tools to continue meeting virtually on their own if desired, and will be followed for an additional 12-week maintenance phase. Receives: Behavioral: MORPH |
| Control | No intervention | This condition receives the wearable activity monitor and simply asked to use it and continue in their daily lives for 24 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
PROMIS (Patient-Reported Outcomes Measurement Information System) 3-item pain intensity scale. Final scores represent t-scores (mean of 50, standard deviation of 10) where greater scores represent greater pain intensity relative to a nationally representative sample.
Measured: Baseline to week 12
Pain Interference
PROMIS (Patient-Reported Outcomes Measurement Information System) 8-item pain interference scale. Final scores represent t-scores (mean of 50, standard deviation of 10) where greater scores represent greater pain interference relative to a nationally representative sample.
Measured: Baseline to week 12
Steps
Daily steps as recorded by the ActivPAL accelerometer.
Measured: Baseline to week 12
Sedentary time
Daily minutes spent sedentary as recorded by the ActivPAL accelerometer.
Measured: Baseline to week 12
Secondary outcomes (1)
Steps
Daily steps at 24 weeks as recorded by the ActivPAL accelerometer.
Measured: Baseline to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start1 Jan 2021
- Primary completion30 Jun 2022
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to a 24-week intervention or a no-contact control
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Fanning, Wake Forest University
- Investigators
- Jason Fanning, PhD, Principal investigator, Wake Forest University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04655001
- Sponsor's protocol ID
- IRB00023965
- Acronym
- MORPH-II
- Status last verified
- Jul 2025
- First submitted
- 3 Dec 2020
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fanning J, Brooks AK, Ip E, Nicklas BJ, Rejeski WJ. A Mobile Health Intervention to Reduce Pain and Improve Health (MORPH) in Older Adults With Obesity: Protocol for the MORPH Trial. JMIR Res Protoc. 2018 May 14;7(5):e128. doi: 10.2196/resprot.9712.
PubMed 29759957Fanning J, Brooks AK, Hsieh KL, Kershner K, Furlipa J, Nicklas BJ, Rejeski WJ. Building on Lessons Learned in a Mobile Intervention to Reduce Pain and Improve Health (MORPH): Protocol for the MORPH-II Trial. JMIR Res Protoc. 2021 Jul 19;10(7):e29013. doi: 10.2196/29013.
PubMed 34279241
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MORPH II: Revisiting A Mobile Intervention to Reduce Pain and Improve Health (MORPH)
- ClinicalTrials.gov ID
- NCT04655001
- Acronym / sponsor ID
- MORPH-II / IRB00023965
- Conditions
- Pain, Obesity, Sedentary Behavior
- Keywords
- Telehealth, Aging, mHealth, Wearable
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- Oct 2025 (estimated)
- First posted
- 4 Dec 2020 (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.
Chronic pain is a pervasive and costly health condition among older adults that is associated with wide-ranging adverse health outcomes including falls, declining mobility, and increasing functional disability. Obesity exacerbates many of these health issues, contributing to a higher frequency of intractable pain episodes, increased pain severity, multi-site pain, and the use of stronger opioid medications compared to normal weight individuals with chronic pain. In addition, older adults who suffer from chronic pain are significantly more sedentary than those without chronic pain. Despite evidence relating increased sedentary behavior to pain, non-pharmacological treatments have largely focused on structured moderate-to-vigorous physical activity (MVPA) by way of conventional forms of exercise.
Recent evidence from an intervention designed to decreased sedentary behavior (SB) demonstrated the approach is effective in preventing weight regain following weight loss. A subsequent study-a mobile intervention to reduce pain and improve health (MORPH: Wake Forest Baptist Health institutional review board [IRB] 00046364)-demonstrated that a primarily home-delivered intervention (9 of 12 delivered in home; 3 of 12 delivered in a research center) supported by technology can produce significant weight loss, reductions in sedentary time, increases in daily steps, less pain intensity, and better physical function compared with a waitlist control. MORPH included a focus on dietary weight loss plus movement across the day through a combination of group telecoaching and a custom mobile health (mHealth) application, but results indicated that participants did not internalize the day-long movement intervention. Instead, they appeared to achieve a greater number of steps through conventional walking exercise, allowing for high levels of sitting, stiffness, and pain.
MORPH concluded with a two-group randomized controlled pilot trial (RCT) in obese (BMI=30-45 kg/m2), low-active, older (55-85 years) adults with chronic pain who were randomized to either 12-weeks of active intervention or a wait-list control. This study represents an extension of MORPH-hereafter MORPH II-with the intention of immediately addressing limitations in the original MORPH study. Participants will be randomize 30 older, low-active, obese adults to the active intervention or to a standard control for 12 weeks. To build upon the last phase of MORPH, the research team will deliver this intervention fully remotely, providing cellular data-equipped tablet computers to protect participant safety and reduce technical issues that may arise due to lack of face-to-face orientation appointments. Given the current COVID-19 climate, the investigators have chosen to deliver the entire intervention remotely. The investigators are implementing intensive individual coaching throughout the program and greater emphasis on frequent movement to drive better uptake of a day-long movement program and will transition participants to a 12-week no-contact follow-up to observe whether behavior change sustains following completion of the focused intervention.
This study is couched within a contemporary engineering-inspired design framework-the multiphase optimization strategy (MOST)-which emphasizes rapid identification of successful intervention components and the removal or redesign of components that are either ineffective or perceived as a nuisance. To this end, the study team will carry momentum from MORPH into MORPH II wherein the team will assess the impact of a fully remote MORPH intervention with the addition of high-contact coaching on pain ratings, physical function, levels of physical activity and sedentary behavior, and body weight. This is particularly timely given limited access to center-based resources for many during the COVID-19 pandemic, and especially those who are high-risk, including older adults with chronic pain.
Aims and Hypotheses Specific Aim 1: To conduct a pilot RCT to provide initial evidence for the effect size associated with the proposed intervention on pain, sitting time, and daily steps. Investigators will also explore the impact of this program on social connection (i.e., relatedness) and physical function.
Hypothesis 1: It is expected that the provision of the in-home application to contribute to clinically meaningful improvements in pain ratings and steps and a reduction in daily sedentary time compared to the control condition.
Specific Aim 2: To examine whether a socially mediated, home-delivered health intervention produces lasting behavior change over a 12-week no-contact period.
Hypothesis 2: It is expected that levels of physical activity at week 24 will remain meaningfully improved over baseline in the intervention condition relative to the control.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to a 24-week intervention or a no-contact control
| Arm | Type | Receives |
|---|---|---|
| MORPH | Experimental | Behavioral: MORPHParticipants engage in 12 weeks of group and 1-on-1 coaching meant to promote physical activity throughout the day and caloric restriction. Participants engage with a custom smartphone application, use a smart scale and physical activity monitor, and meet using video conference software. At the end of 12 weeks, participants are provided with tools to continue meeting virtually on their own if desired, and will be followed for an additional 12-week maintenance phase. |
| Control | No intervention | –This condition receives the wearable activity monitor and simply asked to use it and continue in their daily lives for 24 weeks. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 55-85 years;
- Corrected (based on phone self-reported height and weight) BMI=30-45 kg/m2;
- Has data coverage in the home;
- Weight stable-reporting no loss or gain (±5%) in past 6 months;
- Willing to provide informed consent;
Key exclusion criteria (11 listed)
- Dependent on cane or walker to walk a short distance; >1 fall (injurious or non-injurious) in past year (does not include falls where participant was pushed/pulled by another object and was not injured)
- Vision insufficient to read a smartphone screen, unable to read
- Participation in regular resistance training and/or > 20 mins on 2+ d/w of aerobic exercise in past 6 months
- No contraindication to exercise
- TICS-M score ≤ 31
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 12-week movement and caloric restriction intervention meant to reduce pain and body weight. | Behavioural | MORPH |
Primary outcome
Pain Intensity
Time frame: Baseline to week 12
PROMIS (Patient-Reported Outcomes Measurement Information System) 3-item pain intensity scale. Final scores represent t-scores (mean of 50, standard deviation of 10) where greater scores represent greater pain intensity relative to a nationally representative sample.
Pain Interference
Time frame: Baseline to week 12
PROMIS (Patient-Reported Outcomes Measurement Information System) 8-item pain interference scale. Final scores represent t-scores (mean of 50, standard deviation of 10) where greater scores represent greater pain interference relative to a nationally representative sample.
Steps
Time frame: Baseline to week 12
Daily steps as recorded by the ActivPAL accelerometer.
Sedentary time
Time frame: Baseline to week 12
Daily minutes spent sedentary as recorded by the ActivPAL accelerometer.
1 secondary outcome
Steps
Time frame: Baseline to week 24
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 16 Jul 2025.
- Background: PubMed 29759957Fanning J, Brooks AK, Ip E, Nicklas BJ, Rejeski WJ. A Mobile Health Intervention to Reduce Pain and Improve Health (MORPH) in Older Adults With Obesity: Protocol for the MORPH Trial. JMIR Res Protoc. 2018 May 14;7(5):e128. doi: 10.2196/resprot.9712.
- Derived from this study: PubMed 34279241Fanning J, Brooks AK, Hsieh KL, Kershner K, Furlipa J, Nicklas BJ, Rejeski WJ. Building on Lessons Learned in a Mobile Intervention to Reduce Pain and Improve Health (MORPH): Protocol for the MORPH-II Trial. JMIR Res Protoc. 2021 Jul 19;10(7):e29013. doi: 10.2196/29013.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jason Fanning, PhD principal investigator
Wake Forest University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MORPH in people with Pain and Obesity, 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 8 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2025. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: Baseline to week 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04655001, which also lists 2 linked publications.
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 16 Jul 2025.