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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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
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

Other trials in United States

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.

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 groups in NCT04655001
Study groupRoleWhat they receive
MORPHExperimentalParticipants 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
ControlNo interventionThis 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.

  1. 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

  2. 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

  3. Steps

    Daily steps as recorded by the ActivPAL accelerometer.

    Measured: Baseline to week 12

  4. Sedentary time

    Daily minutes spent sedentary as recorded by the ActivPAL accelerometer.

    Measured: Baseline to week 12

Secondary outcomes (1)
  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.

  1. First posted4 Dec 2020
  2. Study start1 Jan 2021
  3. Primary completion30 Jun 2022
  4. Study completionOct 2025 (estimated)

Resources

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)
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 29759957
  • Fanning 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

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.

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