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NCT Number: NCT06623669

A Mobile Intervention to Reduce Pain and Improve Health-III

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Wake Forest University

Winston-Salem, North Carolina, 27109, United States

Location status: Recruiting

Location contact

Deja Dobson

CONTACT

[email protected]

336-758-6677

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • 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.

Exclusion criteria

  • 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)
  • 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

Treatment and study plan

MORPH

Behavioral

A remote behavioral intervention combining coaching and digital health tools to improve diet and activity behaviors.

Measurement Only

Behavioral

This intervention entails receipt of a body weight scale and wearable activity monitor.

Primary outcomes

  1. 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

Secondary outcomes

  1. Pain Interference

    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.

  2. Body weight

    Time frame: From the start of the intervention through month 18.

    Measured via the BodyTrace wireless body weight scale

  3. 30-second chair stand

    Time frame: Baseline, after 6 months of intervention, after 18 months of intervention

    Measured via in-home chair stand task.

  4. Gait speed

    Time frame: Baseline, after 6 months of intervention, after 18 months of intervention

    Measured via in-home test: 4-meter habitual gait speed

Other outcomes

  1. Physical activity behavior

    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

  2. Adverse Events

    Time frame: Baseline, after 6 months of intervention, after 18 months of intervention

    Assessed via assessor query and spontaneous report

  3. Participant Feedback

    Time frame: After 6 months of intervention

    Assessed via semi-structured interview

  4. Medication usage

    Time frame: Baseline, after 6 months of intervention, after 18 months of intervention

    Assessed via assessor query

  5. Sleep behavior

    Time frame: Nightly over the 18-month intervention

    Assessed via wearable activity monitor

  6. Pain intensity

    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.

  7. Perceived physical function

    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.

  8. Pain Catastrophizing

    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.

  9. Self-determinative needs

    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.

  10. Affect

    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.

  11. Stress

    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.

  12. Exercise Self-Efficacy

    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.

  13. Outcome Expectencies related to Eating Behavior

    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.

  14. Outcome Expectencies related to Activity Behavior

    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.

  15. Self-regulation

    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.

  16. Barriers

    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.

  17. Health-related quality of life

    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.

  18. Perceived Sleep

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Deja O Dobson, MS

CONTACT

[email protected]

3367585042

Jason Fanning, PhD

CONTACT

[email protected]

3367585042

Sponsors and collaborators

Lead sponsor

Wake Forest University

Other

Collaborators

  • Duke University
  • National Institute on Aging (NIA)
  • Wake Forest University Health Sciences

Registry information

Acronym: MORPH-III

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Oct 2, 2024
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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