A Mobile Intervention to Reduce Pain and Improve Health-III

NCT06623669 | Recruiting Phase 2

• 2 other identifiers: IRB00025649R01AG082777
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Pain; Osteoarthritis; Inactivity; Obesity and Overweight

Keywords

Digital health; Randomized Trial; Physical Activity; Weight Loss; Aging

Outcome Measures

Primary Outcomes (1)

• Daily steps

  Daily steps measured over one week via the ActivPAL accelerometer

  Baseline, after 6 months of intervention, after 18 months of intervention

Secondary Outcomes (4)

• Pain Interference

  Baseline, after 6 months of intervention, after 18 months of intervention

• Body weight

  From the start of the intervention through month 18.

• 30-second chair stand

  Baseline, after 6 months of intervention, after 18 months of intervention

• Gait speed

  Baseline, after 6 months of intervention, after 18 months of intervention

Other Outcomes (18)

• Physical activity behavior

  Collected over one week at baseline, after 6 months of intervention, after 18 months of intervention

• Adverse Events

  Baseline, after 6 months of intervention, after 18 months of intervention

• Participant Feedback

  After 6 months of intervention

Study Arms (2)

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.

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.

Behavioral: Measurement Only

Interventions

MORPH BEHAVIORAL

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

MORPH

Measurement Only BEHAVIORAL

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

Measurement Only

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Wake Forest University

Winston-Salem, North Carolina, 27109, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Osteoarthritis; Obesity; Overweight; Sedentary Behavior; Motor Activity; Weight Loss

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Behavior; Body Weight Changes

Study Officials

• Jason Fanning, PhD

  Wake Forest University

  PRINCIPAL INVESTIGATOR

• Amber Brooks, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deja O Dobson, MS

CONTACT

3367585042; dobsondo@wfu.edu

Jason Fanning, PhD

CONTACT

3367585042; fanninjt@wfu.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 2, 2024
• Study Start: August 14, 2025
• Primary Completion (Estimated): June 15, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (1)