A Mobile Intervention to Reduce Pain and Improve Health-III

Phase 2

Recruiting

• Conditions: Chronic Pain; Osteoarthritis; Obesity and Overweight; Inactivity

• Registration Number: NCT06623669
• Lead Sponsor: Wake Forest University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-30
• Study First Submitted QC: 2024-09-30
• Study First Posted: 2024-10-02
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-01
• Last Update Posted: 2025-07-04
• Study Start: 2025-07-15
• Primary Completion: 2028-03-15
• Study Completion: 2029-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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
• Not currently using a weight loss medication
• 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
• Contraindication based on EASY screening 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Daily steps	Baseline, after 6 months of intervention, after 18 months of intervention	Daily steps measured over one week via the ActivPAL accelerometer

Secondary Outcome Measures

Name	Time	Method
Pain Interference	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.
Body weight	From the start of the intervention through month 18.	Measured via the BodyTrace wireless body weight scale
30-second chair stand	Baseline, after 6 months of intervention, after 18 months of intervention	Measured via in-home chair stand task.
Gait speed	Baseline, after 6 months of intervention, after 18 months of intervention	Measured via in-home test: 4-meter habitual gait speed

Trial Locations

Locations (1)

Wake Forest University; 🇺🇸 Winston Salem, North Carolina, United States