A Mobile Intervention to Reduce Pain and Improve Health-III
RecruitingPhase 2NCT06623669
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 investigator…
Study details
- Official title
- A Mobile Intervention to Reduce Pain and Improve Health-III
- Conditions
- Chronic Pain
- Osteoarthritis
- Obesity and Overweight
- Inactivity
- Interventions
- Behavioral: MORPH
- Behavioral: Measurement Only
- Sponsor
- Wake Forest University
- Collaborators
- Wake Forest University Health Sciences; Duke University; National Institute on Aging (NIA)
- Start date
- 2025-08-14
- Primary completion
- 2029-06-15
- Sex
- All
- Age range
- from 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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 hematolo…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06623669