Mobile program to reduce pain and improve health in older adults with osteoarthritis
A Mobile Intervention to Reduce Pain and Improve Health-III
This trial tests a mobile group-based program combining frequent movement and dietary changes to help older adults with obesity and knee or hip osteoarthritis lose weight, move more, and reduce pain.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Academic / other |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT06623669 on ClinicalTrials.gov |
What this trial studies
This phase 2 randomized trial compares a mobile, group-mediated behavioral intervention (MORPH) that emphasizes moving often, avoiding prolonged sitting, and modest dietary change against a measurement-only control. Participants are community-dwelling adults aged 65 and older with obesity and knee or hip osteoarthritis who are currently low active and medically cleared for exercise. The intervention is delivered via mobile technology and leverages social support and behavior-change strategies to promote sustained physical activity and weight loss. Primary outcomes include changes in pain, physical function, activity patterns, and body weight over the trial period.
Who should consider this trial
Good fit: Ideal candidates are community-dwelling adults aged 65 or older with a BMI of 30–45 kg/m2 (or >45 with physician approval), physician-cleared knee or hip osteoarthritis, low current activity levels, and willingness to use mobile tools and attend study procedures.
Not a fit: Patients with contraindications to exercise, recent major weight change, current use of weight-loss medication, residence in assisted living/nursing facilities, or inability to participate in mobile or in-person assessments are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the program could reduce chronic pain and improve mobility and quality of life by promoting lasting increases in daily movement and modest weight loss through a scalable mobile format.
How similar studies have performed: Prior Stage I trials by this group showed meaningful weight loss, lasting weight maintenance, and pilot signals of improved pain and function, but larger randomized trials are still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest University — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Jason Fanning, PhD — Wake Forest University
- Study coordinator: Deja O Dobson, MS
- Email: dobsondo@wfu.edu
- Phone: 3367585042
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.