Mobile program to reduce pain and improve health in older adults with osteoarthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.