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Search / Trial NCT06623669

A Mobile Intervention to Reduce Pain and Improve Health-III

Launched by WAKE FOREST UNIVERSITY · Sep 30, 2024

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

Digital Health Randomized Trial Physical Activity Weight Loss Aging

ClinConnect Summary

The clinical trial titled "Mobile Intervention to Reduce Pain and Improve Health-III" (MORPH-III) is studying how a specially designed program can help older adults with chronic knee or hip pain due to osteoarthritis. The goal is to see if this program can encourage more physical activity, reduce pain, and help participants maintain a healthy weight. The trial will involve 200 older adults, aged 65 and above, who have a body mass index (BMI) of 30 or higher and are not very active. To qualify, participants must live independently and have a confirmed diagnosis of knee or hip osteoarthritis.

During the 6-month program, participants will join weekly group or individual meetings and receive coaching calls to set personal goals. After this active phase, there will be an additional 12 months where participants will try to maintain their goals on their own. The trial will measure changes in daily steps, pain levels, body weight, and overall physical function. This is an exciting opportunity for older adults who are struggling with chronic pain to potentially improve their quality of life through guided support and lifestyle changes.

Gender

ALL

Eligibility 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
  • 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

About Wake Forest University

Wake Forest University is a leading academic institution known for its commitment to innovative research and excellence in education. The university's clinical trial sponsor arm focuses on advancing medical knowledge and improving patient care through rigorous clinical investigations. With a multidisciplinary team of experienced researchers and healthcare professionals, Wake Forest University engages in a wide range of clinical studies that span various therapeutic areas. The institution emphasizes ethical practices, participant safety, and collaboration with industry and regulatory bodies to ensure the integrity and success of its clinical trials. Through its robust research infrastructure, Wake Forest University aims to translate scientific discoveries into effective clinical solutions, ultimately enhancing health outcomes for diverse populations.

Locations

Winston Salem, North Carolina, United States

Patients applied

0 patients applied

Trial Officials

Jason Fanning, PhD

Principal Investigator

Wake Forest University

Amber Brooks, MD

Principal Investigator

Wake Forest University Health Sciences

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported