RightFit
RecruitingPhase 2

A Mobile Intervention to Reduce Pain and Improve Health-III

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
65 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a remote program with group or one-on-one meetings and coaching calls can help older adults walk more, lose weight, and have less pain that limits daily life. It is for adults age 65 or older with obesity and long-term knee or hip pain from osteoarthritis, or joint wear and tear. The program lasts 6 months, followed by 12 months of working on goals without study contact.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 65 or older and living independently.
  • Have a body mass index (BMI), a measure of weight compared with height, of 30–45, or above 45 with a doctor's approval.
  • Have not gained or lost more than 5% of body weight in the past 6 months.
  • Have knee or hip osteoarthritis, based on a study questionnaire.
  • Have low activity levels over the past 3 months, based on a questionnaire about strength training and aerobic exercise.
  • Pass an exercise safety check and have approval from the study's medical director.
  • Do not use weight-loss medicine. Diabetes medicines are allowed if weight is stable.
  • Agree to join the study and complete all study activities and tests.

Who can't join

  • Live in a nursing home, rehab center, or assisted living setting.
  • In the past year, took medicine for a mental health condition other than depression or anxiety, or were hospitalized for a mental health event. Current untreated or unstable depression or anxiety also rules people out.
  • Have a history of mild problems with memory or thinking, dementia, or a low score on the study's thinking test; or have hearing or vision problems that prevent video calls.
  • Have severe arthritis or another muscle or bone condition that makes walking unsafe; are being treated for a broken bone; or had joint replacement or other bone or joint surgery in the past 6 months or plan it in the next 18 months.
  • Use weight-loss medicine, or have exercise safety concerns without a doctor's approval. Diabetes medicines are allowed if weight is stable.
  • Have uncontrolled high blood pressure; severe heart disease with symptoms now or within the past year; uncontrolled heart-related chest pain; stroke; long-term breathing disease other than asthma or COPD; an illness requiring oxygen; or a nerve or blood disease.
  • Have cancer needing treatment, except non-melanoma skin cancer; kidney failure needing dialysis; trouble with basic daily self-care as measured by the study; or drink more than 14 alcoholic drinks a week.
  • Are in another research study testing a treatment or program, or cannot or will not follow study rules, accept assignment to a group by chance, use the technology tools, or attend three online testing visits.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 (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

Study sites (1)

NC