Actively Recruiting

Phase 2
Age: 65Years +
All Genders
NCT06623669

A Mobile Intervention to Reduce Pain and Improve Health-III

Led by Wake Forest University · Updated on 2026-02-20

200

Participants Needed

1

Research Sites

211 weeks

Total Duration

On this page

Sponsors

W

Wake Forest University

Lead Sponsor

W

Wake Forest University Health Sciences

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

A Mobile Intervention to Reduce Pain and Improve Health-III

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 65 years or older
  • Body mass index (BMI) between 30 and 45 kg/m2, or above 45 kg/m2 with physician approval
  • No loss or gain of more than 5% body mass in the past 6 months
  • Presence of knee or hip osteoarthritis confirmed by the Roux questionnaire
  • Living independently
  • Low physical activity level (no regular resistance training or more than 20 minutes/day of aerobic exercise on more than 2 days per week in the past 3 months)
  • No contraindications to safe exercise participation based on EASY screening (including chest pain, dizziness, or frequent falls)
  • Not currently taking weight loss medications (diabetes medications allowed if weight is stable)
  • Medical director approval for participation
  • Willingness to provide informed consent and comply with all study procedures and assessments
Not Eligible

You will not qualify if you...

  • Living in a skilled nursing facility, rehabilitation, or assisted living environment
  • History of pharmacologic treatment for psychiatric disorders other than depression or anxiety within the past year
  • Current untreated or unstable clinical depression or anxiety (PHQ-9 score greater than 15)
  • Psychiatric hospitalization within the past year before screening
  • History of mild cognitive impairment or dementia
  • Cognitive impairment (score less than 32 on the Modified Telephone Interview for Cognitive Status)
  • Hearing or visual impairments preventing use of videoconferencing software
  • Severe arthritis or musculoskeletal conditions unsafe for walking
  • Currently undergoing treatment for an orthopedic fracture
  • Current use of weight loss medication (diabetes medications allowed if weight stable)
  • Contraindications to exercise without physician approval based on EASY screening
  • Joint replacement or orthopedic surgery within the past 6 months or planned within the next 18 months
  • Diagnosed uncontrolled hypertension, severe symptomatic heart disease, uncontrolled angina, stroke, chronic respiratory diseases other than asthma or COPD, diseases requiring oxygen, neurological or hematological diseases, cancer requiring treatment (except non-melanoma skin cancers), kidney failure requiring dialysis
  • Katz Activities of Daily Living disability
  • Heavy alcohol use (more than 14 drinks per week)
  • Participation in other intervention research studies
  • Unable or unwilling to comply with study protocol, including randomization and technology use
  • Unable or unwilling to attend three virtual testing appointments

AI-Screening

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Trial Site Locations

Total: 1 location

1

Wake Forest University

Winston-Salem, North Carolina, United States, 27109

Actively Recruiting

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Research Team

D

Deja O Dobson, MS

CONTACT

J

Jason Fanning, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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