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A Mobile Intervention to Reduce Pain and Improve Health-III

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 65 Years and Over
Gender All
More 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.
  • - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06623669
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Wake Forest University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Jason Fanning, PhDAmber Brooks, MD
Principal Investigator Affiliation Wake Forest UniversityWake Forest University Health Sciences
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Chronic Pain, Osteoarthritis, Obesity and Overweight, Inactivity
Arms & Interventions

Arms

Experimental: MORPH

MORPH participants will attend one weekly group-mediated session alongside a group of their peers plus individual coaching calls. Participants will aim to increase daily steps by moving often throughout the day, using an activity monitor and mHealth app to view feedback and set goals. Participants will also aim to weight via healthy eating while reducing daily calories by ~400kcal/day below weight maintenance needs to achieve approximately 6% weight loss in 6 months and 10% over 18 months.

Active Comparator: Measurement Only

Measurement-only participants will receive an activity monitor and wireless weight scale to account for the effect of these self-monitoring technologies and activity behavior.

Interventions

Behavioral: - MORPH

A remote behavioral intervention combining coaching and digital health tools to improve diet and activity behaviors.

Behavioral: - Measurement Only

This intervention entails receipt of a body weight scale and wearable activity monitor.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Wake Forest University, Winston-Salem 4499612, North Carolina 4482348

Status

Recruiting

Address

Wake Forest University

Winston-Salem 4499612, North Carolina 4482348, 27109

Site Contact

Deja Dobson

[email protected]

336-758-6677

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