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Development of a Mind Body Program for Obese Knee Osteoarthritis Patients With Comorbid Depression
NCT04334278 · View on ClinicalTrials.gov ↗
Study Summary
Knee osteoarthritis (OA) is the most common joint disorder in the U.S. and a leading cause of disability. Depression and obesity are highly comorbid among knee osteoarthritis patients, and the combination of obesity and depression is associated with decreased physical activity, higher pain and disability, and more rapid cartilage degradation. Depression, obesity and osteoarthritis exacerbate one another and share a common pathophysiology involving systemic inflammation and pro-inflammatory cytokines, reflecting a complex mind-body interaction. Current treatments for knee osteoarthritis offer little to no benefit over placebo, and do not emphasize mind-body practices or physical activity to target the underlying pathophysiology. Mind-body interventions to lessen depressive symptoms and increase physical activity offer the ability to target biological, mechanical and psychological mechanisms of osteoarthritis progression in this high-risk subset. The long-term goals are to evaluate the mechanisms by which the Relaxation Response Resiliency Program (3RP) delivered via telehealth, and adapted for patients with depression, obesity and knee OA (GetHealthy-OA) promotes increases in physical activity and improved subjective and objective aspects of knee health. The overarching hypothesis is that the synergistic interaction between mindfulness, adaptive thinking, positive psychology and healthy living skills of the GetHealthy-OA will reduce pro-inflammatory cytokine expression while also promoting optimal mechanical loading of the cartilage thereby slowing the progression of symptomatic knee osteoarthritis. This study aims to adapt the 3RP for the needs of knee osteoarthritis patients with depression and obesity with a focus of increasing physical activity, and iteratively establish the feasibility, credibility and acceptability of the programs and research procedures.
Conditions Studied
Interventions
- BEHAVIORAL Health Enhancement Program
- BEHAVIORAL GetHealthy-OA
Study Locations (2)
Kentucky
- UK Healthcare at Turfland — Lexington
- UK HealthCare Joint Reconstruction and Replacement — Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2021-08-23 |
| Est. Completion | 2023-06-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04334278
The ClinicalTrials.gov registry entry for NCT04334278 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Kentucky, which has 47 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Obesity appearing as the primary indexed condition, and to 2 interventions — of which Health Enhancement Program is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04334278 reports 2 study locations spanning 1 distinct geographic area — top geographies include Kentucky. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04334278 about?
NCT04334278 is a clinical study titled "Development of a Mind Body Program for Obese Knee Osteoarthritis Patients With Comorbid Depression". Knee osteoarthritis (OA) is the most common joint disorder in the U.S. and a leading cause of disability. Depression and obesity are highly comorbid among knee osteoarthritis patients, and the combination of obesity and depression is associated with decreased physical activity, higher pain and disab...
What is the current status of trial NCT04334278?
This trial is currently completed. It is a NA study. The enrollment target is 66 participants. The study started on 2021-08-23. Estimated completion is 2023-06-05.
What conditions does trial NCT04334278 study?
This clinical trial studies the following conditions: Obesity, Depression, Knee Osteoarthritis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04334278?
The interventions under investigation include: Health Enhancement Program (BEHAVIORAL), GetHealthy-OA (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04334278?
This trial is sponsored by University of Kentucky, which has 47 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04334278 being conducted?
This trial has 2 study locations across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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