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NCT04334278 · ClinicalTrials.gov registry record · NA
Development of a Mind Body Program for Obese Knee Osteoarthritis Patients With Comorbid Depression
A NA study of Obesity and Depression, sponsored by University of Kentucky.
- Completed
- Registry status
- NA
- Development phase
- 66
- Enrollment target
- 2
- Study locations
NCT04334278: Completed NA study of Obesity and Depression, sponsored by University of Kentucky.
NCT04334278 is a NA study of Obesity and Depression that has completed, run by University of Kentucky. The registered enrollment target is 66 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (92% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04334278, a NA study of Obesity and Depression, has completed, sponsored by University of Kentucky.
- COMPLETED
- Registry status
- NA
- Development phase
- 66 participants
- Enrollment target
- 2
- Study locations
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.
Primary Outcome
Number of patients that attend a minimum of 4 of 6 weekly sessions
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 |
What the finished NCT04334278 record still lists
NCT04334278 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (92% lower).
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.
NCT04334278 reports a single indexed study location in Kentucky.
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.
What interventions are being tested in trial NCT04334278?
The interventions under investigation include: Health Enhancement Program (BEHAVIORAL), GetHealthy-OA (BEHAVIORAL).
Who is sponsoring clinical trial NCT04334278?
This trial is sponsored by University of Kentucky, which has 54 total clinical trials registered on ClinicalTrials.gov.
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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Where NCT04334278's enrollment target sits among peer trials
66 616th of 1053 higher than 433 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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