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NIH grant 1R01AT013252-01A1: A multi-site feasibility clinical trial of GetHealthy-OA, a mind-body program for those with the combination of knee osteoarthritis, obesity, and depressive symptoms
Institute: {'code': 'AT', 'abbreviation': 'NCCIH', 'name': 'National Center for Complementary and Integrative Health', 'admin_org_id': '12500007', 'admin_funding_url': ''}. PI: Cale Jacobs. Award: $1591498.
Start: 2026-09-18T00:00:00.
Project Summary/Abstract
Knee osteoarthritis (OA) pain is a complex phenomenon influenced by psychosocial, biological, and
mechanical factors. We and others have identified that the subset of individuals with co-occurring OA, obesity,
and comorbid depressive symptoms represents a high-risk population that is more susceptible to OA pain and
structural progression than non-obese individuals and those with obesity but without depression. Depression
and obesity are highly prevalent comorbid conditions among those with knee OA. This combination is
associated with decreased physical activity, higher pain and disability, and more rapid cartilage degradation.
Depression, obesity and OA exacerbate one another and share a common pathophysiology reflecting a
complex mind-body interaction that involves a vicious cycle of increases in proinflammatory cytokine
expression which, in turn, lead to inflammation-induced cartilage catabolism in the knee. This irreversible
cartilage loss has real-world implications. We observed in a cohort of > 1 million Americans that the incidence
of total knee arthroplasty (TKA) within 5 years of OA diagnosis was significantly greater for those with
combined obesity and depression (OR=1.49, p<0.0001). Furthermore, there appears to be an additive effect of
obesity and depression as the incidence of subsequent TKA was significantly greater for those with the
combination of these factors when compared to those with isolated obesity or depression. An estimated 2.2
million Americans with knee OA are obese with concomitant depression. Current knee biomedical OA
treatments provide little to no benefit over placebo for this high-risk population. While diet, exercise, and mind-
body programs have been relatively successful at alleviating pain in the short-term in early phase OA clinical
trials, isolated use of these interventions has not yielded lasting results. To address this unmet need, our team
developed the multicomponent GetHealthy-OA program with mind body skills to reduce pain, increase physical
activity, and promote a healthier diet and sleep habits. The program was developed through a rigorous,
iterative process involving patient focus groups, an open pilot study, and a pilot feasibility RCT. Building on our
successful R34 project, we now propose a multi-site feasibility RCT of the GetHealthy-OA program vs. a
Health Education Program targeting a priori benchmarks (90 total participants; 30 at each site). The 3-center
feasibility study will be performed at geographically diverse orthopaedic centers (Mass General Brigham,
University of Kentucky, and Duke University). Our Specific Aims directly align with the NCCIH high priority
areas of whole person health, pain conditions, and engagement with activity like walking and include 1) to
optimize our fidelity and study implementation protocol procedures in preparation for a future, fully powered
multisite efficacy RCT, and 2) to evaluate multisite feasibility benchmarks including the ability to recruit and
retain a diverse pool of participants. Our overarching hypothesis is that this multi-site feasible study will
demonstrate that the GetHealthy-OA program is feasible and acceptable.document fetched 2026-09-27 02:45