title: OARSI Clinical Trials Recommendations: Design and conduct of clinical trials of lifestyle diet and exercise interventions for osteoarthritis.
abstract: The objective was to develop a set of "best practices" for use as a primer for those interested in entering the clinical trials field for lifestyle diet and/or exercise interventions in osteoarthritis (OA), and as a set of recommendations for experienced clinical trials investigators. A subcommittee of the non-pharmacologic therapies committee of the OARSI Clinical Trials Working Group was selected by the Steering Committee to develop a set of recommended principles for non-pharmacologic diet/exercise OA randomized clinical trials. Topics were identified for inclusion by co-authors and reviewed by the subcommittee. Resources included authors' expert opinions, traditional search methods including MEDLINE (via PubMed), and previously published guidelines. Suggested steps and considerations for study methods (e.g., recruitment and enrollment of participants, study design, intervention and assessment methods) were recommended. The recommendations set forth in this paper provide a guide from which a research group can design a lifestyle diet/exercise randomized clinical trial in patients with OA.
authors.affiliation: Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC, USA; Department of Rheumatology and Immunology, Wake Forest School of Medicine, Winston-Salem, NC, USA; Section on Gerontology and Geriatric Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA. Electronic address: messier@wfu.edu.
authors.forename: S P
authors.initials: SP
authors.lastname: Messier
authors.affiliation: Thurston Arthritis Research Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
authors.forename: L F
authors.initials: LF
authors.lastname: Callahan
authors.affiliation: Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
authors.forename: Y M
authors.initials: YM
authors.lastname: Golightly
authors.affiliation: Department of Psychiatry, Duke University, Durham, NC, USA.
authors.forename: F J
authors.initials: FJ
authors.lastname: Keefe
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D004035:Diet Therapy / Q000592:standards*; D005081:Exercise Therapy / Q000592:standards*; D006801:Humans; D008019:Life Style; D010003:Osteoarthritis / Q000178:diet therapy* / Q000534:rehabilitation*; D017410:Practice Guidelines as Topic
keywords: Behavioral intervention; Clinical trial design; Diet; Exercise; Nonpharmacologic clinical trial; Randomized clinical trial