title: Weight-loss and exercise for communities with arthritis in North Carolina (we-can): design and rationale of a pragmatic, assessor-blinded, randomized controlled trial.
abstract: Recently, we determined that in a rigorously monitored environment an intensive diet-induced weight loss of 10% combined with exercise was significantly more effective at reducing pain in men and women with symptomatic knee osteoarthritis (OA) than either intervention alone. Compared to previous long-term weight loss and exercise trials of knee OA, our intensive diet-induced weight loss and exercise intervention was twice as effective at reducing pain intensity. Whether these results can be generalized to less intensively monitored cohorts is unknown. Thus, the policy relevant and clinically important question is: Can we adapt this successful solution to a pervasive public health problem in real-world clinical and community settings? This study aims to develop a systematic, practical, cost-effective diet-induced weight loss and exercise intervention implemented in community settings and to determine its effectiveness in reducing pain and improving other clinical outcomes in persons with knee OA.
  
  
  
  This is a Phase III, pragmatic, assessor-blinded, randomized controlled trial. Participants will include 820 ambulatory, community-dwelling, overweight and obese (BMI ≥ 27 kg/m2) men and women aged ≥ 50 years who meet the American College of Rheumatology clinical criteria for knee OA. The primary aim is to determine whether a community-based 18-month diet-induced weight loss and exercise intervention based on social cognitive theory and implemented in three North Carolina counties with diverse residential (from urban to rural) and socioeconomic composition significantly decreases knee pain in overweight and obese adults with knee OA relative to a nutrition and health attention control group. Secondary aims will determine whether this intervention improves self-reported function, health-related quality of life, mobility, and is cost-effective.
  
  
  
  Many physicians who treat people with knee OA have no practical means to implement weight loss and exercise treatments as recommended by numerous OA treatment guidelines. This study will establish the effectiveness of a community program that will serve as a blueprint and exemplar for clinicians and public health officials in urban and rural communities to implement a diet-induced weight loss and exercise program designed to reduce knee pain and improve other clinical outcomes in overweight and obese adults with knee OA.
  
  
  
  clinicaltrials.gov Identifier: NCT02577549 October 12, 2015.
authors.affiliation: J.B. Snow Biomechanics Laboratory, Department of Health & Exercise Science, Wake Forest University, Winston-Salem, NC, 27109, USA. messier@wfu.edu.|Section on Gerontology and Geriatric Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA. messier@wfu.edu.|Department of Rheumatology and Immunology, Wake Forest School of Medicine, Winston-Salem, NC, USA. messier@wfu.edu.
authors.forename: Stephen 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: Leigh F
authors.initials: LF
authors.lastname: Callahan
authors.affiliation: Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, NC, USA.
authors.forename: Daniel P
authors.initials: DP
authors.lastname: Beavers
authors.affiliation: Haywood Regional Medical Center, Clyde, NC, USA.
authors.forename: Kate
authors.initials: K
authors.lastname: Queen
authors.affiliation: J.B. Snow Biomechanics Laboratory, Department of Health & Exercise Science, Wake Forest University, Winston-Salem, NC, 27109, USA.
authors.forename: Shannon L
authors.initials: SL
authors.lastname: Mihalko
authors.affiliation: J.B. Snow Biomechanics Laboratory, Department of Health & Exercise Science, Wake Forest University, Winston-Salem, NC, 27109, USA.
authors.forename: Gary D
authors.initials: GD
authors.lastname: Miller
authors.affiliation: Orthopedic and Arthritis Center for Outcomes Research, Department of Orthopedic Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
authors.forename: Elena
authors.initials: E
authors.lastname: Losina
authors.affiliation: Orthopedic and Arthritis Center for Outcomes Research, Department of Orthopedic Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
authors.forename: Jeffrey N
authors.initials: JN
authors.lastname: Katz
authors.affiliation: Thurston Arthritis Research Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
authors.forename: Richard F
authors.initials: RF
authors.lastname: Loeser
authors.affiliation: Department of Epidemiology and Prevention, Wake Forest School of Medicine, Winston-Salem, NC, USA.
authors.forename: Sara A
authors.initials: SA
authors.lastname: Quandt
authors.affiliation: Department of Kinesiology, East Carolina University, Greenville, NC, USA.
authors.forename: Paul
authors.initials: P
authors.lastname: DeVita
authors.affiliation: Rheumatology Department, Institute of Bone and Joint Research, Kolling Institute, University of Sydney, Sydney, Australia.
authors.forename: David J
authors.initials: DJ
authors.lastname: Hunter
authors.affiliation: Section on Gerontology and Geriatric Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.
authors.forename: Mary F
authors.initials: MF
authors.lastname: Lyles
authors.affiliation: J.B. Snow Biomechanics Laboratory, Department of Health & Exercise Science, Wake Forest University, Winston-Salem, NC, 27109, USA.
authors.forename: Jovita
authors.initials: J
authors.lastname: Newman
authors.affiliation: Thurston Arthritis Research Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
authors.forename: Betsy
authors.initials: B
authors.lastname: Hackney
authors.affiliation: Thurston Arthritis Research Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
authors.forename: Joanne M
authors.initials: JM
authors.lastname: Jordan
mesh_terms: D017326:Clinical Trials, Phase III as Topic; D005081:Exercise Therapy; D005260:Female; D006801:Humans; D008019:Life Style; D008297:Male; D008875:Middle Aged; D009657:North Carolina; D020370:Osteoarthritis, Knee / Q000150:complications / Q000628:therapy*; D050177:Overweight / Q000150:complications / Q000178:diet therapy*; D010146:Pain / Q000209:etiology; D059408:Pain Management / Q000379:methods*; D010147:Pain Measurement; D064792:Pragmatic Clinical Trials as Topic; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D020127:Recovery of Function; D057566:Self Report; D016896:Treatment Outcome; D015431:Weight Loss
keywords: Clinical trial; Community based research; Knee pain; Osteoarthritis; Pragmatic