Effects of Intensive Diet and Exercise on Knee Joint Loads, Inflammation, and Clinical Outcomes Among Overweight and Obese Adults With Knee Osteoarthritis The IDEA Randomized Clinical Trial

Department of Health and Exercise Science, Wake Forest University, Winston-Salem, North Carolina 27109, USA.
JAMA The Journal of the American Medical Association (Impact Factor: 35.29). 09/2013; 310(12):1263-73. DOI: 10.1001/jama.2013.277669
Source: PubMed


Knee osteoarthritis (OA), a common cause of chronic pain and disability, has biomechanical and inflammatory origins and is exacerbated by obesity.Objective
To determine whether a ≥10% reduction in body weight induced by diet, with or without exercise, would improve mechanistic and clinical outcomes more than exercise alone.Design, Setting, and Participants
Single-blind, 18-month, randomized clinical trial at Wake Forest University between July 2006 and April 2011. The diet and exercise interventions were center-based with options for the exercise groups to transition to a home-based program. Participants were 454 overweight and obese older community-dwelling adults (age ≥55 years with body mass index of 27-41) with pain and radiographic knee OA.Interventions
Intensive diet-induced weight loss plus exercise, intensive diet-induced weight loss, or exercise.Main Outcomes and Measures
Mechanistic primary outcomes: knee joint compressive force and plasma IL-6 levels; secondary clinical outcomes: self-reported pain (range, 0-20), function (range, 0-68), mobility, and health-related quality of life (range, 0-100).Results
Three hundred ninety-nine participants (88%) completed the study. Mean weight loss for diet + exercise participants was 10.6 kg (11.4%); for the diet group, 8.9 kg (9.5%); and for the exercise group, 1.8 kg (2.0%). After 18 months, knee compressive forces were lower in diet participants (mean, 2487 N; 95% CI, 2393 to 2581) compared with exercise participants (2687 N; 95% CI, 2590 to 2784, pairwise difference [Δ]exercise vs diet = 200 N; 95% CI, 55 to 345; P = .007). Concentrations of IL-6 were lower in diet + exercise (2.7 pg/mL; 95% CI, 2.5 to 3.0) and diet participants (2.7 pg/mL; 95% CI, 2.4 to 3.0) compared with exercise participants (3.1 pg/mL; 95% CI, 2.9 to 3.4; Δexercise vs diet + exercise = 0.39 pg/mL; 95% CI, −0.03 to 0.81; P = .007; Δexercise vs diet = 0.43 pg/mL; 95% CI, 0.01 to 0.85, P = .006). The diet + exercise group had less pain (3.6; 95% CI, 3.2 to 4.1) and better function (14.1; 95% CI, 12.6 to 15.6) than both the diet group (4.8; 95% CI, 4.3 to 5.2) and exercise group (4.7; 95% CI, 4.2 to 5.1, Δexercise vs diet + exercise = 1.02; 95% CI, 0.33 to 1.71; Ppain = .004; 18.4; 95% CI, 16.9 to 19.9; Δexercise vs diet + exercise, 4.29; 95% CI, 2.07 to 6.50; Pfunction < .001). The diet + exercise group (44.7; 95% CI, 43.4 to 46.0) also had better physical health-related quality of life scores than the exercise group (41.9; 95% CI, 40.5 to 43.2; Δexercise vs diet + exercise = −2.81; 95% CI, −4.76 to −0.86; P = .005).Conclusions and Relevance
Among overweight and obese adults with knee OA, after 18 months, participants in the diet + exercise and diet groups had more weight loss and greater reductions in IL-6 levels than those in the exercise group; those in the diet group had greater reductions in knee compressive force than those in the exercise group.Trial Registration Identifier: NCT00381290

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    • "However, research examining optimal treatment approaches for individuals with co-morbid chronic pain and obesity is limited. Current evidence suggests that for individuals with overweight and osteoarthritis, weight loss achieved via exercise and dietary changes may improve pain outcomes [14-16]. Research has also shown a correlation between the amount of weight lost and degree of pain symptom improvement [17]. "
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    ABSTRACT: Background Obesity often occurs co-morbid with chronic, non-cancer pain. While behavioral treatments have proved effective for pain management and weight loss independently, integrated interventions are lacking. The study Simultaneously Targeting Obesity and Pain (STOP) is a prospective, pragmatic, randomized controlled trial that aims to determine whether overweight/obese individuals with chronic pain who are randomized to receive an integrated treatment Simultaneously Targeting Obesity and Pain (STOP) will show more weight loss and greater reduction in pain intensity over a 6-month period and greater maintenance at 12 months than those who receive standard care behavioral weight loss or standard care behavioral pain management. We hypothesize that individuals randomized to receive the STOP treatment will demonstrate improved weight loss, pain reduction, and maintenance compared to standard care treatment approaches. Methods/Design Adults aged ≥ 18 with a body mass index ≥ 25 and who report persistent pain (≥4 out of 0–10 for > 6 months) will be recruited for treatment at the Health Behavior Research Lab at the University of the Sciences. After baseline assessments and goal setting, participants will be randomized to receive one of three treatments. Participants will receive eleven treatment sessions delivered during 1 hour, weekly individual meetings with a clinic therapist. Follow-up will occur at 3, 6 and 12-month time points; assessments will include measures of weight and pain intensity (primary outcomes). A mixed-method approach to evaluating study outcomes will include individual interviews with participants about their treatment experience. These interviews will be led by a research staffer who was not involved in study intervention or assessment using a semi-structured discussion guide. Discussion This study fills an important gap in intervention research, evaluating best-practices for behavioral management of a highly prevalent co-morbidity that has sub-optimal outcomes with currently-implemented approaches. STOP’s pragmatic focus builds upon treatments already in use in clinical practice. Should STOP be found efficacious in achieving the dual outcomes of pain management and weight loss, such an approach could be integrated into practice with minimal additional cost or training. Trial registration Clinical NCT02100995 Date of Registration: March 2014
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