Budget Impact of Funding an Intensive Diet and Exercise Program for Overweight and Obese Patients With Knee Osteoarthritis.
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SUBMITTER: Smith KC
PROVIDER: S-EPMC6957917 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectiveThe Intensive Diet and Exercise for Arthritis (IDEA) trial showed that an intensive diet and exercise (D+E) program led to a mean 10.6-kg weight reduction and 51% pain reduction in patients with knee osteoarthritis (OA). The aim of the current study was to investigate the cost-effectiveness of adding this D+E program to treatment in overweight and obese (body mass index >27 kg/m2 ) patients with knee OA.MethodsWe used the Osteoarthritis Policy Model to estimate quality-adjusted life-years (QALYs) and lifetime costs for overweight and obese patients with knee OA, with and without the D+E program. We evaluated cost-effectiveness with the incremental cost-effectiveness ratio (ICER), a ratio of the differences in lifetime cost and QALYs between treatment strategies. We considered 3 cost-effectiveness thresholds: $50,000/QALY, $100,000/QALY, and $200,000/QALY. Analyses were conducted from health care sector and societal perspectives and used a lifetime horizon. Costs and QALYs were discounted at 3% per year. D+E characteristics were derived from the IDEA trial. Deterministic and probabilistic sensitivity analyses (PSAs) were used to evaluate parameter uncertainty and the effect of extending the duration of the D+E program.ResultsIn the base case, D+E led to 0.054 QALYs gained per person and cost $1,845 from the health care sector perspective and $1,624 from the societal perspective. This resulted in ICERs of $34,100/QALY and $30,000/QALY. In the health care sector perspective PSA, D+E had 58% and 100% likelihoods of being cost-effective with thresholds of $50,000/QALY and $100,000/QALY, respectively.ConclusionAdding D+E to usual care for overweight and obese patients with knee OA is cost-effective and should be implemented in clinical practice.
| S-EPMC6349519 | biostudies-literature
Project description:Physical activity decreases the risk of osteoarthritis (OA)-related disability; however, pain and lack of confidence represent barriers for older adults with knee OA. The purpose of this study was to examine (a) the baseline associations among self-efficacy and physical activity, function, and pain; (b) longitudinal changes in self-efficacy; and (c) whether self-efficacy mediates treatment effects on clinical outcomes. The Intensive Diet and Exercise for Arthritis (IDEA) trial was a single-blind, randomized controlled 18-month study including 454 overweight/obese older adults (M age = 66 years) with knee OA. Participants were randomized to one of three interventions: exercise (E), diet-induced weight loss (D), or both (D+E). Self-efficacy for gait, balance, and walking duration were assessed at baseline, 6 months, and 18 months. Baseline associations were tested using Pearson correlations, and group least squares means were compared using mixed linear models at follow-up. Participants with higher self-efficacy reported significantly better physical function and less knee pain at baseline, walked farther (6-min walk), and were more physically active (all |r| > 0.12, all p < .01). Significant differences between groups were detected for all self-efficacy measures at 18 months; the D+E group reported significantly (all p < .005) higher self-efficacy for gait, walking duration, and balance compared with the D- or E-only groups. Self-efficacy significantly (p < .05) mediated treatment effects on physical function and pain at 18 months. A combined intervention of diet-induced weight loss and exercise is the treatment of choice to maximize self-efficacy, improve physical function, and reduce pain in overweight/obese adults with knee OA.
| S-EPMC6417150 | biostudies-literature
Project description:ObjectiveIt is unclear whether an intensive program of weight loss combined with exercise prevents the onset of knee pain among those at high risk. We examined whether an intensive lifestyle intervention (ILI) prevents incident knee pain compared with a diabetes mellitus support and education (DSE) comparison group among overweight adults with diabetes mellitus.MethodsWe conducted a secondary analysis of the Action for Health in Diabetes (Look AHEAD) study, which is a randomized intervention trial of adults who were obese and had type 2 diabetes mellitus starting in 2001. We studied a subcohort of 2,889 subjects who reported no knee pain at baseline but were at high risk due to obesity. Risk ratios (RRs) were calculated to examine the association of ILI versus DSE with incident knee pain at year 1 and year 4. All analyses were adjusted for potential confounders.ResultsAge, sex, and body mass index were similar among ILI and DSE participants with no knee pain at baseline. At year 1, ILI participants were 15% less likely to develop knee pain compared with DSE participants (RR 0.85, 95% confidence interval 0.74-0.98). At year 4, this difference decreased to 5% and was no longer statistically significant.ConclusionAn ILI of diet and exercise may prevent the development of knee pain among those at high risk in the short term. Health care providers may consider recommending diet and exercise as a means to prevent the development of knee pain among those at high risk.
| S-EPMC4482772 | biostudies-literature
Project description:ImportanceKnee osteoarthritis (OA), a common cause of chronic pain and disability, has biomechanical and inflammatory origins and is exacerbated by obesity.ObjectiveTo 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 participantsSingle-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.InterventionsIntensive diet-induced weight loss plus exercise, intensive diet-induced weight loss, or exercise.Main outcomes and measuresMechanistic 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).ResultsThree 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 [?](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; ?(exercise vs diet + exercise)?=?0.39 pg/mL; 95% CI, -0.03 to 0.81; P?=?.007; ?(exercise 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, ?(exercise vs diet + exercise)?=?1.02; 95% CI, 0.33 to 1.71; P(pain)?=?.004; 18.4; 95% CI, 16.9 to 19.9; ?(exercise vs diet + exercise), 4.29; 95% CI, 2.07 to 6.50; P(function?)<?.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; ?(exercise vs diet + exercise)?=?-2.81; 95% CI, -4.76 to -0.86; P?=?.005).Conclusions and relevanceAmong 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 registrationclinicaltrials.gov Identifier: NCT00381290.
| S-EPMC4450354 | biostudies-literature
Project description:BackgroundAquatic exercise is recommended by the Osteoarthritis Research Society (OARSI), by the American College of Rheumatology (ACR) and by the European League Against Rheumatism (EULAR) as a nonpharmacological method of controlling the knee osteoarthritis (KOA) symptoms. Moreover, given that weight loss results in a reduction of the load that is exerted upon the knee during daily activities, obesity is also considered to be a modifiable risk factor for the development and or exacerbation of KOA. The implementation of an exercise based weight loss program may, however, itself be limited by the symptoms of KOA. The aquatic program against osteoarthritis (termed "PICO" in Portuguese) prioritizes the control of symptoms and the recovery of functionality, with an attendant increase in the patient's physical activity level and, consequently, metabolic rate. Our laboratory is assessing the effectiveness of 3 months of PICO on the symptoms of KOA, on physical function, on quality of life and on gait. In addition, PICO shall examine the effects of said exercise intervention on inflammatory biomarkers, psychological health, life style and body composition.Methods/designThe trial is a prospective, single-blinded, randomized controlled trial, and involves 50 overweight and obese adults (BMI = 28-43.5 kg/m²; age 40-65 yrs) with radiographic KOA. The participants are randomly allocated into either an educational attention (control) group or an aquatic (exercise program) group. This paper describes the experimental protocol that is used in the PICO project.DiscussionThe PICO program shall provide insight into the effectiveness of an aquatic exercise program in the control of KOA symptoms and in the improvement of the quality of life. As such, they are likely to prove a useful reference to health professionals who intend to implement any kind of therapeutic intervention based around aquatic exercise.Trial registrationNCT01832545.
| S-EPMC3830983 | biostudies-literature
Project description:ImportanceSome weight loss and exercise programs that have been successful in academic center-based trials have not been evaluated in community settings.ObjectiveTo determine whether adaptation of a diet and exercise intervention to community settings resulted in a statistically significant reduction in pain, compared with an attention control group, at 18-month follow-up.Design, setting, and participantsAssessor-blinded randomized clinical trial conducted in community settings in urban and rural counties in North Carolina. Patients were men and women aged 50 years or older with knee osteoarthritis and overweight or obesity (body mass index ≥27). Enrollment (N = 823) occurred between May 2016 and August 2019, with follow-up ending in April 2021.InterventionsPatients were randomly assigned to either a diet and exercise intervention (n = 414) or an attention control (n = 409) group for 18 months.Main outcomes and measuresThe primary outcome was the between-group difference in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) knee pain score (range, 0 [none] to 20 [severe]; minimum clinically important difference, 1.6) over 18 months, tested using a repeated-measures mixed linear model with adjustments for covariates. There were 7 secondary outcomes including body weight.ResultsAmong the 823 randomized patients (mean age, 64.6 years; 637 [77%] women), 658 (80%) completed the trial. At 18-month follow-up, the adjusted mean WOMAC pain score was 5.0 in the diet and exercise group (n = 329) compared with 5.5 in the attention control group (n = 316) (adjusted difference, -0.6; 95% CI, -1.0 to -0.1; P = .02). Of 7 secondary outcomes, 5 were significantly better in the intervention group compared with control. The mean change in unadjusted 18-month body weight for patients with available data was -7.7 kg (8%) in the diet and exercise group (n = 289) and -1.7 kg (2%) in the attention control group (n = 273) (mean difference, -6.0 kg; 95% CI, -7.3 kg to -4.7 kg). There were 169 serious adverse events; none were definitely related to the study. There were 729 adverse events; 32 (4%) were definitely related to the study, including 10 body injuries (9 in diet and exercise; 1 in attention control), 7 muscle strains (6 in diet and exercise; 1 in attention control), and 6 trip/fall events (all 6 in diet and exercise).Conclusions and relevanceAmong patients with knee osteoarthritis and overweight or obesity, diet and exercise compared with an attention control led to a statistically significant but small difference in knee pain over 18 months. The magnitude of the difference in pain between groups is of uncertain clinical importance.Trial registrationClinicalTrials.gov Identifier: NCT02577549.
| S-EPMC9856237 | biostudies-literature
Project description:ObjectiveTo determine the dose response effect of weight loss on clinical and mechanistic outcomes in overweight and obese adults with knee osteoarthritis (OA).MethodsThis is a secondary analysis of the diet-induced weight loss only (D) and diet-induced weight loss plus exercise (D + E) groups in the Intensive Diet and Exercise for Arthritis randomized controlled clinical trial. The 240 participants were overweight and obese older community-dwelling adults with pain and radiographic knee OA. Participants were assigned to 1 of 4 groups according to weight loss achieved over an 18-month period: <5% (<5% group), 5-10% (≥5% group), 10-20% (≥10% group), and >20% (≥20% group).ResultsThere were significant dose responses to weight loss for pain (P = 0.01), function (P = 0.0006), 6-minute walk distance (P < 0.0001), physical (P = 0.0004) and mental (P = 0.03) health-related quality of life (HRQoL), knee joint compressive force (P < 0.0001), and interleukin-6 (P = 0.002). Greater weight loss resulted in superior clinical and mechanstic outcomes, with the highest weight loss group (≥20% group) distinguishing itself on all measures compared with the <5% and ≥5% groups; the ≥20% group had 25% less pain and better function compared with the ≥10% group and significantly (P = 0.006) better physical HRQoL.ConclusionLong-term weight loss of 10-19.9% of baseline body weight has substantial clinical and mechanistic benefits compared with less weight loss. The value of an additional 10% weight loss includes significantly improved physical HRQoL and a clinically important reduction of pain and improvement in function.
| S-EPMC6203601 | biostudies-literature
Project description:BackgroundObesity is associated with knee osteoarthritis (OA). Weight loss, alongside exercise, is a recommended treatment for individuals with knee OA and overweight/obesity. However, many patients cannot access weight loss specialists such as dietitians. Innovative care models expanding roles of other clinicians may increase access to weight loss support for people with knee OA. Physiotherapists may be well placed to deliver such support. This two-group parallel, superiority randomized controlled trial aims to compare a physiotherapist-delivered diet and exercise program to an exercise program alone, over 6 months. The primary hypothesis is that the physiotherapist-delivered diet plus exercise program will lead to greater weight loss than the exercise program.Methods88 participants with painful knee OA and body mass index (BMI) > 27 kg/m2 will be recruited from the community. Following baseline assessment, participants will be randomised to either exercise alone or diet plus exercise groups. Participants in the exercise group will have 6 consultations (20-30 min) via videoconference with a physiotherapist over 6 months for a strengthening exercise program, physical activity plan and educational/exercise resources. Participants in the diet plus exercise group will have 6 consultations (50-75 min) via videoconference with a physiotherapist prescribing a ketogenic very low-calorie diet with meal replacements and educational resources to support weight loss and healthy eating, plus the intervention of the exercise only group. Outcomes are measured at baseline and 6 months. The primary outcome is percentage change in body weight measured by a blinded assessor. Secondary outcomes include self-reported knee pain, physical function, global change in knee problems, quality of life, physical activity levels, and internalised weight stigma, as well as BMI, waist circumference, waist-to-hip ratio, physical performance measures and quadriceps strength, measured by a blinded assessor. Additional measures include adherence, adverse events, fidelity and process measures.DiscussionThis trial will determine whether a physiotherapist-delivered diet plus exercise program is more effective for weight loss than an exercise only program. Findings will inform the development and implementation of innovative health service models addressing weight management and exercise for patients with knee OA and overweight/obesity.Trial registrationNIH US National Library of Medicine, Clinicaltrials.gov NCT04733053 (Feb 1 2021).
| S-EPMC9338658 | biostudies-literature
Project description:BackgroundEvidence-based models are needed to deliver exercise-related services for knee osteoarthritis efficiently and according to patient needs.ObjectiveTo examine a stepped exercise program for patients with knee osteoarthritis (STEP-KOA).DesignRandomized controlled trial. (ClinicalTrials.gov: NCT02653768).Setting2 U.S. Department of Veterans Affairs sites.Participants345 patients (mean age, 60 years; 15% female; 67% people of color) with symptomatic knee osteoarthritis.InterventionParticipants were randomly assigned in a 2:1 ratio to STEP-KOA or an arthritis education (AE) control group, respectively. The STEP-KOA intervention began with 3 months of an internet-based exercise program (step 1). Participants who did not meet response criteria for improvement in pain and function after step 1 progressed to step 2, which involved 3 months of biweekly physical activity coaching calls. Participants who did not meet response criteria after step 2 went on to in-person physical therapy visits (step 3). The AE group received educational materials via mail every 2 weeks.MeasurementsPrimary outcome was Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. Scores for the STEP-KOA and AE groups at 9 months were compared by using linear mixed models.ResultsIn the STEP-KOA group, 65% of participants (150 of 230) progressed to step 2 and 35% (81 of 230) to step 3. The estimated baseline WOMAC score for the full sample was 47.5 (95% CI, 45.7 to 49.2). At 9-month follow-up, the estimated mean WOMAC score was 6.8 points (CI, -10.5 to -3.2 points) lower in the STEP-KOA than the AE group, indicating greater improvement.LimitationParticipants were mostly male veterans, and follow-up was limited.ConclusionVeterans in STEP-KOA reported modest improvements in knee osteoarthritis symptoms compared with the control group. The STEP-KOA strategy may be efficient for delivering exercise therapies for knee osteoarthritis.Primary funding sourceDepartment of Veterans Affairs, Health Services Research and Development Service.
| S-EPMC10405203 | biostudies-literature
Project description:ObjectiveTo determine the effects of dietary-induced weight loss (D) and weight loss plus exercise (D + E) compared to exercise alone (E) on bone mineral density (BMD) in older adults with knee osteoarthritis (OA).DesignData come from 284 older (66.0 ± 6.2 years), overweight/obese (body mass index (BMI) 33.4 ± 3.7 kg/m2), adults with knee OA enrolled in the Intensive Diet and Exercise for Arthritis (IDEA) study. Participants were randomized to 18 months of walking and strength training (E; n = 95), dietary-induced weight loss targeting 10% of baseline weight (D; n = 88) or a combination of the two (D + E; n = 101). Body weight and composition (DXA), regional BMD, were obtained at baseline and 18 months.ResultsE, D, and D + E groups lost 1.3 ± 4.5 kg, 9.1 ± 8.6 kg and 10.4 ± 8.0 kg, respectively (P < 0.01). Significant treatment effects were observed for BMD in both hip and femoral neck regions, with the D and D + E groups showing similar relative losses compared to E (both P < 0.01). Despite reduced BMD, fewer overall participants had T-scores indicative of osteoporosis after intervention (9 at 18 months vs 10 at baseline). Within the D and D + E groups, changes in hip and femoral neck, but not spine, BMD correlated positively with changes in body weight (r = 0.21 and 0.54 respectively, both P ≤ 0.01).ConclusionsWeight loss via an intensive dietary intervention, with or without exercise, results in bone loss at the hip and femoral neck in overweight and obese, older adults with OA. Although the exercise intervention did not attenuate weight loss-associated reductions in BMD, classification of osteoporosis and osteopenia remained unchanged.Clinical trial registration numberNCT00381290.
| S-EPMC4051847 | biostudies-literature