Randomised controlled trial of referral to a telephone-based weight management and healthy lifestyle programme for patients with knee osteoarthritis who are overweight or obese: a study protocol.
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ABSTRACT:
SUBMITTER: O'Brien KM
PROVIDER: S-EPMC4785282 | biostudies-other | 2016 Mar
REPOSITORIES: biostudies-other
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Project description:BACKGROUND: There is a need to develop sustainable and clinically effective weight management interventions that are suitable for delivery in community settings where the vast majority of overweight and obese adolescents should be treated. This study aims to evaluate the effect of additional therapeutic contact as an adjunct to the Loozit group program -- a community-based, lifestyle intervention for overweight and lower grade obesity in adolescents. The additional therapeutic contact is provided via telephone coaching and either mobile phone Short Message Service or electronic mail, or both. METHODS AND DESIGN: The study design is a two-arm randomised controlled trial that aims to recruit 168 overweight and obese 13-16 year olds (Body Mass Index z-score 1.0 to 2.5) in Sydney, Australia. Adolescents with secondary causes of obesity or significant medical illness are excluded. Participants are recruited via schools, media coverage, health professionals and several community organisations. Study arm one receives the Loozit group weight management program (G). Study arm two receives the same Loozit group weight management program plus additional therapeutic contact (G+ATC). The 'G' intervention consists of two phases. Phase 1 involves seven weekly group sessions held separately for adolescents and their parents. This is followed by phase 2 that involves a further seven group sessions held regularly, for adolescents only, until two years follow-up. Additional therapeutic contact is provided to adolescents in the 'G+ATC' study arm approximately once per fortnight during phase 2 only. Outcome measurements are assessed at 2, 12 and 24 months post-baseline and include: BMI z-score, waist z-score, metabolic profile indicators, physical activity, sedentary behaviour, eating patterns, and psychosocial well-being. DISCUSSION: The Loozit study is the first randomised controlled trial of a community-based adolescent weight management intervention to incorporate additional therapeutic contact via a combination of telephone coaching, mobile phone Short Message Service, and electronic mail. If shown to be successful, the Loozit group weight management program with additional therapeutic contact has the potential to be readily translatable to a range of health care settings. TRIAL REGISTRATION: The protocol for this study is registered with the Australian Clinical Trials Registry (ACTRNO12606000175572).
| S-EPMC2687446 | biostudies-other
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: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: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:BackgroundFew studies have examined dietary data or objective measures of physical activity (PA) and sedentary behavior among metabolically healthy overweight/obese (MHO) and metabolically unhealthy overweight/obese (MUO). Thus, the purpose is to determine whether PA, sedentary behavior and/or diet differ between MHO and MUO in a sample of young women.MethodsForty-six overweight/obese (BMI ?25 kg/m2) African American and Caucasian women 19-35 years were classified by cardiometabolic risk factors, including elevated blood pressure, triglyceride, glucose and C-reactive protein, low high density lipoprotein, and insulin resistance (MUO ?2; MHO, <2). Time (mins/day) in light, moderate, vigorous PA, and sedentary behavior were estimated using an accelerometer (?3 days; ?8 hrs wear time). Questionnaires were used to quantify sitting time, TV/computer use and usual daily activity. The Block Food Frequency Questionnaire assessed dietary food intake. Differences between MHO and MUO for lifestyle behaviors were tested with linear regression (continuous data) or logistic regression (categorical data) after adjusting for age, race, BMI, smoking and accelerometer wear and/or total kilocalories, as appropriate.ResultsWomen were 26.7±4.7 years, with a mean BMI of 31.1±3.7 kg/m2, and 61% were African American. Compared to MUO (n = 9), MHO (n = 37; 80%) spent less mins/day in sedentary behavior (difference: -58.1±25.5, p = 0.02), more mins/day in light PA (difference: 38.2±16.1, p = 0.02), and had higher daily METs (difference: 0.21±0.09, p = 0.03). MHO had higher fiber intakes (g/day of total fiber, soluble fiber, fruit/vegetable fiber, bean fiber) and daily servings of vegetables; but lower daily dairy servings, saturated fat, monounsaturated fat and trans fats (g/day) compared to MUO.ConclusionCompared to MUO, MHO young women demonstrate healthier lifestyle habits with less sedentary behavior, more time in light PA, and healthier dietary quality for fat type and fiber. Future studies are needed to replicate findings with larger samples that include men and women of diverse race/ethnic groups.
| S-EPMC4575188 | biostudies-literature
Project description:Hand osteoarthritis (OA) is one of the most prevalent musculoskeletal diseases in an adult population and may have a large influence on an individual's functioning, health-related quality of life and participation in society. Several studies have demonstrated that exercises may reduce pain and improve functioning in people with knee OA, with a similar effect suggested for hip OA. For hand OA, available research is very limited and shows conflicting results, and high-quality randomised controlled trials are warranted.This paper outlines the protocol for a randomised controlled trial that aims to determine the effect of an exercise intervention on self-reported hand activity performance in people with hand OA.Participants with physician-confirmed hand OA according to the ACR clinical criteria are being recruited from two Norwegian OA cohorts: the population-based "Musculoskeletal pain in Ullensaker Study" (MUST) OA cohort, and the hospital-based Oslo Hand OA cohort. Participants are randomised into an intervention- or control group. The control group receives "usual care", whereas the intervention group receives a 12-week exercise intervention. The intervention group attends four group sessions and is instructed to perform the exercise program three times a week at home. Adherence will be captured using self-report. During the eight weeks with no group sessions, the intervention group receives a weekly telephone call. The assessments and group sessions are being conducted locally in Ullensaker Municipality and at Diakonhjemmet Hospital, Oslo. Outcomes are collected at baseline, and at 3 and 6 months. The primary outcome measure is self-reported hand activity performance at 3 months post-randomisation, as measured by the Functional Index for Hand Osteoarthritis (FIHOA); and a patient-generated measure of disability, the Patient-Specific Functional Scale (PSFS). Secondary outcome measures are self-reported OA symptoms (e.g. pain, stiffness and fatigue), the Patient Global Assessment of disease activity, measured hand function (e.g. grip strength, thumb web space and hand dexterity) and health-related quality of life. Cost-utility and cost-effectiveness analyses will be conducted.This study will contribute to the knowledge on both the effect and resource use of an exercise programme with telephone follow-up on self-reported hand activity performance among people with hand OA.The trial is registered at ClinicalTrials.gov with registration number: NCT01245842.
| S-EPMC3995554 | biostudies-literature
Project description:BackgroundThe prevalence of knee osteoarthritis is increasing worldwide. Obesity is an important modifiable risk factor for both the incidence and progression of knee osteoarthritis. Consequently, international guidelines recommend all patients with knee osteoarthritis who are overweight receive support to lose weight. However, few overweight patients with this condition receive care to support weight loss. Telephone-based interventions are one potential solution to provide scalable care to the many patients with knee osteoarthritis. The objective of this study is to evaluate, from a societal perspective, the cost-utility and cost-effectiveness of a telephone-based weight management and healthy lifestyle service for patients with knee osteoarthritis, who are overweight or obese.MethodsAn economic evaluation was undertaken alongside a pragmatic randomised controlled trial. Between May 19 and June 30, 2015, 120 patients with knee osteoarthritis were randomly assigned to an intervention or usual care control group in a 1:1 ratio. Participants in the intervention group received a referral to an existing non-disease specific 6-month telephone-based weight management and healthy lifestyle service. Quality-adjusted life years (QALYs) was the utility measure and knee pain intensity, disability, weight, and body mass index (BMI) were the clinical measures of effect. Costs included intervention costs, healthcare utilisation costs (healthcare services and medication use) and absenteeism costs due to knee pain. Data was collected at baseline, 6?weeks and 26?weeks. The primary cost-effectiveness analysis was performed from the societal perspective.ResultsMean cost differences between groups (intervention minus control) were $493 (95%CI: -3513 to 5363) for healthcare costs, $-32 (95%CI: -73 to 13) for medication costs, and $125 (95%CI: -151 to 486) for absenteeism costs. The total mean difference in societal costs was $1197 (95%CI: -2887 to 6106). For QALYs and all clinical measures of effect, the probability of the intervention being cost-effective compared with usual care was less than 0.36 at all willingness-to-pay values.ConclusionsFrom a societal perspective, telephone-based weight loss support, provided using an existing non-disease specific 6-month weight management and healthy lifestyle service was not cost-effective in comparison with usual care for overweight and obese patients with knee osteoarthritis.Trial registration numberACTRN12615000490572 , registered 18th May 2015.
| S-EPMC6307168 | biostudies-literature
Project description:There was an increasing trend in the prevalence of obesity and its comorbidities over the past decades in Malaysia. Effective intervention for obesity remains limited. This study aimed to compare the effectiveness of a group based lifestyle modification programme amongst obese individuals with an existing dietary counseling programme.We recruited one hundred and ninety four overweight and obese (BMI>27.5 kg/m2) employees from a local university. They were randomly allocated to either Group Support Lifestyle Modification (GSLiM) (intervention)(n = 97) or dietary counseling (comparison)(n = 97). The GSLIM activities included self monitoring, cognitive-behaviour sessions, exercise as well as dietary change advocacy, which were conducted through seminars and group sessions over 24 weeks. The comparison group was given dietary counselling once in 12 weeks. Both groups were followed up for additional 12 weeks to check for intervention effect sustenance. Anthropometric and biochemical parameters were measured at baseline, 12, 24 and 36 weeks; while dietary intake, physical activities, psychological measures and quality of life measured at baseline, 24 and 36 weeks. Data analysis was conducted using ANOVA repeated measures with intention to treat principle.The participants were predominantly women with mean (standard deviation) age of 40.5 (9.3) years. A total of 19.6% of the participants in GSLiM achieved 6% weight loss compared to 4.1% in the comparison group (Risk Ratio 4.75; 95% CI: 1.68, 13.45). At 24 weeks, the retention rate was 83.5% for GSLiM and 82.5% for comparison group. GSLiM participants also achieved significant improvement in total weight self-efficacy score, negative emotions and physical discomfort subscales, MDPSS friend subscale and all domains in quality of life. Participants in the comparison group experienced reduction in negative self-thoughts.The GSLiM programme proved to be more effective in achieving targeted weight loss, improving weight self-efficacy, friend social support, and quality of life compared to dietary counseling.Iranian Registry of Clinical Trials IRCT201104056127N1.
| S-EPMC4990415 | biostudies-other
Project description:OBJECTIVE:Diet and exercise (D+E) for knee osteoarthritis (OA) is effective and cost-effective. However, cost-effectiveness does not imply affordability; the impact of knee OA-specific D+E programs on insurer budgets is unknown. METHODS:We estimated changes in undiscounted medical expenditures (2016 US dollars) with and without a D+E program. We accounted for both additional program outlays and potential savings from reduced use of other knee OA treatments and from reduced incidence of comorbidities. We adopted the perspective of a representative commercial insurance plan covering 200 000 individuals aged 25 to 64 years and a representative Medicare Advantage plan covering 200 000 Medicare-eligible individuals aged 65 years and older. We used the Osteoarthritis Policy Model, a validated microsimulation model of knee OA, to model D+E efficacy (measured by pain and weight reduction), adherence, and price based on the Intensive Diet and Exercise for Arthritis (IDEA) trial. In sensitivity analyses, we varied time horizon, D+E efficacy, and D+E price. RESULTS:Over 3 years, the D+E program increased spending by $752 200 ($0.10 per member per month [PMPM]) in the commercial plan and by $6.0 million ($0.84 PMPM) in the Medicare plan. Over 3 years, the D+E program reduced opioid use by 6% and 5% and reduced total knee replacements by 5% and 4% in the commercial and Medicare plans, respectively. Expenses were higher in the Medicare plan because it had more patients with knee OA than the commercial plan. CONCLUSION:Although there is no established threshold to define affordability, a D+E program for knee OA would likely produce expenditures comparable with outlays for other health-promotion interventions.
| S-EPMC6957917 | biostudies-literature
Project description:The objective of this article was to conduct a treatment development study to examine the feasibility, acceptability, and preliminary efficacy of treating depressed, overweight/obese adolescents using both an exercise regimen and a Cognitive Behavioral Therapy (CBT) protocol modified to address aspects of healthy living and nutrition (CBT plus healthy lifestyle; CBT-HL). A randomized controlled repeated measures design was used to test the hypothesis that CBT-HL would lead to greater reductions in depressed mood and weight compared to CBT for Depression Only (CBT). Participants (n=33; 24 in CBT-HL condition) included 33 adolescents (median age 15, 73% female, 61% white, 36% Hispanic) who met DSM-IV criteria for Current Major Depressive Episode (MDE) and had BMI ? 85th percentile. CBT-HL was found to be feasible to implement with most adolescents. Both conditions resulted in improvement in depressed mood. The CBT-HL protocol was more effective in stabilizing weight status as assessed by BMI. Percent time spent in MVPA was increased at 12 weeks for adolescents in CBT-HL compared to those in CBT. The CBT-HL protocol was acceptable to most, but not all, adolescents, and resulted in an improvement in depressed mood as well as stabilization of weight status. A larger study to test efficacy and moderators of treatment outcome is necessary to better understand which adolescents would benefit most from the increased demands of exercise and adhering to nutrition recommendations in addition to standard CBT for depression. Revisions to the treatment protocol to support weight loss, not just stabilization, are also suggested.
| S-EPMC6204098 | biostudies-literature