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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.

ABSTRACT: INTRODUCTION:Knee osteoarthritis (OA) is one of the most common chronic diseases worldwide and is associated with significant pain and disability. Clinical practice guidelines consistently recommend weight management as a core aspect of care for overweight and obese patients with knee OA; however, provision of such care is suboptimal. Telephone-based interventions offer a novel approach to delivery of weight management care in these patients. The aim of the proposed study is to assess the effectiveness of referral to a telephone-based weight management and healthy lifestyle programme, previously shown to be effective in changing weight, in improving knee pain intensity in overweight or obese patients with knee OA, compared to usual care. METHODS AND ANALYSIS:A parallel, randomised controlled trial will be undertaken. Patients with OA of the knee who are waiting for an outpatient orthopaedic consultation at a tertiary referral public hospital within New South Wales, Australia, will be allocated to either an intervention or a control group (1:1 ratio). After baseline data collection, patients in the intervention group will receive a 6-month telephone-based intervention, and patients in the control group will continue with usual care. Surveys will be conducted at baseline, 6 and 26 weeks post-randomisation. The study requires 60 participants per group to detect a two-point difference in pain intensity (primary outcome) 26 weeks after baseline. ETHICS AND DISSEMINATION:The study is approved by the Hunter New England Health Human Research Ethics Committee (13/12/11/5.18) and the University of Newcastle Human Research Ethics Committee (H-2015-0043). The results will be disseminated in peer-reviewed journals and at scientific conferences. TRIAL REGISTRATION NUMBER:ACTRN12615000490572, Pre-results.

SUBMITTER: O'Brien KM

PROVIDER: S-EPMC4785282 | biostudies-other | 2016 Mar

REPOSITORIES: biostudies-other

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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.

O'Brien Kate M KM Wiggers John J Williams Amanda A Campbell Elizabeth E Wolfenden Luke L Yoong Serene S Robson Emma K EK McAuley James J Haskins Robin R Kamper Steven J SJ Williams Christopher C

BMJ open 20160303 3

<h4>Introduction</h4>Knee osteoarthritis (OA) is one of the most common chronic diseases worldwide and is associated with significant pain and disability. Clinical practice guidelines consistently recommend weight management as a core aspect of care for overweight and obese patients with knee OA; however, provision of such care is suboptimal. Telephone-based interventions offer a novel approach to delivery of weight management care in these patients. The aim of the proposed study is to assess th ...[more]

PMID: 26940110

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Project description:BackgroundThere 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 designThe 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.DiscussionThe 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 registrationThe protocol for this study is registered with the Australian Clinical Trials Registry (ACTRNO12606000175572).

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.

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.

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.

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.

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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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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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