Effectiveness of a telehealth-delivered clinician-supported exercise and weight loss program for hip osteoarthritis - protocol for the Better Hip randomised controlled trial.

BACKGROUND: Hip osteoarthritis (OA) is a leading cause of chronic pain and disability worldwide. Self-management is vital with education, exercise and weight loss core recommended treatments. However, evidence-practice gaps exist, and service models that increase patient accessibility to clinicians who can support lifestyle management are needed. The primary aim of this study is to determine the effectiveness of a telehealth-delivered clinician-supported exercise and weight loss program (Better Hip) on the primary outcomes of hip pain on walking and physical function at 6 months, compared with an information-only control for people with hip OA. METHODS: A two-arm, parallel-design, superiority pragmatic randomised controlled trial. 212 members from a health insurance fund aged 45 years and over, with painful hip OA will be recruited. Participants will be randomly allocated to receive: i) Better Hip; or ii) web-based information only (control). Participants randomised to the Better Hip program will have six videoconferencing physiotherapist consultations for education about OA, prescription of individualised home-based strengthening and physical activity programs, behaviour change support, and facilitation of other self-management strategies. Those with a body mass index > 27 kg/m2, aged < 80 years and no specific health conditions, will also be offered six videoconferencing dietitian consultations to undertake a weight loss program. Participants in the control group will be provided with similar educational information about managing hip OA via a custom website. All participants will be reassessed at 6 and 12 months. Primary outcomes are hip pain on walking and physical function. Secondary outcomes include measures of pain; hip function; weight; health-related quality of life; physical activity levels; global change in hip problem; willingness to undergo hip replacement surgery; rates of hip replacement; and use of oral pain medications. A health economic evaluation at 12 months will be conducted and reported separately. DISCUSSION: Findings will determine whether a telehealth-delivered clinician-supported lifestyle management program including education, exercise/physical activity and, for those with overweight or obesity, weight loss, is more effective than information only in people with hip OA. Results will inform the implementation of such programs to increase access to core recommended treatments. TRIAL REGISTRATION: Australia New Zealand Clinical Trials Registry (ACTRN12622000461796).

Net cost savings arising from patient completion of an active self-management program.

OBJECTIVE: The objective of this study is to investigate changes in willingness for total knee replacement (TKR) surgery following a randomised control trial (RCT) of an osteoarthritis management program, and to extrapolate orthopaedic cost consequences for private health insurers (PHI). METHODS: Willingness for surgery data from the RCT is analysed using a multinomial logistic regression model. A decision analytic model is used to conduct a break-even cost benefit analysis of the intervention from a PHI payer perspective. The analysis estimates the minimum probability of progression to surgery required for the intervention to be cost-neutral when considering savings limited to reduced orthopaedic costs. Cost data and orthopaedic pathway probabilities are sourced from payer data. RESULTS: At baseline, 39% of participants in the treatment and control group were willing for surgery. At 12 months, 16% of participants in the treatment group remained willing for surgery, versus 36% in the control group. Participants in the treatment group are 2.96 (95% CI: 1.01-8.66) times more likely than those in the control group to move from initially willing for surgery, to unsure or unwilling at 12 months. The analysis indicates that the intervention is likely to be cost saving when at least 60% of initially willing participants progress to surgery over a 5-year time horizon. CONCLUSION: Our study estimates that an education, exercise and weight loss intervention can deliver both improved participant outcomes and a return on investment to Australian PHIs through a reduction in TKR surgery incidence.

'The fact that I know I can do it is quite a motivator now': a qualitative study exploring experiences maintaining weight loss 6 months after completing a weight loss programme for knee osteoarthritis.

OBJECTIVE: To explore experiences maintaining weight loss 6 months after completing a multicomponent weight loss programme for knee osteoarthritis. DESIGN: Qualitative study based on an interpretivist paradigm and a phenomenological approach that was embedded within a randomised controlled trial. SETTING: Semistructured interviews were conducted with participants 6 months after completing a 6-month weight loss programme (ACTRN12618000930280) involving a ketogenic very low calorie diet (VLCD), exercise and physical activity programme, videoconferencing consultations with a dietitian and physiotherapist, and provision of educational and behaviour change resources and meal replacement products. Interviews were audio recorded, transcribed verbatim and data were analysed based on the principles of reflexive thematic analysis. PARTICIPANTS: 20 people with knee osteoarthritis. RESULTS: Three themes were developed: (1) successfully maintained weight loss; (2) empowering self-management of weight (understand importance of exercise; increased knowledge about food and nutrition; resources from programme still useful; knee pain as a motivator; confidence in ability to self-regulate weight) and (3) challenges keeping on track (loss of accountability to dietitian and study; old habits and social situations; stressful life events or changes in health). CONCLUSION: Participants had overall positive experiences maintaining their weight loss since completing the weight loss programme and were confident in their ability to self-regulate their weight in the future. Findings suggest a programme incorporating dietitian and physiotherapist consultations, a VLCD, and educational and behaviour change resources supports confidence maintaining weight loss in the medium term. Further research is required to explore strategies to overcome barriers like loss of accountability and returning to old eating habits.

How Does Exercise, With and Without Diet, Improve Pain and Function in Knee Osteoarthritis? A Secondary Analysis of a Randomized Controlled Trial Exploring Potential Mediators of Effects.

OBJECTIVE: To explore the mediators of effects of two 6-month telehealth-delivered exercise programs, including exercise with and without weight-loss diet, on pain and function improvements in knee osteoarthritis (OA). METHODS: Secondary analysis of 345 participants from a 3-arm randomized controlled trial of exercise (Exercise program) and exercise plus diet (Diet + Exercise program) versus information (Control program) was conducted. Outcomes were changes in pain (11-point numeric rating scale) and function (Western Ontario and McMaster Universities Osteoarthritis Index [score range 0-68]) at 12 months. Potential mediators were change at 6 months in attitudes toward self-management, fear of movement, arthritis self-efficacy, weight, physical activity, and willingness for knee surgery. For the Diet + Exercise program versus the Exercise program, only change in weight was evaluated. RESULTS: Possible mediators of the Exercise program versus the Control program included reduced fear of movement (accounting for -1.11 units [95% confidence interval (95% CI) -2.15, -0.07] improvement in function) and increased arthritis self-efficacy (-0.40 units [95% CI -0.75, -0.06] reduction in pain, -1.66 units [95% CI -3.04, -0.28] improvement in function). The Diet + Exercise program versus the Control program mediators included reduced fear of movement (-1.13 units [95% CI -2.17, -0.08] improvement in function), increased arthritis self-efficacy (-0.77 units [95% CI -1.26, -0.28] reduction in pain, -5.15 units [95% CI -7.34, -2.96] improvement in function), and weight loss (-1.20 units [95% CI -1.73, -0.68] reduction in pain, -5.79 units [95% CI -7.96, -3.63] improvement in function). Weight loss mediated the Diet + Exercise program versus the Exercise program (-0.89 units [95% CI -1.31, -0.47] reduction in pain, -4.02 units [95% CI -5.77, -2.26] improvement in function). CONCLUSION: Increased arthritis self-efficacy, reduced fear of movement, and weight loss may partially mediate telehealth-delivered exercise program effects, with and without diet, on pain and/or function in knee OA. Weight loss may partially mediate the effect of diet and exercise compared to exercise alone.

Cost-Effectiveness of Telehealth-Delivered Exercise and Dietary Weight Loss Programs for Knee Osteoarthritis Within a Twelve-Month Randomized Trial.

OBJECTIVE: To evaluate the cost-effectiveness of telehealth-delivered exercise and diet-plus-exercise programs within 12 months. METHODS: An economic evaluation within a 12-month, 3-arm, parallel randomized trial of two 6-month telehealth-delivered exercise programs, with and without a dietary component. A total of 415 people with knee osteoarthritis ages 45-80 years and body mass index of 28-40 kg/m2 were assigned to 1 of 2 telehealth-delivered exercise programs, 1 without (n = 172) and 1 with (n = 175) a dietary component (ketogenic very low calorie diet), or to an education control (n = 67), for 6 months, with 6 months follow-up. The primary economic outcomes were quality-adjusted life years (QALYs) and health system costs. Measured costs were the direct intervention (consultations, equipment/resources, and meal replacements) and health care use in 2020 Australian dollars ($AU1.5 = $US1). Secondary analysis included weight loss and work productivity gains. RESULTS: The clinical trial demonstrated greater improvements in pain and function compared to information only for individuals with knee osteoarthritis and overweight/obesity. We can be 88% confident that diet plus exercise is cost effective ($45,500 per QALY), 53% confident that exercise is cost-effective ($67,600 per QALY) compared to the control, and 86% confident that augmenting exercise with the diet program is cost effective ($21,100 per QALY). CONCLUSION: Telehealth-delivered programs targeting exercise with dietary intervention for people with knee osteoarthritis who have overweight/obesity are likely to be cost-effective, particularly if potential long-term gains from weight loss and work productivity are realized.

Comparing Video-Based, Telehealth-Delivered Exercise and Weight Loss Programs With Online Education on Outcomes of Knee Osteoarthritis : A Randomized Trial.

BACKGROUND: Scalable knee osteoarthritis programs are needed to deliver recommended education, exercise, and weight loss interventions. OBJECTIVE: To evaluate two 6-month, telehealth-delivered exercise programs, 1 with and 1 without dietary intervention. DESIGN: 3-group, parallel randomized (5:5:2) trial. (Australian New Zealand Clinical Trials Registry: ACTRN12618000930280). SETTING: Australian private health insurance members. PARTICIPANTS: 415 persons with symptomatic knee osteoarthritis and a body mass index between 28 and 40 kg/m2 who were aged 45 to 80 years. INTERVENTION: All groups received access to electronic osteoarthritis information (control). The exercise program comprised 6 physiotherapist consultations via videoconference for exercise, self-management advice, and behavioral counseling, plus exercise equipment and resources. The diet and exercise program included an additional 6 dietitian consultations for a ketogenic very-low-calorie diet (2 formulated meal replacements and a low-carbohydrate meal daily) followed by a transition to healthy eating, as well as nutrition and behavioral resources. MEASUREMENTS: Primary outcomes were changes in knee pain (numerical rating scale [NRS] of 0 to 10, higher indicating worse) and physical function (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]; scale, 0 to 68, higher indicating worse) at 6 months (primary time point) and 12 months. Secondary outcomes were weight, physical activity, quality of life, mental health, global change, satisfaction, willingness to have surgery, orthopedic appointments, and knee surgery. RESULTS: A total of 379 participants (91%) provided 6-month primary outcomes, and 372 (90%) provided 12-month primary outcomes. At 6 months, both programs were superior to control for pain (between-group mean difference in change on NRS: diet and exercise, -1.5 [95% CI, -2.1 to -0.8]; exercise, -0.8 [CI, -1.5 to -0.2]) and function (between-group mean difference in change on WOMAC: diet and exercise, -9.8 [CI, -12.5 to -7.0]; exercise, -7.0 [CI, -9.7 to -4.2]). The diet and exercise program was superior to exercise (pain, -0.6 [CI, -1.1 to -0.2]; function, -2.8 [CI, -4.7 to -0.8]). Findings were similar at 12 months. LIMITATION: Participants and clinicians were unblinded. CONCLUSION: Telehealth-delivered exercise and diet programs improved pain and function in people with knee osteoarthritis and overweight or obesity. A dietary intervention conferred modest additional pain and function benefits over exercise. PRIMARY FUNDING SOURCE: Medibank, the Medibank Better Health Foundation Research Fund, and a National Health and Medical Research Council Centre of Research Excellence.

Private health insurance reforms: impact of the psychiatric care waiting period exemption policy.

Younger people are more likely to experience incident mental health conditions and hold lower levels of private health insurance coverage. Government reforms introduced in 2018 enabled customers to avoid 2-month waiting periods to access mental health hospital care. Effectiveness in reducing time to admission is assessed.

Better Knee, Better Me™: effectiveness of two scalable health care interventions supporting self-management for knee osteoarthritis - protocol for a randomized controlled trial.

BACKGROUND: Although education, exercise, and weight loss are recommended for management of knee osteoarthritis, the additional benefits of incorporating weight loss strategies into exercise interventions have not been well investigated. The aim of this study is to compare, in a private health insurance setting, the clinical- and cost-effectiveness of a remotely-delivered, evidence- and theory-informed, behaviour change intervention targeting exercise and self-management (Exercise intervention), with the same intervention plus active weight management (Exercise plus weight management intervention), and with an information-only control group for people with knee osteoarthritis who are overweight or obese. METHODS: Three-arm, pragmatic parallel-design randomised controlled trial involving 415 people aged ≥45 and ≤ 80 years, with body mass index ≥28 kg/m2 and < 41 kg/m2 and painful knee osteoarthritis. Recruitment is Australia-wide amongst Medibank private health insurance members. All three groups receive access to a bespoke website containing information about osteoarthritis and self-management. Participants in the Exercise group also receive six consultations with a physiotherapist via videoconferencing over 6 months, including prescription of a strengthening exercise and physical activity program, advice about management, and additional educational resources. The Exercise plus weight management group receive six consultations with a dietitian via videoconferencing over 6 months, which include a very low calorie ketogenic diet with meal replacements and resources to support behaviour change, in addition to the interventions of the Exercise group. Outcomes are measured at baseline, 6 and 12 months. Primary outcomes are self-reported knee pain and physical function at 6 months. Secondary outcomes include weight, physical activity levels, quality of life, global rating of change, satisfaction with care, knee surgery and/or appointments with an orthopaedic surgeon, and willingness to undergo surgery. Additional measures include adherence, adverse events, self-efficacy, and perceived usefulness of intervention components. Cost-effectiveness of each intervention will also be assessed. DISCUSSION: This pragmatic study will determine whether a scalable remotely-delivered service combining weight management with exercise is more effective than a service with exercise alone, and with both compared to an information-only control group. Findings will inform development and implementation of future remotely-delivered services for people with knee osteoarthritis. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN12618000930280 (01/06/2018).

Predictors of inpatient rehabilitation after total knee replacement: an analysis of private hospital claims data.

OBJECTIVE: To investigate inpatient rehabilitation rates after private total knee replacements (TKRs) in Australia since 2009; to quantify the contributions of hospital-, surgeon- and patient-related factors to predicting inpatient rehabilitation. DESIGN: Retrospective cohort study; multivariate linear regression analysis of linked, de-identified Medibank administrative claims data and hospital casemix protocol data, adjusted for patient-related characteristics. Setting, participants: 35 389 patients undergoing Medibank-funded TKRs in 170 private hospitals in Australia, 2009-2016. MAIN OUTCOME MEASURES: Hospital inpatient rehabilitation rate; relative contributions of patient- and provider-related characteristics to variation in inpatient rehabilitation rates. RESULTS: The overall inpatient rehabilitation rate increased from 31% in 2009 to 45% in 2016, but varied between hospitals (range, 0-100%). The reduction in mean acute length of stay during this period explained about 15% of this increase, and about 30% was explained by patient-related factors; more than half of the increase was explained by neither reduced length of stay or patient-related factors. Patient-related characteristics explained little of the variation in rates between hospitals. Rates at 27% of hospitals lay above the 95% confidence limit for the mean inpatient rehabilitation rate in private hospitals (38%), both before and after adjusting for patient-related factors. Provider characteristics explained three times as much of the variation as patient characteristics (75% v 25%); hospital-related factors made the largest contribution to variation (47%). CONCLUSION: Inpatient rehabilitation after TKR has increased in private health care during the past 8 years. Substantial variation in inpatient rehabilitation rates is not explained by patient-related factors, suggesting that some inpatient rehabilitation is low value care.

The impact of a tax on sugar-sweetened beverages according to socio-economic position: a systematic review of the evidence.

OBJECTIVE: A tax on sugar-sweetened beverages (SSB) has been proposed to address population weight gain but the effect across socio-economic position (SEP) is unclear. The current study aimed to clarify the differential impact(s) of SSB taxes on beverage purchases and consumption, weight outcomes and the amount paid in SSB taxes according to SEP. DESIGN: Databases (OVID and EMBASE) and grey literature were systematically searched in June 2015 to identify studies that examined effects of an SSB price increase on beverage purchases or consumption, weight outcomes or the amount paid in tax across SEP, within high-income countries. RESULTS: Of the eleven included articles, three study types were identified: (i) those that examined the association between variation in SSB taxes and SSB consumption and/or body weight (n 3); (ii) price elasticity estimation of SSB demand (n 1); and (iii) modelling of hypothetical SSB taxes by combining price elasticity estimates with population SEP-specific beverage consumption, energy intake or body weight (n 7). Few studies statistically tested differences in outcomes between SEP groups. Nevertheless, of the seven studies that reported on changes in weight outcomes for the total population following an increase in SSB price, all reported either similar reductions in weight across SEP groups or greater reductions for lower compared with higher SEP groups. All studies that examined the average household amount paid in tax (n 5) reported that an SSB tax would be regressive, but with small differences between higher- and lower-income households (0·10-1·0 % and 0·03 %-0·60 % of annual household income paid in SSB tax for low- and high-income households, respectively). CONCLUSIONS: Based on the available evidence, a tax on SSB will deliver similar population weight benefits across socio-economic strata or greater benefits for lower SEP groups. An SSB tax is shown to be consistently financially regressive, but to a small degree.

Health-care costs over 15 years after bariatric surgery for patients with different baseline glucose status: results from the Swedish Obese Subjects study.

BACKGROUND: Bariatric surgery prevents and induces remission of type 2 diabetes in many patients. The effect of preoperative glucose status on long-term health-care costs is unknown. We aimed to assess health-care costs over 15 years for patients with obesity treated conventionally or with bariatric surgery and who had either euglycaemia, prediabetes, or type 2 diabetes before intervention. METHODS: The Swedish Obese Subjects (SOS) study is a prospective study of adults who had bariatric surgery and contemporaneously matched controls who were treated conventionally (age 37-60 years; BMI of ≥34 in men and ≥38 in women) recruited from 25 Swedish surgical departments and 480 primary health-care centres. Exclusion criteria were identical for both study groups, and were previous gastric or bariatric surgery, recent malignancy or myocardial infarction, selected psychiatric disorders, and other contraindicating disorders to bariatric surgery. Conventional treatment ranged from no treatment to lifestyle intervention and behaviour modification. In this study, we retrieved prescription drug costs for the patients in the SOS study via questionnaires and the nationwide Swedish Prescribed Drug Register. We retrieved data for inpatient and outpatient visits from the Swedish National Patient Register. We followed up the sample linked to register data for up to 15 years. We adjusted mean differences for baseline characteristics. Analyses were by intention to treat. The SOS study is registered with ClinicalTrials.gov, number NCT01479452. FINDINGS: Between Sept 1, 1987, and Jan 31, 2001, 2010 adults who had bariatric surgery and 2037 who were treated conventionally were enrolled into the SOS study. In this study, we followed up 4030 patients (2836 who were euglycaemic; 591 who had prediabetes; 603 who had diabetes). Drug costs did not differ between the surgery and conventional treatment groups in the euglycaemic subgroup (surgery US$10,511 vs conventional treatment $10,680; adjusted mean difference -$225 [95% CI -2080 to 1631]; p=0·812), but were lower in the surgery group in the prediabetes ($10,194 vs $13,186; -$3329 [-5722 to -937]; p=0·007) and diabetes ($14,346 vs $19,511; -$5487 [-7925 to -3049]; p<0·0001) subgroups than in the conventional treatment group. Compared with the conventional treatment group, we noted greater inpatient costs in the surgery group for the euglycaemic ($51,225 vs $25,313; $22,931 [19,001-26,861]; p<0·0001), prediabetes ($58,699 vs $32,861; $27,152 [18,736-35,568]; p<0·0001), and diabetes ($61,569 vs $47,569; 18,697 [9992-27,402]; p<0·0001) subgroups. We noted no differences in outpatient costs. Total health-care costs were higher in the surgery group in the euglycaemic ($71,059 vs $45,542; $22,390 [17,358-27,423]; p<0·0001) and prediabetes ($78,151 vs $54,864; $26,292 [16,738-35,845]; p<0·0001) subgroups than in the conventional treatment group, whereas we detected no difference between treatment groups in patients with diabetes ($88,572 vs $79,967; $9081 [-1419 to 19,581]; p=0·090). INTERPRETATION: Total health-care costs were higher for patients with euglycaemia or prediabetes in the surgery group than in the conventional treatment group, but we detected no difference between the surgery and conventional treatment groups for patients with diabetes. Long-term health-care cost results support prioritisation of patients with obesity and type 2 diabetes for bariatric surgery. FUNDING: AFA Försäkring and Swedish Scientific Research Council.

Reducing duplicate testing: a comparison of two clinical decision support tools.

OBJECTIVES: Unnecessary duplicate laboratory testing is common and costly. Systems-based means to avert unnecessary testing should be investigated and employed. METHODS: We compared the effectiveness and cost savings associated with two clinical decision support tools to stop duplicate testing. The Hard Stop required telephone contact with the laboratory and justification to have the duplicate test performed, whereas the Smart Alert allowed the provider to bypass the alert at the point of order entry without justification. RESULTS: The Hard Stop alert was significantly more effective than the Smart Alert (92.3% vs 42.6%, respectively; P < .0001). The cost savings realized per alert activation was $16.08/alert for the Hard Stop alert vs $3.52/alert for the Smart Alert. CONCLUSIONS: Structural and process changes that require laboratory contact and justification for duplicate testing are more effective than interventions that allow providers to bypass alerts without justification at point of computerized physician order entry.

Prevalence of class-I, class-II and class-III obesity in Australian adults between 1995 and 2011-12.

OBJECTIVE: To compare the prevalence of class-I, II and III obesity in Australian adults between 1995, 2007-08 and 2011-12. METHODS: Prevalence data for adults (aged 18+ years) were sourced from customised data from the nationally representative National Nutrition Survey (1995), the National Health Survey (2007-08), and the Australian Health Survey (2011-12) conducted by the Australian Bureau of Statistics. Obesity classifications were based on measured height and weight (class-I body mass index: 30.0-34.9 kg/m(2), class-II: 35.0-39.9 kg/m(2) and class-III: ≥ 40.0 kg/m(2)). Severe obesity was defined as class-II or class-III obesity. RESULTS: Between 1995 and 2011-12, the prevalence of obesity (all classes combined) increased from 19.1% to 27.2%. During this 17 year period, relative increases in class I, II and III obesity were 1.3, 1.7 and 2.2-fold respectively. In 2011-12, the prevalence of class I, II and III obesity was 19.4, 5.9 and 2.0 per cent respectively in men, and 16.1, 6.9 and 4.2 per cent respectively in women. One in every ten people was severely obese, increasing from one in twenty in 1995, and women were disproportionally represented in this population. Obesity prevalence increased with increasing levels of area-level socioeconomic disadvantage, particularly for the more severely obese classes. Severe obesity affected 6.2% and 13.4% in the least and most disadvantaged quintiles respectively. CONCLUSION: Over the last two decades, there have been substantial increases in the prevalence of obesity, particularly the more severe levels of obesity. This study highlights high risk groups who warrant targeted weight gain prevention interventions.

Cost-effectiveness of whole-of-community obesity prevention programs: an overview of the evidence.

Whole-of-community obesity prevention programs that impact on multiple players and promote community capacity show promise as an important strategy in the fight against global obesity. This paper reviews the economic evaluation literature of multifaceted, community based obesity prevention programs. There are few cost effectiveness studies. Whilst results to date are encouraging, there is considerable uncertainty surrounding the long term results given the lack of evidence regarding sustainability of program effect and a consequent reliance on economic modeling to fill the gaps. More empirical studies of longer duration are needed to demonstrate the longer term effectiveness and cost effectiveness of these programs, and to facilitate identification of the elements necessary for their sustainability.

Trends in child and adolescent obesity prevalence according to socioeconomic position: protocol for a systematic review.

BACKGROUND: Obesity is a significant public health issue and is socially patterned, with greater prevalence of obesity observed in the most socioeconomically disadvantaged groups. Recent evidence suggests that the prevalence of childhood obesity is levelling off in some countries. However, this may not be the case across all socioeconomic strata. The aim of this review is to examine whether trends in child and adolescent obesity prevalence since 1990 differ according to socioeconomic position in developed countries. METHODS: An electronic search will be conducted via Ovid Medline, Embase, Cumulative Index to Nursing and Allied Health Literature, Scopus and Cochrane Collaboration to identify articles that report trends in obesity prevalence in children and adolescents according to socioeconomic position. We will also search grey literature databases including the Virtual Library for Public Health and the System for Information on Grey Literature, as well as websites from relevant organisations. Articles that report on a series of cross sectional studies; describe one or more measure of obesity with data recorded at two or more time points since 1990; and report trends by at least one indicator of socioeconomic position will be included. Quality of included studies will be evaluated according to criteria that consider both internal and external validity. Descriptive analysis will be performed to examine trends since 1990 in childhood obesity prevalence according to socioeconomic position. DISCUSSION: The review will provide a picture of change over time in developed countries of childhood obesity prevalence across socioeconomic strata and identify whether changes in childhood obesity prevalence are experienced equally across socioeconomic groups. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42014007625.

Effectiveness and implementation of an obesity prevention intervention: the HeLP-her Rural cluster randomised controlled trial.

BACKGROUND: To impact on the obesity epidemic, interventions that prevent weight gain across populations are urgently needed. However, even the most efficacious interventions will have little impact on obesity prevention unless they are successfully implemented in diverse populations and settings. Implementation research takes isolated efficacy studies into practice and policy and is particularly important in obesity prevention where there is an urgent need to accelerate the evidence to practice cycle. Despite the recognised need, few obesity prevention interventions have been implemented in real life settings and to our knowledge rarely target rural communities. METHODS: Here we describe the rationale, design and implementation of a Healthy Lifestyle Program for women living in small rural communities (HeLP-her Rural). The primary goal of HeLP-her Rural is to prevent weight gain using a low intensity, self-management intervention. Six hundred women from 42 small rural communities in Australia will be randomised as clusters (n-21 control towns and n = 21 intervention towns). A pragmatic randomised controlled trial methodology will test efficacy and a comprehensive mixed methods community evaluation and cost analysis will inform effectiveness and implementation of this novel prevention program. DISCUSSION: Implementing population interventions to prevent obesity is complex, costly and challenging. To address these barriers, evidence based interventions need to move beyond isolated efficacy trials and report outcomes related to effectiveness and implementation. Large pragmatic trials provide an opportunity to inform both effectiveness and implementation leading to potential for greater impact at the population level. Pragmatic trials should incorporate both effectiveness and implementation outcomes and a multidimensional methodology to inform scale-up to population level. The learnings from this trial will impact on the design and implementation of population obesity prevention strategies nationally and internationally. TRIAL REGISTRATION: ANZ clinical trial registry ACTRN12612000115831. Date of registration 24/01/2012.