Patients', physiotherapists' and other stakeholders' experiences and perceptions about supported home physiotherapy for people with musculoskeletal conditions: a qualitative study.

OBJECTIVES: Exercise, support and advice are the key treatment strategies of musculoskeletal problems. The aims of this study were to determine patients', physiotherapists', and other stakeholders' perspectives about supported home physiotherapy for the management of musculoskeletal problems and to identify the barriers and facilitators to rolling out this model of physiotherapy service delivery. METHODS: This study was conducted as part of a process evaluation run alongside a large trial designed to determine whether supported home physiotherapy is as good or better than a course of in-person physiotherapy. Forty interviews were conducted with 20 trial participants, 15 physiotherapists, and 5 other stakeholders. The interviews were semi-structured and based on interview guides. Each interview was transcribed and a three-tiered coding tree was developed. RESULTS: Six key themes were identified. Supported home physiotherapy (i) is convenient for some patients, (ii) does not always align with patients' and therapists' expectations about treatment (iii) is suitable for some but not all, (iv) can reduce personal connection and accountability, (v) has implications for physiotherapists' workloads, and (vi) has barriers and facilitators to future implementation. CONCLUSIONS: Findings suggest that patients are far more accepting of supported home physiotherapy than physiotherapists assume. This model of service delivery could be rolled out to improve access to physiotherapy and to provide a convenient and effective way of delivering physiotherapy to some patients with musculoskeletal conditions if our trial results indicate that supported home physiotherapy is as good or better than in-person physiotherapy. CLINICAL TRIAL REGISTRY NUMBER: ACTRN12619000065190 CONTRIBUTIONS OF THIS PAPER.

Remotely delivered physiotherapy is as effective as face-to-face physiotherapy for musculoskeletal conditions (REFORM): a randomised trial.

QUESTION: Is remotely delivered physiotherapy as good or better than face-to-face physiotherapy for the management of musculoskeletal conditions? DESIGN: Randomised controlled, non-inferiority trial with concealed allocation, blinded assessors and intention-to-treat analysis. PARTICIPANTS: A total of 210 adult participants with a musculoskeletal condition who presented for outpatient physiotherapy at five public hospitals in Sydney. INTERVENTION: One group received a remotely delivered physiotherapy program for 6 weeks that consisted of one face-to-face physiotherapy session in conjunction with weekly text messages, phone calls at 2 and 4 weeks, and an individualised home exercise program delivered through an app. The other group received usual face-to-face physiotherapy care in an outpatient setting. OUTCOME MEASURES: The primary outcome was the Patient Specific Functional Scale at 6 weeks with a pre-specified non-inferiority margin of -15 out of 100 points. Secondary outcomes included: the Patient Specific Functional Scale at 26 weeks; kinesiophobia, pain, function/disability, global impression of change and quality of life at 6 and 26 weeks; and satisfaction with service delivery at 6 weeks. RESULTS: The mean between-group difference (95% CI) for the Patient Specific Functional Scale at 6 weeks was 2.7 out of 100 points (-3.5 to 8.8), where a positive score favoured remotely delivered physiotherapy. The lower end of the 95% CI was greater than the non-inferiority margin. Whilst non-inferiority margins were not set for the secondary outcomes, the 95% CI of the mean between-group difference ruled out clinically meaningful differences. CONCLUSION: Remotely delivered physiotherapy with support via phone, text and an app is as good as face-to-face physiotherapy for the management of musculoskeletal conditions. TRIAL REGISTRATION: ACTRN12619000065190.

Economic evaluation of a mobile phone text-message intervention for Australian adults with type 2 diabetes.

Background: The rising prevalence of type 2 diabetes in Australia is a public health concern, contributing to significant disease burden and economic costs. Text-message programs have been shown to improve health outcomes for people with type 2 diabetes, however they remain underutilized, and no evidence exists on their cost-effectiveness or costs of scale up to a population level in Australia. This study aimed to determine the cost-effectiveness and cost-utility of a 6-month text-message intervention (DTEXT) to improve glycated hemoglobin (HbA1c) and self-management behaviors for Australian adults with type 2 diabetes. Methods: A within-trial economic evaluation was conducted on the DTEXT randomized controlled trial. Incremental cost-effectiveness ratios (ICERs) were determined per 11 mmol/mol (1%) reduced HbA1c and per quality adjusted life year (QALY) gained, compared to usual care. Cost-effectiveness acceptability curves (CEAC) determined the probability of the intervention being cost-effective over a range of willingness to pay thresholds. A scenario analysis was conducted to determine how cost-effectiveness was impacted by using current implementation costs. Results: The DTEXT intervention cost AU$36 (INT$24) per participant, with an ICER of AU$311 (INT$211) per 11 mmol/mol (1%) reduced HbA1c. Based on HbA1c outcomes, DTEXT had a 33% probability of being effective and cost-saving. Based on the QALY outcomes, the intervention had only a 24% probability of being cost-effective. Scenario analysis indicated costs per participant of AU$13 (INT$9) to deliver the intervention, with a reduced incremental cost effectiveness ratio of AU$151 (INT$103) per 11 mmol/mol (1%) reduced HbA1c and a 38% probability of being effective and cost-saving. Conclusions: DTEXT was low cost and potentially scalable, but only had a low to moderate probability of being effective and cost saving. Further research should determine more targeted approaches that may improve cost-effectiveness. Trial Registration: ACTRN12617000416392.

Protocol for a process evaluation: face-to-face physiotherapy compared with a supported home exercise programme for the management of musculoskeletal conditions: the REFORM trial.

INTRODUCTION: The REFORM (REhabilitation FOR Musculoskeletal conditions) trial is a non-inferiority randomised controlled trial (n=210) designed to determine whether a supported home exercise programme is as good or better than a course of face-to-face physiotherapy for the management of some musculoskeletal conditions. The trial is currently being conducted across Sydney government hospitals in Australia. This process evaluation will run alongside the REFORM trial. It combines qualitative and quantitative data to help explain the trial results and determine the feasibility of rolling out supported home exercise programmes in settings similar to the REFORM trial. METHODS AND ANALYSIS: Two theoretical frameworks underpin our process evaluation methodology: the Realist framework (context, mechanism, outcomes) considers the causal assumptions as to why a supported home exercise programme may be as good or better than face-to-face physiotherapy in terms of the context, mechanisms and outcomes of the trial. The RE-AIM framework describes the Reach, Effectiveness, Adoption, Implementation and Maintenance of the intervention. These two frameworks will be broadly used to guide this process evaluation using a mixed-methods approach. For example, qualitative data will be derived from interviews with patients, healthcare professionals and stakeholders, and quantitative data will be collected to determine the cost and feasibility of providing supported home exercise programmes. These data will be analysed iteratively before the analysis of the trial results and will be triangulated with the results of the primary and secondary outcomes. ETHICS AND DISSEMINATION: This trial will be conducted in accordance with the National Health and Medical Research Council National Statement on Ethical Conduct in Human Research (2018) and the Note for Good Clinical Practice (CPMP/ICH-135/95). Ethical approval was obtained on 17 March 2017 from the Northern Sydney Local Health District Human Research Ethics Committee (trial number: HREC/16HAWKE/431-RESP/16/287) with an amendment for the process evaluation approved on 4 February 2020. The results of the process evaluation will be disseminated through publications in peer-reviewed journals and presentations at scientific conferences. TRIAL REGISTRATION NUMBER: ACTRN12619000065190.

Unpacking the behavioural components and delivery features of early childhood obesity prevention interventions in the TOPCHILD Collaboration: a systematic review and intervention coding protocol.

INTRODUCTION: Little is known about how early (eg, commencing antenatally or in the first 12 months after birth) obesity prevention interventions seek to change behaviour and which components are or are not effective. This study aims to (1) characterise early obesity prevention interventions in terms of target behaviours, delivery features and behaviour change techniques (BCTs), (2) explore similarities and differences in BCTs used to target behaviours and (3) explore effectiveness of intervention components in preventing childhood obesity. METHODS AND ANALYSIS: Annual comprehensive systematic searches will be performed in Epub Ahead of Print/MEDLINE, Embase, Cochrane (CENTRAL), CINAHL, PsycINFO, as well as clinical trial registries. Eligible randomised controlled trials of behavioural interventions to prevent childhood obesity commencing antenatally or in the first year after birth will be invited to join the Transforming Obesity in CHILDren Collaboration. Standard ontologies will be used to code target behaviours, delivery features and BCTs in both published and unpublished intervention materials provided by trialists. Narrative syntheses will be performed to summarise intervention components and compare applied BCTs by types of target behaviours. Exploratory analyses will be undertaken to assess effectiveness of intervention components. ETHICS AND DISSEMINATION: The study has been approved by The University of Sydney Human Research Ethics Committee (project no. 2020/273) and Flinders University Social and Behavioural Research Ethics Committee (project no. HREC CIA2133-1). The study's findings will be disseminated through peer-reviewed publications, conference presentations and targeted communication with key stakeholders. PROSPERO REGISTRATION NUMBER: CRD42020177408.

Transforming Obesity Prevention for CHILDren (TOPCHILD) Collaboration: protocol for a systematic review with individual participant data meta-analysis of behavioural interventions for the prevention of early childhood obesity.

INTRODUCTION: Behavioural interventions in early life appear to show some effect in reducing childhood overweight and obesity. However, uncertainty remains regarding their overall effectiveness, and whether effectiveness differs among key subgroups. These evidence gaps have prompted an increase in very early childhood obesity prevention trials worldwide. Combining the individual participant data (IPD) from these trials will enhance statistical power to determine overall effectiveness and enable examination of individual and trial-level subgroups. We present a protocol for a systematic review with IPD meta-analysis to evaluate the effectiveness of obesity prevention interventions commencing antenatally or in the first year after birth, and to explore whether there are differential effects among key subgroups. METHODS AND ANALYSIS: Systematic searches of Medline, Embase, Cochrane Central Register of Controlled Trials, Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycInfo and trial registries for all ongoing and completed randomised controlled trials evaluating behavioural interventions for the prevention of early childhood obesity have been completed up to March 2021 and will be updated annually to include additional trials. Eligible trialists will be asked to share their IPD; if unavailable, aggregate data will be used where possible. An IPD meta-analysis and a nested prospective meta-analysis will be performed using methodologies recommended by the Cochrane Collaboration. The primary outcome will be body mass index z-score at age 24±6 months using WHO Growth Standards, and effect differences will be explored among prespecified individual and trial-level subgroups. Secondary outcomes include other child weight-related measures, infant feeding, dietary intake, physical activity, sedentary behaviours, sleep, parenting measures and adverse events. ETHICS AND DISSEMINATION: Approved by The University of Sydney Human Research Ethics Committee (2020/273) and Flinders University Social and Behavioural Research Ethics Committee (HREC CIA2133-1). Results will be relevant to clinicians, child health services, researchers, policy-makers and families, and will be disseminated via publications, presentations and media releases. PROSPERO REGISTRATION NUMBER: CRD42020177408.

Effects of telephone support or short message service on body mass index, eating and screen time behaviours of children age 2 years: A 3-arm randomized controlled trial.

BACKGROUND: Few randomized controlled trial (RCT) interventions targeted children's early risk behaviours using telephone or short message service (SMS) support. OBJECTIVE: To evaluate the effectiveness of telephone or SMS early intervention focusing on mothers' behaviours starting from late pregnancy to improve BMI, and eating and screen time behaviours of children aged 2 years in comparison with the control group. METHODS: A 3-arm RCT was conducted in Australia, 2017-2019. Two arms involved the interventions using nurse-led telephone or SMS support, delivered in nine stages from late pregnancy to age 2 years. The third arm was control. The primary outcome was children's objectively measured BMI and BMI z-score at 2 years. Secondary outcomes included child eating and screen time behaviours as reported by parents at 2 years. RESULTS: At 2 years, 797 mother-child dyads (69%) completed the telephone survey with 666 (58%) completing weight and height measurements. The study found no statistically significant difference in BMI between the groups. The mean BMI for telephone support was 16.93 (95% CI: 16.73 to 17.13), for SMS 16.92 (95% CI: 16.73 to 17.11) or for control 16.95 (95% CI: 16.73 to 17.16) with a difference of -0.02 (95% CI: -0.31 to 0.27, p = 0.907) in telephone versus control, and a difference of -0.03 (95% CI: -0.30 to 0.24, p = 0.816) in SMS versus control. Telephone support was associated with higher odds of no bottle at bedtime (adjusted odds ratio [AOR]: 2.99; 95% CI: 2.01 to 4.47), family meals (AOR: 2.05; 95% CI: 1.26 to 3.33), drinking from a cup (AOR: 1.89; 95% CI: 1.24 to 2.88), less screen time (<1 h/day) (AOR: 1.56; 95% CI: 1.10 to 2.23) and not eating dinner in front of the TV (AOR: 1.50; 95% CI: 1.09 to 2.06). SMS support was also associated with higher odds of no bottle at bedtime (AOR 2.30, 95% CI: 1.58 to 3.33) than the control. CONCLUSION: The telephone or SMS support intervention had no significant effects on BMI, but was effective in increasing no bottle use at bedtime. Telephone support showed more effects than SMS on reducing screen time and eating behaviours.

Face-to-face physiotherapy compared with a supported home exercise programme for the management of musculoskeletal conditions: protocol of a multicentre, randomised controlled trial-the REFORM trial.

INTRODUCTION: Exercise, support and advice are considered core components of management for most musculoskeletal conditions and are typically provided by physiotherapists through regular face-to-face treatments. However, exercise can be provided remotely as part of a home exercise programme, while support and advice can be provided over the telephone. There is initial evidence from trials and systematic reviews to suggest that remotely provided physiotherapy can be used to manage a variety of musculoskeletal conditions safely and effectively. METHODS AND ANALYSIS: The aim of this single-blind randomised controlled non-inferiority trial is to determine whether a supported home exercise programme is as good as or better than face-to-face physiotherapy for the treatment of musculoskeletal conditions. Two hundred and ten participants will be recruited from five public hospitals in Sydney, Australia. Participants will be randomised to either the supported home exercise group or the face-to-face physiotherapy group. Participants allocated to the supported home exercise group will initially receive one face-to-face session with the trial physiotherapist and will then be managed remotely for the next 6 weeks. Participants allocated to the face-to-face physiotherapy group will receive a course of physiotherapy as typically provided in Sydney government hospitals. The primary outcome is function measured by the Patient Specific Functional Scale at 6 weeks. There will be nine secondary outcomes measured at 6 and 26 weeks. Separate analyses will be conducted on each outcome, and all analyses will be conducted on an intention-to-treat basis. A health economic evaluation will be conducted from a health funder plus patient perspective. ETHICS AND DISSEMINATION: Ethical approval was obtained on the 17 March 2017 from the Northern Sydney Local Health District HREC, trial number HREC/16HAWKE/431-RESP/16/287. The results of this study will be submitted for publication to peer-reviewed journals and be presented at national and international conferences. Recruitment commenced in March 2019, and it is anticipated that the trial will be completed by December 2021. This trial will investigate two different models of physiotherapy care for people with musculoskeletal conditions. TRIAL REGISTRATION NUMBER: CPMP/ICH-135/95. PROTOCOL VERSION: The most recent version of the protocol is V.1.2 dated November 2019.

Looking backwards and forwards: tracking and persistence of weight status between early childhood and adolescence.

BACKGROUND/OBJECTIVE: Many studies have shown that child BMI or weight status tracks over time, but the demographic predictors of high tracking have not been investigated. Our objective was to identify demographic predictors of persistence (duration) of healthy weight and overweight/obesity throughout childhood, and to examine whether tracking was age dependent. METHODS: We conducted secondary data analysis of 4606 children from the Birth cohort and 4983 children from the Kindergarten cohort of the Longitudinal Study of Australian Children with follow-up to age 12/13 and 16/17 years, respectively. Retrospective and prospective tracking were examined descriptively. Time-to-event analysis determined demographic predictors of persistence of healthy weight and overweight/obesity beyond age 4-5 years, after controlling for child BMI z-score. Weight status was determined using WHO methods. RESULTS: Tracking of healthy weight was consistently higher than that of overweight/obesity, and incident overweight was equally likely throughout childhood and adolescence. Tracking of overweight was lower for children under 7 years than in middle childhood and adolescence (2-year probability 65%, compared with 80%; 2-year resolution of overweight 35 and 20%). Children of lower socioeconomic position, those from culturally and linguistically diverse backgrounds, and girls were more likely to move into overweight (hazard ratios [95%CI] for incident overweight: 1.39 [1.26-1.52], 1.16 [1.02-1.31] and 1.12 [1.02-1.23], respectively) and less likely to resolve their overweight (hazard ratios for resolution of overweight/obesity: 0.77 [0.69-0.85], 0.8 [0.69-0.92] and 0.79 [0.71-0.81], respectively) during childhood. However, persistence of weight status was not significantly affected by rurality or Indigenous status (P > 0.05). CONCLUSIONS: Lowest tracking and highest natural resolution of overweight in children under 7 years suggests this may be an opportune time for interventions to reduce overweight. Primary and secondary prevention programmes during the school years should be designed with special consideration for lower socioeconomic communities, for culturally and linguistically diverse populations and for girls.

Trends in Ischaemic Heart Disease in Australia, 2001-2015: A Comparison of Urban and Rural Populations.

OBJECTIVE: Ischaemic heart disease (IHD) is a major source of disease burden worldwide. Recent trends show incidence is declining but it is unclear whether the trends are similar in urban and rural populations. This study examines the trends of IHD events (i.e. hospitalisations and deaths) in New South Wales, Australia by rurality. METHODS: This was a retrospective analysis of linked administrative data for hospitalisation and death records across NSW between 2001 and 2015. Participants were NSW residents aged 15-105 years who died or were hospitalised with a principal diagnosis of IHD. The main outcome measures were annual age-standardised mortality and hospitalisations for IHD by calendar year and rurality. RESULTS: Between 2001 and 2015, age-standardised annual IHD hospitalisations declined in urban areas from 587 to 260 and in rural areas from 766 to 395 per 100,000 people. The annual decline in hospitalisations was greater in urban than rural areas, with Annual Percentage Change (APC) of -5.6% (95% CI, -6.1%, -5.0%) and -4.5% (95% CI, -5.0%, -4.0%), respectively (p=0.012). Ischaemic heart disease mortality declined at a similar rate in urban and rural regions (APC -7.6% and -6.7% per annum, p=0.28). Absolute inequalities in IHD deaths persisted until 2015 when there were 49 (urban) and 70 (rural) IHD deaths per 100,000 people. CONCLUSIONS: Ischaemic heart disease hospitalisations and mortality have declined considerably between 2001 and 2015 in both rural and urban areas, yet inequalities persist, suggesting more intensive preventive efforts are required to further reduce the burden of IHD in rural populations.

Cost-Effectiveness of a Novel Sleep Intervention in Infancy to Prevent Overweight in Childhood.

OBJECTIVE: The purpose of this study was to determine, from a health funder perspective, whether a sleep intervention, delivered in infancy, either alone or in combination with food, activity, and breastfeeding advice was cost-effective compared with usual care. METHODS: A cost-effectiveness analysis was conducted alongside the Prevention of Overweight in Infancy (POI) randomized controlled trial for outcomes at 5 years and cost-effectiveness was modeled to age 15 years using the Early Prevention of Obesity in Childhood microsimulation model. Intervention costs for the Sleep (n = 192), Combination (n = 196), and control (n = 209) groups were determined in 2018 Australian dollars. Incremental cost-effectiveness ratios (ICERs) were determined for BMI outcomes at 5 and 15 years, with the primary outcome being quality-adjusted life years (QALYs) modeled over 15 years. RESULTS: The average costs of the Sleep and Combination interventions were $184 and $601 per child, respectively. The ICER for the Sleep intervention was $18,125 per QALY gained, with a 74% probability of being cost-effective at a willingness-to-pay threshold of $50,000 per QALY. The ICER for the Combination intervention was $94,667 per QALY gained with a 23% probability of being cost-effective. CONCLUSIONS: The POI Sleep intervention, without additional advice, was a low-cost and cost-effective approach to reducing childhood obesity. Sleep modification programs offer a very promising approach to obesity prevention in children.

Linking two randomised controlled trials for Healthy Beginnings©: optimising early obesity prevention programs for children under 3 years.

BACKGROUND: Beginning in 2017 we have conducted a 3-arm randomised controlled trial (RCT) to determine the effectiveness of an early obesity intervention in the first two years of life using either telephone or Short Message Service (SMS) support for mothers. The trial recruited 1155 mothers from their third trimester of pregnancy. This protocol is for a new trial to build on the existing trial using the mother-child dyads retained at 24 months for recruitment to the new RCT. The aim of this new trial is to test whether use of a combination of telephone and SMS interventions is effective in promoting healthy eating and physical activity, as well as reducing child body mass index (BMI) at 3 years of age. METHODS: We will conduct a parallel RCT with an estimated sample of 750 mother-child dyads retained from the existing trial at 24 months. Mothers who completed the 24 months survey, including a telephone survey and measurement of child's height and weight will be invited to participate in the new trial. Informed consent will be obtained at the 24 months survey. The participating mother-child dyads will then be randomly allocated to the intervention (combined telephone and text messaging intervention) or the control group. The intervention will comprise three staged telephone consultations and text messages after each of the three intervention booklets is mailed to mothers at specific time-points between two and three years of child age. The main trial outcome measures include a) BMI and BMI z-score measured at 36 months, b) diet, physical activity and screen time c) cost-effectiveness, and d) feasibility and acceptability of the intervention. DISCUSSION: This unique opportunity to link two studies will expedite project start up time, utilise existing research infrastructure and systems to run the study, and optimise the use of an already engaged population of study participants. It can address a significant knowledge gap regarding early obesity prevention for children aged 2 to 3 years. The feasibility and effectiveness of the combined telephone and SMS intervention will indicate whether this is a scaleable, broad-reach and low-cost early obesity intervention. TRIAL REGISTRATION: The trial was registered with the Australian Clinical Trial Registry ( ACTRN12618001571268 ) on 20/09/2018.

Patterns and costs of health-care utilisation in Australian children: The first 5 years.

AIM: To describe patterns of health-care utilisation and costs of a cohort of Australian children in the first 5 years of life and to investigate demographic factors associated with high health-care utilisation. METHODS: This was a secondary data analysis of prospectively linked health-care utilisation data, including primary and secondary health-care consults, hospitalisations and emergency. The subjects were 350 children from a disadvantaged area of Sydney. Outcomes were the frequency and cost of all health-care consults from birth to 5 years of age. Multivariable logistic regression examined the odds of being a high health-care user in relation to child and family characteristics. RESULTS: Children had more health-care consults and higher annual health-care costs in the first 2 years of life (mean 12 health-care visits per year, mean cost Australian dollars (AUD) 1400 per child) than in the next 3 years (8 visits per year, AUD 900 per child). Primary care consults formed 86% of all health-care encounters but only contributed to 30% of the total costs. Factors positively associated with frequent use of health care in the first 2 years of life included being male, mother not married/de facto and annual household income of less than AUD 40000. Frequent users mostly accessed primary care services. There was no association between demographic factors and frequent use of health care in years 3-5 of life. CONCLUSIONS: Children from low-income or single-parent families may require additional support services during the first 2 years of life. Maintaining or increasing access to free or very low-cost primary health-care services for disadvantaged families will promote equity in health.

Is there an association between early weight status and utility-based health-related quality of life in young children?

PURPOSE: Few studies focus on the health-related quality of life (HRQoL) of preschool children with overweight or obesity. This is relevant for evaluation of obesity prevention trials using a quality-adjusted life year (QALY) framework. This study examined the association between weight status in the preschool years and HRQoL at age 5 years, using a preference-based instrument. METHODS: HRQoL [based on parent proxy version of the Health Utilities Index Mark 3 (HUI3)] and weight status were measured in children born in Australia between 2007 and 2009. Children's health status was scored across eight attributes of the HUI3-vision, hearing, speech, ambulation, dexterity, emotion, cognition and pain, and these were used to calculate a multi-attribute utility score. Ordinary least squares (OLS), Tobit and two-part regressions were used to model the association between weight status and multi-attribute utility. RESULTS: Of the 368 children for whom weight status and HUI3 data were available, around 40% had overweight/obesity. After adjusting for child's sex, maternal education, marital status and household income, no significant association between weight status in the preschool years and multi-attribute utility scores at 5 years was found. CONCLUSIONS: Alternative approaches for capturing the effects of weight status in the preschool years on preference-based HRQoL outcomes should be tested. The application of the QALY framework to economic evaluations of obesity-related interventions in young children should also consider longitudinal effects over the life-course. Clinical Trial Registration The Healthy Beginnings Trial was registered with the Australian Clinical Trial Registry (ACTRNO12607000168459).

The acceptability, effectiveness, and impact of different models of care for pediatric weight management services: protocol for a concurrent mixed-methods study.

BACKGROUND: Pediatric obesity is a serious, but clinically neglected, chronic health problem. Despite the high prevalence, excess weight problems are rarely managed when children attend clinical services. It is recommended that obesity treatment uses a "chronic-care" approach to management, with different types and intensity of treatment dependent upon severity of obesity. There are several new secondary and tertiary weight management services being implemented within New South Wales (NSW), Australia in 2017/2018 with differing models of care. This study will ascertain what factors affect acceptability, reach, and participation, as well as measure the clinical effectiveness of these services. METHODS: This is a acceptability and effectiveness study building upon existing and planned secondary and tertiary level service delivery in several health districts. This study will recruit participants from seven different pediatric weight management services (PWMS) across five Local Health Districts in NSW, Australia. Using a mixed-methods approach we will document a range of process, impact and clinical outcome measures in order to better understand the context and the effectiveness of each PWMS model. The project development and implementation is guided by the Theoretical Domains Framework. Participants will include parents of children less than 18 years of age attending PWMS, clinicians working as part of PWMS and health service managers. Data will be captured using a combination of anthropometric measures, questionnaires, one-on-one semi-structured interviews and focus groups. DISCUSSION: Results from this study will assess the acceptability and effectiveness of different models of care for pediatric weight management. Such information is required to inform long-term sustainability and scalability of secondary and tertiary care services to the large number of families with children above a healthy weight.

A 3-Arm randomised controlled trial of Communicating Healthy Beginnings Advice by Telephone (CHAT) to mothers with infants to prevent childhood obesity.

BACKGROUND: With an increasing prevalence of obesity in young children globally, there is an urgent need for the development of effective early interventions. A previous Healthy Beginnings Trial using a nurse-led home visiting program has demonstrated that providing mothers with evidence-based advice can improve maternal practice regarding obesity prevention, and can reduce Body Mass Index (BMI) in the first few years of life. However, the costs for scale-up of home visiting limit its population reach. This trial aims to determine the efficacy of Communicating Healthy Beginnings Advice by Telephone (CHAT) to mothers with infants in improving infant feeding practices and preventing the early onset of childhood overweight and obesity. METHODS/DESIGN: We propose a 3-arm randomised controlled trial (RCT) with a consecutive sample of 1056 mothers with their newborn children in New South Wales (NSW) Australia. Pregnant women who are between weeks 28 and 34 of their pregnancy will be invited to participate in the CHAT trial. Informed consent will be obtained, and after baseline data collection, participants will be randomly allocated to the telephone intervention, text messaging intervention, or the control group. The intervention comprises telephone consultations or text messages, together with 6 intervention packages being mailed at specific times from the third trimester of pregnancy until 12 months post birth. The main trial outcome measures include a) duration of breastfeeding, b) timing of introduction of solids, c) nutrition behaviours, physical activity and television viewing, and d) weight and BMI z-score at 12 and 24 months, e) cost-effectiveness, as well as f) feasibility and acceptability of the interventions. DISCUSSION: The results will ascertain whether early intervention using telephone consultation or text messaging together with staged mailed intervention resources can be feasible and effective in improving infant feeding practices, physical activity and reducing children's BMI in the early years of life. If proven to be feasible, effective as well as cost-effective, the trial results will inform a series of recommendations for policy and practice related to promoting healthy infant feeding and physical activity in young children in the first years of life. TRIAL REGISTRATION: The CHAT Trial is registered with the Australian Clinical Trial Registry ( ACTRN12616001470482p ). It was registered on October 21, 2016.

Sustainability of Effects of an Early Childhood Obesity Prevention Trial Over Time: A Further 3-Year Follow-up of the Healthy Beginnings Trial.

IMPORTANCE: Little evidence exists on whether effects of an early obesity intervention are sustainable. OBJECTIVE: To assess the sustainability of effects of a home-based early intervention on children's body mass index (BMI) and BMI z score at 3 years after intervention. DESIGN, SETTING, AND PARTICIPANTS: A longitudinal follow-up study of the randomized clinical Healthy Beginnings Trial was conducted with 465 participating mothers consenting to be followed up at 3 years after intervention until their children were age 5 years. This study was conducted in socially and economically disadvantaged areas of Sydney, Australia, from March 2011 to June 2014. INTERVENTIONS: No further intervention was carried out in this Healthy Beginnings Trial phase 2 follow-up study. The original intervention in phase 1 comprised 8 home visits from community nurses delivering a staged home-based intervention, with one visit in the antenatal period and 7 visits at 1, 3, 5, 9, 12, 18, and 24 months after birth. MAIN OUTCOMES AND MEASURES: Primary outcomes were children's BMI and BMI z score. Secondary outcomes included dietary behaviors, quality of life, physical activity, and TV viewing time of children and their mothers. RESULTS: In total, 369 mothers and their children completed the follow-up study, a phase 2 completion rate of 79.4% (80.9% for the intervention group and 77.7% for the control group). The differences between the intervention and control groups at age 2 years in children's BMI and BMI z score disappeared over time. At age 2 years, the difference (intervention minus control) in BMI (calculated as weight in kilograms divided by height in meters squared) was -0.41 (95% CI, -0.71 to -0.10; P = .009), but by age 5 years it was 0.03 (95% CI, -0.30 to 0.37). No effects of the early intervention on dietary behaviors, quality of life, physical activity, and TV viewing time were detected at age 5 years. CONCLUSIONS AND RELEVANCE: The significant effect of this early life home-visiting intervention on child BMI and BMI z score at age 2 years was not sustained at age 5 years without further intervention. Obesity prevention programs need to be continued or maintained during the early childhood years.

Cost-effectiveness of a Home-Exercise Program Among Older People After Hospitalization.

BACKGROUND: Older people who have been recently discharged from hospital are at increased risk of falls and deterioration in physical functioning. OBJECTIVE: To investigate the cost-effectiveness of a 12-month home-exercise program for older adults after hospitalization. METHOD: An economic evaluation was conducted alongside a randomized controlled trial. The analysis was conducted from the health and community service provider perspective. A total of 340 people aged 60 years and older, with a recent hospital admission, were randomized into exercise and usual care control groups. Incremental costs per extra person showing improvement in mobility performance (using the Short Physical Performance Battery), per person indicating improvement in health (self-reported using a 3-point Likert scale) and per quality-adjusted life year (QALY) gained (utility measured using the EQ-5D) were estimated. Uncertainty was represented using cost-effectiveness acceptability curves. Subgroup analyses for participants with better cognition (above the median MMSE score of 28) also were undertaken. RESULTS: The average cost of the intervention was $A751 per participant. The incremental cost-effectiveness of the program relative to usual care was $A22,958 per extra person showing an improvement in mobility, $A19,020 per extra person indicating an improvement in health, and $A77,403 per QALY. The acceptability curve demonstrates that the intervention had an 80% probability of being cost-effective relative to the control at a threshold of $A48,000 per extra person achieving mobility improvement and $A36,000 indicating an improvement in self-reported health. There was no threshold value at which the program can be considered as having an 80% probability of cost-effectiveness for the QALY outcome. Subgroup analyses for participants with better cognitive status indicated improved cost-effectiveness for all outcomes. CONCLUSION: The exercise intervention appeared to offer reasonable value for money for mobility outcomes and self-reported health status. Value for money for all measures was greater in the higher cognitive status subgroup.

A meta-analysis of the relative risk of mortality for type 1 diabetes patients compared to the general population: exploring temporal changes in relative mortality.

AIMS: Type 1 diabetes has been associated with an elevated relative risk (RR) of mortality compared to the general population. To review published studies on the RR of mortality of Type 1 diabetes patients compared to the general population, we conducted a meta-analysis and examined the temporal changes in the RR of mortality over time. METHODS: Systematic review of studies reporting RR of mortality for Type 1 diabetes compared to the general population. We conducted meta-analyses using a DerSimonian and Laird random effects model to obtain the average effect and the distribution of RR estimates. Sub-group meta-analyses and multivariate meta-regression analysis was performed to examine heterogeneity. Summary RR with 95% CIs was calculated using a random-effects model. RESULTS: 26 studies with a total of 88 subpopulations were included in the meta-analysis and overall RR of mortality was 3.82 (95% CI 3.41, 3.4.29) compared to the general population. Observations using data prior to 1971 had a much larger estimated RR (5.80 (95% CI 4.20, 8.01)) when compared to: data between; 1971 and 1980 (5.06 (95% CI 3.44, 7.45)); 1981-90 (3.59 (95% CI 3.15, 4.09)); and those after 1990 (3.11 (95% CI 2.47, 3.91)); suggesting mortality of Type 1 diabetes patients when compared to the general population have been improving over time. Similarly, females (4.54 (95% CI 3.79-5.45)) had a larger RR estimate when compared to males (3.25 (95% CI 2.82-3.73) and the meta-regression found evidence for temporal trends and sex (p<0.01) accounting for heterogeneity between studies. CONCLUSIONS: Type 1 diabetes patients' mortality has declined at a faster rate than the general population. However, the largest relative improvements have occurred prior to 1990. Emphasis on intensive blood glucose control alongside blood pressure control and statin therapy may translate into further reductions in mortality in coming years.

Adapting and validating diabetes simulation models across settings: accounting for mortality differences using administrative data.

AIMS: To develop age and sex-specific risk equations for predicting mortality following major complications of diabetes, using a large linked administrative dataset from Western Australia (WA) and to incorporate these into an existing diabetes simulation model. METHODS: The study uses linked hospital and mortality records on 13,884 patients following a major diabetes-related complication with a mean (SD) duration of 2.62 (2.25) years. Risk equations for predicting mortality were derived and integrated into the UKPDS Outcomes Model. Estimates of life expectancy and incremental QALYs gained as a result of two theoretical therapies (a reduction of HbA1c of 1%, and reduction of systolic blood pressure of 10 mmHg) were determined using the original and adapted models. RESULTS: The two versions of the model generated differences in life expectancy following specific events; however there was little impact of using alternative mortality equations on incremental QALYs gained as a result of reducing HbA(1c) or systolic blood pressure, or on outcomes of life expectancy for a cohort initially free of complications. CONCLUSIONS: Mortality following complications varies across diabetic populations and can impact on estimates of life expectancy, but appears to have less impact on incremental benefits of interventions that are commonly used in pharmoeconomic analyses.