Search

Background: Anxiety and depressive disorders typically emerge in adolescence and can be chronic and disabling if not identified and treated early. School-based universal mental health screening may identify young people in need of mental health support and facilitate access to treatment. However, few studies have assessed the potential harms of this approach. This paper examines some of the potential mental health-related harms associated with the universal screening of anxiety and depression administered in Australian secondary schools. Methods: A total of 1802 adolescent students from 22 secondary schools in New South Wales, Australia, were cluster randomised (at the school level) to receive either an intensive screening procedure (intervention) or a light touch screening procedure (control). Participants in the intensive screening condition received supervised self-report web-based screening questionnaires for anxiety, depression and suicidality with the follow-up care matched to their symptom severity. Participants in the light touch condition received unsupervised web-based screening for anxiety and depression only, followed by generalised advice on help-seeking. No other care was provided in this condition. Study outcomes included the increased risk of anxiety, depression, psychological distress, decreased risk of help-seeking, increased risk of mental health stigma, determined from measures assessed at baseline, 6 weeks post-baseline, and 12 weeks post-baseline. Differences between groups were analysed using mixed effect models. Results: Participants in the intensive screening group were not adversely affected when compared to the light touch screening condition across a range of potential harms. Rather, participants in the intensive screening group were found to have a decreased risk of inhibited help-seeking behaviour compared to the light touch screening condition. Conclusions: The intensive screening procedure did not appear to adversely impact adolescents' mental health relative to the light touch procedure. Future studies should examine other school-based approaches that may be more effective and efficient than universal screening for reducing mental health burden among students. Trial registration Australian and New Zealand Clinical Trials Registry (ACTRN12618001539224) https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375821. [ABSTRACT FROM AUTHOR]

Background: Children who experience adversity are more vulnerable to language difficulties. Early interventions beginning antenatally, such as home visiting, are provided to help prevent these problems. To improve the precision of early interventions, the impact of combinations of risk and protective factors over time must be explored and understood. There is, however, limited research investigating how such factors interact with intervention to change language outcomes over time. Aim: To explore the different paths that lead to Good and Poor language in a cohort of children experiencing adversity whose mothers received an optimal dose of the Maternal Early Childhood Sustained Home visiting (MECSH) intervention over 2.5 years. Methods & Procedures: A total of 24 low socioeconomic status (SES) mothers experiencing adversity and their children who received more than half the scheduled dose of the MECSH intervention were followed over time: from before birth to school entry. Data were extracted from surveys and direct measurement over the study course. Child language outcome at school entry and the influence of seven key child, maternal and environmental factors, which have been shown in previous research to result in Good and Poor language outcomes, were explored through qualitative comparative analysis (QCA). QCA is a qualitative analytical technique that provides a deeper understanding of factor combinations influencing language development. Outcomes & Results: Multiple paths to Good (six paths) and Poor language (seven paths) were found. Paths with mostly protective factors resulted in Good language, except when maternal antenatal distress was present. Paths with two or more influential risks usually resulted in Poor language outcomes. When children experiencing adversity received the MECSH home visiting intervention, there was no one risk or protective factor necessary for Good or Poor language outcomes; however, there were clear patterns of factor combinations. Conclusions & Implications: Mothers' antenatal psychological resources were a flag for future language concerns which can be used to improve the precision of the MECSH intervention. They were highly influential to their children's Good and Poor language outcomes by 5 years, when over time they were combined with characteristics such as early childhood education, poor maternal responsivity and/or the number of children in the home. Knowledge of early conditions associated with later Poor language can help clinicians identify and respond in preventative and promoting ways to improve language skills. What this paper addsWhat is already known on the subjectChildren experiencing adversity are more vulnerable to language difficulties. Both risk for language difficulties and protection against them in this group are via a complex combination of factors. It is unknown how intervention works with these complex factors to result in Good and Poor language outcomes.What this paper adds to existing knowledgeThere are multiple paths to both Good and Poor language outcomes for children experiencing adversity. Mothers' psychological resources antenatally in combination with other key factors were particularly influential to Good and Poor language outcomes.What are the clinical implications of this work?In this study, maternal antenatal distress together with poor maternal responsivity were present in children's paths to Poor language outcomes at school entry. An extra focus on responsivity is required in antenatally distressed mothers of children experiencing adversity in early interventions. Children of mothers with good psychological resources antenatally who received home visiting intervention had Good language outcomes at 5 years when combined with 3 years or more of early childhood education and if there were one to two children in the home. Knowledge of these influences on language development can improve the precision of home visiting interventions and help clinicians tailor their visits to individual families' needs. [ABSTRACT FROM AUTHOR]

Background: Despite strong evidence giving guidance for effective fall prevention interventions in community-residing older people, there is currently no clear model for engaging general medical practitioners in fall prevention and routine use of allied health professionals in fall prevention has been slow, limiting widespread dissemination. This protocol paper outlines an implementation-effectiveness study of the Integrated Solutions for Sustainable Fall Prevention (iSOLVE) intervention which has developed integrated processes and pathways to identify older people at risk of falls and engage a whole of primary care approach to fall prevention.Methods/design: This protocol paper presents the iSOLVE implementation processes and change strategies and outlines the study design of a blended type 2 hybrid design. The study consists of a two-arm cluster randomized controlled trial in 28 general practices and recruiting 560 patients in Sydney, Australia, to evaluate effectiveness of the iSOLVE intervention in changing general practitioner fall management practices and reducing patient falls and the cost effectiveness from a healthcare funder perspective. Secondary outcomes include change in medications known to increase fall risk. We will simultaneously conduct a multi-methodology evaluation to investigate the workability and utility of the implementation intervention. The implementation evaluation includes in-depth interviews and surveys with general practitioners and allied health professionals to explore acceptability and uptake of the intervention, the coherence of the proposed changes for those in the work setting, and how to facilitate the collective action needed to implement changes in practice; social network mapping will explore professional relationships and influences on referral patterns; and, a survey of GPs in the geographical intervention zone will test diffusion of evidence-based fall prevention practices. The project works in partnership with a primary care health network, state fall prevention leaders, and a community of practice of fall prevention advocates.Discussion: The design is aimed at providing clear direction for sustainability and informing decisions about generalization of the iSOLVE intervention processes and change strategies. While challenges exist in hybrid designs, there is a potential for significant outcomes as the iSOLVE pathways project brings together practice and research to collectively solve a major national problem with implications for policy service delivery.Trial Registration: Australian New Zealand Clinial Trials Registry ACTRN12615000401550. [ABSTRACT FROM AUTHOR]

Background: 'Physical Activity 4 Everyone' (PA4E1) was an efficacious multi-component school-based physical activity (PA) program targeting adolescents. PA4E1 has seven PA practices. It is essential to scale-up, evaluate effectiveness and assess implementation of such programs. Therefore, the aim is to assess the impact of implementation support on school practice uptake of the PA4E1 program at 12 and 24 months. Methods: A cluster randomised controlled trial, utilising a type III hybrid implementation-effectiveness design, was conducted in 49 randomly selected disadvantaged Australian Government and Catholic secondary schools. A blinded statistician randomly allocated schools to a usual practice control (n = 25) or the PA4E1 program group (n = 24), with the latter receiving seven implementation support strategies to support school PA practice uptake of the seven practices retained from the efficacy trial. The primary outcome was the proportion of schools adopting at least four of the seven practices, assessed via telephone surveys with Head Physical Education Teachers and analysed using exact logistic regression modelling. This paper reports the 12-month outcomes. Results: Schools were recruited from May to November 2017. At baseline, no schools implemented four of the seven practices. At 12 months significantly more schools in the program group had implemented four of the seven practices (16/24, 66.7%) than the control group (1/25, 4%) (OR = 33.0[4.15–1556.4], p < 0.001). The program group implemented on average 3.2 (2.5–3.9) more practices than the control group (p < 0.001, mean 3.9 (SD 1.5) vs 0.7 (1.0)). Fidelity and reach of the implementation support intervention were high (both > 80%). Conclusions: Through the application of multiple implementation support strategies, secondary schools were able to overcome commonly known barriers to implement evidence based school PA practices. As such practices have been shown to result in an increase in adolescent PA and improvements in weight status, policy makers and practitioners responsible for advocating PA in schools should consider this implementation approach more broadly when working with schools. Follow-up is required to determine whether practice implementation is sustained. Trial registration: Australian New Zealand Clinical Trials Registry ACTRN12617000681358 registered 12th May 2017. [ABSTRACT FROM AUTHOR]

Background: Surveys are commonly used in health research to assess patient satisfaction with hospital care. Achieving an adequate response rate, in the face of declining trends over time, threatens the quality and reliability of survey results. This paper evaluates a strategy to increase the response rate in a postal satisfaction survey with women who had recently given birth.Methods: A sample of 2048 Australian women who had recently given birth at seven maternity units in New South Wales were invited to participate in a postal survey about their recent experiences with maternity care. The study design included a randomised controlled trial that tested two types of pre-notification letter (with or without the option of opting out of the survey). The study also explored the acceptability of a request for consent to link survey data with existing routinely collected health data (omitting the latter data items from the survey reduced survey length and participant burden). This consent was requested of all women.Results: The survey had an overall response rate of 46% (913 completed surveys returned, total sample 1989). Women receiving the pre-notification letter with the option of opting out of the survey were more likely to actively decline to participate than women receiving the letter without this option, although the overall numbers of women declining were small (27 versus 12). Letter type was not significantly associated with the return of a completed survey. Among women who completed the survey, 97% gave consent to link their survey data with existing health data.Conclusions: The two types of pre-notification letters used in our study did not influence the survey response rate. However, seeking consent for record linkage was highly acceptable to women who completed the survey, and represents an important strategy to add to the arsenal for designing and implementing effective surveys. In addition to aspects of survey design, future research should explore how to more effectively influence personal constructs that contribute to the decision to participate in surveys. [ABSTRACT FROM AUTHOR]

Background: Knee arthroscopy is a common procedure in orthopaedic surgery. In recent times the efficacy of this procedure has been questioned with a number of randomized controlled trials demonstrating a lack of effect in the treatment of osteoarthritis. Consequently, a number of trend studies have been conducted, exploring rates of knee arthroscopy and subsequent conversion to Total Knee Arthroplasty (TKA) with varying results. Progression to TKA is seen as an indicator of lack of effect of primary knee arthroscopy. The aim of this paper is to measure overall rates of knee arthroscopy and the proportion of these patients that undergo subsequent total knee arthroplasty (TKA) within 24 months, and to measure trends over time in an Australian population. Methods: We conducted a retrospective cohort study of all adults undergoing a knee arthroscopy and TKA in all hospitals in New South Wales (NSW), Australia between 2000 and 2008. Datasets obtained from the Centre for Health Record Linkage (CHeReL) were analysed using negative binomial regression. Admission rates for knee arthroscopy were determined by year, age, gender and hospital status (public versus private) and readmission for TKA within 24 months was calculated. Results: There was no significant change in the overall rate of knee arthroscopy between 2000 and 2008 (-0.68%, 95% CI: -2.80 to 1.49). The rates declined in public hospitals (-1.25%, 95% CI: -2.39 to -0.10) and remained relatively steady in private hospitals (0.42%, 95% CI: -1.43 to 0.60). The proportion of patients 65 years or over undergoing TKA within 24 months of knee arthroscopy was 21.5%. After adjusting for age and gender, there was a significant decline in rates of TKA within 24 months of knee arthroscopy for all patients (-1.70%, 95% CI:-3.13 to -0.24), patients admitted to private hospitals (-2.65%, 95% CI: -4.06 to -1.23) and patients aged ⩾65 years (-3.12%, 95% CI: -5.02 to -1.18). Conclusions: Rates of knee arthroscopy are not increasing, and the proportion of patients requiring a TKA within 24 months of a knee replacement is decreasing in the age group most likely to have degenerative changes in the knee. [ABSTRACT FROM AUTHOR]

The aim of this paper was to describe and test a social cognitive model of physical activity tailored for adolescent girls. Participants were 1518 girls (aged 13.6 ± 0.02 years) from 24 secondary schools in New South Wales, Australia. Useable accelerometer (≥10 hours day−1 on at least 3 days) and questionnaire data were obtained from 68% of this sample (N = 1035). Participants completed questionnaires assessing psychological, behavioural, social and environmental correlates of activity. The theoretical model was tested using structural equation modelling in AMOS. The model explaining accelerometer counts per minute was an adequate-to-good fit to the data (Tucker–Lewis Index = 0.89, the comparative fit index = 0.97 and the root mean square of approximation = 0.098; 90% confidence interval = 0.075–0.122) but explained only 5% of the variance in activity. There were significant model pathways from self-efficacy (r = 0.11, P = 0.01), school environment (r = 0.07, P = 0.02) and physical self-worth (r = 0.07, P = 0.04) to accelerometer counts. Although the proposed model provided an adequate-to-good fit to the data, it explained a small portion of the variance. Shared method variance may explain the larger portions of variance explained in previous studies. Future studies are encouraged to evaluate theories of physical activity behaviour change using objective measures of physical activity. [ABSTRACT FROM PUBLISHER]

Background: A poor understanding of the specific lifestyle behaviors that result in weight loss has hindered the development of effective interventions. The aim of this paper was to identify potential behavioral mediators of weight loss in the Healthy Dads, Healthy Kids (HDHK) intervention for overweight fathers. Findings: The three-month intervention was evaluated in a randomized controlled trial and conducted in Newcastle, New South Wales, Australia. Baseline, three month (immediate post-intervention) and six month assessments were conducted. Recruitment and follow-up occurred between October 2008 and May 2009. The study sample included 53 overweight/obese men [mean (± SD) age = 40.6(± 97.1) years; body mass index (BMI) = 33.2 (±3.9) kgm-2] and their primary school-aged children [n = 71, 54% boys; age = 8.2 (±2.0) years] who were randomized to HDHK program or a wait-list control group. Physical activity (PA) was assessed using pedometers and dietary behaviors were measured using a validated food frequency questionnaire. The intervention resulted in significant weight loss (−5.13 ± 1.27 kg, P<0.0001) and increased PA among fathers (2769 ± 750 steps/day, P<0.001) and their children (1486 ± 521 steps/day, P<0.01). Fathers’ PA mediated weight loss in the intervention (AB = −2.31, 95% CI = −4.63 to −0.67) and was responsible for 47% of the intervention effect. Changes in dietary behaviors were not statistically significant. Conclusions: PA was an important mediator of weight loss in the HDHK intervention. Encouraging overweight fathers to be more active with their children appears to be a promising strategy for obesity treatment in men. [ABSTRACT FROM AUTHOR]

Background: Lifetime trajectories of mental ill-health are often established during adolescence. Effective interventions to prevent the emergence of mental health problems are needed. In the current study we assessed the efficacy of the cognitive behavioural therapy (CBT)-informed Climate Schools universal eHealth preventive mental health programme, relative to a control. We also explored whether the intervention had differential effects on students with varying degrees of social connectedness. Method: We evaluated the efficacy of the Climate Schools mental health programme (19 participating schools; average age at baseline was 13.6) v. a control group (18 participating schools; average age at baseline was 13.5) which formed part of a large cluster randomised controlled trial in Australian schools. Measures of internalising problems, depression and anxiety were collected at baseline, immediately following the intervention and at 6-, 12- and 18-months post intervention. Immediately following the intervention, 2539 students provided data on at least one outcome of interest (2065 students at 18 months post intervention). Results: Compared to controls, we found evidence that the standalone mental health intervention improved knowledge of mental health, however there was no evidence that the intervention improved other mental health outcomes, relative to a control. Student's social connectedness did not influence intervention outcomes. Conclusion: These results are consistent with recent findings that universal school-based, CBT-informed, preventive interventions for mental health have limited efficacy in improving symptoms of anxiety and depression when delivered alone. We highlight the potential for combined intervention approaches, and more targeted interventions, to better improve mental health outcomes. [ABSTRACT FROM AUTHOR]

Background: Sixty percent of people have non-functional arms 6 months after stroke. More effective treatments are needed. Cochrane Reviews show low-quality evidence that task-specific training improves upper limb function. Our feasibility trial showed 56 h of task-specific training over 6 weeks resulted in an increase of a median 6 points on the Action Research Arm test (ARAT), demonstrating the need for more definitive evidence from a larger randomised controlled trial. Task-AT Home is a two-arm, assessor-blinded, multicentre randomised, controlled study, conducted in the home setting. Aim: The objective is to determine whether task-specific training is a more effective treatment than usual care, for improving upper limb function, amount of upper limb use, and health related quality of life at 6 weeks and 6 months after intervention commencement. Our primary hypothesis is that upper limb function will achieve a = 5 point improvement on the ARAT in the task-specific training group compared to the usual care group, after 6 weeks of intervention. Methods: Participants living at home, with remaining upper limb deficit, are recruited at 3 months after stroke from sites in NSW and Victoria, Australia. Following baseline assessment, participants are randomised to 6 weeks of either task-specific or usual care intervention, stratified for upper limb function based on the ARAT score. The task-specific group receive 14 h of therapist-led taskspecific training plus 42 h of guided self-practice. The primary outcome measure is the ARAT at 6 weeks. Secondary measures include the Motor Activity Log (MAL) at 6 weeks and the ARAT, MAL and EQ5D-5 L at 6 months. Assessments occur at baseline, after 6 weeks of intervention, and at 6 months after intervention commencement. Analysis will be intention to treat using a generalised linear mixed model to report estimated mean differences in scores between the two groups at each timepoint with 95% confidence interval and value of p. Discussion: If the task-specific home-based training programme is more effective than usual care in improving arm function, implementation of the programme into clinical practice would potentially lead to improvements in upper limb function and quality of life for people with stroke. [ABSTRACT FROM AUTHOR]

Introduction: Although comprehensive school-based physical activity interventions are efficacious when tested under research conditions, they often require adaptation in order for implementation at scale. This paper reports the effectiveness of an adapted efficacious school-based intervention in improving children's moderate to vigorous physical activity. The impact of strategies to support program implementation was also assessed.Design: A cluster RCT of low socioeconomic elementary schools in New South Wales, Australia.Setting/participants: Consenting schools were randomized (25 intervention, 21 control) using a computerized random number function. Follow-up measures were taken at 6 months post-randomization (May-August 2015) by blinded research assistants. The multicomponent school-based intervention, based on an efficacious school-based physical activity program (Supporting Children's Outcomes using Rewards, Exercise and Skills), consisted of four physical activity strategies and seven implementation support strategies. The intervention was adapted for scalability and delivery by a local health service over 6 months. The primary outcome was accelerometer assessed, student mean daily minutes spent in moderate to vigorous physical activity. Physical education lesson quality and other school physical activity practices were also assessed.Results: Participants (n=1,139, 49% male) were third- through sixth-grade students at follow-up (May-August 2015). Valid wear time and analysis of data were provided for 989 (86%) participants (571 intervention, 568 control). At 6-month follow-up, there were no significant effects in overall daily minutes of moderate to vigorous physical activity between groups (1.96 minutes, 95% CI= -3.49, 7.41, p=0.48). However, adjusted difference in mean minutes of overall vigorous physical activity (2.19, 95% CI=0.06, 4.32, p=0.04); mean minutes of school day moderate to vigorous physical activity (2.90, 95% CI=0.06, 5.85, p=0.05); and mean minutes of school day vigorous physical activity (1.81, 95% CI=0.78, 2.83, p≤0.01) were significantly different in favor of the intervention group. Physical education lesson quality and school physical activity practices were significantly different favoring the intervention group (analyzed October 2015-January 2016).Conclusions: The modified intervention was not effective in increasing children's overall daily minutes of moderate to vigorous physical activity, when adapted for implementation at scale. However, the intervention did improve daily minutes of vigorous physical activity and school day moderate to vigorous physical activity, lesson quality, and school physical activity practices.Trial Registration: Australian New Zealand Clinical Trials Registry: ACTRN12615000437561. [ABSTRACT FROM AUTHOR]

Introduction: Few interventions have been successful in reducing the physical activity decline typically observed among adolescents. The aim of this paper is to report the 24-month effectiveness of a multicomponent school-based intervention (Physical Activity 4 Everyone) in reducing the decline in moderate to vigorous physical activity (MVPA) among secondary school students in disadvantaged areas of New South Wales, Australia.Study Design: A cluster RCT was conducted in five intervention and five control schools with follow-up measures taken at 24 months post-randomization.Setting/participants: The trial was undertaken within secondary schools located in disadvantaged communities in New South Wales, Australia.Intervention: A multicomponent school-based intervention based on the Health Promoting Schools Framework was implemented. The intervention consisted of seven physical activity promotion strategies that targeted the curriculum (teaching strategies to increase physical activity in physical education lessons, student physical activity plans, and modification of school sport program); school environment (recess/lunchtime activities, school physical activity policy); parents (parent newsletters); and community (community physical activity provider promotion). Six additional strategies supported school implementation of the physical activity intervention strategies.Main Outcome Measure: Minutes per day spent in MVPA, objectively measured by accelerometer.Results: Participants (N=1,150, 49% male) were a cohort of students aged 12 years (Grade 7) at baseline (March-June 2012) and 14 years (Grade 9) at follow-up (March-July 2014). At 24-month follow-up, there were significant effects in favor of the intervention group for daily minutes of MVPA. The adjusted mean difference in change in daily MVPA between groups was 7.0 minutes (95% CI=2.7, 11.4, p<0.002) (analysis conducted December 2014-February 2015). Sensitivity analyses based on multiple imputation were consistent with the main analysis (6.0 minutes, 95% CI=0.6, 11.3, p<0.031).Conclusions: The intervention was effective in increasing adolescents' minutes of MVPA, suggesting that implementation of the intervention by disadvantaged schools has the potential to slow the decline in physical activity.Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12612000382875. [ABSTRACT FROM AUTHOR]

Introduction. Low response rates to surveys can lead to non-response bias, limiting generalisability of findings. When survey topics pertain to uncommon conditions, the decision of general practitioners (GPs) to complete a questionnaire may be swayed by the perceived relevance of the questionnaire content to their practice. Aim. To explore whether targeted wording of a questionnaire for GPs about head and neck cancer referral patterns affects response rates. Methods. A randomised controlled trial was embedded into a larger survey on referral practices for head and neck cancer among GPs in New South Wales, Australia. GPs were randomly allocated to receive versions of the study material with explanatory text written using either a 'symptom-frame' or a 'cancer-frame'; however, the questions and responses were the same in both groups. Results. The overall response rate was 10.9% (196/1803). The response rate to the 'cancer-frame' version was 10.6% and 11.1% for the 'symptom-frame' version. After adjusting for practice location and GP gender, the difference in response rate based on wording was not significant (difference 0.5% [95%CI: -2.4, 3.4%]). A sub-analysis showed that GPs practicing in regional New South Wales were more likely to respond to the survey compared to those practicing in metropolitan New South Wales, independent of the intervention group or participant sex (AOR 1.61 [95%CI: 1.12, 2.31]; P = 0.01). Discussion. The wording 'frame' of the survey did not appear to impact response rates in a survey of referral practices for suspected head and neck cancer; however, the significantly higher response rate from regional GPs warrants further investigation as to whether the content was considered more salient to their practice. [ABSTRACT FROM AUTHOR]

Abstract: Introduction: The negative consequences of unhealthy weight gain and the high likelihood of pediatric obesity tracking into adulthood highlight the importance of targeting youth who are ‘at risk’ of obesity. The aim of this paper is to report the rationale and study protocol for the ‘Active Teen Leaders Avoiding Screen-time’ (ATLAS) obesity prevention intervention for adolescent boys living in low-income communities. Methods/design: The ATLAS intervention will be evaluated using a cluster randomized controlled trial in 14 secondary schools in the state of New South Wales (NSW), Australia (2012 to 2014). ATLAS is an 8-month multi-component, school-based program informed by self-determination theory and social cognitive theory. The intervention consists of teacher professional development, enhanced school-sport sessions, researcher-led seminars, lunch-time physical activity mentoring sessions, pedometers for self-monitoring, provision of equipment to schools, parental newsletters, and a smartphone application and website. Assessments were conducted at baseline and will be completed again at 9- and 18-months from baseline. Primary outcomes are body mass index (BMI) and waist circumference. Secondary outcomes include BMI z-scores, body fat (bioelectrical impedance analysis), physical activity (accelerometers), muscular fitness (grip strength and push-ups), screen-time, sugar-sweetened beverage consumption, resistance training skill competency, daytime sleepiness, subjective well-being, physical self-perception, pathological video gaming, and aggression. Hypothesized mediators of behavior change will also be explored. Discussion: ATLAS is an innovative school-based intervention designed to improve the health behaviors and related outcomes of adolescent males in low-income communities. [Copyright &y& Elsevier]

Background: People with a mental health condition have a shorter life expectancy than the general population. This is largely attributable to higher rates of chronic disease and a higher prevalence of modifiable health risk behaviours including tobacco smoking, alcohol consumption, poor nutrition, and physical inactivity. Telephone support services offer a viable option to provide support to reduce these health risk behaviours at a population-level; however, whilst there is some research pertaining to Quitlines, there is limited other research investigating whether telephone services may offer effective support for people with a mental health condition. This protocol describes a randomised controlled trial that aims to evaluate the referral of people with a mental health condition to a population-level telephone coaching service to increase physical activity, healthy eating, or weight management, and increase attempts to do so.Methods: A parallel-group randomised controlled trial will be conducted recruiting participants with a mental health condition through community mental health services and advertisement on social media. Participants will be randomly assigned to receive either a health information pack only (control) or a health information pack and a proactive referral to a free, government-funded telephone coaching service, the NSW Get Healthy Coaching and Information Service® (intervention), which offers up to 13 telephone coaching calls with a University Qualified Health Coach to assist with client-identified goals relating to physical activity, healthy eating, weight management, or alcohol reduction. Data will be collected via telephone surveys at baseline and 6 months post-recruitment. Primary outcomes are as follows: (1) minutes of moderate to vigorous physical activity per week, (2) serves of fruit consumed per day, (3) serves of vegetables consumed per day, and (4) a composite measure assessing attempts to change at least one health risk behaviour (any attempts to change physical activity, fruit consumption, vegetable consumption, or other parts of nutrition). Secondary outcomes include weight and body mass index.Discussion: This study is the first to evaluate the effectiveness of referral to a population-level telephone support service for reducing health risk behaviours relating to physical activity, healthy eating, and weight in people with a mental health condition. Results will inform future policy and practice regarding the delivery of telephone-based behaviour change coaching services and the management of physical health for this population to reduce health inequity and the burden of chronic disease.Trial Registration: The Australian New Zealand Clinical Trials Registry ACTRN12620000351910 . Retrospectively registered on 12 March 2020. [ABSTRACT FROM AUTHOR]

Background: The burden of disease attributable to alcohol and other drug (AOD) use in young people is considerable. Prevention can be effective, yet few programs have demonstrated replicable effects. This study aimed to replicate research behind Climate Schools: Alcohol and Cannabis course among a large cohort of adolescents. Methods: Seventy-one secondary schools across three States participated in a cluster-randomised controlled trial. Year 8 students received either the web-based Climate Schools: Alcohol and Cannabis course (Climate, n = 3236), or health education as usual (Control, n = 3150). Outcomes were measured via self-report and reported here for baseline, 6- and 12-months for alcohol and cannabis knowledge, alcohol, cannabis use and alcohol-related harms. Results: Compared to Controls, students in the Climate group showed greater increases in alcohol- [standardised mean difference (SMD) 0.51, p < 0.001] and cannabis-related knowledge (SMD 0.49, p < 0.001), less increases in the odds of drinking a full standard drink[(odds ratio (OR) 0.62, p = 0.014], and heavy episodic drinking (OR 0.49, p = 0.022). There was no evidence for differences in change over time in the odds of cannabis use (OR 0.57, p = 0.22) or alcohol harms (OR 0.73, p = 0.17). Conclusions: The current study provides support for the effectiveness of the web-based Climate Schools: Alcohol and Cannabis course in increasing knowledge and reducing the uptake of alcohol. It represents one of the first trials of a web-based AOD prevention program to replicate alcohol effects in a large and diverse sample of students. Future research and/or adaptation of the program may be warranted with respect to prevention of cannabis use and alcohol harms. [ABSTRACT FROM AUTHOR]

Objectives Active telephone recruitment ('cold calling') can enrol almost 45 times more smokers to cessation services than media. However, the effectiveness of proactive telephone counselling with cold-called smokers from the broader community is unknown. This study examined whether proactive telephone counselling improved abstinence, quit attempts and reduced cigarette consumption among cold-called smokers. Methods From 48 014 randomly selected electronic telephone directory numbers, 3008 eligible smokers were identified and 1562 (51.9%) smokers recruited into the randomised controlled trial. Of these, 769 smokers were randomly allocated to proactive telephone counselling and 793 to the control (ie, mailed self-help) conditions. Six counselling calls were offered to intervention smokers willing to quit within a month and four to those not ready to quit. The 4-month, 7-month and 13-month follow-up interviews were completed by 1369 (87.6%), 1278 (81.8%) and 1245 (79.9%) participants, respectively. Results Proactive telephone counselling participants were significantly more likely than controls to achieve 7-day point prevalence abstinence at 4 months (13.8% vs 9.6%, p=0.005) and 7 months (14.3% vs 11.0%, p=0.02) but not at 13 months. There was a significant impact of telephone counselling on prolonged abstinence at 4 months (3.4% vs 1.8%, p=0.02) and at 7 months (2.2% vs 0.9%, p=0.02). At 4 months post recruitment, telephone counselling participants were significantly more likely than controls to have made a quit attempt (48.6% vs 42.9%, p=0.01) and reduced cigarette consumption (16.9% vs 9.0%, p=0.0002). Conclusions Proactive telephone counselling initially increased abstinence and quitting behaviours among cold-called smokers. Given its superior reach, quitlines should consider active telephone recruitment, provided relapse can be reduced. [ABSTRACT FROM AUTHOR]

Background Overuse of lumbar imaging is common in the emergency department (ED). Few trials have examined interventions to address this. We evaluated the effectiveness of a multifaceted intervention to implement guideline recommendations for low back pain in the emergency department. Methods We conducted a stepped-wedge, cluster- randomised trial in four EDs in New South Wales, Australia. After a 13-month control phase of usual care, the EDs received a multifaceted intervention to support guideline- endorsed care in a random order, based on a computer-generated random sequence, every 4 weeks over a 4- month period. All sites were followed up for at least 3 months. The primary outcome was the proportion of low back pain presentations receiving lumbar imaging. Secondary healthcare utilisation outcomes included prescriptions of opioid and non- opioid pain medicines, inpatient admissions, length of ED stay, specialist referrals and re- presentations. Clinician beliefs and knowledge about low back pain care were measured before and after the intervention. Patient-reported pain, disability, quality of life and satisfaction were measured at 1, 2 and 4 weeks post ED presentation. Results A total of 269 ED clinicians and 4625 episodes of care for low back pain (4491 patients) were included. The data did not provide clear evidence that the intervention reduced lumbar imaging (OR 0.77; 95% CI 0.47 to 1.26; p=0.29). It did reduce opioid use (OR 0.57; 95% CI 0.38 to 0.85; p=0.006) and improved clinicians' beliefs (mean difference (MD), 2.85; 95% CI 1.85 to 3.85; p<0.001; on a scale from 9 to 45) and knowledge about low back pain care (MD, 0.48; 95% CI 0.13 to 0.83; p<0.01; on a scale from 0 to 11). There was no difference in pain scores at 1-week follow-up (MD, 0.04; 95% CI -1.00 to 1.08; p=0.94; on a scale from 0 to 10). A similar trend was observed for all other patient- reported outcomes and time points. This study found no effect on the other secondary healthcare utilisation outcomes. Conclusion It is uncertain if a multifaceted intervention to implement guideline recommendations for low back pain care decreased lumbar imaging in the ED; however, it did reduce opioid prescriptions without adversely affecting patient outcomes. [ABSTRACT FROM AUTHOR]

Background: Spinal cord injury (SCI) is associated with autonomic imbalance and significant secondary conditions, including cardiac and brain dysfunction that adversely impact health and wellbeing. This study will investigate the effectiveness (intention-to-treat) of a neuro-cardiac self-regulation therapy to improve autonomic and neural/brain activity in adults with SCI living in the community.Methods: A two-arm parallel, randomised controlled trial in which adults with SCI living in the community post-rehabilitation will be randomly assigned to a treatment or control group. The treatment group (N = 60) aged 18-70 years with a chronic traumatic or non-traumatic SCI, will receive intervention sessions once per week for 10 weeks, designed to regulate autonomic activity using computer-based feedback of heart rate variability and controlled breathing (called HRV-F). Comprehensive neurophysiological and psychological assessment will occur at baseline, immediate post-treatment, and 6 and 12-months post-treatment. Primary outcome measures include electrocardiography/heart rate variability (to assess autonomic nervous system function) and transcranial doppler sonography (to assess cerebral blood circulation in basal cerebral arteries). Secondary outcomes measures include continuous blood pressure, electroencephalography, functional near-infrared spectroscopy, respiration/breath rate, electrooculography, cognitive capacity, psychological status, pain, fatigue, sleep and quality of life. Controls (N = 60) will receive usual community care, reading material and a brief telephone call once per week for 10 weeks and be similarly assessed over the same time period as the HRV-F group. Linear mixed model analysis with repeated measures will determine effectiveness of HRV-F and latent class mixture modelling used to determine trajectories for primary and selected secondary outcomes of interest.Discussion: Treatments for improving autonomic function after SCI are limited. It is therefore important to establish whether a neuro-cardiac self-regulation therapy can result in improved autonomic functioning post-SCI, as well as whether HRV-F is associated with better outcomes for secondary conditions such as cardiovascular health, cognitive capacity and mental health.Trial Registration: The study has been prospectively registered with the Australian and New Zealand Clinical Trial Registry ( ACTRN12621000870853 .aspx). Date of Registration: 6th July 2021. Trial Sponsor: The University of Sydney, NSW 2006. Protocol version: 22/07/2021. [ABSTRACT FROM AUTHOR]

Background: Although many people with chronic low back pain (LBP) improve following conservative treatment, one in five will experience worsening symptoms after discharge from treatment and seek health care again. The current LBP clinical care pathway in many health services lacks a well-integrated, systematic approach to support patients to remain physically active and self-manage their symptoms following discharge from treatment. Health coaching can support people to improve physical activity levels and may potentially reduce health care utilisation for LBP. The primary aim of this study is to evaluate the effect of introducing a coordinated support system (linking hospital outpatient physiotherapy services to a public health coaching service) at discharge from LBP treatment, on the future use of hospital, medical, and health services for LBP, compared with usual care provided at discharge.Methods: Three hundred and seventy-four adults with chronic non-specific LBP will be recruited from the outpatient physiotherapy departments of public hospitals in New South Wales, Australia. Participants will be individually randomised to a support system (n = 187) or usual care group (n = 187). All participants will receive usual care provided at discharge from treatment. Participants allocated to the support system will also receive up to 10 telephone-based health coaching sessions, delivered by the Get Healthy Service®, over a 6-month period. Health coaches will monitor and support participants to improve physical activity levels and achieve personal health-related goals. The primary outcome is the total number of encounters with hospital, medical, and health services for LBP, at 12 months from baseline. A within-trial economic evaluation will quantify the incremental costs and benefits of the support system from a health system perspective, to support reimbursement decision making.Discussion: This study will establish the effect of a coordinated support system, introduced at discharge from treatment, on the future use of hospital, medical, and health services for LBP and various health outcomes.Conclusion: Innovative community-driven solutions to support people with chronic LBP after discharge from treatment are urgently needed. Study findings will help inform health care policy and clinical practice in Australia.Trial Registration: Prospectively registered on the Australian New Zealand Clinical Trials Registry ( ACTRN12620000889954 ) on 10/09/2020. [ABSTRACT FROM AUTHOR]

The aim of this randomized controlled trial was to evaluate the impact of a novel 8-week coach development intervention (MASTER) on game-based coaching practices of netball coaches from one netball club (n = 16; 8 intervention, 8 active-control; NSW Australia), and player outcomes for the junior athletes being coached. The multi-component MASTER intervention aimed to educate coaches on how to design and implement high quality game-based coaching sessions. The core pillar of MASTER is 'positive coaching,' delivered through games-based coaching practices. At baseline and 10-weeks, two coaching sessions per coach were filmed and assessed using the MASTER assessment tool. Players (8-16yrs; n = 85) were videoed during structured gameplay, with three aspects of game play assessed using Game Performance Assessment Instrument. Coaches and players (n = 75; 12-16yrs) completed a perceptions questionnaire. Using linear mixed model ITT analysis, significant interventions effects were observed for the primary outcome: percentage of time spent performing playing-form activities [25.7% (95% CI (7.79-43.65), P = 0.008, d = 1.52]. Significant interventions effects were also observed for coach perceptions, player game skills, and player self-perceptions (P < 0.05). No significant changes were observed for player enjoyment, motivation, or wellbeing. The MASTER program was effective in improving coach and player self-perceptions, and coaching practices of netball coaches during training sessions. [ABSTRACT FROM AUTHOR]

Background: Most subsequent new primary or recurrent melanomas might be self-detected if patients are trained to systematically self-examine their skin and have access to timely medical review (patient-led surveillance). Routinely scheduled clinic visits (clinician-led surveillance) is resource-intensive and has not been shown to improve health outcomes; fewer visits may be possible if patient-led surveillance is shown to be safe and effective. The MEL-SELF trial is a randomised controlled trial comparing patient-led surveillance with clinician-led surveillance in people who have been previously treated for localised melanoma.Methods: Stage 0/I/II melanoma patients (n = 600) from dermatology, surgical, or general practice clinics in NSW Australia, will be randomised (1:1) to the intervention (patient-led surveillance, n = 300) or control (usual care, n = 300). Patients in the intervention will undergo a second randomisation 1:1 to polarised (n = 150) or non-polarised (n = 150) dermatoscope. Patient-led surveillance comprises an educational booklet, skin self-examination (SSE) instructional videos; 3-monthly email/SMS reminders to perform SSE; patient-performed dermoscopy with teledermatologist feedback; clinical review of positive teledermoscopy through fast-tracked unscheduled clinic visits; and routinely scheduled clinic visits following each clinician's usual practice. Clinician-led surveillance comprises an educational booklet and routinely scheduled clinic visits following each clinician's usual practice. The primary outcome, measured at 12 months, is the proportion of participants diagnosed with a subsequent new primary or recurrent melanoma at an unscheduled clinic visit. Secondary outcomes include time from randomisation to diagnosis (of a subsequent new primary or recurrent melanoma and of a new keratinocyte cancer), clinicopathological characteristics of subsequent new primary or recurrent melanomas (including AJCC stage), psychological outcomes, and healthcare use. A nested qualitative study will include interviews with patients and clinicians, and a costing study we will compare costs from a societal perspective. We will compare the technical performance of two different models of dermatoscope (polarised vs non-polarised).Discussion: The findings from this study may inform guidance on evidence-based follow-up care, that maximises early detection of subsequent new primary or recurrent melanoma and patient wellbeing, while minimising costs to patients, health systems, and society.Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12621000176864 . Registered on 18 February 2021. [ABSTRACT FROM AUTHOR]

Background: Many school-based physical activity (PA) interventions are complex and have modest effects when delivered in real world contexts. A commonly reported barrier to students' PA, particularly among girls, are uniforms that are impractical (e.g. tunic/dress and black leather shoes). Modifying student uniforms may represent a simple intervention to enhance student PA. The primary aim of this trial was to assess the impact of a PA enabling uniform intervention (shorts, polo shirt and sports shoes) on girls' moderate-to-vigorous physical activity (MVPA) and total PA i.e. counts per minute (cpm). Methods: A cluster randomized controlled trial was undertaken in 42 primary schools in New South Wales, Australia. Schools were randomized on one school day to the intervention group, where students wore a PA enabling uniform (their sports uniform) or a control group, where students wore their usual traditional uniform. Student PA was measured using wrist-worn Actigraph GT3X and GT9X accelerometers. Linear mixed models controlling for student characteristics were used to examine the effects of the intervention.. Results: Of the 3351 eligible students, 2315 (69.1%) had parental consent and 2180 of these consenting students participated (94.2%) of which 1847 (84.7%) were included in the analysis. For the primary aim the study found no significant differences between girls at schools allocated to the intervention relative to the control on change in MVPA (0.76 min, 95% CI − 0.47 to 1.99, p = 0.22) or cpm (36.99, 95% CI − 13.88 to 87.86, p = 0.15). Exploratory analysis revealed small effects for a number of findings, including significant reduction in sedentary activity (− 1.77, 95% CI − 3.40 to − 0.14, p = 0.035) among all students at schools allocated to the intervention, and non-significant improvements in girls' light intensity PA (1.47 min, 95% CI − 0.06 to 3.00, p = 0.059) and sedentary activity (− 2.23 min; 95% CI − 4.49 to 0.02, p = 0.052). Conclusion: The findings suggests that the intervention may yield small improvements in some measure of PA and require substantiation in a larger RCT with longer-term follow-up. The inclusion of additional intervention components may be required to achieve more meaningful effects. Trial registration: The trial was prospectively registered with Australian New Zealand Clinical Trials Register ACTRN12617001266358 1st September 2017. [ABSTRACT FROM AUTHOR]

Background: Transfer of residential aged-care facility (RACF) residents to Emergency Departments (ED) is common, risky and expensive. RACF residents who present to ED are more likely to have hospital readmissions, longer stays and face major risks related to hospital acquired complications. Aged Care Emergency services (ACE) is a nurse led, protocol- guided, telephone RACF/ED outreach model that has been shown to be effective in reducing hospitalisation and length of hospital stay for RACF residents in the Hunter New England Local Health District, New South Wales (NSW). The Partnerships in Aged-Care Emergency services using Interactive Telehealth (PACE-IT) project enhances ACE by incorporating interactive video assessment and consultation. The PACE-IT project's primary aim is to assess whether augmentation of ACE services through the addition of protocol-guided interactive Visual Telehealth Consultation (VTC) for clinical decision-making, plus telephone follow-up, reduces RACF resident transfers to ED.Methods: A stepped-wedge cluster randomised controlled trial will be conducted. The intervention will be delivered sequentially to 8 clusters; each cluster comprises one ED and two RACFs in NSW, Australia. The 16 RACFs in the study will be selected for order of implementation using a computer-generated randomisation sequence. A 2-step randomisation process will be undertaken, randomising the hospital EDs first and then randomising the RACFs aligned with each hospital. The PACE-IT intervention comprises: an initial phone call by RACFs to the ACE service in the ED; the ACE service in ED responds with a protocol-guided VTC, a management plan agreed between all participants; an automated consultation summary letter to the General Practitioner and the RACF; a post VTC 24 h follow-up phone call to the RACF.Discussion: If shown to be effective, the intervention has the potential to improve the clinical care and quality of life for residents. Findings will provide high level evidence that will inform sustainable change and broad translation into practice across NSW. It will show how the change has been achieved and highlight success factors for scalability and sustainability. It will inform review of processes, the development of policy and guidelines that will integrate PACE-IT into existing service models in NSW.Trial Registration: The trial is registered with the Australian New Zealand Clinical Trials Registry (Trial ID ACTR N12619001692123 ) 02/12/2020.). [ABSTRACT FROM AUTHOR]

Background: Clinical practice guidelines and policies direct community mental health services to provide preventive care to address chronic disease risks, however, such care is infrequently provided in routine consultations. An alternative model of care is to appoint a clinician to the dedicated role of offering and providing preventive care in an additional consultation: the 'specialist clinician' model. Economic evaluations of models of care are needed to determine the cost of adhering to guidelines and policies, and to inform pragmatic service delivery decisions. This study is an economic evaluation of the specialist clinician model; designed to achieve policy concordant preventive care delivery.Methods: A retrospective analysis of the incremental costs, cost-effectiveness, and budget impact of a 'specialist preventive care clinician' (an occupational therapist) was conducted in a randomised controlled trial, where participants were randomised to receive usual care; or usual care plus the offer of an additional preventive care consultation with the specialist clinician. The study outcome was client acceptance of referrals to two free telephone-based chronic disease prevention services. This is a key care delivery outcome mandated by the local health district policy of the service. The base case analysis assumed the mental health service cost perspective. A budget impact analysis determined the annual budget required to implement the model of care for all clients of the community mental health service over 5 years.Results: There was a significantly greater increase from baseline to follow-up in the proportion of intervention participants accepting referrals to both telephone services, compared to usual care. The incremental cost-effectiveness ratio was $347 per additional acceptance of a referral (CI: $263-$494). The annual budget required to implement the model of care for all prospective clients was projected to be $711,446 over 5-years; resulting in 2616 accepted referrals.Conclusions: The evaluation provides key information regarding the costs for the mental health service to adhere to policy targets, indicating the model of care involved a low per client cost whilst increasing key preventive care delivery outcomes. Additional modelling is required to further explore its economic benefits.Trial Registration: ACTRN12616001519448. Registered 3 November 2016, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371709. [ABSTRACT FROM AUTHOR]

Purpose: Individuals diagnosed with a high-grade hematological malignancy are at high risk for psychosocial distress. This study aimed to examine the effectiveness of a web-based information tool and nurse delivered telephone support in reducing: (i) unmet information needs; (ii) depression; and (iii) anxiety, among hematological cancer patients and their support persons (SPs). Methods: Patients with a new diagnosis of acute myeloid leukemia, acute lymphoblastic leukemia, Burkitt lymphoma, or lymphoblastic lymphoma and their SPs were enrolled in a prospective multi-site randomized trial. Participants received either access to an online information tool and telephone support from a hematology nurse, or usual care. Outcome data were collected 2, 4, 8, and 12 weeks post-recruitment. The primary endpoint was unmet information needs. Results: Data from 60 patients and 15 SPs were included in the analysis. There were no statistically significant differences in unmet information needs, depression or anxiety between intervention and control groups for patients. Patients in both groups demonstrated a decrease in information needs over the intervention period. Post hoc analyses revealed that patients who did not achieve remission with the first cycle of treatment experienced increased anxiety from 4 weeks until the end of the study (p = 0.008). Conclusions: A web-based information tool and nurse delivered telephone support did not reduce unmet information needs, depression or anxiety among hematological cancer patients, however this finding is inconclusive given the low power of the study. Implications for Psychosocial Providers or Policy: Patients who do not achieve remission are at high risk of anxiety, and may benefit from targeted psychological intervention. [ABSTRACT FROM AUTHOR]

Background: Anxiety and acute distress are significant concerns in the emergency department (ED). Adult coloring books are often utilized as an effective means of relaxation in waiting rooms and newsstands, but there are no reported randomized trials examining their effectiveness as a treatment for anxiety. Methods: We set out to examine the effectiveness of adult coloring books using a randomized placebo‐controlled trial at a university‐affiliated tertiary ED. Anxiety was measured using a validated self‐reporting score, the Hospital Anxiety and Depression Scale (HADS‐A), with a range of 0 to 21. Patients with HADS‐A ≥ 7 were randomly assigned to either an adult coloring pack (n = 26) or placebo pack (n = 27). The primary outcome measure was the within‐patient change in HADS‐A scores following 2 hours of exposure. Results: A convenience sample of 117 patients were screened, and 53 patients were randomized. Characteristics of allocated groups were similar in terms of sex, diagnosis, and ethnicity. A higher proportion of intervention subjects spent ≥1 hour engaged with their activity (46.2% vs. 4.0%, p = 0.01). For the primary outcome measure, the mean within‐patient decrease in HADS‐A score at 2 hours for intervention subjects was 3.7 (95% confidence interval [CI] = 2.4 to 5.1, p < 0.001) versus a decrease of 0.3 (95% CI = –0.6 to 1.2, p = 0.51) in the placebo group. Conclusions: Among ED patients, exposure to adult coloring books resulted in lower self‐reported levels of anxiety at 2 hours compared to placebo. [ABSTRACT FROM AUTHOR]

Background: A priority area in the field of substance dependence treatment is reducing the rates of relapse. Previous research has demonstrated that telephone delivered continuing care interventions are both clinically and cost effective when delivered as a component of outpatient treatment. This protocol describes a NSW Health funded study that assesses the effectiveness of delivering a telephone delivered continuing care intervention for people leaving residential substance treatment in Australia.Methods/design: All participants will be attending residential alcohol and other drug treatment provided by The Salvation Army or We Help Ourselves. The study will be conducted as a randomised controlled trial, where participants will be randomised to one of three treatment arms. The treatment arms will be: (i) 12-session continuing care telephone intervention; (ii) 4-session continuing care telephone intervention, or (iii) continuing care plan only. Baseline assessment batteries and development of the participants' continuing care plan will be completed prior to participants being randomised to a treatment condition. Research staff blind to the treatment condition will complete follow-up assessments with participants at 3-months and 6-months after they have been discharged from their residential service.Discussion: This study will provide comprehensive data on the effect of delivering the continuing care intervention for people exiting residential alcohol and other drug treatment. If shown to be effective, this intervention can be disseminated to improve the rates of relapse among people leaving residential alcohol and other drug treatment.Trial Registration: Australian New Zealand Clinical Trials Registry, ACTRN12618001231235. Registered on 23rd July 2018. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375621&isReview=true. [ABSTRACT FROM AUTHOR]

Abstract: Objectives Get Healthy in Pregnancy (GHiP) is a telephone based lifestyle coaching service for pregnant women, in New South Wales, Australia. GHiP had two service options; a telephone-based health coaching program consisting of up to 10 calls and information only (including one call). This study sought to compare the outcomes of the two GHiP options, to determine the characteristics of women likely to use the service and to explore the feedback from women and health professionals. Methods A pragmatic stratified clustered randomised controlled trial was conducted. Two metro and three rural hospitals were randomised into health coaching or information only arms. Self-reported measures of height and weight and health behaviours (dietary and physical activity) were collected at baseline and 36 weeks gestation. Process evaluation included descriptive analysis of routine program data, and semi-structured interviews with participants and health professionals. Results Of 3736 women screened, 1589 (42.5%) were eligible to participate, and of those eligible, 923 (58.1%) were recruited. More women in the health coaching arm gained weight within the target range for their BMI at 36 weeks gestation (42.9%) compared with information only (31.9%). Women found GHiP to be useful and supportive and midwives and doctors said that it facilitated conversations about weight with pregnant women. Conclusions for Practice Telephone-based lifestyle programs integrated with routine clinical care show promise in helping pregnant women achieve healthy gestational weight gain, but in this case was not significantly different from one information telephone call. Strong positive feedback suggests that scaled-up service delivery would be well received.Trial Registration: ACTRN12615000397516 (retrospectively registered). [ABSTRACT FROM AUTHOR]

Objective: To examine the efficacy of a multi-modal web-based therapy program, Move it to improve it (Mitii™) delivered at home to improve Executive Functioning (EF) in children with an acquired brain injury (ABI). Design: Randomised Waitlist controlled trial. Setting: Home environment. Participants: Sixty children with an ABI were matched in pairs by age and intelligence quotient then randomised to either 20-weeks of Mitii™ training or 20 weeks of Care As Usual (waitlist control; n=30; 17 males; mean age=11y, 11m (±2y, 6m); Full Scale IQ=76.24± 17.84). Fifty-eight children completed baseline assessments (32 males; mean age=11.87±2.47; Full Scale IQ=75.21±16.76). Main Measures: Executive functioning was assessed on four domains: attentional control, cognitive flexibility, goal setting, and information processing using subtests from the Wechsler Intelligence Scale for Children (WISC-IV), Delis-Kaplan Executive Functioning System (D-KEFS), Comprehensive Trail Making Test (CTMT), Tower of London (TOL), and Test of Everyday Attention for Children (Tea-Ch). Executive functioning performance in everyday life was assessed via parent questionnaire (Behaviour Rating Inventory of Executive Functioning; BRIEF). Results: No differences were observed at baseline measures. Groups were compared at 20-weeks using linear regression with no significant differences found between groups on all measures of EF. Out of a potential total dose of 60 hours, children in the Mitii™ group completed a mean of 17 hours of Mitii™ intervention. Conclusion: Results indicate no additional benefit to receiving Mitii™ compared to standard care. Mitii™, in its current form, was not shown to improve EF in children with ABI. [ABSTRACT FROM AUTHOR]

Purpose state:Determine the efficacy of Move-it-to-improve-it (Mitii™), a multi-modal web-based program, in improving Executive Function (EF) in children with unilateral cerebral palsy (UCP). Method:Participants (n = 102) were matched in pairs then randomized to: intervention (Mitii™ for 20 weeks;n = 51; 26 males; mean age = 11 years 8 months (SD = 2 years 4 months); Full Scale IQ = 84.65 (SD = 15.19); 28 left UCP; GMFCS-E&R (I = 20, II = 31) or waitlist control (n = 50; 25 males; mean age = 11 years 10 months (SD = 2 years 5 months); Full Scale IQ = 80.75 (SD = 19.81); 20 left UCP; GMFCS-E&R (I = 25, II = 25). Mitii™ targeted working memory (WM), visual processing (VP), upper limb co-ordination and physical activity. EF capacity was assessed: attentional control (DSB; WISC-IV); cognitive flexibility (inhibition and number-letter sequencing DKEFS); goal setting (D-KEFs Tower Test); and information processing (WISC-IV Symbol Search and Coding). EF performance was assessed via parent report (BRIEF). Groups were compared at 20 weeks using linear regression (SPSS 21). Results:There were no significant between group differences in attentional control (DSB;p = 0.20;CI= −0.40,1.87); cognitive flexibility (Inhibition,p = 0.34; CI= −0.73,2.11; number/letter sequencing,p = 0.17; CI= −0.55,2.94); problem solving (Tower;p = 0.28; CI= −0.61,2.09), information processing (Symbol;p = 0.08; CI= −0.16, 2.75; Coding;p = 0.07; CI= −0.12,2.52) or EF performance (p = 0.13; CI= −10.04,1.38). Conclusion:In a large RCT, MitiiTMdid not lead to significant improvements on measures of EF or parent ratings of EF performance in children with UCP.Implications for rehabilitationA large RCT of the multi-modal web based training; Move It to Improve It (MitiiTM) improves motor processing, visual perception, and physical capacity but does demonstrate statistically significant improvements or clinical significance in executive function in children with mild to moderate unilateral cerebral palsy (UCP).MitiiTM training completed by an intervention group was highly variable with few children reaching the target dosage of 60 h. Technical issues including server and internet connectively problems lead to disengagement with the program.Web-based training delivered in the home has the potential to increase therapy dose and accessibility, however, MitiiTM needs to be tailored to include tasks involving goal-setting, more complex problem solving using multi-dimensional strategies, mental flexibility, switching between two cognitively demanding tasks, and greater novelty in order to increase the cognitive component and challenge required to drive changes in EF. [ABSTRACT FROM AUTHOR]

Background: Older Australians are high consumers of complementary and alternative medicines (CM). To help older people to take an active role in their health, we will develop and evaluate a novel educational intervention to support decision self-efficacy, and improve health literacy skills.Methods: The primary hypothesis is that participants receiving a web/DVD plus booklet intervention compared with a booklet-only group will demonstrate an increase in decision self-efficacy. This study is a randomised controlled trial. One hundred and sixty-eight people aged 65 years and older will be recruited from community settings comprising retirement villages and community groups, based in Sydney, Australia. Participants will be randomly allocated to either the education intervention delivered by the Internet or a DVD plus booklet versus a control group (booklet only). The primary outcome measure is CM decision self-efficacy. Secondary outcomes are health literacy, knowledge and attitudes, and change in health-seeking behaviour. Participants' views on the ease of using the resources, the length of the modules, the amount of information, and participant understanding of the modules will be assessed. Outcomes will be collected on completion of the intervention at 3 weeks, and at a 2-month follow up from trial entry.Discussion: This trial has the potential to improve CM health literacy in older Australians. There are no educational resources designed to support decision self-efficacy and improve health literacy amongst older people related to CM.Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12616000135415 . Registered on 5 February 2016. [ABSTRACT FROM AUTHOR]

Purpose state: Determine the efficacy of Move-it-to-improve-it (Mitii™), a multi-modal web-based program, in improving Executive Function (EF) in children with unilateral cerebral palsy (UCP). Method: Participants (n=102) were matched in pairs then randomized to: intervention (Mitii™ for 20 weeks; n=51; 26 males; mean age=11 years 8 months (SD=2 years 4 months); Full Scale IQ=84.65 (SD=15.19); 28 left UCP; GMFCS-E&R (I=20, II=31) or waitlist control (n=50; 25 males; mean age=11 years 10 months (SD=2 years 5 months); Full Scale IQ=80.75 (SD=19.81); 20 left UCP; GMFCS-E&R (I=25, II=25). Mitii™ targeted working memory (WM), visual processing (VP), upper limb co-ordination and physical activity. EF capacity was assessed: attentional control (DSB; WISC-IV); cognitive flexibility (inhibition and number-letter sequencing DKEFS); goal setting (D-KEFs Tower Test); and information processing (WISC-IV Symbol Search and Coding). EF performance was assessed via parent report (BRIEF). Groups were compared at 20 weeks using linear regression (SPSS 21). Results: There were no significant between group differences in attentional control (DSB; p=0.20; CI=-0.40,1.87); cognitive flexibility (Inhibition, p=0.34; CI=-0.73,2.11; number/letter sequencing, p=0.17; CI=-0.55,2.94); problem solving (Tower; p=0.28; CI=-0.61,2.09), information processing (Symbol; p=0.08; CI=-0.16, 2.75; Coding; p=0.07; CI=-0.12,2.52) or EF performance (p=0.13; CI=-10.04,1.38). Conclusion: In a large RCT, Mitii™ did not lead to significant improvements on measures of EF or parent ratings of EF performance in children with UCP. [ABSTRACT FROM AUTHOR]

Background: Levels of sitting among adolescents are high, especially during the school day. The acute cognitive and health consequences associated with prolonged sitting are poorly understood in adolescents. This randomized crossover design study examined the acute effects of a simulated school day with reduced sitting or usual sitting on adolescents' cognitive function and cardiometabolic biomarkers.Methods: Eighteen healthy school aged adolescents were recruited from the community to the study (11 males; 7 females; mean age [SD] = 13.5 ± 0.9 years). Two protocols were developed to simulate an adolescent school day, the amount of time spent sitting was manipulated reflecting: a 'typical' day (65% of the time spent sitting with two sitting bouts sitting >20 min) and a 'reduced sitting' day (adolescents sat for 50% less time with no bouts of sitting >20 mins). The order that participants were exposed to each condition was randomized (via random number generator). Participants were not fully blinded as they could observe the difference between conditions. Energy intake and moderate to vigorous physical activity (MVPA) were standardized for both conditions and monitored for 48 h post-condition for compensatory effects. Cognitive (working memory) and cardiometabolic outcomes (lipids, glucose, insulin, IL-6, apo-A1, apo-B, blood pressure,) were assessed pre and post for both conditions, BMI and body fat were assessed on the morning of the intervention. Data were analyzed using linear mixed models. Standardised effect sizes were calculated.Results: Compared with the typical school day, the reduced sitting day demonstrated significant positive effects for apoB/apoA-1 ratio (adjusted difference ± SD) -0.02 ± 0.03; P = 0.03; effect size [Cohen's d] = -0.67. Findings for total cholesterol -0.19 ± 0.27; P = 0.28; d = -0.71; HDL cholesterol -0.23 ± 0.50; P = 0.12 d = -0.66; and total cholesterol/HDL ratio 0.25 ± 0.53; P = 0.25; d = 0.51 and for cognition 0.64 ± 0.15; P = 0.15; d = 0.54 were non-significant. There were no compensatory changes in participant energy expenditure or energy intake for 48 h post intervention.Conclusion: Reducing school day sitting time in adolescents' resulted in significant improvements in apoB/apoA-1 ratio with medium effect sizes for total cholesterol, HDL cholesterol and total cholesterol/HDL ratio. Cognitive function results showed the equivalent of a 6 month improvement in effective mental-attentional capacity.Trial Registration: The trial was registered as a clinical trial with the Australian and New Zealand Clinical Trials Registry ( ACTRN12614001064695 ) on the 3rd of October 2014 - registered retrospectively. [ABSTRACT FROM AUTHOR]

Background: Current research indicates that obese individuals have cognitive deficits in executive function, leading to difficulties with planning, impulse control and decision-making. High levels of inflammation have been proposed to contribute to executive function deficits in individuals with obesity.Methods/design: One hundred and seventy-six obese participants will be randomly assigned to one of two groups: (1) behavioural weight loss alone (BWL) group = 8 sessions of individual BWL sessions plus 12 group BWL sessions or (2) Cognitive Remediation Therapy for Obesity (CRT-O) plus BWL group (CRT-O + BWL) = 8 sessions of individual CRT-O plus 12 group BWL sessions. The study is double blind - participants will only be told that two weight-loss treatments are being compared and research assistants conducting outcome assessments will not know participants' group allocation. Blood tests will be conducted to measure inflammatory markers. Measurement points will be at baseline, post treatment and 1-year follow-up. The primary outcomes will be differences between treatment groups in percentage weight loss, executive function, binge eating and an examination of whether changes in executive function predict changes in weight and binge eating. Secondary outcome measures will examine changes on inflammation, quality of life, and grazing behaviour and whether these predict changes in executive function and weight.Discussion: If CRT-O + BWL is more effective in assisting people to lose weight long term than BWL alone it should significantly improve treatment outcomes. This study expands upon our recent trial which showed that CRT-O enhanced executive function and weight loss in obese adults. The current study is strengthened by several factors: it is double-blind, it uses an active control, has a larger sample size, and measures inflammation to examine the mechanisms.Trial Registration: The RCT is registered with the Australian New Zealand Registry of Clinical Trial, trial identifier: ACTRN12616000658415 . Registered on 20 May 2016. [ABSTRACT FROM AUTHOR]

Background: Shifts in the gastrointestinal microbiome have been shown to contribute to the progression of metabolic diseases including prediabetes and type 2 diabetes mellitus. Research suggests that in-vivo modulation of the gut microbiome by specific probiotic microorganisms may improve insulin sensitivity and blood sugar management, preventing or delaying the development of type 2 diabetes mellitus. However, further research is needed to understand the effect of probiotics as a therapy for the treatment of metabolic diseases. An evidence-based multi-species probiotic was developed to encourage a shift in the gastrointestinal bacterial cohort from a disease-prone to a balanced state with the aim of improving metabolic markers associated with type 2 diabetes mellitus.Methods: Sixty adults with a body mass index ≥25 kg/m2 with prediabetes or type 2 diabetes mellitus (diagnosed within the previous 12 months) will be enrolled in a double-blind, placebo-controlled pilot study. Participants will be randomized to a multi-species probiotic or placebo for 12 weeks. Both groups will receive lifestyle and nutritional advice. The primary outcome measure is the change between groups in fasting plasma glucose levels from baseline to 12 weeks. Secondary outcome measures include, but are not limited to, the change in lipid profile, systemic inflammation, gut permeability, and faecal microbial and metabolomic profiles. Blood and stool samples are collected at baseline and 12 weeks after treatment.Discussion: Intentional manipulation of gastrointestinal microbial profiles may be useful for preventing and controlling type 2 diabetes mellitus and its associated metabolic complications.Trial Registration: Australian New Zealand Clinical Trials Registry, ACTRN12613001378718 . Registered on 16 December 2013. [ABSTRACT FROM AUTHOR]

Background: Previous evaluations have supported the link between sun protection policies and improved sun protection behaviours. However these evaluations have relied on self-reported data.Methods: A cross-sectional design as part of an ongoing 18-month cluster-controlled trial in primary schools (n = 20) was used. Researchers conducted direct observations to record students' hat use and teachers' use of sun protective measures during recess and lunch. Researchers also recorded the volume of sunscreen consumed in each school.Results: Only 60% of primary school children wear a sun-safe hat during their breaks when observed using objective measures. Weak correlations were observed between the wearing of a sun-safe hat and a school's socio-economic status (r = 0.26). All other independent variables measured had only very weak correlations (r < 0.19) with sun-safe hat wearing behaviour of students. Sunscreen consumption by school students during the school day is negligible.Conclusions: A large percentage of NSW primary schools in this study wear sun-safe hats during the school day but this is well below what has been reported in previous national surveys. Given the finite resources of schools and the correlation, though small, with SES status for these behaviours, it behoves researchers to investigate low-cost solutions to these problems. Further qualitative data will also be needed to inform the enablers and barriers for sun-safe behaviour interventions to be adopted in NSW primary schools. [ABSTRACT FROM AUTHOR]

Background Exposure to secondhand smoke (SHS) is a significant contributor to ill health in children. A study was undertaken to determine the effectiveness of two brief multi-strategic child health nurse delivered interventions in: decreasing the prevalence of infants exposed to SHS; decreasing the prevalence of smoking amongst parent/carers of infants and increasing the prevalence of household smoking bans. Methods This study was a 3 arm, cluster randomised controlled trial. Clusters were 39 community based well child health clinics in one local area health service. Clinics were stratified according to annual number of client appointments and then randomly assigned in a 1:1:1 ratio, (Intervention 1: Intervention 2: Control), with 13 clinics in each cluster. Parents/carers of infants in the intervention groups received a brief multi-strategic intervention from child health nurses during clinic consultations. Treatment condition 1 included computer delivered risk assessment and feedback and nurse brief advice. Treatment condition 2 included all elements of Treatment condition 1 with the addition of biochemical feedback of infant SHS exposure. Results When compared to the Control group at 12 months, no significant differences in the prevalence of infant exposure to SHS were detected from baseline to follow-up for Treatment condition 1 (OR 1.16, 95 % CI 0.73-1.85, p = 0.53) or Treatment condition 2 (OR 1.30, 95 % CI 0.88-1.92, p = 0.19) Similarly, no significant differences were detected in the proportion of parent/carers who reported that they were smokers (T1:OR 0.95, 95 % CI 0.78-1.15, p = 0.58 and T2:OR 0.97, 95 % CI 0.80-1.18, p = 0.77), or in the proportion of households reported to have a complete smoking ban (T1:OR 1.21, 95 % CI 0.89-1.64, p = 0.23 and T2:OR 1.06, 95 % CI 0.79-1.43, p = 0.68). Conclusions Further research is required to identify effective interventions that can be consistently provided by child health nurses if the potential of such settings to contribute to reductions in child SHS exposure is to be realised. [ABSTRACT FROM AUTHOR]

Background: The implementation of nutrition policies in schools has been recommended as a strategy to improve child dietary intake. Internationally, research suggests that the majority of schools do not implement these policies. In New South Wales (NSW), Australia, the NSW Healthy School Canteen Policy requires that school canteens prohibit the sale of 'red' foods (i.e. foods that are typically nutrient poor and high in energy, such as confectionary and deep-fried foods) and 'banned'drinks (i.e. soft drinks); and that the majority of items on the menu are 'green' (i.e. foods that are good sources of nutrients, such fruits, vegetables and lean meats). This study examined the impact of a multicomponent audit and feedback intervention on schools' implementation of the NSW Healthy School Canteen Policy. A secondary aim was to assess the impact of the intervention on menu composition. Methods: This study was a parallel group randomised controlled trial with 72 rural and remote primary schools (36 interventions, 36 controls) located in one region within NSW, Australia. Intervention schools received an initial face to face contact and up to four cycles of audit and feedback (consisting of a menu audit, written feedback report and telephone feedback) over a 12-month period. The primary trial outcomes were the proportion of schools with a canteen menu that had: i) no 'red' foods or 'banned' drinks; and ii) >50% 'green' items, as assessed via standardised menu audits undertaken by trained dietitians. For each primary outcome, between-group differences were assessed using Fisher's exact test under an intention to treat approach. Results: There was insufficient evidence to conclude the intervention had a positive impact on the proportion of intervention schools with no 'red' or 'banned' items on their menu (RR = 2.8; 95% CI: 0.9 to 8.9; p = 0.0895), or on the proportion of intervention schools with more than 50% 'green' items (RR = 1.5; 95% CI: 0.7 to 3.2; p = 0.2568). These findings remained non-significant in the multiple imputation analyses. Intervention schools were significantly more likely to have a lower percentage of 'red' items (p-value: 0.007) and a higher percentage of 'green' items on the menu (p-value: 0.014). This remained statistically significant in the multiple imputation analyses for 'red items' (p-value: 0.0081) but not for 'green' items (p-value: 0.0910). Conclusions: While there was insufficient statistical evidence to suggest that this multicomponent audit and feedback intervention was effective in improving primary schools' compliance with a healthy canteen policy, the intervention demonstrated some positive impact in reducing the availability of 'red' items on the menu. Trial registration: This trial was prospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12613000543785). Registered 15th May 2013. [ABSTRACT FROM AUTHOR]

Background: Self-monitoring is an essential behavioral strategy for effective weight loss programs. Traditionally, self-monitoring has been achieved using paper-based records. However, technology is now more frequently used to deliver treatment programs to overweight and obese adults. Information technologies, such as the Internet and mobile phones, allow innovative intervention features to be incorporated into treatment that may facilitate greater adherence to self-monitoring processes, provide motivation for behavior change, and ultimately lead to greater weight loss success.Objective: The objective of our study was to determine whether the consistency of self-monitoring differed between participants randomly assigned to a basic or an enhanced 12-week commercial Web-based weight loss program.Methods: We randomly assigned a sample of 301 adults (mean age 42.3 years; body mass index 31.3 kg/m2; female 176/301, 58.5%) to the basic or enhanced group. The basic program included tools for self-monitoring (online food and exercise diary, and a weekly weigh-in log) with some feedback and reminders to weigh in (by text or email). The enhanced program included the basic components, as well as extra individualized feedback on self-monitoring entries and reminders (by text, email, or telephone) to engage with self-monitoring tools. We evaluated the level of self-monitoring by examining the consistency of self-monitoring of food, exercise, and weight during the 12 weeks. Consistency was defined as the number of weeks during which participants completed a criterion number of entries (ie, ≥3 days of online food or exercise diary records per week and ≥1 weigh-in per week).Results: The enhanced group's consistency of use of self-monitoring tools was significantly greater than that of the basic group throughout the 12 weeks (median consistency for food 8 vs 3 weeks, respectively, P<.001; for exercise 2.5 vs 1 weeks, respectively, P=.003).Conclusions: Enhanced features, including additional individualized feedback and reminders, are effective in enhancing self-monitoring behaviors in a Web-based weight loss program.Clinicaltrial: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12610000197033; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=335159 (Archived by WebCite at http://www.webcitation.org/6gCQdj21G). [ABSTRACT FROM AUTHOR]

Background: The Safety Attitudes Questionnaire (SAQ) is commonly used to assess staff perception of safety climate within their clinical environment. The psychometric properties of the SAQ have previously been explored with confirmatory factor analysis and found to have some issues with construct validity. This study aimed to extend the psychometric evaluations of the SAQ by using Rasch analysis.Methods: Assessment of internal construct validity included overall fit to the Rasch model (unidimensionality), response formats, targeting, differential item functioning (DIF) and person-separation index (PSI).Results: A total of 420 nurses completed the SAQ (response rate 60 %). Data showed overall fit to a Rasch model of expected item functioning for interval scale measurement. The questionnaire demonstrated unidimensionality confirming the appropriateness of summing the items in each domain. Score reliabilities were appropriate (internal consistency PSI 0.6-0.8). However, participants were not using the response options on the SAQ in a consistent manner. All domains demonstrated suboptimal targeting and showed compromised score precision towards higher levels of safety climate (substantial ceiling effects).Conclusion: There was general support for the reliability of the SAQ as a measure of safety climate although it may not be able to detect small but clinically important changes in safety climate within an organisation. Further refinement of the SAQ is warranted. This may involve changing the response options and including new items to improve the overall targeting of the scale.Trial Registration: This study was registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12611000332921 (21 March 2011). [ABSTRACT FROM AUTHOR]

Background: In 2011, more than half of the patients with stroke in Australian hospitals were not assessed for the need for rehabilitation. Further, there were no recommended criteria to guide rehabilitation assessment decisions. Subsequently, a decision-making tool called the Assessment for Rehabilitation Tool (ART) was developed. The ART was designed to assist Australian hospital clinicians to identify the rehabilitation needs of patients with stroke using evidence-based criteria. The ART was released and made freely available for use in 2012. This study evaluated the effectiveness of an education-only intervention (1 onsite education session and distribution of the ART) and a multifaceted intervention (2 or more onsite education sessions, distribution of the ART, audit and feedback, barrier identification, site-specific strategy development, promotion of interdisciplinary teamwork, opinion leaders and reminders) for improving assessments of rehabilitation needs after stroke.Methods: Ten hospitals in 2 states of Australia were randomly assigned to an education-only or a multifaceted intervention. Medical records were audited by assessors blinded to group allocation before and after the implementation period. Difference in the proportion of patients assessed for rehabilitation before and after the intervention was analysed using mixed-effects logistic regression analysis, with time period as the dependent variable, an interaction between intervention type and time included to test for differences between the interventions, and hospital included as the random effect to account for patient clustering.Results: Data from 586 patients (284 pre-intervention; 302 post-intervention; age 76 years, 59 % male) showed that the multifaceted intervention was not more effective than education-only in improving the proportion of patients whose rehabilitation needs were assessed (reference category education-only; odds ratio 1.29, 95 % confidence interval 0.63-2.67, p = 0.483). Post-intervention, the odds of a patient's rehabilitation needs being assessed was 3.69 times greater than pre-intervention (95 % confidence interval 2.57-5.30, p < 0.001). Evidence-based criteria were not consistently used when patients were deemed to have no rehabilitation needs.Conclusions: A multifaceted intervention was not more effective than education-only in improving the assessment of rehabilitation needs of patients with stroke. Further interventions are required to ensure that all patients are assessed for the need for rehabilitation using evidence-based criteria.Trial Registration: ANZCTR (Australian New Zealand Clinical Trials Registry), ACTRN12616000340437. [ABSTRACT FROM AUTHOR]

Aim: To describe difficulties experienced with recruitment of frail, malnourished inpatients aged 65+ years to a 12‐week multidisciplinary home‐based nutrition and physical activity intervention (SUSTAIN) and to identify factors associated with non‐participation. Methods: A multidisciplinary team approach to recruitment involved monthly team meetings, weekly clinician case conferences and strategic planning to accommodate patient needs (provision of transport, easy access to facilities, appropriate written/verbal information). Intensive recruitment occurred in eligible inpatients from a major acute tertiary and rehabilitation hospitals in a local health district over seven months. Results: Of the 124 patients screened, 88 were not eligible, 32 declined, and 4 consented. Neither socio‐demographic nor clinical characteristics (age, gender, clinical diagnosis, birthplace, cognitive function, length of stay or nutritional status) explained non‐participation or ineligibility or refusals rates. Conclusions: The advanced age and poor overall health status of this population necessitates alternative recruitment strategies to improve participation in clinical trials and improve generalisability for clinical practice. [ABSTRACT FROM AUTHOR]

Background: Many adults are insufficiently physically active, have prolonged sedentary behaviour and report poor sleep. These behaviours can be improved by interventions that include education, goal setting, self-monitoring, and feedback strategies. Few interventions have explicitly targeted these behaviours simultaneously or examined the relative efficacy of different self-monitoring methods.Methods/design: This study aims to compare the efficacy of two self-monitoring methods in an app-based multi-behaviour intervention to improve objectively measured physical activity, sedentary, and sleep behaviours, in a 9 week 2-arm randomised trial. Participants will be adults (n = 64) who report being physically inactive, sitting >8 h/day and frequent insufficient sleep (≥14 days out of last 30). The "Balanced" intervention is delivered via a smartphone 'app', and includes education materials (guidelines, strategies to promote change in behaviour), goal setting, self-monitoring and feedback support. Participants will be randomly allocated to either a device-entered or user-entered self-monitoring method. The device-entered group will be provided with a activity tracker to self-monitor behaviours. The user-entered group will recall and manually record behaviours. Assessments will be conducted at 0, 3, 6, and 9 weeks. Physical activity, sedentary behaviour and sleep-wake behaviours will be measured using the wrist worn Geneactiv accelerometer. Linear mixed models will be used to examine differences between groups and over time using an alpha of 0.01.Discussion: This study will evaluate an app-based multi-behavioural intervention to improve physical activity, sedentary behaviour and sleep; and the relative efficacy of two different approaches to self-monitoring these behaviours. Outcomes will provide information to inform future interventions and self-monitoring targeting these behaviours.Trial Registration: ACTRN12615000182594 (Australian New Zealand Clinical Trials Registry. Registry URL: www.anzctr.org.au ; registered prospectively on 25 February 2015). [ABSTRACT FROM AUTHOR]

Background: The school system has been identified as an ideal setting for the implementation of prevention and early intervention programs for suicide. However, in Australia, suicide-prevention programs that are routinely delivered in the schools are lacking. Internationally, evidence exists for the effectiveness of peer-led interventions that take a social connectedness approach to improve help-seeking for suicide. The aim of the current trial is to test the effectiveness of the Sources of Strength program to promote help-seeking for suicide in adolescents in Australian high schools.Methods/design: This study is a two-arm, cluster-randomised, controlled trial that will compare the evidence-based Sources of Strength program to a wait-list control condition. Sixteen Australian high schools will be recruited to the trial, with all adolescents in years 7 to 10 (12-16 years of age) invited to participate. Peer leaders from intervention-condition schools will receive training in the Sources of Strength program and will integrate positive messages, across 3 months, with the support of adult advisors. Activities may take the form of class presentations, posters, videos, and messages on social media sites and will aim to change help-seeking norms, strengthen youth-adult connections, and promote positive coping. The primary outcome measure for the study is help-seeking intentions, whereas secondary outcomes include help-seeking behaviour, help-seeking attitudes and norms, referral of distressed peers, availability of adult help, positive coping, and suicidal behaviour. Data will be collected pre-intervention, post-intervention (after the initial 3 months of messaging), and at the end of the first (6-month follow-up) and the second year after implementation (18-month follow-up). Primary analyses will compare changes in help-seeking intentions for the intervention condition relative to the wait-list control condition using mixed-effect repeated-measures analyses to account for clustering within schools.Discussion: If proven effective, this universal social connectedness program for suicide could be more widely delivered in Australian high schools, providing a valuable new resource. The Sources of Strength program has the potential to significantly contribute to the mental health of young people in Australia by improving help-seeking for suicide. The findings from this research will also contribute to the evidence-base for peer-leadership programs internationally.Trial Registration: Australian New Zealand Clinical Trials Registry, ACTRN12616000048482 . Registered on 19 January 2016. [ABSTRACT FROM AUTHOR]