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Background: Continuity of care by a primary midwife during the antenatal, intrapartum and postpartum periods has been recommended in Australia and many hospitals have introduced a caseload midwifery model of care. The aim of this paper is to evaluate the effect of caseload midwifery on women's satisfaction with care across the maternity continuum.Methods: Pregnant women at low risk of complications, booking for care at a tertiary hospital in Melbourne, Australia, were recruited to a randomised controlled trial between September 2007 and June 2010. Women were randomised to caseload midwifery or standard care. The caseload model included antenatal, intrapartum and postpartum care from a primary midwife with back-up provided by another known midwife when necessary. Women allocated to standard care received midwife-led care with varying levels of continuity, junior obstetric care, or community-based general practitioner care. Data for this paper were collected by background questionnaire prior to randomisation and a follow-up questionnaire sent at two months postpartum. The primary analysis was by intention to treat. A secondary analysis explored the effect of intrapartum continuity of carer on overall satisfaction rating.Results: Two thousand, three hundred fourteen women were randomised: 1,156 to caseload care and 1,158 to standard care. The response rate to the two month survey was 88% in the caseload group and 74% in the standard care group. Compared with standard care, caseload care was associated with higher overall ratings of satisfaction with antenatal care (OR 3.35; 95% CI 2.79, 4.03), intrapartum care (OR 2.14; 95% CI 1.78, 2.57), hospital postpartum care (OR 1.56, 95% CI 1.32, 1.85) and home-based postpartum care (OR 3.19; 95% CI 2.64, 3.85).Conclusion: For women at low risk of medical complications, caseload midwifery increases women's satisfaction with antenatal, intrapartum and postpartum care.Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN012607000073404 (registration complete 23rd January 2007). [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: Pragmatic randomised controlled trials (PRCTs) aim to assess intervention effectiveness by accounting for 'real life' implementation challenges in routine practice. The methodological challenges of PRCT implementation, particularly in primary care, are not well understood. The Kanyini Guidelines Adherence to Polypill study (Kanyini GAP) was a recent primary care PRCT involving multiple private general practices, Indigenous community controlled health services and private community pharmacies. Through the experiences of Kanyini GAP participants, and using data from study materials, this paper identifies the critical enablers and barriers to implementing a PRCT across diverse practice settings and makes recommendations for future PRCT implementation.Methods: Qualitative data from 94 semi-structured interviews (47 healthcare providers (pharmacists, general practitioners, Aboriginal health workers; 47 patients) conducted for the process evaluation of Kanyini GAP was used. Data coded to 'trial impact', 'research motivation' and 'real world' were explored and triangulated with data extracted from study materials (e.g. Emails, memoranda of understanding and financial statements).Results: PRCT implementation was facilitated by an extensive process of relationship building at the trial outset including building on existing relationships between core investigators and service providers. Health providers' and participants' altruism, increased professional satisfaction, collaboration, research capacity and opportunities for improved patient care enabled implementation. Inadequate research infrastructure, excessive administrative demands, insufficient numbers of adequately trained staff and the potential financial impact on private practice were considered implementation barriers. These were largely related to this being the first experience of trial involvement for many sites. The significant costs of addressing these barriers drew study resources from the task of achieving recruitment targets.Conclusions: Conducting PRCTs is crucial to generating credible evidence of intervention effectiveness in routine practice. PRCT implementation needs to account for the particular challenges of implementing collaborative research across diverse stakeholder organisations. Reliance on goodwill to participate is crucial at the outset. However, participation costs, particularly for organisations with little or no research experience, can be substantial and should be factored into PRCT funding models. Investment in a pool to fund infrastructure in the form of primary health research networks will offset some of these costs, enabling future studies to be implemented more cost-effectively.Trial Registration: ACTRN126080005833347. [ABSTRACT FROM AUTHOR]

Background: Depression treatments are typically less effective for young people than for adults. However, treatments rarely target loneliness, which is a key risk factor in the onset, maintenance and development of depression.Aims: This study evaluated the efficacy of a novel loneliness intervention, Groups 4 Health (G4H), relative to the best-practice treatment of cognitive-behavioural therapy (CBT) in reducing loneliness and depression over a 12-month period (Australian New Zealand Clinical Trial Registry: ACTRN12618000440224).Method: The study was a phase 3 randomised non-inferiority trial comparing G4H with dose-controlled group CBT. Participants were 174 people aged 15-25 years experiencing loneliness and clinically significant symptoms of depression, who were not in receipt of adjunct treatment. Participants were recruited from mental health services in Southeast Queensland, Australia. Randomisation was conducted using computer software. Follow-up assessments and statistical analyses were masked to allocation. Both interventions consisted of five 75 min group-based psychotherapy sessions. The primary outcomes were depression and loneliness, with a non-inferiority margin of 2.20 for depression.Results: The trial enrolled 174 participants between 24 April 2018 and 25 May 2019, with 84 in the G4H condition and 90 in the CBT condition. All randomised participants were included in the intention-to-treat analyses (n = 174). The pre-post effect sizes for depression were dG4H = -0.71 and dCBT = -0.91. For loneliness, they were dG4H = -1.07 and dCBT = -0.89. At 12-month follow-up, the absolute difference between groups on depression was 1.176 (95% CI -1.94 to 4.29) and on loneliness it was -0.679 (95% CI -1.43 to 0.07). No adverse effects were observed.Conclusions: G4H was non-inferior to CBT for depression and showed a slight advantage over CBT for loneliness that emerged after treatment completion. [ABSTRACT FROM AUTHOR]

Buprenorphine was registered in Australia as a maintenance and detoxification agent for the management of opioid dependence in November, 2000, and became widely available in August, 2001. This paper provides an overview of key developments in the introduction of buprenorphine treatment in Australia, with an emphasis upon the delivery of services in community-based (primary care) settings. A central study in this work was the Buprenorphine Implementation Trial (BIT), a randomized, controlled trial comparing buprenorphine and methadone maintenance treatment delivered under naturalistic conditions by specialist and community-based service providers (general practitioners and community pharmacists) in 139 subjects across nineteen treatment sites. In addition to conventional patient outcome measures (treatment retention, drug use, psychosocial functioning, and cost effectiveness), the BIT study also involved the development and evaluation of clinical guidelines, training programs for clinicians, and client literature, which are described here. Integration of treatment systems (methadone with buprenorphine, specialist and primary-care programs) and factors thought to be important in the uptake of buprenorphine treatment in Australia since registration are discussed. [ABSTRACT FROM AUTHOR]

Background: Lateral elbow pain (LEP) due to tendinosis is one of the most common musculoskeletal pains of the upper limbs, yet there is no satisfactory treatment. This study was an international, prospective, multi-centre, randomized, controlled, clinical trial to evaluate the efficacy of acupuncture compared to sham laser in the treatment of LEP.Methods: The study used a parallel and stratified design (1:1 allocation using a computer-generated sequence) and was participant-, outcome assessor- and statistician-blinded. Subjects from 18 to 80 years with unilateral chronic LEP (minimum three months) were recruited at four centres in Australia, China, Hong Kong and Italy. The treatment group received manual acupuncture at acupoints LI 10 and LI 11 on the affected side whereas the control group received sham laser acupuncture at the same acupoints. The primary endpoint was disabilities of the arm, shoulder, and hand (DASH) questionnaire score at the three-week post-treatment follow-up visit. Three VAS scales (pain at rest, pain on motion and pain during exertion) were secondary outcomes measures. Ninety-six subjects were allocated to either the treatment group (n = 47) or control group (n = 49) and were all included in the analysis.Results: At the follow-up visit, we found significant differences in DASH score between the two groups (p = .015). The median change to baseline for the treatment group was -11.7 (interval: -50.83 to 23.33), and for the control group -7.50 (interval: -36.67 to 29.10). The estimated effect size was 0.47, indicating a medium effect. Significant differences were also found for secondary outcome measures for VAS of pain. There were no severe adverse events. Our findings suggest that acupuncture has a moderate efficacy in the treatment of LEP.Conclusions: Acupuncture was shown to be efficacious in improving the function of the arm associated with lateral elbow tendinosis. Both the DASH score and the pain VAS on two occasions (at rest and during motion) showed a significant change over time indicating acupuncture as a potential treatment for LEP due to tendinosis. [ABSTRACT FROM AUTHOR]

The aim of this study was to investigate the feasibility and impact of an action and coping planning intervention deployed in gambling venues to improve adherence to expenditure limits. We conducted a 2-group parallel-block randomised controlled trial comparing one 20-min session of action and coping planning to an assessment alone. Gamblers who were intending to set a monetary limit on EGMs (n = 184) were recruited in venues and administered the intervention prior to gambling. Measures were adherence to self-identified gambling limits and adherence to expenditure intentions at 30-days post-intervention using the Time Line Follow-Back. The intervention was feasible in terms of recruitment and willingness of gamblers to engage in a pre-gambling intervention. Most gamblers enacted strategies to limit their gambling prior to entering the venue, albeit these limits were on average higher than the Australian low risk gambling guidelines. In terms of impact, the intervention did not improve adherence to limits at post or 30-day follow-up assessment. However, Moderate Risk/Problem Gamblers in the Intervention group spent less (a median of $60 less) than intended (median $100) within the venue. All intervention participants intended to spend significantly less in the 30 days after the intervention compared to the amount spent in the 30 days prior to the intervention. This reduction was not found for participants in the control group. A simple brief intervention appears feasible in gambling venues and have an impact on gambling intentions over the short term. [ABSTRACT FROM AUTHOR]

Background: A single assessment of psychological distress, which includes depression and anxiety, has been associated with increased mortality in patients with coronary heart disease, but the prognostic importance of persistence of distress symptoms is less certain.Aim: To determine whether intermittent and/or persistent psychological distress is associated with long-term cardiovascular (CV) and total mortality in patients with stable coronary artery disease.Methods: 950 participants in the Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) trial completed at least four General Health Questionnaires (GHQ-30) at baseline and after ½, 1, 2 and 4 years. In a landmark analysis from 4 years, Cox proportional hazards models evaluated the risk of CV and total mortality by increasing levels of psychological distress: never distressed, sometimes any severity (GHQ score >5), persistent mild (GHQ score >5 on three or more occasions) and persistent moderate distress (GHQ score >10) on three or more occasions, over a median of 12.1 (IQR 8.6-12.5) years. The models were both unadjusted and adjusted for known baseline risk factors.Results: Persistent moderate or greater psychological stress was reported on three or more assessments by 35 (3.7%) subjects. These patients had a higher risk of both CV death (adjusted HR 3.94, 95% CI 2.05 to 7.56, p<0.001) and all-cause mortality (adjusted HR 2.85, 95% CI 1.74 to 4.66, p<0.001) compared with patients with no distress. In contrast, patients who reported persistent mild distress (n=73, 7.7%) on three or more visits, and those who met criteria for distress on only one or two assessments (n=255, 26.8%), did not have an increased risk of CV or all-cause mortality during follow-up.Conclusion: In patients with stable coronary artery disease, persistent psychological distress of at least moderate severity is associated with a substantial increase in CV and all-cause mortality. [ABSTRACT FROM AUTHOR]

Background: Reducing alcohol related harms in Australian Defence Force (ADF) trainees has been identified as a priority, but there are few evidence-based prevention programs available for the military setting. The study aims to test whether the P.A.R.T.Y. program delivered in-hospital or on-base, can reduce harmful alcohol consumption among ADF trainees.Methods/design: The study is a 3-arm randomized controlled trial, involving 953 Royal Australian Navy trainees from a single base. Trainees, aged 18 to 30 years, will be randomly assigned to the study arms: i. in-hospital P.A.R.T.Y.; ii. On-base P.A.R.T.Y.; and iii.Control Group: All groups will receive the routine ADF annual alcohol awareness training. The primary outcome is the proportion of participants reporting an Alcohol Use Disorders Identification Test (AUDIT) score of 8 or above at 12 months' post-intervention. The secondary outcome is the number of alcohol related incidents reported to the Royal Australian Navy (RAN) in the 12 months' post-intervention.Discussion: This is the first trial of the use of the P.A.R.T.Y. program in the military. If the proposed intervention proves efficacious, it may be a useful program in the early education of RAN trainees.Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12614001332617 , date of registration: 18/12/2014 'retrospectively registered'. [ABSTRACT FROM AUTHOR]

Background: Excessive gestational weight gain can result in poor maternal and child health outcomes. Estimates from single studies indicate the prevalence of excessive gestational weight gain in Australia could lie between 38 and 67 %. The risk of excessive weight gain can be reduced through healthy eating and exercise. We describe the rationale and methods of the Get Healthy in Pregnancy Service, a trial service which aims to support women in achieving appropriate gestational weight gain through an existing telephone-based health coaching service.Methods/design: This study aims to compare the effectiveness of a telephone-based health coaching program versus provision of information only in supporting pregnant women to achieve appropriate gestational weight gain. A pragmatic stratified clustered randomised controlled trial will be conducted with 710 women who present to 5 hospitals for their first antenatal appointment during the recruitment period (6-8 months), have a pre-pregnancy body mass index (BMI) ≥ 18.50 (healthy weight or above), are 18 years and over, singleton gestation, English speaking, have no pre-existing medical conditions that may limit their ability to exercise or require a restricted diet and are 18 weeks or less gestation. Hospitals will be randomised into one of two intervention models: a) information only; or b) information plus 10 telephone-based health coaching sessions with a university qualified coach. Both interventions will set a weight-range target with pregnant women. The women attending antenatal clinics at participating hospitals will be screened at their initial hospital appointment to assess their eligibility. Women recruited to the trial will have a number of measures recorded including anthropometrics (self-reported height and weight) and dietary and physical activity scores during and following pregnancy. These measurements will be collected at baseline (prior to 18 weeks gestation), 36 weeks gestation and 12 months post-birth.Discussion: This study responds to a need for an effective intervention that targets excessive gestational weight gain at a population level. This study investigates the potential for an innovative intervention combining two existing services; a free state-wide telephone-based health coaching service and hospital-based antenatal care to support pregnant women to achieve healthy weight gain during pregnancy. The use of existing services provides the potential for immediate post-study implementation. While the impacts of telephone-based lifestyle programmes have been tested in a number of settings, there are few studies which evaluate the effectiveness and acceptability of telephone support in achieving healthy gestational weight gain in association with routine antenatal care.Trial Registration: ACTRN12615000397516 (Registration date: 26 June 2014, retrospectively registered). [ABSTRACT FROM AUTHOR]

Background: Pulmonary rehabilitation (PR) is an effective intervention for the management of people with chronic obstructive pulmonary disease (COPD). However, available resources are often limited, and many patients bear with poor availability of programmes. Sustaining PR benefits and regular exercise over the long term is difficult without any exercise maintenance strategy. In contrast to traditional centre-based PR programmes, telerehabilitation may promote more effective integration of exercise routines into daily life over the longer term and broaden its applicability and availability. A few studies showed promising results for telerehabilitation, but mostly with short-term interventions. The aim of this study is to compare long-term telerehabilitation with unsupervised exercise training at home and with standard care.Methods/design: An international multicentre randomised controlled trial conducted across sites in three countries will recruit 120 patients with COPD. Participants will be randomly assigned to telerehabilitation, treadmill and control, and followed up for 2 years. The telerehabilitation intervention consists of individualised exercise training at home on a treadmill, telemonitoring by a physiotherapist via videoconferencing using a tablet computer, and self-management via a customised website. Patients in the treadmill arm are provided with a treadmill only to perform unsupervised exercise training at home. Patients in the control arm are offered standard care. The primary outcome is the combined number of hospitalisations and emergency department presentations. Secondary outcomes include changes in health status, quality of life, anxiety and depression, self-efficacy, subjective impression of change, physical performance, level of physical activity, and personal experiences in telerehabilitation.Discussion: This trial will provide evidence on whether long-term telerehabilitation represents a cost-effective strategy for the follow-up of patients with COPD. The delivery of telerehabilitation services will also broaden the availability of PR and maintenance strategies, especially to those living in remote areas and with no access to centre-based exercise programmes.Trial Registration: ClinicalTrials.gov: NCT02258646 . [ABSTRACT FROM AUTHOR]

Background: In 2002, the World Health Organization recommended that the age for starting complementary feeding should be changed from 4 to 6 months of age to 6 months. Although this change in age has generated substantial debate, surprisingly little attention has been paid to whether advice on how to introduce complementary foods should also be changed. It has been proposed that by 6 months of age most infants will have developed sufficient motor skills to be able to feed themselves rather than needing to be spoon-fed by an adult. This has the potential to predispose infants to better growth by fostering better energy self-regulation, however no randomised controlled trials have been conducted to determine the benefits and risks of such a "baby-led" approach to complementary feeding. This is of particular interest given the widespread use of "Baby-Led Weaning" by parents internationally.Methods/design: The Baby-Led Introduction to SolidS (BLISS) study aims to assess the efficacy and acceptability of a modified version of Baby-Led Weaning that has been altered to address potential concerns with iron status, choking and growth faltering. The BLISS study will recruit 200 families from Dunedin, New Zealand, who book into the region's only maternity hospital. Parents will be randomised into an intervention (BLISS) or control group for a 12-month intervention with further follow-up at 24 months of age. Both groups will receive the standard Well Child care provided to all parents in New Zealand. The intervention group will receive additional parent contacts (n = 8) for support and education on BLISS from before birth to 12 months of age. Outcomes of interest include body mass index at 12 months of age (primary outcome), energy self-regulation, iron and zinc intake and status, diet quality, choking, growth faltering and acceptability to parents.Discussion: This study is expected to provide insight into the feasibility of a baby-led approach to complementary feeding and the extent to which this method of feeding affects infant body weight, diet quality and iron and zinc status. Results of this study will provide important information for health care professionals, parents and health policy makers.Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12612001133820 . [ABSTRACT FROM AUTHOR]

Background: The obesity epidemic is well established, particularly in rural settings. Programs promoting healthy lifestyles for rural women are urgently needed; however, participant engagement is challenging. In the context of a large randomized controlled trial targeting the prevention of weight gain in rural women, we explored successful recruitment strategies and aimed to understand participants' barriers, enablers and reasons for program participation.Methods: We recruited women (aged 18-55 years) from the general rural Australian population. A mixed-methods approach was applied to explore factors that influenced program participation, including quantitative questionnaires for all participants (n = 649) and qualitative semi-structured interviews conducted for a subgroup of participants (n = 45). Data were collected at three time points: baseline, 6 and 12 months post program commencement.Results: We recruited 649 rural women through a community communication and partnering strategy, a program marketing campaign and mobilization of social networks. Program participants were diverse across education and income levels and were representative of the wider Australian regional population. Factors that influenced program engagement were divided into personal (perceived program benefits and program accessibility) and social (peer persuasion and support). Identified enablers included convenience of the program location, perceived program utility, such as weight management and optimization of lifestyle choices, as well as attending the program with peer support. Barriers to engagement, which are likely exacerbated in rural communities included lack of anonymity, self-consciousness and segregated social networks in rural settings. Participants reported that eliciting local support and maximizing publicity is fundamental to improving future program engagement.Conclusion: Multiple program promotion strategies including communication, marketing and partnering, as well as mobilization of social networks and peer persuasion, enabled engagement of rural women into a healthy lifestyle program. These recruitment strategies are consistent with successful strategies utilized previously to recruit urban-dwelling women into lifestyle programs. Future engagement efforts in rural settings could be enhanced by hosting multiple sessions within existing socio-cultural networks and assuring participants that they will not need to share their personal health information with others in their community.Trial Registration: Australia & New Zealand Clinical Trial Registry. Trial number ACTRN12612000115831. Date of registration 24 January 2012. [ABSTRACT FROM AUTHOR]

Background: The National Human Papillomavirus (HPV) Vaccination Program in Australia commenced in 2007 for females and in 2013 for males, using the quadrivalent HPV vaccine (HPV 6,11,16,18). Thus far, we have demonstrated very substantial reductions in genital warts and in the prevalence of HPV among young Australian women, providing early evidence for the success of this public health initiative. Australia has a long history of school-based vaccination programs for adolescents, with comparatively high coverage. However, it is not clear what factors promote success in a school vaccination program. The HPV.edu study aims to examine: 1) student knowledge about HPV vaccination; 2) psycho-social outcomes and 3) vaccination uptake.Methods/design: HPV.edu is a cluster randomised trial of a complex intervention in schools aiming to recruit 40 schools with year-8 enrolments above 100 students (approximately 4400 students). The schools will be stratified by Government, Catholic, and Independent sectors and geographical location, with up to 20 schools recruited in each of two states, Western Australia (WA) and South Australia (SA), and randomly allocated to intervention or control (usual practice). Intervention schools will receive the complex intervention which includes an adolescent intervention (education and distraction); a decisional support tool for parents and adolescents and logistical strategies (consent form returns strategies, in-school mop-up vaccination and vaccination-day guidelines). Careful process evaluation including an embedded qualitative evaluation will be undertaken to explore in depth possible mechanisms for any observed effect of the intervention on primary and secondary outcomes.Discussion: This study is the first to evaluate the relative effectiveness of various strategies to promote best practice in school-based vaccination against HPV. The study aims to improve vaccination-related psychosocial outcomes, including adolescent knowledge and attitudes, decision-making involvement, self-efficacy, and to reduce fear and anxiety. The study also aims to improve school vaccination program logistics including reduction in time spent vaccinating adolescents and increased number of consent forms returned (regardless of decision). Less anxiety in adolescents will likely promote more efficient vaccination, which will be more acceptable to teachers, nurses and parents. Through these interventions, it is hoped that vaccination uptake will be increased.Trial Registration: Australian and New Zealand Clinical Trials Registry, ACTRN12614000404628 , 14.04.2014. [ABSTRACT FROM AUTHOR]

Background: Although insufficient sleep has emerged as a strong, independent risk factor for obesity in children, the mechanisms by which insufficient sleep leads to weight gain are uncertain. Observational research suggests that being tired influences what children eat more than how active they are, but only experimental research can determine causality. Few experimental studies have been undertaken to determine how reductions in sleep duration might affect indices of energy balance in children including food choice, appetite regulation, and sedentary time. The primary aim of this study is to objectively determine whether mild sleep deprivation increases energy intake in the absence of hunger.Methods: The Daily, Rest, Eating, and Activity Monitoring (DREAM) study is a randomized controlled trial investigating how mild sleep deprivation influences eating behaviour and activity patterns in children using a counterbalanced, cross-over design. One hundred and ten children aged 8-12 years, with normal reported sleep duration of 8-11 h per night will undergo 2 weeks of sleep manipulation; seven nights of sleep restriction by going to bed 1 hr later than usual, and seven nights of sleep extension going to bed 1 hr earlier than usual, separated by a washout week. During each experimental week, 24-h movement behaviours (sleep, physical activity, sedentary behaviour) will be measured via actigraphy; dietary intake and context of eating by multiple 24-h recalls and wearable camera images; and eating behaviours via objective and subjective methods. At the end of each experimental week a feeding experiment will determine energy intake from eating in the absence of hunger. Differences between sleep conditions will be determined to estimate the effects of reducing sleep duration by 1-2 h per night.Discussion: Determining how insufficient sleep predisposes children to weight gain should provide much-needed information for improving interventions for the effective prevention of obesity, thereby decreasing long-term morbidity and healthcare burden.Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12618001671257 . Registered 10 October 2018. [ABSTRACT FROM AUTHOR]

Background: Increasing physical activity in children is a health priority. The Healthy Active Peaceful Playgrounds for Youth (HAPPY) study aimed to examine a multi-component playground intervention designed to increase the proportion of physical activity during recess and lunch of primary school students.Methods: The 2016 Australian focused HAPPY Study was a 12-month, metropolitan primary school based intervention, which was evaluated using a stepped wedge design. The intervention combined teacher development, environmental modifications, and peer support, with the outcomes of increasing physical activity, and analysing students' sources of social support to be physically active.Results: Between baseline and follow-up, the proportion of students involved in vigorous activities during recess and lunch times increased significantly from 15 to 25% (p < 0.001). No differences were recorded in sources of social support.Conclusions: The HAPPY project demonstrated an increase in the proportion of physical activity intensity during recess and lunch times in primary schools, although further investigation is required to determine what components of the study had the greatest effect.Trial Registration: This study was retrospectively registered with the Australian and New Zealand Clinical Trials Registry ACTRN12616000575437 . Date of registration: 4 May 2016. [ABSTRACT FROM AUTHOR]

Background: Physical activity and consuming a healthy diet have clear benefits to the physical and psychosocial health of cancer survivors, with guidelines recognising the importance of these behaviors for cancer survivors. Interventions to promote physical activity and improve dietary behaviors among cancer survivors and carers are needed. The aim of this study was to determine the effects of a group-based, face-to-face multiple health behavior change intervention on behavioral outcomes among cancer survivors of mixed diagnoses and carers.Methods: The Exercise and Nutrition Routine Improving Cancer Health (ENRICH) intervention was evaluated using a two-group pragmatic randomized controlled trial. Cancer survivors and carers (n = 174) were randomly allocated to the face-to-face, group-based intervention (six, theory-based two-hour sessions delivered over 8 weeks targeting healthy eating and physical activity [PA]) or wait-list control (after completion of 20-week data collection). Assessment of the primary outcome (pedometer-assessed mean daily step counts) and secondary outcomes (diet and alcohol intake [Food Frequency Questionnaire], self-reported PA, weight, body mass index, and waist circumference) were assessed at baseline, 8-and 20-weeks.Results: There was a significant difference between the change over time in the intervention group and the control group. At 20 weeks, the intervention group had increased by 478 steps, and the control group had decreased by 1282 steps; this represented an adjusted mean difference of 1761 steps (184 to 3337; P = 0.0028). Significant intervention effects for secondary outcomes, included a half serving increase in vegetable intake (difference 39 g/day; 95 % CI: 12 to 67; P = 0.02), weight loss (kg) (difference -1.5 kg; 95 % CI, -2.6 to -0.3; P = 0.014) and change in body mass index (kg/m(2)) (difference -0.55 kg/m(2); 95 % CI, -0.97 to -0.13; P = 0.012). No significant intervention effects were found for self-reported PA, total sitting time, waist circumference, fruit, energy, fibre, alcohol, meat, or fat consumption.Conclusions: The ENRICH intervention was effective for improving PA, weight, body mass index, and vegetable consumption even with the inclusion of multiple cancer types and carers. As an example of successful research translation, the Cancer Council NSW has subsequently adopted ENRICH as a state-wide program.Trial Registration: Australian New Zealand Clinical Trials Register identifier: ANZCTRN1260901086257. [ABSTRACT FROM AUTHOR]