ANZCTR search results

One-fifth of Australian children are overweight and at increased risk of becoming overweight adults. This study will evaluate if an intervention to equip parents with the confdence and skills to intitiate and maintain positive early feeding practices can foster healthy food preferences, dietary intakes and eating patterns in young children. The 18-month study will use a randomised controlled design and aims to enrol 830 first time mothers with healthy term infants in Brisbane and Adelaide. The intervention will provide anticipatory guidance via 2x12 week parent education and peer support modules (6 x 1.5hr group sessions), each followed by 6xmonthly maintenance contacts (choice sms/email). The modules will commence at ages 4-7 and 13-16 months to coicide with establishment of solid feeding and development of autonomy and independence. The intervention will be delivered in established community child health clinics in Brisbane and Adelaide. The control group will have self-directed access to usual services provided by local Child Health Clinics. Outcome measures will be assessed at baseline (age 4-7m), 9 m (age 13-16m) and 18 m (final, age 2y) and will include infant food intake and preferences, feeding behaviour and growth and maternal feeding style/practices, parenting efficacy and BMI. Additional co-variate measures include: demographics, maternal mental health, dietary restraint and weight concern, and infant temperament. This study will provide the first Level II evidence for efficacy of a comprehensive, structured intervention to promote positive feeding practices on early childhood intake and food preferences. It is consistent with current community interest in early childhood as the foundation for health and well being and addresses National Research Priority 2: Promoting and maintaining heath – ‘A healthy start to life’ and ‘Preventive health care’.

Few management options are available to the 200,000 Australian children with established obesity. Paradoxically, whereas speciality obesity clinics improve body mass index (BMI) but are accessible to very few obese children, general practice is universally available - but so far frustratingly ineffectual. We aim to trial an innovative shared-care approach to the management of childhood obesity, drawing together four established lines of research: (i) specialist child obesity approaches that are known to be effective; (ii) positive aspects of our previous child obesity prevention general practice trials; (iii) computerised support and decision assistance in primary care; and (iv) the effectiveness of shared-care approaches. Because all elements are already in place, it has a high degree of feasibility and, we believe, a high chance of success. This trial addresses the urgent need identified in the 2003 NHMRC Clinical Practice Guidelines for the Management of Overweight and Obesity in Children and Adolescents for ‘simple, well-designed intervention studies which can be translated into usual clinical practice’. In the first year, the software support and clinical approaches will be customized and focus-tested. The trial itself will involve approximately 45 general practitioners and 172 obese children aged 3-9 years and their families in the second and third years. Half the children will attend a specialist multidisciplinary obesity session, followed by supported general practice care for 12 months. The other half will be offered usual care. After 12 months, we aim for reductions in BMI, percentage body fat, and waist girth in the shared care compared to the usual care group. We will also conduct an economic evaluation, to understand the costs of the new model, compared with usual care, to government and families against all outcomes at 12 months. If effective, benefits would include increased general practitioner identification of childhood obesity; a shift in focus towards younger obese children (for whom treatment is more effective and secondary prevention of morbidity is still possible); and a replicable, feasible, cost-effective primary care approach to childhood overweight/obesity tailored to the Australian health care system.

The best way of determining a CPAP pressure to control sleep apnoea is not known. We are comparing 3 common methods of determining this pressure and assessing the effect on the compliance with CPAP and response to therapy

The primary aim of the study is to determine whether providing EGDT, compared to standard care, reduces 90-day mortality in patients presenting to the ED of hospitals in Australasia with severe sepsis. Each patient meeting all of the exclusion criteria and none of the exclusion criteria will be randomised in the ED to receive either EGDT for a total of 6 hours post-randomisation, or standard care. Patients assigned to receive EGDT will be cared for by the dedicated ARISE study team. The patient will receive treatment as per the study protocol for 6 hours with central blood oxygen levels as the target end-point, then receive standard care. Patients assigned to receive standard care will continue to be cared for by the hospital team in accordance with current best practice. Patients in both groups will also receive any additional treatment needed, such as antibiotics or surgery. The study will be conducted in 32 hospitals in Australasia with 1600 patients enrolled in the study over a 2.5 year period.

The primary purpose of this study is to access the results of using laser acupuncture to assist long term smoking cessation. Long term smoking cessation is assessed at 26 weeks after treatment commences. This trial has attempted to remedy the deficiencies of a previous laser acupuncture trials. It has been designed to address several questions: 1. Does true [verum] laser acupuncture have better outcomes of smoking cessation than sham laser acupuncture ? This style of laser acupuncture treatment has been chosen because there is not enough evidence from trials of this type of treatment to assess its validity. The Cochrane Library Review, Acupuncture and Related Interventions for Smoking Cessation [White, Rampes et al, 2007] was updated in 2007 and stated that “there is no consistent evidence that acupuncture, acupressure, laser therapy or electro-stimulation are effective for smoking cessation, but methodological problems mean that no firm conclusions can be drawn.” Research has shown acupuncture is a safe therapy with few side effects. Using the drug therapy of nicotine replacement therapy and Bupropion therapy as aids to assist smoking cessation is not suitable for everybody. The outcome of this trial will be clearer information about the role of true [verum] laser acupuncture This will inform recommendations for interventions that will assist smokers wishing to quit. It will add worthwhile information to the debate concerning the use of acupuncture and may influence future meta-analysis and reviews concerning the efficacy of laser acupuncture treatment and its role in assisting people to cease smoking.

Prior case-control studies on selected samples showed highly promising levels of sensitivity and specificity for uRNA. The next phase in the evaluation of the uRNA tests is to carry out a nested case-control study in a clinical population in which uRNA could potentially be useful. This would enable more accurate estimations of sensitivity and specificity as well as estimations of positive and negative predictive values for this population. This study would also enable a formal comparison of sensitivity and specificity for uRNA and each of the FDA-approved NMP22 tests. The clinical population chosen for this phase is patients with no history of TCC who present with a history of gross haematuria. This is the most common presentation for TCC and forms a relatively well defined population. In this study’s patient population, the potential use of uRNA is in conjunction with cystoscopy, where it would aim to identify TCCs which were missed during initial cystoscopy. Currently cytology is routinely used for this purpose and an alternative non-invasive assay NMP22 (Matritech) is also FDA approved for use, although it is not in routine use. The nested case control study described here will explore the value of uRNA as an adjunct to cystoscopy and in particular compare the performance of uRNA to that of cytology and the NMP22 tests for the detection of primary TCC in patients with a history of gross haematuria. Of particular interest are the relative sensitivity, specificity, positive and negative predictive values, the variation in sensitivity and specificity by grade and stage of disease, and the ability of the tests to identify invasive TCC.

This project will compare the growth rates and nutritional status of infants who are exclusively fed formulae either based on goat milk or cow milk. Growth will be assessed regularly (2 weeks, 1, 2, 3, 4, 6 and 12 months). Blood biochemical profile of infants, including plasma amino acids, will be assessed at 4 months. Formula tolerance and stool frequency will be assessed through to 4 months of age and stool microbiota will be assessed through to 2 months of age. A gold standard reference group of breastfed infants will also be included.

The objective of the proposed research is to establish a clinical program to test novel therapeutic interventions for TBI patients with fatigue and/or sleep disturbance. Specifically, the proposed four-year study aims to evaluate, in a randomized controlled trial, the effectiveness of two interventions, cognitive-behavioral therapy (CBT) and light therapy, administered for 8 weeks alone and in combination, in alleviating fatigue, sleep complaints, and cognitive performance following TBI. These innovative interventions will be evaluated in a TBI civilian population, with the aim of translating the program to military populations. Our primary hypotheses are that participants receiving CBT will show reduced self-reported fatigue, reduced daytime sleepiness, and improved sleep (assessed subjectively and objectively) and improved cognitive performance, 4 and 8 weeks after commencement of the CBT program and at one-and six-month follow-up compared to those receiving the current standard of care. In addition, that participants receiving blue light therapy daily will show reduced self-reported fatigue, reduced daytime sleepiness, improved sleep (assessed subjectively and objectively) and improved cognitive performance 4 and 8 weeks after commencement of therapy compared to those receiving the current standard of care. And finally, that patients receiving CBT and blue light therapy (combined) will show greater reductions in self-reported fatigue, reduction in daytime sleepiness, improvement in sleep (assessed subjectively and objectively) and in cognitive performance, after 4 and 8 weeks of the combined treatment and at one- and six-month follow-up compared to those receiving the current standard of care.