ANZCTR search results

This study aims to test experimental hypotheses which will assist in improving the design of behavioural intervention trials, and inform the interpretation of findings reported to date, leading to better decisions about health policy and clinical practice.

More than half of the Australian population do not meet the levels of physical activity recommended to achieve health benefits. The Internet has become an increasingly important communication tool, and Internet based physical activity interventions which include innovative technology have the potential to reach large groups of individuals and contribute to the promotion of physical activity and behaviour change. Each year there is a proliferation of health-related and health-promotion websites, yet virtually no work has been done to study the utility and effectiveness of these population-targeted websites. This study will develop a website featuring Web 2.0 applications and evaluate the efficacy and utility of the website to promote physical activity in comparison to a conventional (Web 1.0) physical activity promotion website. The ET takes advantage of the unique 'real world' sample available to the research team through the existing 10,000 Steps website to evaluate engagement by users from the broader community. The efficacy of the intervention is initially being tested in the in a randomised control trial (RCT). The RCT is investigating efficacy, adherence and behaviour change in a rigorous, controlled setting with high internal validity. The RCT has been registered separately (ACTRN12611000157976). We expect that the current proposal will provide an increased understanding of the benefits of newer web-based technologies and applications in engaging and retaining participants on web-based physical activity promotion sites. This work has the potential to improve health outcomes from increased engagement/retention in physical activity.

Lipoprotein(a) [Lp(a)] is one of the most atherogenic lipoproteins and consists of a glycoprotein called apo(a) which is covalently linked to an LDL particle. Lp(a) is mostly synthesized in the liver and metabolized both via the kidney and liver. A size polymorphism of apo(a) (high and low molecular weight isoforms) exists that negatively correlates with plasma Lp(a) levels. We could previously show that fragments of apo(a) are secreted into the urine and the daily secretion rate correlates with plasma Lp(a) concentrations. Nicotinic acid (NA) and extended release nicotinic acid (ERN) are currently the only lipid lowering drugs that consistently reduce plasma Lp(a) by up to 30%. Since the mechanism by which ERN lowers Lp(a) is not entirely clear we aim to investigate this mechanism in vivo and in vitro.

Snoring and mild sleep disordered breathing (SDB) are a common consequence of increased upper airway resistance during sleep. Habitual snoring (every night or almost every night) without overt obstructive sleep apnoea hypopnoea syndrome (OSAHS) is common in the community. Increasingly it is recognized that snoring and mild SDB are not just an annoying social problem but may pose real risks to health. Emerging research is highly suggestive of an independent role in the occurence of hypertension, stroke, coronary and carotid atherosclosis. The aim of this study is to further explore the linkage between heavy snoring with mild SDB and early carotid artery atherosclerosis by looking for regression or stabilisation of early changes of carotid atherosclerosis in heavy snorers with mild non-hypoxic SDB when snoring and SDB are prevented by the use of nasal continuous positive airway pressure (CPAP).

Diabetes is the commonest cause of adult onset blindness. Vision loss, which is irreversible, is a most feared complication of diabetes. A blood fat lowering drug called fenofibrate, available in Australia, has been shown to reduce eye damage in people with Type 2 diabetes by 35-40%, and to prevent eye damage in Type 1 diabetic animal models. This study will evaluate the potential benefits of fenofibrate in 450 adults with Type 1 diabetes who are at high risk of eye damage.

The aim of this study is to determine whether the consumption of lutein with milk increases exercise-self efficacy, leading to increased exercise participation in older adults. The overall purpose is to provide scientific substantiation for a novel nutritional supplement aimed at increasing physical activity to improve health and reduce disability in an ageing population. Preliminary research in rats demonstrated that the consumption of lutein-fortified milk increased the duration of voluntary wheel running. This increased wheel running was associated with enhanced muscle development and reduced body fat. The mechanism by which the lutein-fortified milk stimulated the rats to increase the volume of wheel running is not known, but it seems likely that there was some change in their mood which promoted exercise behaviour. If this supplement were to elicit a similar effect in people being encouraged to undertake regular physical activity this might result in them undertaking a greater volume of exercise and thus potentially achieving health benefits.

A two arm randomised controlled trial in more than 1500 preterm babies less than 1500 grams to compare standard feeding regimens versus adding BLF to feeds on the incidence of death and major disability in VLBW infants.

This study aims to evaluate the safety and efficacy of combining panitumumab with the standard cisplatin and gemcitabine treatment for advanced biliary tract cancer. Who is it for? You may be eligible to join this study if you are 18 years or above and have been diagnosed with biliary tract cancer. You should have locally advanced or metastatic disease that is not suitable for removal by surgery OR disease which has come back after previous surgical treatment or radiotherapy. It has been shown that in other cancer types, panitumumab may be less likely to have an effect if the cancer cells have any mutation detected in a particular gene. That gene is known as KRAS. As part of screening for this study, you will be asked to consent to a test to find out whether your cancer cells have a KRAS mutation. If you consent, cells taken from a previous diagnostic procedure will be sent to a central lab for the KRAS test. Only patients with cancer that does not have any mutation in the KRAS gene can participate in this study. Trial details The patient population that may participate in this trial would routinely be treated with a combination of the chemotherapy drugs gemcitabine and cisplatin. Participants in this study will additionally receive panitumumab; so that the outcomes associated with treatment using the 3 drugs together can be evaluated. Participants will be monitored closely for side effects (toxicity) and for tumour response to treatment. Treatment will continue until disease progression, unacceptable toxicity, investigator discretion or patient request to cease. Once off study treatment, participants will be followed up for 30 days, then every 12 weeks until disease progression or commencement of new treatment, then according to best practice until death. Data from this trial can inform us about how safe and tolerable the treatment is, and we can make some comparisons to other trials of chemotherapy alone for this disease. If positive, this study may lead to improved treatment for patients with biliary tract cancer. If negative, it will still give information regarding the biology of the disease, including the incidence of KRAS mutation in this tumour type.

When patients are established on CPAP treatment they must first undergo a titration study of some description which determines the pressure required to hold the upper airway open. Titration studies are commonly performed using a nasal mask but some patients may prefer a full-face or oronasal mask. This study looks at therpeutic pressures for full-face and nasal masks and patient preferences.

Acceptance and Commitment Therapy (ACT; Hayes, Strosahl & Wilson, 1999) is a third-wave behavioural therapy that has been receiving greater attention in the empirical literature in recent years. ACT is a mindfulness, acceptance and values-based psychotherapy which proposes different processes of change and outcome compared to traditional cognitive and behavioural treatments (Hayes, Masuda, & De Mey, 2003). In ACT, acceptance, mindfulness and values strategies are used to create a context for an individual to engage in effective and valued behaviours, even in the presence of difficult thoughts and emotions. Within an ACT framework, two key processes are seen as contributing to the development and maintenance of many forms of psychopathology: experiential avoidance (i.e. behavioural and psychological attempts to avoid an unpleasant experience) and cognitive fusion (i.e. responding to a thought or feeling as if it were the actual event it describes; Hayes, Strosahl, & Wilson, 1999; Hayes, Wilson, Gifford, Follette, & Strosahl, 1996). Chronic worry and rumination are key cognitive processes associated with the onset and maintenance of generalised anxiety disorder (GAD) and depression (Hoeksema, Wisco, & Lyubomirsky, 2008; Watkins, 2008). Worry and rumination have been considered by researchers to be forms of both experiential avoidance and cognitive fusion. The literature on clinical interventions for rumination is surprisingly scarce, and although there are currently a number of efficacious cognitive behavioural treatments for chronic worry and GAD, it is evident that there is room for improvement as only about half of those treated are achieving high end state functioning (Hayes, Orsillo & Roemer, 2010). To date, beyond case studies (Ruiz, 2010) there has been no research specifically investigating ACT for chronic worry and rumination amongst sufferers of GAD and Depression. A randomised control trial comparing ACT to CBT will address this gap in the literature and inform the treatment and management of anxiety and depression. Furthermore, investigating the mechanisms of change, specifically that of acceptance of psychological experience and greater behavioural engagement with valued areas of life, will enhance our understanding of the predictive elements of ACT and improve its application in the treatment of mood and anxiety disorders.