ANZCTR search results

The aim of this study is to compare glycaemic control with 50, 90 and 130 g carbohydrates per day in people with type 2 diabetes and to test whether a 90g carbohydrate reduction is enough to improve time in range (3.9-10 mmol/L) and decrease time above range (>10 mmol/L) compared to the commonly used lower carbohydrate definitions of 50g and 130g carbohydrates per day for the management and treatment of T2D (hyperglycaemia) through diet.

The aim of this randomised controlled trial is to increase adoption of the lunchbox nutrition program ‘SWAP IT ’in primary schools located in the Hunter New England Local Health District. This trial will evaluate whether a theory-based multi-component dissemination strategy targeting barriers to adoption can improve the adoption rates of the nutrition program. Schools will be randomly allocated to receive either a month multi-component dissemination strategy over a 3-4 month period, or a minimal intervention control group. Intervention effectiveness will be determined by comparing, relative to control, the absolute difference in the proportion of schools adopting the program at 6-month follow up. The trial aims to generate evidence regarding the effectiveness of strategies to inform broader dissemination of the lunchbox nutrition program.

For women with a BMI>40, or a BMI 30-40 and one or more comorbidities, continuous electronic fetal monitoring via cardiotocograph (CTG) monitoring, is recommended (RANZCOG 2019). Conventional forms of CTG monitoring require the labouring woman to wear two tight elastic belts around her abdomen and to be tethered to a machine by wiring, thus restricting her mobility. A wireless and beltless monitoring device, the non-invasive fetal electrocardiogram (NIFECG) was registered by the Therapeutic Goods Administration (TGA) for clinical use in Australia in 2018. The aim of this study is to determine how the use of an innovative monitoring technology, NIFECG, in women with increased BMI, compares with the current standard monitoring, CTG in: • Detection of fetal distress requiring intervention • Fetal scalp electrode (FSE) use • Maternal feelings of control and agency during labour and birth • Capacity for midwives to provide woman-centred care. Using the results of both the quantitative and qualitative data that will be collected, the study will also explore barriers and facilitators to implementation of the NIFECG as routine care for women with increased BMI. Hybrid RCT Type 1 methodology, following the approach of Curran et al. (2012), uses a hybrid effectiveness-implementation typology. The study design therefore enables a dual focus a priori, testing the effectiveness of a clinical intervention on specified outcomes whilst also synthesising implementation needs. The RCT will be conducted at three clinical sites in Australia. The sample size is 450 women.

The “NEMO” resuscitation monitor has been designed to fill a current gap in respiratory monitoring need during resuscitation of babies at birth. The purpose of the NEMO is to provide immediate feedback on mask seal and technique to clinicians during resuscitation where manual positive pressure ventilation (PPV) is performed. It is hypothesised that this will improve the effectiveness of manual PPV, helping to improve short- and long-term health outcomes for babies who require resuscitation at birth. The NEMO is a new medical device that currently has only been used during training on manikins. This study aims to investigate the safety and acceptability of the NEMO resuscitation monitor for babies who require resuscitation with manual PPV following birth.

PTSD can be a debilitating syndrome of prolonged stress reactions that may develop after either direct or indirect exposure to a traumatic event. It is a significant issue among veterans with up to one in four veterans experiencing PTSD in their lifetime. Treatment usually involves psychotherapy and pharmacotherapy. EMDR and trauma-focused cognitive behavioural therapy (CBT) are both widely used and equally effective therapies. EMDR involves attention to the past, present, and future with a focus on disturbing memories and related events. Targeted memories are identified and the patient attends to those memories while simultaneously focusing on an external lateral stimulation, typically involving eye movements. The COVID-19 pandemic has significantly altered the way in which mental health intervention has been delivered and telehealth has been rapidly implemented throughout Australia. A number of companies have adapted EMDR to telehealth, but the evidence base remains limited. From a clinical perspective, the capacity to deliver EMDR via telehealth provides an opportunity to provide access to rural and remote patients, as well as enabling preparedness for future pandemics. This trial will aim to investigate whether EMDR via telehealth to veterans with PTSD provides similar safety and efficacy outcomes to delivering EMDR in person.

CLIMATE is an observational study which aims to see if additional blood sampling during active surveillance (no additional treatment) following surgery (orchidectomy) in patients with testicular germ cell cancer may help predict the risk of the cancer recurring. Who is it for? You may be eligible for this study if you are a male 18 years or older and you have been diagnosed with a clinical stage 1 testicular germ cell tumour, and are recommended for active surveillance following your recent surgery. Study details All participants will receive active surveillance for 2 years post-enrolment in accordance with the Australian and New Zealand Urogenital and Prostate (ANZUP) Cancer Trials Group’s surveillance recommendations for clinical stage 1 seminoma or non-seminomatous germ cell tumour. Active surveillance requires attendance at face-to-face clinical appointments with an oncologist and involves physical examination, the collection of blood samples within 6 weeks of orchidectomy and at 3, 6, 9, 12, 15, 18, 21 and 24 months post orchidectomy, as well as a CT of abdomen and pelvis at 6, 12, 18 and 24 months post orchidectomy (seminoma) or CT of abdomen and pelvis and chest x-ray at 4, 8, 12, 18 and 24 months post orchidectomy (NSGCT). Blood samples to assess miR-371 will be collected at various time points (within 6 weeks of orchidectomy, at 3, 6, 9, 12, 15, 18, 21 and 24 months post orchidectomy) or until relapse, whichever occurs first. Blood for study purposes will be collected at the same time as standard of care blood is taken for tumour markers. Assessment of miR-371 levels in the blood will be compared to the findings of active surveillance to determine if it is an accurate marker of disease relapse. It is hoped that this study may show that miR-371 levels are able to predict disease relapse, which may help to guide decision-making following surgery in the future.

People with type 2 diabetes have high blood glucose levels largely due to reduced action or section of the main hormone insulin. Larger spikes in glucose levels typically occur following the consumption of carbohydrates. Lowering carbohydrate intake is one way to improve glucose levels. However, it unknown if the distribution of carbohydrate at each meal and snack also influences daily blood glucose averages; specifically in the context of a lower carbohydrate diet. The main objective of this study is to determine if consuming a moderately low-carbohydrate diet of 90g across different distribution patterns will have an impact on blood glucose management. The primary outcome is the change in blood glucose with continuous glucose monitoring over each of the three 3-day periods following different carbohydrate distribution patterns.

Obesity is a relapsing chronic and complex condition with genetic, environmental, physiological, psychological, and behavioural determinants. Obesity is associated with significant comorbidities, particularly type 2 diabetes, cardiovascular disease, osteoarthritis, sleep apnoea and specific cancers. For people living with obesity and type 2 diabetes, the risks of diabetes-related complications adverse cardiovascular and musculoskeletal outcomes are increased. Managing obesity in people with type 2 diabetes through lifestyle modification, screening, and early detection of secondary complications can improve the management of diabetes-related complications. Evidence supports multidisciplinary person-centred approaches to providing obesity and diabetes care where individuals are active decision-makers in their healthcare. Nevertheless, while multidisciplinary management of people living with obesity and type 2 diabetes is the best-evidence practice, barriers to this level of support exist in rural, regional and remote areas. The development of the national guidelines was underpinned by a comprehensive systematic review of the literature (conducted by AI Shaw). This literature review identified important evidence gaps in the management of patients with diabetes mellitus who also have obesity (NHMRC, 2013). A number of these evidence gaps are the focus of this project. Diabetes services routinely focus on managing and treating diabetes, and obesity management are more of an afterthought. Furthermore, there is a greater prevalence of socioeconomically disadvantaged people living in rural, regional and remote areas and less access to services that support behaviour change when needed. This study aims to assess the feasibility and effectiveness of a rural, multidisciplinary model of obesity care personalised for adults living with type 2 diabetes mellitus and obesity. The research design is a randomised controlled clinical trial. The project will recruit 212 patients with diabetes and randomise them to active intervention or usual care. The active intervention group will receive an integrated, multidisciplinary model of care for obesity management devised in partnership with the person receiving the care and including multi-intervention as desired. In so doing, the participant can choose the care model that suits them best considering their circumstances.

Binge drinking is common in residential colleges in Australia and abroad. The objective of this study is to determine what type of AOD harm minimisation intervention is most effective for reducing risky AOD use and related harms among first year residential college students. Six colleges will be randomised to one of three different types AOD interventions: 1) trivia style AOD harm-minimisation workshop; 2) the AOD harm-minimisation workshop + QuikFix brief intervention; and 3) usual AOD / harm minimisation messaging. We expect students at colleges who receive the AOD harm-minimisation workshop + QuikFix brief intervention will have better outcomes.

The PICOBOO study platform is designed to be an adaptive randomised trial to evaluate the safety and effectiveness of COVID-19 booster vaccine strategies in the Australian context. This will enable regulators, researchers and policymakers to flexibly respond to new policy questions as they arise, for example as new vaccine formulations become available and new variants arise in Australia necessitating changes in strategy. This study aims to evaluate, pragmatically and efficiently, the immunogenicity and reactogenicity offered by alternative booster vaccination strategies against SARS-CoV-2. This adaptive trial is designed to allow for perpetual enrolment for as long as is needed to generate high-quality data to inform Australia's national COVID-19 booster vaccination practice and policy.