ANZCTR search results

Obesity-related type 2 diabetes (T2D) is increasing in prevalence in Australia and globally, We have shown that there is considerable inter-individual variability in weight loss and glucose benefit in response to a given dose of exercise in adults with obesity, Therefore, the ‘one-size-fits-all’ approach to exercise prescription, which is the basis of current exercise recommendations for obesity-related disease management, is inadequate. This study will employ a ‘Stepped Care’ methodology to meet the need for tailored, individualised strategies for the management of obesity and related conditions. Participants will be randomised into either the Stepped Care arm or a Comparator group (n=80, randomised in 2:1 ratio for Stepped Care: Comparator). All participants in the Stepped Care arm commence on the ‘lowest dose’ prescription, which is incrementally increased based on individual response as defined by predetermined clinical targets. Step 1: = 150 minutes of moderate to vigorous exercise per week; Step 2: = 300 minutes of moderate to vigorous exercise per week; Step 3: = 300 minutes of moderate to vigorous exercise per week including 3 sessions/week of high intensity interval training (HIIT) (4 x 4 min at 85-95% maximal heart rate, interspersed with 3 min recovery bouts at 60-65% maximal heart rate, 3 days/week, with one session/week supervised). The primary AIM of this study is to determine the overall difference between the proportion of individuals with central obesity and type 2 diabetes who achieve the target health outcomes (that is, = 3% weight loss and/or HbA1c = -0.4%) in the Stepped Care and the Comparator groups. The secondary AIMs of this study are to determine the overall difference between the proportion of individuals with central obesity and type 2 diabetes who achieve the target health outcomes in the Stepped Care and the Comparator at i) follow up (6 months), and ii) at each step in the Stepped Care intervention, and iii) determine the magnitude of change in body mass and HbA1c between the Stepped Care and the Comparator groups.

SmartStartAllergy (SSA) is a novel SMS and smartphone-based application currently integrated with general practices to promote and monitor the introduction of allergenic foods. We hypothesise that parents of infants who receive SMS when their child is 6 and 9 months of age, from their general practice that is using SSA, are more likely to feed their child peanut paste before they turn 1 compared with those who do not receive the messages. Parents are randomised to receive automated SMSs from their general practice when their child is 6, 9 and 12 months old, or to only receive SMSs at 12 months (control group). A questionnaire, accessed via link from SMS, collects additional information about infant feeding and food allergy. Proportions of infants who have introduced peanut by 12 months of age, based on responses from parents to an SMS question, will be compared between the two groups.

This study aims to evaluate novel imaging technologies to study breast cancers prior to and following neo-adjuvant chemotherapy. Who is it for? You may be eligible to join this study if you are a woman aged 18 years or above who has previously untreated invasive breast cancer grade 1, 2, or 3. Study details Participants in this study will undergo novel imaging technologies in addition to standard care. This will comprise 3 scans, a MRI, FDG and FES PET/CT scan before starting neo-adjuvant chemotherapy and after the completion of neo-adjuvant chemotherapy. The MRI scans are performed according to routine care, with the participant lying on her stomach with breasts positioned in prone breast coils. The FDG and FLT scans are performed as a whole body scans with the particpant lying on her back, and a prone scan of the breasts. Particiapants need to fast for 4-6 hours prior to the PET/CT scans. Each scan will take approximately 30-45 minutes. These scans will enable us to assess and compare tumours on all imaging studies with pathological samples before and after chemotherapy. These data will provide clinicians with highly accurate functional, volumetric and spatial information. Ultimately, these studies will facilitate individualised treatment strategies, including de-escalation of surgery and radiation therapy.

The aim of this randomised controlled trial is to determine whether the use of a therapeutic dose of lignocaine enhances elective outpatient gastroscopy episodes as measured by time to eye opening, gastroscope insertion conditions, time from patient discharge from recovery and patient comfort (measured by a pain score). Hypothesis: Lignocaine is a local anaesthetic which may assist with improved endoscope insertion conditions, less post gastroscopy discomfort and faster time to wake-up and discharge from the post-anaesthetic recovery unit (PACU).

This study is to assess whether serum tryptases released from degranulating mast cells alone, or in combination with other neuron-specific candidates, can serve as a reliable and rapid biomarker for sports related concussion in children. We hypothesis that a rapid increase in serum tryptases released from degranulating mast cells in the brain, alone or in combination with selected neuron-specific proteins, is a reliable indicator of concussion in young people. This study aims to determine whether biomarkers released following a concussion is an accurate tool for the diagnosis and management of sports related concussions.

Over 1 million patients globally currently manage their Type 1 Diabetes mellitus using continuous subcutaneous insulin infusion with an infusion set that needs to be changed every 3 days. This study will assess the feasibility and device performance of the study device, the Achilles infusion set over three periods during routine insulin infusion. This study will include 20 participants and has 3 periods: Period 1 (up to 7 days): Trial run with study device with saline infusion. Period 2 (up to 7 days): participants will manage their blood glucose solely with their insulin pump and the Achilles infusion set. Blood glucose will be closely monitored with a continuous glucose monitoring (CGM) device. Period 3 (up to 7 days): Participants will return to study centre to receive a fresh Achilles infusion set and continue blood glucose management at home until infusion set failure or 7 days.

Parent-child interactions comprise one of the most profoundly influential experiences in a child’s development, and the quality of these interactions during early infancy in particular can have a lasting impact on neurodevelopment. This randomised controlled trial is a two-arm (Treatment vs Control), single blind (assessor) randomised controlled trial to test the efficacy of a new intervention designed to promote parent sensitivity and responsiveness to their newborns with a family liability for Autism Spectrum Disorder. We hypothesise that the newborn intervention will decrease parental directiveness and increase parental sensitivity during parent-infant interactions when measured when the baby is 9 months of age, and decreases the severity of autistic symptoms, and improve a range of child development outcomes, when measured when the baby is 2 years of age.

This project is investigating the presence and experience of pain in people admitted to hospital with an acute exacerbation or flare-up of COPD. Participants will be asked to complete a series of questionnaires, investigating the presence and experience of pain and breathlessness during an exacerbation of COPD. Based on the results of the questionnaires, participants who report experiencing pain will be invited to participate in an interview to further investigate the experience of pain and how they believe that the symptoms of pain and breathlessness interact during acute exacerbations of COPD.

Appendicitis which is perforated has a high complication rate in children. To decrease this some surgeons use a washout to remove the purulent fluid whilst others don't, and there is conflicting evidence as to which is best. Our aim is to investigate this to improve the care and outcomes of children with this common condition

This project will examine how two shoulder stabilisation procedures (arthroscopic Bankart and open Latarjet) affect shoulder joint function in athletes following a shoulder instability injury. This study will examine: 1) shoulder joint movement during activities of daily living involving the shoulder and an overhead sporting task; 2) self-reported shoulder function and health; and 3) shoulder range of motion strength; between the two procedures in comparison to an uninjured control group. Participants will attend Deakin University’s Biomechanics Laboratory prior to and six-months after their stabilisation surgery during which their shoulder strength and range of motion, and movement during experimental tasks will be assessed. Participants will complete self-report surveys pertaining to their perceived shoulder joint function and health prior to, and three, six and 12 months post surgery. This project will provide an understanding of how shoulder joint function is impacted by common shoulder stabilisation surgeries following instability injury. This may provide evidence for the use of a specific procedure in restoring movement capacity, reducing the potential for future instability, and minimising joint degradation over time.