ANZCTR search results

The aim of this two-arm cluster-randomised controlled trial is to determine whether the less resource- and cost-intensive version of the PACE program (i.e., ePACE) is non-inferior with regards to increasing teachers’ implementation of classroom physical activity via Energisers, relative to the original PACE program. Eighty primary schools will be recruited to examine this. In each of the two arms, teachers will receive support to increase the amount of physical activity time, in particular Energisers, they deliver across the school week. Schools in the ePACE program will receive executive support, access to an online portal, equipment pack vouchers and ongoing project officer support. The comparator (i.e., PACE) condition will include the original face-to-face in-school champion training, an educational session delivered to teachers by in-school champions as well as executive support, and information and resources to support implementation. Eighty primary schools will be randomly allocated to one of two intervention groups. The final trial endpoint is defined as 12 months after baseline.

This project aims to extend research conducted by Alt and colleagues in the United States in 2014 and 2020 which found preliminary efficacy of a speech pathology treatment for children who are late to talk (late language emergence). This treatment was based on theories of statistical word learning where a speech pathologist spoke to the child in language containing target words spoken a large number of times (high dose), within different types of sentences (linguistic variability) and referencing a number of different physical objects (physical variability). This treatment was found to result in children speaking more target words and in a quicker timeframe than established treatments. This treatment was administered by speech pathologists however, which is not traditional for this young population (commonly parent-administered) or cost effective. This project aims to examine if this treatment can be trained to a group of parents, to be administered at home. The specific research questions are: 1 - Can parents be successfully trained in administering an intervention to their children which presents target words with high dosage and variability? 2 - Will the parent group training program be acceptable to parents, children and study personnel? 3 - Will children with late language emergence (LLE) receiving the parent intervention learn a significantly higher number of treated words relative to control words? 4 - Will children with LLE receiving the intervention protocol acquire untreated words at a rate exceeding that of typical language acquisition in late talking toddlers?

Mothers of preterm infants often struggle to produce enough breast milk to meet the daily feed requirements of their infants, especially in the longer-term. This randomized multi-centre double-blind parallel controlled trial will resolve the issue of whether a higher dose of domperidone (60 mg/day) leads to greater improvements in maternal breast milk supply compared to a lower dose (30 mg/day), while also evaluating differences in adverse events, impacts on breast milk composition, and identifying predictors of treatment response to domperidone. Eligible women will be randomised to a high dose (60 mg/day) or low dose (30 mg/day) domperidone for 21 days. All women will initially commence on the low dose for 2-days before continuing with their assigned treatment dose for a further 19 days. The primary outcome will be assessed at day 21 following treatment initiation. After this point in time, women will be provided with the option to taper their dose to twice daily for four days and then once daily for three days, before stopping. All participants will undertake regular study assessments including at baseline (study enrolment), day 7, 14, 21 of treatment, one-week following intervention, and at infant discharge to home or term corrected (whichever comes first). Women will undergo a breast assessment by a lactation consultant or nurse/midwife, and complete a breast milk diary throughout the study. Women will regularly undertake questionnaires evaluating demographics and lifestyle, breast health, milk expression, postnatal health, mental health and wellbeing, and infant feeding practices. Women will provide breast milk, blood, urine, stool and buccal cell swab samples.

This is a substudy of the Cancer Molecular Screening and Therapeutics (MoST) Program, which is registered on ANZCTR with ID ACTRN12616000908437. This substudy will evaluate the clinical activity of the combination of durvalumab and acalabrutinib in participants with high grade B cell lymphoma. Who is it for? You may be eligible to join the study if you are aged 18 years and older, with high grade B cell lymphoma. Study details: Participants will receive 2 drugs: 1/ durvalumab, to be administered via intravenous infusion at a dose of 1500mg every 4 weeks, and 2/ acalabrutinib, to be administered orally at a dose of 100mg twice daily. Both drugs will be given to participants continuously as long as they and their doctor agree there is a benefit from treatment. Participants will undergo clinical assessments at 4 weekly intervals from first treatment until end of treatment, then 8 weekly intervals until disease progression. Imaging will be at 8 weekly intervals until disease progression. Safety and tolerability of treatment will be assessed at 4 weekly intervals. Health related quality of life during treatment will be assessed at 4 weekly intervals and then every 8 weeks after end of treatment until progression. We cannot guarantee that participants will receive any benefits from this study. This study is being carried out to improve the way we treat cancer patients who have limited treatment options available to them. It is hoped that the combination of durvalumab and acalabrutinib will be well tolerated and will improve outcomes for future patients, however there may be no clear benefit from participation in this study.

Non-ambulant children with cerebral palsy experience more sedentary behaviour, spending up to 96% of their waking day sitting. With limited evidence-based interventions available, this can have a devastating impact on health and well-being. CPMovetime aims to develop new interventions that reduce sedentary behaviour to improve health outcomes.

The Diabetes Clinic project aims to examine the feasibility, acceptability and preliminary efficacy of an Accredited Exercise Physiologist (AEP) delivered type 2 diabetes (T2D) group service for older adults. The Diabetes Clinic will be delivered within the UNSW Medicine Lifestyle Clinic, as part of usual clinical service, with the aim of improving diabetes management through increased participation in healthy lifestyle behaviours including exercise. The primary research question is whether the Diabetes Clinic is feasible as well as acceptable to patients. The secondary research questions are to evaluate the impact of the Diabetes Clinic program on cardiometabolic risk factors (blood pressure, lipid and metabolic profile, body composition), cardiorespiratory/muscular fitness, quality of life, cardiovascular risk, and physical activity levels in older adults with T2D. We hypothesise that the Diabetes Clinic will be feasible and acceptable amongst older adults with T2D. The group service is designed to positively impact cardiometabolic health.

The aim of this study is to assess the safety and performance of a new vaccine delivery device that uses a patch to deliver vaccines. This study will explore how how the device performs in older people, No vaccine is used in this study. A placebo coating on the patch is used to represent the vaccine.

The primary objective of this study is to identify factors influencing breast milk volume in the first three weeks postpartum following preterm birth. Women will be recruited within 168 hours of birth of an infant born < 34 weeks gestation. All participants will undertake regular study assessments including at baseline (0-168 hrs postpartum), day 7, 14, 21, at infant discharge to home or term corrected (whichever comes first). Women will regularly undertake questionnaires evaluating demographics and lifestyle, breast health, milk expression, postnatal health, mental health and wellbeing, and infant feeding practices. Women will provide breast milk, blood, urine, stool and buccal cell swab samples. The primary outcome of the study is daily expressed breast milk volume on day 21 postpartum. This will be identified from expressed volume recorded over a 24-hour period.

This study will investigate the effect of co-designed community programs on health lifestyle choices for people with chronic conditions, including cancer survivors. Who is it for? You may be eligible to join this study if you are aged 18 and above, have been referred from The Queen Elizabeth Hospital medical outpatients, emergency department, pre-surgery clinics; local primary care practices (general practice and allied health), community services or self-referred and have at least one diagnosed chronic condition (diabetes I or II; respiratory, cardiovascular, kidney disease; chronic mental or musculoskeletal disorders; chronic pain; cancer survivors). Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will receive the ‘Healthy Choices’ program over 3 months. Participants in the other group will receive 'usual care' as care which is routinely available for management of their chronic condition and be offered the ‘Healthy Choices’ program after a 3 month waiting period. Participants will learn about their conditions, set health and well-being goals and receive support to achieve these using a 'health coach' who helps them navigate through various resources and services in the wider community. The ‘Healthy Choices’ program involves education package sessions specific to participants’ chronic disease, individual health coaching, and individual and group sessions with targeted disciplines. The participant will also be encouraged to identify a ‘health buddy’ to attend sessions with them and to support them in their identified goals and strategies. These components run concurrently and in some cases in parallel if reinforcement or reiteration is needed. Effectiveness of the intervention will be assessed using Life’s Simple 7 Factors to determine changes in health and lifestyle factors over 12 months. It is hoped that this research project will provide evidence of how best to support people in the community to improve their health and wellbeing when faced with chronic conditions.

In this randomised, double-blind, placebo-controlled study, 60 recreationally-active adults will be randomly assigned to receive tablets containing either a saffron extract (28mg a day) or placebo for 6 weeks. We will assess change in exercise enjoyment, mood, and quality of life via several validated self-report measures (to be completed fortnightly). We will also examine change in sleep quality, heart rate variability, and resting heart rate using a wrist-word device (WHOOP strap) that will be worn for 6 weeks. Change in blood concentrations of brain-derived neurotrophic factor, oxytocin, and neuropeptide Y will also be assessed.