ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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30806 results sorted by trial registration date.
  • Investigating the effectiveness of mindfulness meditation and clinical hypnosis for injury-related pain management in competitive athletes: A replicated single-case experimental design

  • Evaluation of scaling up the Play Active program for children’s physical activity in Australian early childhood education and care services

    Physically active play is critical during the early years of life for facilitating children’s health and development. Just one in three Australian children aged 2 to 5 years achieve the recommended three hours of daily physical activity. Early childhood education and care (ECEC) services are a key setting to intervene to improve physical activity levels. Our prior research addressed the need for an ECEC specific physical activity policy. We successfully developed, implemented, and evaluated an evidence-informed ‘Play Active’ program (a Play Active policy with accompanying implementation support strategies) in a pilot trial of 79 ECEC services. With our partners, we are now investigating how best to scale-up Play Active to ensure its effective and fit for purpose. This scale-up research will reach more than 700 ECEC services and 100,000 children across Australia.

  • Phase 1 study of BRB-002 in healthy male volunteers

    This is a first in human (FIH), double blind, placebo- controlled single ascending dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous BRB-002 in healthy male volunteers. Up to approximately 48 healthy male participants will be randomised into this study. Participants will be randomised to receive a dose of either BRB-002 or matching placebo. A total of 8 participants are planned for each cohort, with 6 participants receiving BRB-002 and 2 participants receiving placebo. For each cohort, a Safety Review Committee (SRC) will review all emerging safety and tolerability data. The next planned cohort will be initiated only after it is confirmed by the SRC that the latest cohort dose was safe and tolerated.

  • EMU (Education, Movement and Understanding): A school-based Indigenous games program targeting cultural appreciation in children, and improvements in their physical activity and fitness levels, health and well-being, and academic achievement at school.

    The EMU program is designed to enhance the health and well-being of children, and their numeracy and literacy levels, through participation in an enjoyable and engaging PA program in the community/at school. The EMU program will specifically target the development of a positive learning environment through positive teaching practices i.e., through Aboriginal/Indigenous games. The overall aim of this study is to evaluate the impact of the EMU program on PA levels, well-being outcomes, and literacy and numeracy attainment in a sample of primary school-aged children. We hypothesise that students may receive various benefits to a variety of health outcomes i.e., resulting from participation in EMU. Phase 1 - pilot (completed) Phase 2 = train the teacher

  • Breaking Barriers: Transforming Teen Behaviours with Kai Fella Workshops

    This study seeks to evaluate the impact of the Kai Fella "Challenging Stereotypes" workshop on transforming the behaviours, attitudes, and perceptions of young adolescent males. Specifically, this study will assess changes to help-seeking behaviours, conformity to normalised masculine traits and ideologies, comfort levels in discussing difficult conversations, and perceptions of surrounding support structures. By investigating the impact of secondary school-based gendered mental health programs, this study hopes to address behaviours linked with the increasing mental health and suicide rates in young males. Lastly, by reflecting on the feedback provided by both teachers and students partaking in the workshops, this study will ensure that future gendered-workshops and the development of such are tailored to the needs and expectations of the core consumers.

  • A pilot randomised controlled implementation study to support women at high-risk of cardiometabolic pregnancy complications

    Pregnant women, at high risk of developing gestational diabetes and/or hypertensive disorders of pregnancy who receive information about future risk of diabetes and cardiovascular disease, alongside healthy lifestyle coaching from their first trimester antenatally through to 7 months postpartum will be more likely to undergo cardiometabolic screening tests in postpartum, compared with women who receive standard antenatal care. This is a randomised controlled pragmatic implementation trial to optimise lifestyle management and screening of DM2 and CVD in women who are at high risk of developing GDM and HDP during pregnancy. The primary outcome for the RCT component is screening for DM2 or CVD at 12 months postpartum (yes screening occurred; vs not done).

  • Coronary Artery disease SCreening in young ADult relativEs of individuals with premature Myocardial Infarction (CASCADE-MI study)

    Premature cardiovascular disease (CVD) remains a significant cause of morbidity and mortality despite advances in prevention. Patients with myocardial infarction (MI) at a young age represent a unique cohort, with differences in cardiovascular (CV) risk factor profile, underlying pathophysiology, and coronary plaque compared with their older counterparts. In young patients with MI, genetic predisposition contributes to the development of coronary artery disease (CAD). Indeed, family history of premature CVD is a well-recognised risk factor for MI. It is therefore recommended that family members of patients with premature MI undergo CV risk assessment. There are risk scores available for CV risk assessment, such as the Australian CVD risk calculator, which estimates 5-year CVD risk based on clinical factors. Cardiac imaging has shifted the playing field regarding non-invasive detection and assessment of subclinical atherosclerosis. However, cardiac imaging is not currently recommended for large-scale screening in asymptomatic patients but may improve CV risk-stratification and guide use of preventive medications in certain individuals. Families with premature CAD are a high-risk cohort that remain a neglected target for primary prevention. In 300 adult first-degree relatives of individuals with premature MI, this randomised trial will aim to assess whether addition of computed tomography coronary angiography (CTCA) to routine CV risk factor assessment can lead to superior primary prevention low-density lipoprotein cholesterol (LDL-C) levels

  • Sleeping Sound Community Trial: A waitlist randomized controlled trial of a brief behavioural sleep intervention program for autistic children aged 5-13 years

    This study aims to evaluate the efficacy of a brief behavioural sleep program (Sleeping sound) in reducing children's sleep problems and emotional behavioural disturbance and parents functioning and wellbeing in a sample of primary school aged autistic children with sleep problems, within a community clinic context.

  • Exploring whether home-based neuromodulation can boost the potential analgesic effects of exercise in people with knee osteoarthritis

    In our proposed study, all participants will get an exercise program (so all will experience some benefit), but half will get real tDCS to apply at home and half will get sham (‘fake’) tDCS. We will explore whether delivering this intervention at home is feasible and whether it produces any negative or unwanted effects. Critically, we will examine whether home-based tDCS boosts the effects of exercise in treating pain among people with knee OA. If successful, this intervention could lead to further trials and one day provide a more accessible and cost-effective treatment for individuals with knee OA, revolutionising management of this global health concern.

  • The impact of COVID-19 on colorectal cancer in regional Northern Queensland and changes to treatment related to distance to care

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