ANZCTR search results

The primary purpose of this study is to assess the feasibility of conducting a placebo controlled trial in the Corrective Services setting and also to generate pilot data for use in the application of funding for a multi-centre trial in due course. It is expected that the fish oil plus micronutrients supplemented group will have reduced aggressive behaviour comapred to the placebo group.

The study is evaluating the impact of a telehealth-based intervention on service provision for palliative care patients as well as assessing its potential in replacing current usual care through increased video link contact opportunities and remote monitoring of patients and their carers at home. Who is it for? You may be eligible to join this study if you are aged over 18 years, require palliative care in Seaford, Aldinga, McLaren Vale and Willunga in South Australia, and have access to a National Broadband Network (NBN) connection. Trial details: Participants in this study will be provided with regular and responsive online access to health professionals, and access to quality information and resources to support palliative care patients and their carers. Participants will be monitored on a regular and ongoing basis to determine the feasibility, acceptability and utility of the telehealth-based intervention.

Vitamin D deficiency is a public health issue in developed countries. Many countries recommend supplementing infants with 400 IU/day of vitamin D. These recommendations have been introduced based on the evidence that supplementation reduces the risk of rickets, which occurs generally among those with moderate to severe vitamin D deficiency. There is debate whether a similar policy should be introduced in Australia where rickets only occurs in high risk groups which can be easily identified. While vitamin D has potential benefits for bone health beyond the prevention of rickets by improving bone acquisition, the current evidence in infants is sparse, inconsistent and cannot even rule out a detrimental effect on bone. An expansion from supplementation of at-risk to supplementing all infants should only occur if there are health benefits beyond rickets. However, practice is starting to run ahead of the evidence, and infants are now increasingly being supplemented in the absence of this evidence. High quality and well-powered randomised controlled trial (RCT) evidence is required to show that supplementation of mildly deficient infants is beneficial and does not cause harm. Aim – To determine whether vitamin D supplementation of 400 IU/day of cholecalciferol from birth to age 2 yrs improves bone health outcomes Hypothesis – Compared to placebo, vitamin D supplementation from birth to age 2 years improves whole body bone mineral content at age 2 and 4 years. Significance – Irrespective of its outcome, this study is critical to our ability to make evidence-based decisions around vitamin D supplementation programs in infancy. If our hypothesis is supported, it has the potential to reduce childhood fracture risk by ~50% with a 5% increase in bone mineral density and to delay the onset of osteoporosis in later life by as much as 13 years with a 10% increase in peak bone mass.

This study is evaluating a proactive and structured telephone based intervention for carers of cancer patients. Who is it for? You may be eligible to join this study if you are aged 18 years or above and a carer of a newly diagnosed cancer patient attending chemotherapy or radiotherapy treatment with curative intent. Trial details Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will receive the new telephone based intervention. This is a proactive and structured outcall program of information and support, delivered by experienced Cancer Council Helpline nurses to carers. The Helpline nurse screens carers for distress and links them to a range of community based supportive care services as required. Carers in this group will be contacted by a Cancer Council Helpline nurse at 7-10 days post referral (Outcall One), four weeks later (Outcall Two), and three months later (Outcall Three). Participants in the second group will receive three telephone outcalls at the same timepoints as group one. The purpose of the calls is to remind participants about the availability of the Cancer Helpline. Participants who choose to contact the Cancer Helpline will not receive the Outcall program but the usual support provided by cancer helpline nurses. Carers will complete questionnaires at Baseline, 1 month and 6 months, and patients will be complete questionnaires at Baseline and 1 month, in order to evaluate carer burden, psychological health, carers’ ability to navigate health services, quality of life, unmet needs, and cost-effectiveness.

The aim of the research is to compare the established prectice of the Pain Clinic versus this intervention, consisiting of 5 hours of education to promote self management in persistent pain conditions. The study will be one of a randomised controlled trial pilot design; 2 care pathways; firstly usual care where patients will be assessed by a doctor and other allied health professionals. The intervention will be the education sessions followed by the option of patients attending clinic for consultations with the doctor and other health care professionals. The study will look at the research questions: 1. To see if pre-clinic education is a significant improved model of care compared with usual care, 2. To see the interaction between education sessions and medial intervention, 3. To monitor the changes in patients self management over time.

MiYoga has the potential to assist children with CP, training them to focus their attention on the present moment so that they can fully focus on activities in school, in therapy or when interacting with peers. At the same time, hatha yoga postures may provide additional physical benefits to complement the on-going therapy for children with CP. It is hypothesized that the MiYoga program will lead to improvement in the following child outcomes: 1) enhance sustained attention; 2) increase physical functioning – strength, balance and flexibility; 3) enhance present-moment awareness (mindfulness); 4) enhance in parent-reported child executive functioning in everyday life; and 5) decrease in parent-reported child behavioural and emotional problems; and 6) enhance parent-reported (if <9 years old) or child self-reported (if >9 years old) child quality of life. In addition, it is predicted that there will be improvements in the following parent outcomes: 1) decrease parent’s stress levels; 2) enhance child-parent relationship; and 3) enhance parent's psychological flexibility.

The aims of this study are to investigate the effects of altering the timing of food intake during Ramadan on: 1. The secretion of appetite regulating hormones and various metabolic parameters during a mixed-nutrient challenge test at dinner, 2. Body composition 3. Resting energy expenditure and respiratory quotient (to assess fat oxidation) in subjects with and without type 2 diabetes.

The long-term aim of this research is to develop a safe, effective and economical program that uses dexamphetamine to assist individuals in the establishment of a healthy pattern of diet and exercise for the treatment of obesity and maintenance of weight control.

Wholegrains are rich in nutrients and other substances with antioxidant activity that have the potential to benefit human health, in a similar way to the effects of fruits and vegetables. Wholegrain foods have been associated with reduced weight gain, slowly digested carbohydrates and improved heart health, particularly in studies of populations that consume certain wholegrains as a staple food. We wish to investigate if some positive effects can be identified and measured in people consuming specific wholegrains in a single meal. This study aims to demonstrate the immediate effects of eating a range of wholegrain breakfasts on appetite and blood levels of glucose, appetite hormones and antioxidants. Therefore, this study is a very important step towards building evidence for specific wholegrains as important foods in appetite control and disease prevention.

This study is evaluating how well six different types of ultrasound enhanced breast biopsy markers can be visualised using ultrasound on the day of surgery to act as a target for preoperative ultrasound guided lesion localisation with hook wire for surgical removal. Who is it for? You may be eligible to join this study if you have a mammographic abnormality requiring stereotactic vacuum assisted core biopsy. Trial details Following vacuum assisted core biopsy of one (or more) breast lesions, a participant will have one marker randomly (by chance) selected from six different marker types inserted into the biopsy site. Each participant may have more than one breast lesion that requires a biopsy in which case the next marker on the list will be used to ensure a different marker is used for each lesion. The performance of each marker (how visible it is on ultrasound and whether it stays at the biopsy site) will be assessed and compared to determine if any of these markers can be reliably used for preoperative lesion localisation using ultrasound guided hook wire insertion.