ANZCTR search results

This study aims to determine if an Omega-3 powder, rich in docosahexaenoic acid (DHA), can improve cognitive function and mood in healthy male participants aged between 40-60 years. A total of 30 participants will be recruited to take part in this trial. Previous clinical trials have demonstrated improvements in cognitive function and mood after supplementation with long-chain omega-3 fatty acids. This will be the first clinical trial to investigate the specific supplement at this dosage, however, the supplement is currently used as a food additive by a number of companies. The benefits of omega-3 supplements on health is well established, and has led to an increase in use, as well as the addition of omega-3 fatty acids in dietary supplements. Despite this, only a small number of controlled trials have directly investigated the acute (short-term) cognitive benefits associated with omega-3 supplementation. The current study therefore aims to investigate the acute effects of a DHA-rich omega-3 supplement on cognitive function. We will be measuring the effects of the omega-3 supplement compared to a placebo using assessments of mental fatigue, cognition, memory and mood.

Approximately 250 volunteers will be required for this study. The study will test whether a 6-month multicomponent intervention (involving health coaching, sit-stand workstations at work, and a smartphone behavioural promoting tool) can reduce daily sitting time and improve blood glucose control as well as risk markers for cardiovascular disease (blood pressure and blood vessel health). The results of this trial will build on our understanding of the cardiometabolic consequences (i.e. high risk of developing heart disease) of too much sitting in individuals with type 2 diabetes and will help design intervention strategies in the community to reduce the risk of developing complications associated with diabetes.

Low blood pressure (hypotension) that does not improve with administration of fluids is a common reason for admission to intensive care. These patients usually require drugs that tighten blood vessels (vasopressor) to be given by continuous drip into a vein (intravenous infusion) to support the circulation and maintain a sage blood pressure for a period of time until the patient improves. Underlying causes of this hypotension may relate to sepsis, inflammatory conditions such as pancreatitis, use of medications and inflammation as sometimes seen in patients after surgery. Midodrine is a drug that tightens blood vessels that can be taken by mouth and has been successfully used in many patients with diseases that cause low blood pressure and faintness when standing (orthostatic hypotension). It can be given as a tablet and is well tolerated. Recent studies have focused on its use in patients with other causes of hypotension and suggest it may be safely used in critically unwell patients already receiving vasopressor infusions for hypotension to shorten the length of time requiring such infusions. This may have additional patient benefits with shorter length of time of invasive monitoring and shorter length of ICU and hospital stay. There are, however, no randomised controlled trials assessing this effect, making it unclear whether reports published so far are correct. We aim to compare the effect of midodrine added to usual care against usual care in critically ill patients on low dose vasopressor infusions for fluid-unresponsive hypotension. We plan to enrol a total of thirty patients who have required a vasopressor infusion for more than 24 hours and remain on an infusion due to continuing hypotension. These thirty patients will be randomly (like the toss of coin) assigned to receive either midodrine in three divided doses of 10 mg each per day or usual care. To understand the effect of the midodrine administration, we will record routinely recorded patient demographic data, circulation data (such as blood pressure, heart rate, central venous pressure and cardiac output), baseline laboratory data (haemoglobin, white cell count, alanine aminotransferase, international normalised ratio, bilirubin, urea, creatinine, troponin, lactate), urine output and fluid balance and dose of intravenous vasopressor. The primary outcome measure will be time in hours from initial administration of Midodrine to cessation of intravenous vasopressor. Secondary outcome measures, such as length of ICU and hospital stay, will also be recorded. The results of this study will provide insight into the effects of midodrine in attenuating duration of vasopressor infusions in intensive care patients with fluid resistant hypotension and, if positive, will allow our patients to be able to stop their infusion and return to the ward and home more quickly.

The aim of the trial is to evaluate the safety and pharmacokinetics of ACP-015 in healthy male subjects. Such data will be descriptive rather than based on a statistical approach. ACP-015 is designed to provide long-term CNP exposure with the goal of optimizing efficacy with a well-tolerated and convenient once weekly dose. No identified or potential risks for use of ACP-015 in humans have been established as no data is available regarding the use of ACP-015 in humans.

Eating disorders (ED) and disordered eating (DE) are widespread, serious problems. Efficacious prevention programs that can be delivered at-scale are needed. An online randomized-controlled trial of 2 online programs was conducted. Participants were young-adult women from Australia and New Zealand seeking to improve their body image. Media Smart-Targeted (MS-T) and Student Bodies (SB) were both 9-module interventions released weekly, whilst control participants received positive body image information. Outcome measures were completed at baseline, post-program, 6- and 12-month follow-up. It was expected that both interventions would be superior than controls at lowering eating disorder risk.

The objective of this study is to a) determine the effects of androgen deprivation therapy (ADT) on the structure and function of the heart in prostate cancer patients and b) evaluate whether a targeted exercise intervention can reduce the ADT-induced impacts on the heart. Who is it for? You may be eligible to take part in the study if you are male aged 40 years and over, are diagnosed with prostate cancer and are currently receiving or scheduled to receive ADT (<1 month of initiating ADT) with or without upfront chemotherapy. You may also be able to take part if you are male and have not been diagnosed with cancer. Trial details: Participants in this study will be randomly (by chance) divided into two groups. Participants in one group (i.e. exercise intervention group) will attend a 3-month physical exercise intervention program that involves aerobic (e.g. cycling) and resistance exercise (i.e. lifting weights) undertaken 3 times per week at various community-based fitness centres/gyms throughout Melbourne. Exercise sessions will take approximately 60 minutes and will be conducted under the supervision of an accredited exercise physiologist. The usual care group will have no formalised exercise intervention during the three-month study period. During the research study period, the usual care participants will receive no formal advice from study investigators regarding physical activity. All participants will be offered an optional consultation with an exercise physiologist who will develop an individualised exercise program for each participant after completion of the three months follow up evaluation. All participants will be required to complete a number of tests at baseline and 3 months in order to assess the function and structure of their heart, their physical fitness, and body composition. All participants will be asked to complete an optional follow-up evaluation at 12-months. Participants will also be required to complete a number of questionnaires to assess their physical and psychological wellbeing.

There has been an increasing concern on the possible negative effects of excessive sugar intake, particularly added sugar, on the quality of diet and health status. Intake of free sugar, which is defined as added sugar and sugars naturally occurring in honey, syrups and fruit juices, should be limited according to WHO. Recent studies show that sugar-sweetened beverages promotes weight gain and possibly elevated blood pressure as well. Meanwhile, different added sugars sources (solids vs. liquids) may have different health outcomes. Current analysis aims to examine association of free sugar intake with blood pressure and obesity, and association between free sugar intake and blood pressure and obesity based on source of sugar (beverage vs non-beverage) among a nationally representative sample of Australian adults.

The primary objective of the TEXTME-2 study is to determine the impact of a program of lifestyle ­focused text messages on multiple modifiable cardiovascular risk factors, in a population of high­ cardiovascular risk individuals who have been referred to outpatient cardiology services for chest pain but without documented coronary artery disease (i.e. primary prevention cohort). In addition, this study will look at the effect of such a program on quality of life, health literacy, medication adherence and depression/anxiety scores. TEXTME-­2 builds on the work of TEXTME which is a randomised controlled trial that has demonstrated that lifestyle­ focused text messaging service compared to usual care in patients with coronary artery disease (i.e. secondary prevention cohort) resulted in reductions in LDL­C, blood pressure, BMI, significant increases in physical activity, and a significant reduction in smoking. It is unknown whether the text-messaging prevention program will be effective in a primary prevention cohort. TEXTME­-2 is a single­ blinded randomised controlled trial. Recruitment will occur over 12 months. The TEXTME­-2 program will be delivered over 6 months. The study population will consist of patients referred to an outpatient cardiology clinic for chest pain within a 12­ month period, at high cardiovascular risk WITHOUT documented coronary artery disease. The intervention group will receive text messages up to 4 times a week. Control participants will receive standard lifestyle change advice and medication care only. The primary outcome is percent change in the proportion of patients who have 3 or more uncontrolled modifiable risk factors (low density lipoprotein cholesterol, systolic blood pressure, body mass index, physical activity, and smoking status).

The NAVKID2 trial is a multi-centre, staggered entry, waitlisted randomised controlled trial that assesses the health benefits and costs of a patient navigator program in children with chronic kidney disease (CKD) stages 1-5, on dialysis (CKD-D) and with kidney transplants (CKD-T) and of low socioeconomic backgrounds. CKD is a devastating illness associated with increased mortality, reduced quality of life, impaired growth, neurocognitive impairment and psychosocial maladjustment in children. The overall annual mortality rate for children on dialysis is 35 per 1000 population and is thirty-fold higher than children without CKD. Such large discrepancies in mortality rates remain unchanged despite medical advances over the past two decades. The key findings of our observational KCAD study indicated that poor health in children with CKD is not only attributed to the direct influence of the chronic illness but also reflects outcomes of the complex pathway that defines equitable access to healthcare. We found that children with CKD of the lowest and second lowest socioeconomic status (SES) quartiles were at least 3 and 2 times more likely to experience poorer overall health compared to the highest SES quartile. Patient navigators are trained non-medical personnel who assist patients with complex and/or chronic conditions journey through the continuum of care and transit across different care settings. They help the vulnerable and underserved populations with chronic illness to better understand their diagnoses, treatment options, and available resources, to guide them through the very complex medical system and to overcome barriers to health care access and bridge gaps in transitions of care. Using a staggered entry, waitlist randomised control design, this study will aim to: 1. Assesses the impact of a patient navigator program on the overall health and well-being of children with CKD in a multi-centre, staggered-entry, waitlisted randomised controlled trial. 2. Determine the cost-effectiveness of a patient-navigator program compare with standard care. 3. Identify the barriers and facilitators of developing and implementing a patient navigator program in clinical practice.

The updated REACH program is designed for individuals with a mood disorder (bipolar disorder, depression) who have finished psychological therapy. The updated REACH program provides information and teaches pragmatic skills to help maintain well-being, manage stress, and prevent relapse. The aim of this project is to test whether: (a) the study procedures used to evaluate the updated REACH program are feasible, and (b) the updated REACH program is acceptable to users. Feasibility of the study procedures will be examined in terms of the participant recruitment rate, and the satisfactory completion of questionnaires and interviews at all assessment time-points by participants (pre-intervention, 9-week post-intervention commencement, and 6-month follow-up). Acceptability of the program will be examined in terms of participant satisfaction with the program. The project will also allow a preliminary examination of the impact of the updated REACH program on well-being, coping, and relapse. It is anticipated that the study procedures of this project will demonstrate feasibility, and the updated REACH program will have high acceptability.