ANZCTR search results

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.

The primary purpose of this pilot study is to assess the feasibility of successfully conducting a randomised controlled trial that investigates the effect of adding Explain Pain (vs adding sham ultrasound) to an individualised, physiotherapist-led physical activity and general education program in people with painful knee osteoarthritis. Our primary feasibility objectives relate to participant eligibility and recruitment, participant follow-up rates, feasibility of objective physical activity measurement using wrist-based accelerometry in this population (i.e., valid wear time), and the fidelity of intervention delivery. Our primary pilot objectives relate to the perceived credibility of the sham intervention (inactive ultrasound with inert gel) and the acceptability of Explain pain content and its delivery format for participants and treating clinicians. Our secondary objectives are to identify barriers to study participation and to determine treatment effect estimates for pain intensity and physical activity. This information will help us to calculate the required sample size for a full-scale randomised controlled trial. Participants will be randomised to one of two groups: Explain Pain or Standard Education & Sham Ultrasound Control group. Both groups will receive 4, in-person treatment sessions with a physiotherapist, followed by 4 weeks of at-home activities (weekly check-in by physiotherapist). Both groups will receive general education about osteoarthritis and the importance of physical activity for general health and osteoarthritis benefits. Both groups will also receive a graded walking program. The Explain Pain group will receive enhanced pain education to supplement general education. Specifically, the overall aim of Explain Pain is to shift participants’ conceptualisation of pain from that of a marker of tissue damage to that of a marker of the perceived need to protect the body. The Participants will receive the Explain Pain Handbook. During the at-home sessions, participants will complete an interactive workbook called the Protectometer. The Standard Education & Sham Ultrasound group will receive standard education about osteoarthritis, pain and physical activity as per Arthritis Australia recommendations. They will also receive sham ultrasound (inactive ultrasound and inert gel) to 4 locations on the most painful knee (5 mins each). This will be performed to match time with the therapist between groups. Participants will receive the Arthritis Australia osteoarthritis and physical activity handbook. During the at-home sessions, participants will complete an general workbook that asks questions about osteoarthritis and activity. Outcome measures (pain, physical activity, function, pain beliefs, etc..) will be assessed at baseline, at 4 weeks, 8 weeks, and 6 months by an outcome assessor blinded to treatment group. Treatment efficacy will not be evaluated (between group comparisons) given that this is a feasibility study.

The NSW Government’s Active Kids Voucher is a program designed to help families meet the cost of getting their kids into sport and active fitness and recreation activities. The initiative aims to reduce barriers to participation and help change the physical activity behaviours of children and young people in NSW. The NSW Government will provide a $100 voucher to parents/guardians of school enrolled children aged 4.5 to 18 years’ old. The $100 voucher can be used for registration and participation costs for sport and fitness activities and will not be means tested. One voucher will be available for every child in the family annually over the next four years and there will be no limits on the number of applications per family, as long as every child is enrolled in school. From 31 January 2018, parents/guardians/carers with legal responsibility of an eligible child resident in NSW will be able to download a voucher from an online platform, run by Service NSW. Vouchers are valid for redemption in the current calendar year and will expire at the end of each calendar year. The Active Kids Voucher is an opportunity to increase physical activity of children and will therefore be promoted to all schools within the HNE region during usual interaction with schools as part of health service delivery. The identification of strategies to increase the uptake and advantages of the program, are also warranted. The primary aim of this study is to assess the effectiveness of promoting the Active Kids Voucher program to parents using a school based mobile communication platform on voucher redemption. The study will employ a cluster randomised controlled trial (RCT) design including six intervetnion and six control schools. The intervention involves partnering with a third party school app provider - Skoolbag. Skoolbag is an app commonly used by schools to provide a communication platform between school administration and parents. Parents can download the app for free and the school can communicate school events, documentation and messages in a simple, easy to use way. The Skoolbag app will be used to send notifications to parents aimed at increasing uptake of the Active Kids Voucher. The effectiveness of the intervention will be determined by comparing post intervention differences between uptake and redemption of the Active Kids Voucher. The proposed research will be one of the first RCTs of its kind and addresses questions of particular policy relevance.

“Sarcopenia” describes the age-related decline in skeletal muscle mass and function which contributes to increased risk of disability and loss of independence. In the presence of obesity, these effects may be exacerbated, and we have demonstrated that the “sarcopenic obese” population have increased risk for falls and fractures, as well as poor cardiometabolic health. We hypothesise that a 12-week gym-based high-intensity resistance and impact training (HiRIT) program will result in significant improvements in physical function, bone quality, insulin sensitivity and glucose tolerance compared with home-based aerobic exercise program (control) in 60 sarcopenic obese community-dwelling older adults undergoing weight loss through dietary intervention. The findings from OSMOSIS-P will contribute to the development of guidelines for exercise in obese older adults at increased risk for functional decline, falls and fractures.

Patients undergoing bifurcation coronary stenting as part of standard of care and who give informed consent will be included in this study. All of the following are part of standard of care: Participants will be seen in pre-admission clinic or in their hospital bed by the PI. The registry will be discussed and if agreeable informed consent will be obtained. The participant will have a bifurcation stent inserted, discharged from hospital and followed up in the clinic at the Princess Alexandra Hospital. An exercise echocardiogram will be performed at Month 12 and if this is positive a coronary angiogram will be performed. The registry then ends for the participant. Registry research: Data from all of these time points will be collected.