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Can a smart phone application assist in reducing dietary phosphate and sodium intake?
The purpose of the study is to investigate whether using a smart phone application can assist in the reduction of intake of foods which contain phosphate and sodium by helping people to adhere to a diet. We believe that using this app will help people adhere to a diet over a 2 week period. We will measure whether this has happened by collecting a sample of all the urine passed over 24 hours at both the beginning and end of the 2 week period and compare the result from that to others in the study who receive routine dietetic advice. Once all of the data has been collected, the researchers will aim to see whether the app has been helpful or not and to see if it can be used as a valid research tool in future experiments. Participants will then be asked for some information about themselves including: 1. Age, weight, gender, height, blood pressure, body mass index. 2. A food questionnaire and 3 day food record. Participation in the trial will require the following procedures: 1. A urine analysis 2. A 24 hour urinary collection for phosphate, sodium, creatinine and urine volume Participating in the trial will require some restrictions upon lifestyle during the study. These include changing ones diet to one which contains low levels of phosphate and sodium. Participants will be allocated in a group: 1.Diet sheets outlining dietary measures, including foods to avoid, to achieve the required dietary sodium and phosphate reduction (given out and explained by the student investigator), plus a telephone interview with a trained dietician in which the dietary intervention will be further explained and reinforced. 2.Instructions on the use of the dietary app, which participants will be able to use to monitor their sodium and phosphate targets. The app will be supplied on an iPad and taught how to use the app. Use of the app will be explained by the student investigator. This app has many functions including allowing users to input their dietary intake on a daily basis. It then keeps a running tally of nutrient intake and allows users to identify the nutrient content of individual foods, bar scans foods and indicates how well users are meeting or exceeding nutrient targets. All trial participants will be asked to keep a 3 day food diary (either via the app or via usual paper food diary) prior to the final repeat urine collection.
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Relationship between glycated haemoglobin (HbA1c) point-of-care and laboratory testing in intensive care unit (ICU) patients with diabetes
Point-of-care HbA1c testing in the intensive care setting may be advantageous for patients with diabetes who are admitted to ICU because including rapid availability of the result may guide insulin therapy. This may be of particular benefit for patients with poor glycemic control that are at a greater risk of hypoglycemic complications. However the accuracy of the HbA1c point of care testing has not been validated in the critically ill.
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Tailored feedback to change overweight adults’ diet and physical activity behaviours.
Excess weight is a major risk factor for chronic diseases, such as heart disease, diabetes and some cancers. In Australia over 60% of adults are overweight or obese. Lack of exercise, overconsuming foods high in fat and sugars and not enough fruits and vegetables are recognised as key lifestyle factors leading to obesity in the population. Therefore new cost-effective approaches to improving the diet and physical activity of the population are needed. Self-monitoring is recognised as effective strategy in helping people improve their diet and physical activity. As people may not always know what changes to make, the addition of personalised feedback which provides specific recommendations may assist in weight maintenance. LiveLighter, is a public health education program to encourage people to eat well, be physically active and maintain a healthy weight. The aim of this study is to investigate in an overweight population whether diet and physical activity can be improved with personalised feedback. Volunteers will be invited from those who enrol in the LiveLighter Campaign. There will be three groups of 200 people (total 600 people). To record their diet, people will use an app designed by the investigators, known as a mobile Food Record for four days. They will also wear an activity monitor for 7 days. After recording details of their diet and physical activity, one group will receive frequent personalised feedback on their diet and physical activity for six months and provided with fitness tracker. Another group will record details of their diet and physical activity. A third group will only fill out only on-line surveys with questions about their diet and physical activity. All groups will be followed up again at one year. This will make it possible to determine if the addition of personalised feedback has any added benefit and if it helps people improve their diet and physical activity, as well as being able to achieve a healthy weight. Details of all costings will be collected making it possible to work out how cost effective the program is. If successful and cost-effective, expansion for use in large scale state-wide and national interventions will be highly feasible.
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The Ages and Stages Questionnaire - Talking about raising Aboriginal Kids (ASQ-TRAK) developmental screening tool for Australian Aboriginal children. Determining the reliability and face validity of the ASQ-TRAK and exploring the characteristics of developmental delay in Aboriginal children in urban, regional and remote areas of South Australia.
The project aims to establish the reliability and face validity characteristics of the ASQ-TRAK, a culturally adapted version of a developmental screening tool, for use with Australian Aboriginal children. The project also aims to explore the characteristics of developmental difficulty or delay in South Australian Aboriginal children. The project will contribute to an existing study about the validation of the ASQ-TRAK. Aboriginal children and their caregivers who attend the Child and Family Health Services (CaFHS) in four South Australian locations will be invited to participate in the project. THe proposed sites are Port Adelaide (urban), Morphett Vale (urban), Port Augusta (regional), and Anangu Pitjantjatjara Yankunytjatjara - the APY lands (remote), Child health staff will be trained to use the ASQ-TRAK. The project will employ a cross-sectional design and the methods will be as follows: 1. Reliability: for test-retest reliability, the same practitioner will re-administer the ASQ-TRAK within a two week period. For inter-observer reliability, a different practitioner will re-administer the ASQ-TRAK within a two week period. To calculate internal consistency, the ASQ-TRAK only needs to be administered once. In the urban and regional sites, the ASQ-TRAK will be conducted twice and this data will establish test-retest and inter-observer reliability. In the remote site, the ASQ-TRAK will be conducted once. For children who have the ASQ-TRAK, this data will contribute to establishing internal consistency. 2. Face validity: practitioners and caregivers will be surveyed about their experiences with the ASQ-TRAK. 3. Prevalence: rates of developmental difficulties or delay will be estimated for the four locations, using hte cut-off rates determined by the ASQ-3. The project will provide information about the accuracy and acceptability of the culturally adapted ASQ-3. This will help to fill a gap in providing developmental services to Australian Aboriginal children.
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Impact of Exercise Intervention on the Phenome (Metabolism and Predictive Complications) in Well Characterised Pre-diabetes and New Onset Type 2 diabetes Cohorts in China and Australia.
This study aims to: 1. compare baseline phenotypes amongst those with recently identified prediabetes and type 2 diabetes, in Sydney, Australia and in Shanghai, China. 2. examine the effect of an exercise program on changes in metabolic end-points, complications, surrogate biomarkers, gut microbial profile and cognitive measures. 3. examine the effectiveness of an intervention to improve exercise maintenance. Study Hypotheses: 1. The phenotypes amongst those with recently identified prediabetes and type 2 diabetes, in Sydney, Australia and in Shanghai, China, differ in their body composition and adiposity (by DXA scan and abdominal MRI), and degree of insulin deficiency (by insulin, glucose and C-peptide measures). 2. A structured exercise program involving high intensity interval training (HIIT) and resistance exercise will lead to improved percentage of liver steatosis (1H-MRS), non-alcoholic fatty liver disease (steatosis greater than or equal to 5.5% and insulin-fibrosis measures), body composition, metabolic end-points (including HbA1c, fructosamine), lesser organ complications (including albuminuria, cardiac diastolic dysfunction, cardiac autonomic neuropathy, peripheral neuropathy), improved surrogate blood biomarkers of complications (including CD monocyte markers, CTGF and FAP), and more normal gut microbial profile, mood state and cognition. 3. An intervention aiming to improve exercise maintenance will result in improved exercise adherence, sustained outcomes in exercise parameters (adherence to exercise amount, greater intensity) and cardiovascular fitness, NAFLD, body composition, improved metabolic end-points, lesser organ complications, improved surrogate biomarkers of complications, and more normal gut microbial profile, mood state and cognitive function.
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Carbohydrate taste sensitivity testing in healthy volunteers to determine human oral carbohydrate taste function and its association with food consumption, BMI, and ad libitum consumption of carbohydrate foods
The aim of this project is to investigate if humans are able to detect small amounts of carbohydrate orally and investigate links with dietary consumption, ad libitum consumption of carbohydrate foods, and weight. Over the past decades, behavioural studies demonstrated that rats are very attracted to starch and that starch is preferred to sucrose at low concentrations, suggesting that rats have different taste receptors for sucrose and starch. Carbohydrates, in the form of sugar and starch, represent a major source of food energy. Except for some fruits, plants contain much more starch than sugar, but it is sugar with its sweet taste that is the most sought after carbohydrate. Compared to sugar, starch is rather bland to the human palate, and has been assumed to be tasteless for other animals as well. However, in the past decades, studies using animal models reported that rats are very attracted to the taste of maltodextrin (starch). The results of these studies suggest that starch and sucrose stimulate different taste qualities, indicating there is an independent taste receptor for polysaccharides. Recent studies investigating carbohydrate sensing in the human oral cavity through exercise performance have also found that exercise performance significantly improved after participants rinsed their mouth with solutions containing maltodextrin (see review by e-Silva et al., 2014). The results suggest that there may be an independent mechanism and pathway for oral carbohydrate detection, but as yet, there is not method for assessing carbohydrate detection thresholds in humans. A targeted sample of 150 participants will participate in this project and subjects must be over the age of 18 years. It is also preferred that subjects are non-smokers.
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A prospective, observational, cohort study of the MASTER-SL Femoral stem in patients with degenerative disease of the hip
Factors for operative treatment include severity of diseases that affect the hip, symptoms, clinical finding on physical examination and radiological assessment of the hip. When referring to total hip replacement (THR) surgery, both the acetabular socket and the head of the femur are replaced with a suitable prosthetic device consisting of a cup fitted into the acetabulum (socket) and a new head (ball) with stem fitted into the upper shaft of the femur. Two major factors influence the outcome of THR (outside the surgery process itself) and these are the fixation of the components to the bone and wear of the implanted surfaces. (between the ball and socket). THR is an extremely successful operation due to continuous improvements in surgical techniques, bio-materials and implant design. It is necessary however, to safely evaluate new advances in the design of hip replacement components so that improvements are sought to continually enhance patient outcomes. The design and materials used in the MASTER-SL femoral implant are very similar to other prosthesis already used by surgeons. The aim of this trial is to assess the clinical performance of the MASTER-SL femoral stem over a two year period under standard condition of use in THR.
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HeadGear – A mental health smartphone application for the prevention of depression: A randomised controlled trial
Our research team has recently been awarded an Australian Mental Health Award by Beyondblue and the Movember Foundation that will fund a program of research aimed at developing and evaluating a range of new e-health interventions for Australian workers. This is intended to cover the evaluation via a multisite randomised controlled trial (RCT) of a smartphone intervention aimed at promoting mental health and well-being. Specifically, this study aims to evaluate the efficacy of a smartphone application (‘app’) designed to prevent depression in workers, with an intervention condition (‘HeadGear’ app) and attention-matched control condition (‘HeadGear lite’ app). Specifically, the relative efficacy of the application as a tool for primary prevention of common mental disorders will be evaluated. All employees of several partner organisations will be invited to participate, and directed to their app store via advertisements or via visiting the trial website. Upon downloading the app, participants will undergo initial screening, provide informed consent, and complete baseline assessments of outcomes including: depression (PHQ-9) and anxiety (PHQ-2) symptomatology, wellbeing (WHO-5 Well-being Index) and work performance (HPQ). Participants scoring below 9 on the PHQ-9 at baseline will then be randomised to receive either the intervention ‘HeadGear’ application or the attention-matched control version of the app. Those scoring above 9 or meeting MDD diagnosis using the PHQ-9 algorithm will be provided with appropriate referral information to health services and crisis lines, and will be encouraged to seek help from their GP. Participants are encouraged to use the smartphone application for 30 days. Post-intervention assessment will occur at 5 weeks post-baseline, and 3 and 12 months later at follow-up, with measures similar to those assessed at baseline. All assessment (apart from diagnostic interviews) will be completed online. Individuals whose results indicate depressive symptomatology or diagnosis (via PHQ-9); and a random sample of 10% of participants at 3 months, will receive a follow-up diagnostic telephone calls from trial staff. Researchers will be evaluating the relative impact of the smartphone application intervention on the prevention of common mental disorders, primarily depression, and its effects on health and wellbeing outcomes, immediately after trial participation, and 3 and 12 months later.
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HeadGear – A mental health smartphone application for those with elevated symptoms of depression
Our research team has recently been awarded an Australian Mental Health Award by Beyondblue and the Movember Foundation that will fund a program of research aimed at developing and evaluating a range of new e-health interventions for Australian Workers.. This is intended to cover the evaluation via a multisite randomised controlled trial (RCT) of a smartphone intervention aimed at promoting mental health and well-being. Specifically, this study aims to evaluate the efficacy of a smartphone application (‘app’) designed to treat depression in workers, with an intervention condition (‘HeadGear’ app) and attention-matched control condition (‘HeadGear lite’ app). Specifically, the relative efficacy of the application as a tool for treatment of common mental disorders will be evaluated. All employees of several partner organisations will be invited to participate, and directed to their app store via advertisements or via visiting the trial website. Upon downloading the app, participants will undergo initial screening, provide informed consent, and complete baseline assessments of outcomes including: depression (PHQ-9) and anxiety (PHQ-2) symptomatology, wellbeing (WHO-5 Well-being Index), Overall health (SF-12), resilience (CD-RISC 10) and work performance (HPQ). Participants scoring below 14 or not meeting diagnostic criteria on the PHQ-9 on the PHQ-9 at baseline will be excluded from this trial. Eligible users will then be randomised to receive either the intervention ‘HeadGear’ application or the attention-matched control version of the app (users will also be provided with appropriate referral information to health services and crisis lines, and will be encouraged to seek help from their GP). Participants are encouraged to use the smartphone application for 30 days. Post-intervention assessment will occur at 5 weeks post-baseline, and 3 and 12 months later at follow-up, with measures similar to those assessed at baseline. All assessment (apart from diagnostic interviews) will be completed online. Individuals whose results indicate depressive symptomatology or diagnosis (via PHQ-9); and a random sample of 5% of participants at 3 months, will receive a follow-up diagnostic telephone calls from trial staff. Project researchers will be evaluating the relative impact of the smartphone application intervention on the treatment of common mental disorders, primarily depression, and its effects on health and well-being outcomes, immediately after trial participation, and 3 and 12 months later.
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Effect of denosumab and zoledronic acid on bone turnover markers in critically ill women
Intensive care patients face health issues that extend beyond their critical illness, including weakness, changes in quality of life, and an increase likelihood of disease and death. One area of post-ICU illness that may be preventable is fragility fracture. Fragility fractures occur due to weakening of bone, most commonly due to osteoporosis in postmenopausal women. Fragility fractures have devastating effects, resulting in hospitalisation, loss of independence and function, and increased likelihood of dying in the following year. Critical illness appears to increase the rate of bone loss, with studies showing an increased in markers of bone turnover, an accelerated loss of bone mass, and an increase in rate of fragility fractures, during and after critical illness. This is particularly evident in women, suggesting critically ill women face an extra injury to their bones at a time when they are already at risk. Medications that prevent or reduce bone loss have been extensively tested and shown to be effective in post-menopausal women, and other groups at risk of losing bone rapidly. This includes some types of cancer, and patients receiving therapies that cause bone loss. There is limited experience in using antiresorptive medications in critical illness, although some evidence suggests they may be effective at reducing bone turnover. Denosumab is a more recent antiresorptive medication that acts to prevent bone loss, and has been shown to be effective in large trials. It has not be used in critical illness, so we would like to perform a small study to ensure it is safe and effective in this group. Bisphosphonates, like Zoledronic Acid, have been used to treat critically ill patients with biochemical evidence of bone resorption, and shown to be associated with reduced mortality in retrospective studies of critically ill patients. Denosumab and Zolderonic Acid have side effects, including acute hypocalcaemia, flu like symptoms, osteonecrosis of the jaw, real impairment (zoledronic acid), change in immune function (denosumab), and post cessation bone loss (denosumab). Given these we plan to delay study drug administration until there is no active infection, and stable renal function. At the completion of this study we will examine the safety and effect of denosumab and zoledronic acid on bone turnover in postmenopausal critically ill women. If it appears safe and show signs of benefit, we will plan a larger study to assess effect on bone mass, fractures, and survival.