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Does the distribution of carbohydrates in meals effect blood sugar responses for adults with Type 2 Diabetes following a low carbohydrate diet?
Expand descriptionPeople with type 2 diabetes have high blood glucose levels largely due to reduced action or section of the main hormone insulin. Larger spikes in glucose levels typically occur following the consumption of carbohydrates. Lowering carbohydrate intake is one way to improve glucose levels. However, it unknown if the distribution of carbohydrate at each meal and snack also influences daily blood glucose averages; specifically in the context of a lower carbohydrate diet. The main objective of this study is to determine if consuming a moderately low-carbohydrate diet of 90g across different distribution patterns will have an impact on blood glucose management. The primary outcome is the change in blood glucose with continuous glucose monitoring over each of the three 3-day periods following different carbohydrate distribution patterns.
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The Assessment and Management of Obesity and Self maintenance (AMOS) Clinic Evaluation
Expand descriptionObesity is a relapsing chronic and complex condition with genetic, environmental, physiological, psychological, and behavioural determinants. Obesity is associated with significant comorbidities, particularly type 2 diabetes, cardiovascular disease, osteoarthritis, sleep apnoea and specific cancers. For people living with obesity and type 2 diabetes, the risks of diabetes-related complications adverse cardiovascular and musculoskeletal outcomes are increased. Managing obesity in people with type 2 diabetes through lifestyle modification, screening, and early detection of secondary complications can improve the management of diabetes-related complications. Evidence supports multidisciplinary person-centred approaches to providing obesity and diabetes care where individuals are active decision-makers in their healthcare. Nevertheless, while multidisciplinary management of people living with obesity and type 2 diabetes is the best-evidence practice, barriers to this level of support exist in rural, regional and remote areas. The development of the national guidelines was underpinned by a comprehensive systematic review of the literature (conducted by AI Shaw). This literature review identified important evidence gaps in the management of patients with diabetes mellitus who also have obesity (NHMRC, 2013). A number of these evidence gaps are the focus of this project. Diabetes services routinely focus on managing and treating diabetes, and obesity management are more of an afterthought. Furthermore, there is a greater prevalence of socioeconomically disadvantaged people living in rural, regional and remote areas and less access to services that support behaviour change when needed. This study aims to assess the feasibility and effectiveness of a rural, multidisciplinary model of obesity care personalised for adults living with type 2 diabetes mellitus and obesity. The research design is a randomised controlled clinical trial. The project will recruit 212 patients with diabetes and randomise them to active intervention or usual care. The active intervention group will receive an integrated, multidisciplinary model of care for obesity management devised in partnership with the person receiving the care and including multi-intervention as desired. In so doing, the participant can choose the care model that suits them best considering their circumstances.
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Evaluation of the QuikFix Alcohol and Other Drug (AOD) Harm Minimisation Program for residential college students.
Expand descriptionBinge drinking is common in residential colleges in Australia and abroad. The objective of this study is to determine what type of AOD harm minimisation intervention is most effective for reducing risky AOD use and related harms among first year residential college students. Six colleges will be randomised to one of three different types AOD interventions: 1) trivia style AOD harm-minimisation workshop; 2) the AOD harm-minimisation workshop + QuikFix brief intervention; and 3) usual AOD / harm minimisation messaging. We expect students at colleges who receive the AOD harm-minimisation workshop + QuikFix brief intervention will have better outcomes.
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A randomised trial to evaluate the immune response of COVID-19 vaccines in adults and adolescents
Expand descriptionThe PICOBOO study platform is designed to be an adaptive randomised trial to evaluate the safety and effectiveness of COVID-19 booster vaccine strategies in the Australian context. This will enable regulators, researchers and policymakers to flexibly respond to new policy questions as they arise, for example as new vaccine formulations become available and new variants arise in Australia necessitating changes in strategy. This study aims to evaluate, pragmatically and efficiently, the immunogenicity and reactogenicity offered by alternative booster vaccination strategies against SARS-CoV-2. This adaptive trial is designed to allow for perpetual enrolment for as long as is needed to generate high-quality data to inform Australia's national COVID-19 booster vaccination practice and policy.
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Evaluation of a tailored pathway for frail and pre frail older people awaiting elective hip or knee arthroplasty
Expand descriptionThe objective of this study is to evaluate the effect of multi-domain tailored interventions administered through a POPS (Perioperative care of Older People undergoing Surgery) service among patients with varying degrees of frailty awaiting elective hip or knee arthroplasty on post-operative complications and length of stay. We aim to improve our understanding of how individual characteristics, frailty and comorbidities may have an impact on post-operative outcomes. We hypothesised that a geriatrican-led preoperative comprehensive geriatric assessment (CGA), combined with targeted interventions, along with 6 weeks centre-based exercise program as prehabilitation, would reduce post-operative complications and hence length of stay in older individuals undergoing elective arthroplasty surgery. This was retrospective observational study comparing a post intervention cohort with historic controls. Patients aged 65 years or older with a Clinical Frailty Scale (CFS) of 4 or greater, who were awaiting elective knee or hip replacement surgery were evaluated in our POPS @NALHN service between October 2018 to December 2019. Post-operative outcomes were compared with individuals who underwent joint replacement surgery between July 2017 to September 2018 without any pre-operative interventions.
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A pilot study of the effectiveness of a comprehensive Chinese language based introductory pulmonary rehabilitation program for individuals with pulmonary disease in Australia
Expand descriptionPulmonary rehabilitation is a standard of care for patients with chronic obstructive pulmonary disease and other chronic lung diseases, including lung cancer. Language and cultural barriers prevent sufficient uptake of this treatment in particular subgroups. One large population in our region is the Chinese community. This study aims to demonstrate that a tailored Chinese language-specific pulmonary rehabilitation program will provide benefits to a significant population in our local region, and that this may influence funding and policy-making for respiratory interventions. Who is it for? You may be eligible for this study if you are aged 50 years and over, have a pulmonary disorder that may benefit from pulmonary rehabilitation, and have a level of English that is not proficient enough to partake in English-based classes. Study details All participants will take part in weekly 60 minutes classes for 8 weeks, overseen by a physiotherapist and respiratory physician who are fluent in Cantonese and Mandarin. Each class will involve exercises and education to improve lung function, symptoms, and functional status. Before starting the classes and after completion of the 8-week program, participants will have their lung function and physical function tested, as well as completing a questionnaire regarding quality of life relating to their respiratory disease. It is hoped that this research may show that a Chinese language-specific pulmonary rehabilitation class can improve lung function and quality of life for individuals with lung disease from the Chinese community.
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The Tina Trial: A trial of mirtazapine for methamphetamine dependence
Expand descriptionThis is a multi-site randomised placebo-controlled trial of mirtazapine (30 mg/day for 12 weeks) for methamphetamine dependence. We hypothesise that mirtazapine will reduce methamphetamine use, reduce depression, improve sleep, improve quality of life and reduce HIV risk. We will also examine safety and tolerability of mirtazapine when delivered in routine clinical care in Australia.
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Monitoring Intermittent vs Regular inhaled corticoSteroids in asthma: MIRSA study
Expand descriptionThe Global Initiative for Asthma (GINA) and various national guidelines have recently recommended the use of Symbicort (a combination inhaled corticosteroid or ICS and long acting beta2 agonist formoterol or FORM) as-needed as an alternative treatment strategy (track-1) for patients with mild asthma. The existing evidence comparing regular ICS plus a short acting beta2 agonist (SABA) as-needed with ICS/FORM as-needed in GINA Step 2 asthma patients, however this data is limited to only four clinical trials. These have consistently demonstrated benefits in favour of regular ICS plus SABA as-needed in terms of symptom control and lung function improvement compared to ICS/FORM as-needed. An open-label study demonstrated a significantly greater reduction in forced exhaled nitric oxide (FeNO) with regular ICS plus SABA as-needed compared to ICS/FORM as-needed despite suboptimal adherence of 56% to twice-daily ICS. This suggests that regular ICS plus SABA as-needed provides more effective attenuation of inflammation compared to ICS/FORM as-needed in patients with mild asthma. To date there is no evidence evaluating the effect of ICS/FORM as-needed on airway hyperresponsiveness (AHR) a key feature of asthma that identifies active asthma. Thus, based on the established understanding of the mechanisms of attenuation of indirect AHR to inhaled mannitol, the hypothesis of this study is that regular ICS plus SABA as-needed suppresses AHR more effectively than ICS/FORM as-needed.
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The PICNIC Project: New parent peer educators sharing infant and child nutrition and feeding information: A multi-strategy approach
Expand descriptionPICNIC aims to influence parents feeding practices and infant/child quality. The PICNIC study is a peer education model with peer educators supported by a website and social media. New parents with an infant aged 0-2 living on the Mid North Coast of NSW who consent to the project will receive an intervention over 12 months including online workshops, discussion groups, participant forums, and social media messaging, in view of on-sharing feeding information within their social and family networks. This study will use a progressive recruitment strategy within health services, through previous participants and online. Parents feeding practices will be measured when they start the project then again at 6 and 12 months to measure any changes. Parents feeding practices at 12 months will be compared with population data. Participants will complete a diet survey at 24 months after they first participated in the study and this will be compared against population data. Participants will work together with the research team (participatory action research) to guide ongoing intervention characteristics, to ensure modification and adaptation of the project model in partnership, consideration of participant and group characteristics. Over the intervention period the research team will provide opportunities for networking, consultation and input into all aspects of the program. Data will be collected in a number of methods including focus groups, participant correspondence, including social media forum activity.
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A Pilot Study of Cognitive Behavioural Therapy for Migraine in Multiple Sclerosis
Expand descriptionIndividuals with MS and migraine can face difficulties with thinking skills (e.g. concentration and memory), mood, fatigue, work and social activities. However, to date, there has been no CBT program developed that is specifically tailored to these difficulties for individuals with MS and migraine. The project aims to assess how feasible and acceptable such a CBT program would be among people with MS and migraine. The brief cognitive behavioural therapy program will be conducted in five sessions across, with one-hour weekly sessions and a follow-up phone call 4-weeks later. The study will be conducted entirely on telehealth via internet, so participants can attend from home. Sessions will be on a one-on-one basis, with a neuropsychology registrar. The CBT program itself targets reducing the frequency and intensity of migraines, and in turn improve fatigue, low mood, anxiety, thinking skills, and work and social functioning. The techniques learnt in therapy aim to prevent migraines from occurring and when they do occur, lessen their impact on daily life. This CBT includes education about migraines, relaxation strategies, skills to adapt negative thoughts, and strategies to manage thinking skills difficulties (e.g. with concentration).