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Taping and exercise for the treatment of exercise related leg pain.
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Diabetes Prevention Programs Project DP3: Testing the acceptability and effectiveness of different interventions and modalities
Proposal Aim To compare the effectiveness and cost-effectiveness of several different diabetes prevention programs including face to face groups, phone only interventions and those that use the internet to deliver lifestyle modification programs. Research design Screening, recruitment and referral Screening, recruitment and referral will be undertaken by the two Medicare Locals (IWSML and WSML). Eligible participants will be English-speaking 40-65 years, have completed an AUSDRISK >12, and have diabetes excluded, and medical clearance from a doctor. Target number of referrals (i.e. participants who are allocated to one of the four programs (see below). IWSML = 200 participants WSML = 200 participants Diabetes Prevention Programs Once eligible participants will be referred to a central point in each ML. The ‘Program Coordinator’ in each ML will contact the eligible participants explain the study, confirm interest and motivation, obtain consent and give them a choice to take up one of the four programs available in each of their ML areas. There will be a slight variation in each ML as follows: Inner West Sydney ML: Get Healthy Service [phone only] Prevent Diabetes Live Life Well [face-to-face and phone] Prevent Diabetes Live Life Well [internet and phone] 50 in each stream and 100 in PDLLW face to face group program Western Sydney ML: Get Healthy Service [phone only] SHAPE [face-to-face and phone] Prevent Diabetes Live Life Well [internet and phone] 50 in each stream and 100 in SHAPE program The programs will have to be offered in random order to each participant to avoid a possible bias here. Once the numbers for each arm have been reached then the participant will be told that they only have a choice of what is left. In this research design the PDLLW face-to-face program is the reference group that we will compare the three others to. It has been estimated that a sample size of 100 participants in each arm will be sufficient to detect between 1-1.5kgs weight difference at the 12-month evaluation between groups. The follow up period has been set as short-term evaluation 6-months from entry into the program and medium-term – 12 months from baseline. This allows completion of the intensive intervention 3-month phase and both short-term and medium term effects to be assessed. Evaluation outcomes It is proposed that once participants have been referred and agreed to be in one of the four arms but before they begin one they will be contacted by Computer Assisted Telephone Interviewers from the Boden to assess the main outcomes. Weight/Height Physical Activity Dietary assessment Waist circumference A welcome pack with a letter and tape measure will be sent to participants advising them to have their weight and waist circumference measures ready to report. In addition, sociodemographics and other relevant information will be collected by CATI. Primary outcomes: The primary goals assessed as follows: Weight (self-report) Physical Activity: Active Australia questions at baseline and 12-months collected as part of the CATI. Nutrition: Fat and Fibre index could be measured by CATI or a 3-day non-weighed food diary collected at baseline at the 12-month review. Secondary outcomes: Waist circumference (self-report) General health will be measured using the SF12. CATI to be repeated at 6 and 12 months after baseline.
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Mobile 'App' to Improve Iron and Zinc Intake, Iron and Zinc Status, Cognition, Mood and Fatigue in Premenopausal Women
Premenopausal women are at increased risk of iron deficiency due to iron losses in menstrual blood and increased requirements during pregnancy. Additionally, inadequate consumption of dietary iron or over-consumption of compounds that impede absorption of iron (e.g. phytate) can result in iron requirements not being met. In addition, women who have a low dietary intake of iron and a low iron level are frequently at risk of a low intake of zinc. Rich dietary sources of iron also tend to be rich sources of zinc. Currently very little is known about the zinc status of Australian women. The aim of this study is to investigate the use of technology to improve iron status, by determining if the dietary advice delivered by the mobile apps can 1) increases intake of bioavailable iron and zinc compared to a control "healthy diet" group; and 2) results in a significant improvement in iron and zinc status and markers of cognition, mood and fatigue compared with a control "healthy diet" group. We hypothesise that: The use of a mobile phone app to optimise intakes of bioavailable iron and zinc over a 16-week period in premenopausal women with low serum ferritin will result in: a) higher dietary intake of bioavailable iron and zinc; b) a greater improvement in iron status; c) a greater improvement in cognition, mood (including indicators of depression and anxiety), fatigue and sleep compared to a control "healthy diet" group.
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Phase III randomised trial of high dose Cyclophosphamide, Epirubicin, Vincristine and Prednisolone (CEOP) chemotherapy regimen & Filgrastim versus standard dose CEOP chemotherapy regimen in patients with non-Hodgkin’s lymphoma
This study evaluated the effectiveness of high dose Cyclophosphamide, Epirubicin, Vincristine and Prednisolone ifosfamide (CEOP) chemotherapy regime with Filgrastim, and standard dose CEOP chemotherapy regime in patients with non-Hodgkin's lymphoma (NHL). Who was it for? Patients were eligible to join this study if they were aged 16 years or more, had been diagnosed with NHL (Histological types: Follicular large cell (Group D), Diffuse mixed small cleaved and large cell (Group F), Diffuse large cell (Group G) or Large cell immunoblastic (Group H)), and had not received previous chemotherapy or radiation therapy for NHL. Trial details Participants in this trial were randomly (by chance) allocated to one of two treatment groups. Participants in group 1 received a high dose CEOP chemotherapy regime with Filgrastim which involved 1500mg/m2 of Cyclophosphamide intravenously on day 1, 150 mg/m2 of Epirubicin intravenously on day 1, 1.4 mg/m2 (maximum of 2.0mg) of Vincristine intravenously on day 1, 100 mg/day of Prednisolone orally from days 1 to 5, and 5 micrograms/kg/day of Filgrastim subcutaneously from day 2 until Absolute Neutrophil Count was greater than 10 x 109/L for a maximum of 14 days. This treatment regime was repeated every 3 weeks and was administered to participants 6 times. Participants in group 2 received standard dose CEOP which included 750mg/m2 of Cyclophosphamide intravenously on day 1, 75mg/m2 of Epirubicin intravenously on day 1, 1.4mg/m2 (maximum of 2.0 mg) of Vincristine intravenously on day 1, and 100 mg/day of Prednisolone orally from days 1 to 5. Similarly to group 1, this treatment regime was repeated every 3 weeks and was administered to participants 6 times. All participants were assessed prior to treatment, after 3 courses of the treatment, at completion of the 6 courses of the treatment, at 3 months post treatment, at 6 months post treatment and at 5 years post treatment to assess the effectiveness of the treatment regimes.
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Prevention of avoidable hospital admissions of older people living at home in Western Australia: a pilot randomized control trial.
There is published evidence for avoidable hospital admission of older people. However no effective intervention has been adopted as routine practice. A pilot randomized controlled trial is proposed for initial evaluation of a complex intervention, comprising multidisciplinary input into the care of older people at risk of hospital admission for unmet need. Older people will be identified by a review of admission records and further described using a set of measures assessing for physical, social and psychological needs. The needs of those assigned to receive the intervention will be reviewed and addressed by a general practitioner supported by a multidisciplinary team. The study will generate data on: 1)Identifying and engaging at-risk patients 2)Operating a multidisciplinary team- including primary care practitioners who are not formally employed in general practice 3)The relevant interventions that are funded by Medicare and the logistics of delivering those interventions 4)The uptake of such interventions by patients 5)Developing the role of GP as care coordinator within a multidisciplinary team structure. This project will address the recommendations of a recent Cochrane review on reducing hospital admissions. The intervention will be developed with reference to published Australia data and the UK Medical Research Council framework for the development and evaluation of complex interventions. This pilot study is a forerunner to a multi-centered, fully powered randomized controlled trial.
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Prospective Validation Study of the International Classification of Functioning, Disability and Health Score in Crohn’s disease and ulcerative colitis.
The central hypothesis is that the IBD-DI is an objective measure of disability in IBD that correlates with work absenteeism. The primary objective of the study was to design and validate a numerical scoring system for the IBD-DI to measure IBD disability using standard statistical techniques. Secondary endpoints include identification of the extent of severe disability, correlation of disability with work absenteeism, and identifying predictors of employment status.
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Effects of L-leucine (alone or in combination with L-tryptophan or lauric acid) on gut functions, gastric emptying, gut hormone release and blood glucose control in healthy, and obese humans with type 2 diabetes
There is increasing evidence that nutrient stimuli in the gut, especially in the small intestine, induce changes in gut motor and hormonal functions that play a central role in the control of energy intake and blood glucose. Previous research by our group has shown individual amino acids (L-tryptophan) and free fatty acids (lauric acid) to markedly reduce energy intake at a subsequent meal when administered intraduodenally or orally, respectively. This study aims to investigate the effects of the amino acids L-leucine, alone or in combination with L-tryptophan or lauric acid, on gut motility, gut hormone release, blood glucose control and energy intake in healthy lean individuals and obese patients with T2DM. We hypothesise that L-leucine, administered in combination with L-tryptophan or lauric acid, will take advantage of the several pathways activated by these two classes of nutrients enhancing their potency and thus, resulting in a marked improvement in the beneficial effects on gut functions and energy intake regulation previously associated with these nutrients alone.
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Testing the effectiveness of a mindfulness-based intervention to reduce distress in people with diabetes
Mindfulness-based intervention programs are a promising intervention in the treatment of psychological distress in a range of clinical populations including pain disorders, cancer and other medical problems. There is, however a paucity of studies that have examined mindfulness in people with diabetes. The few studies that have been undertaken have shown the intervention to result in improvements in emotional well-being (anxiety and depression), improved self-care behaviours and decreased HbA1c values. This study will assess the effects of a mindfulness-based intervention undertaken and self-directed in people with diabetes at home over an eight-week period. This study will seek to determine whether a mindfulness-intervention undertaken in the patients’ home can: Reduce anxiety and depression Reduce perceived diabetes –specific stress Improve diabetes self-care and management Improve glycemic control (HbA1c) Increase mindfulness strategies (acceptance and action) in relation to diabetes
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An Intervention to Increase Meaningful Occupation After Traumatic Brain Injury: The Participation, Engagement and Productive Alliance (PEPA) Program
Participation in the workforce is often not possible for people who have sustained a severe traumatic brain injury (TBI). Furthermore, a large proportion of those who are unable to return to work also do not engage in any meaningful occupation in lieu of work. Such people generally have sustained major impairments of the cognitive functions essential to the development of meaningful occupational activities; specifically the ability to plan, initiate action, and to monitor and/or sustain activity. They often require structure and support if they are to develop a program of meaningful activities. This project specifically addresses the issue of diminished meaningful occupational activity for those who have sustained a TBI and are unable to return to work. Using single case experimental design methodology this study will provide individual intervention specifically aimed at increasing the person’s engagement in meaningful activity.
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The Maternal Pertussis Study: best practice for the communication of pertussis (whooping cough) booster vaccine recommendations to new mothers.
The cocooning strategy, which was implemented in Australia in 2009, can have a strong protective effect (indirect) against pertussis in infants. To achieve high maternal coverage, understanding maternal attitudes and other potentially influential factors is important. In this study, we examined the influence of baseline attitudes, modifiable factors and health message framing on pertussis booster vaccine uptake among postpartum women in the public hospital setting.