ANZCTR search results

The study will employ a cluster randomised controlled trial design and be conducted in metropolitan and regional areas of two Australian states. Community football clubs with over 40 junior members will be recruited from within Leagues. The intervention will be developed based on frameworks which build organisational capacity for implementation and consider the social, cultural and environmental factors that influence health behaviours. Intervention clubs will be supported to implement practices targeting alcohol management, tobacco use, nutrition practices, new player recruitment activity, equal participation for players, and the development of policies to support these practices. Trained research staff will collect outcome data via telephone interviews at baseline and follow-up. Primary outcome data will be collected from club representatives regarding the club’s implementation of the health promotion practices. Secondary outcome data will also be collected via telephone interview from parents/guardians of junior players and will focus on child and parent behaviours at the club.

This study aims to investigate left-right cerebral blood flow asymmetries and how it relates to lateralised behaviour in the infant. A non-experimental quantitative design will be utilised, allowing for analysis of numerical data. This study will be relational as it measures the potential relationships between lateralised behaviour and multiple hemodynamic characteristics of the trunks of the left and right middle cerebral and lenticulostriate arteries. The variables were selected because of their strong characterisation of the hemodynamic properties of arterial blood flow.

The primary purpose of this research is to determine whether consuming a polyphenol-rich seaweed supplement for 12 weeks will reduce LDL cholesterol levels in adults with elevated LDL cholesterol at baseline. It is hypothesised that the group who receive the seaweed extract supplement will have a greater reduction in LDL cholesterol levels than the group who receive the rice flour supplement.

The research project aims to evaluate the effectiveness of a Brief Crisis Intervention for Adolescents who present to a community-based, public mental health service with recent suicidal behaviour/plan or deliberate self-harm (within the past 2 weeks). This intervention is offered to young people aged 12 to 18 years and their parents/carers as part of routine mental health care by mental health clinicians within the team. The Brief Crisis Intervention for Adolescents comprises four to five 60-minute appointments that include a beginning, middle and end phase of treatment. The treatment involves both the young person and their carer/s and covers the following therapeutic tasks: Keeping safe and building a shared story about the young person’s crisis situation; Working through selected individual and family treatment modules that have been specifically chosen to build coping skills relevant to the young person’s unique situation; and Relapse prevention (i.e. reviewing what has been learned and planning for the future). Young people and their parents/carers who participate in the Brief Crisis Intervention for Adolescents as part of the young person’s routine care, will also be invited to participate in this research study. Young people and parents/carers who decide to participate in this study are consenting for the young person's information and outcome measures be included in the evaluation. The questionnaires will include routine outcome measures given to all families receiving mental health care at this service, in addition to a few specific questionnaires that evaluate the young person’s suicidal ideation and behaviours, self-harm behaviours as well as resiliency. It is expected that participants who were provided the Brief Crisis Intervention will demonstrate less risk of future suicidal or self-harm behaviours and have gained coping skills to better manage stress experienced in their lives.

Children with cystic fibrosis (CF) need to spend a lot of time on physiotherapy. Families have very busy lives, and using telehealth may reduce the burden of management, and contribute to improved quality of life. Telehealth offers home management with reduced travel requirements, saving time and money for families, and reducing the risk of hospital-acquired infections. Standards of care recommend that there are no interactions between people with CF due to cross infection risks. Telehealth allows young people with CF to connect with each other, and safely do physiotherapy in a fun & socially supportive environment. Aim: to investigate the clinical effectiveness & impact of a purpose-designed telehealth service (CyFiT) in physiotherapy management of CF. Our proposed research will investigate the comparison between CyFiT Intervention Group and standard outpatient physiotherapy for CF. We hypothesise that there will be no difference in functional activity capacity, hospitalisation rate, or increased cost to health providers between the two groups, but there will be significant differences in quality of life and patient satisfaction measures. Research Design: Randomised controlled trial comparing CyFiT Intervention Group and standard outpatient physiotherapy. Balanced block design; 110 participants. All participants will receive the same physiotherapy care, at the same time that would otherwise occur. The difference is that participants will be randomly assigned to physiotherapy delivered face to face (standard outpatient physiotherapy), or at home through telehealth consultations and online group exercise classes (CyFiT Intervention Group). Participants allocated to the CyFiT Intervention Group will be provided with a Garmin activity tracker. The tracked information will guide clinicians during individual and group sessions, and help identify deteriorations. The trial period will continue for 12 months, after which children will return to standard outpatient physiotherapy care. Methods: All participants in this study will receive 4x1 hour reassessment sessions (at 0, 6, 12, and 18 months post commencing the trial). Appoints will align with their regular multi-disciplinary clinics every three monthly to minimise inconvenience for families. Any additional follow-up physiotherapy will be delivered according to allocation to telehealth or control group. Outcome measures are: - Functional Exercise Capacity - Quality of Life - Quality & Quantity of Social Participation - Adherence to physiotherapy - Hospitalisation Rate - Cost Effectiveness/utility - Perception of Service Previous researchers have commented on the efficacy of telehealth in managing CF. No researchers have directly replaced face to face physiotherapy with a comprehensive telehealth equivalent in an operating CF clinic. Through this trial, researchers will investigate the effectiveness of CyFiT Telehealth to integrate into a contemporary and family centred clinic.

This is a two arm crossover study investigating the effects of a high fat, high carbohydrate meal on endotoxin levels and its effect on reproductive hormones in overweight and obese males. The study involves male participants aged between 18-50 with a BMI over 25 engaging in two clinical sessions. The first session requires the participant to be completely fasted. Blood endotoxin, testosterone, inflammatory markers and gut permeability markers are tested over a 5 hour period. Saliva testosterone is also measured over the 5 hours. The second session the participant consumes a designated high fat, high carbohydrate meal immediately to determine whether the meal has an effect on endotoxin in circulation and whether this is reflected in changes in reproductive hormone levels and inflammation.

Purpose of this Study: To investigate the safety and efficacy of oral forms of folate supplements in healthy individuals. The aim of this study is to see if there is a difference between the different forms for absorption and utilisation by the body and to see if there is a difference in efficacy between the different forms. This is an important study as it will help clinicians and the general public make informed choices. Procedure: One capsule per day of 500mcg of either L-5-methyltetrahydrofolate (5-MTHF), folinic acid or folic acid or a control group with no supplementation for four weeks. Visit 1- Baseline and Beginning of Treatment (Week 1) Blood pathology tests for MTHFR, serum folate and vitamin B12. A case report and food diary. Visit 2 - Mid Treatment (Week 2) Serum folate blood testing and food diary End of Treatment – Visit 3 (Week 4) Serum folate blood testing and food diary Discomforts and Risks Folate is generally considered safe and is essentially non-toxic. More than 15mg can cause abdominal distention, hyperactivity, nausea, sleep disturbances and vivid dreams. There are some concerns that folate supplements can mask a B12 deficiency so this will be measured at baseline. Benefits The information you provide during the study will help to guide further research which will inform clinicians and the general public about the effectiveness of different oral forms of folate supplements. Participant Protection and Voluntary Participation Participation in the trial is voluntary. Information that is supplied for the study will be maintained in strict confidence and will be de-identified to protect the participant’s privacy. You are entitled to withdraw from the study at any time. Findings Findings from the study will be published in the form of reports, journal articles and conferences or local presentations. Published results will not include your name or any information that could identify you.

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. Added sugar was found to be associated with poorer nutrient intake. A similar impact on micronutrient dilution was expected from free sugar as an estimation of approximately 10 g difference between added sugar and free sugar intake was found in the Australian population. The hypotheses of the current analysis include: a) the WHO cut-offs were not suitable for assessing micronutrient dilution; and b) micronutrient dilution is not evident until %energy from free sugars reaches 25% or above.

The primary aim of this study is to explore the impact of antenatal pelvic floor muscle exercises (PFME) on sexual dysfunction and quality of life in women during pregnancy and in the first three months following birth. A secondary aim is to determine the effect of antenatal PFMT on labour and birth outcomes, urinary and faecal incontinence and specific quality of life three months following birth. This is a randomised controlled trial and the primary hypothesis of this study is that: women who perform antenatal PFMT have better sexual function during pregnancy and three months following birth compared with women who receive antenatal standard care alone. The secondary hypothesis is that; women who perform antenatal PFMT have improved childbirth outcomes, less urinary and faecal incontinence symptoms and also better specific quality of life compared with women who receive antenatal standard care alone. Findings from this study will help to establish an evidence base for the use and effectiveness of antenatal pelvic floor muscle exercise to improve primiparous women’s quality of life, sexual function, childbirth outcome and urinary and faecal incontinence symptoms.

Little is known about dietary intake at the level of an “eating occasion (EO)”, which includes meals and snacks. Current dietary advice is framed around the amount and types of food populations should consume, rather than a consideration of eating patterns. Eating patterns describe the frequency and temporal distribution of meals and snacks. Eating patterns are likely to be important determinants of adults’ dietary intakes and health; however, the nutritional and health impacts of EO, meal and snack frequency and temporal eating patterns are inconclusive. Further, inconsistent evidence for eating patterns and health may be partly attributed to the lack of consensus on approaches for defining an EO or for assessing temporal eating patterns. The aims of these secondary analyses were to: 1) explore the influence of different definitions of EOs on the characterisation of eating patterns, 2) to examine temporal eating patterns using a novel data-driven analytic approach, and 3) to investigate associations of different eating patterns (e.g. frequency of all EOs, meals and snacks; temporal eating patterns) with nutrient intakes, overall diet quality and measures of adiposity and blood pressure. The Census and Statistics Act 1905 provides ethics approval for the Australian Bureau of Statistics to conduct household interview components of national surveys, including the National Nutrition and Physical Activity Survey (NNPAS). At this is a secondary analysis of the NNPAS data which is de-identified, an exemption for ethics approval was granted by the Deakin University Human Research Ethics Committee on April 16, 2015. (Project number: 2015-073).