ANZCTR search results

Twenty percent of adults meet criteria for food addiction, with 70% reporting greater than four symptoms of food addiction. Food ‘addicted’ individuals have significantly lower diet quality, higher intakes of junk foods and higher weight status. The personality characteristic of impulsivity is a common risk factor for substance use and food addiction. There are currently no evidence-based interventions run by clinicians for food addiction. Current treatment options largely stem from online self-help groups such as Food Addicts Anonymous and Overeaters Anonymous which have 10 000+ members, demonstrating the clear need for services and evidence-based programs. Interventions targeting personality risk factors and motivational interviewing for other addictions, such as alcohol use, are effective. This project builds on an existing pilot study utilising a personality-based intervention for the targeted treatment of addictive overeating in individuals with food addiction and is a subgroup study of our parent study ‘Examining the efficacy of a personality-based intervention targeting addictive overeating in Australian adults: a randomised controlled trial’. The current study will determine if the personality-based intervention targeting addictive overeating has an effect on cardio-metabolic profiles and neural reward responses in individuals with food addiction at 3 months follow up. Cardio-metabolic will be assessed via a fasting blood test, and neural reward responses will be assessed via a brain scan through clinical fMRI imaging. Additionally, this subgroup study will determine if individuals with food addiction are different from those without food addiction, in terms of their cardio-metabolic profiles, genetic profiles and structural brain function. It is hypothesised, individuals with food addiction will have improved cardio-metabolic profiles and altered neural reward responses at 3 months post-intervention compared to baseline, and individuals with food addiction will have different cardio-metabolic and genetic profiles (assessed via a fasting blood test), and heightened neural reward responses, compared to individuals without food addiction at baseline. If successful, this project will provide an evidence-based treatment for those individuals with food addiction and addictive overeating behaviours in the community and clinical services.

The care partner of a person with Alzheimer’s disease can be as much a “client” of a health service as a patient. They are heavily involved in facilitating the treatment and engagement of a patient, and thus need to be supported in this role that may have been unexpectedly thrust upon them. Care partner burnout has been identified as one of the main reasons individuals with dementia enter long-term care, therefore early intervention to support and empower care partners is critical. Interventions for care partners of individuals with a chronic illness have been shown to improve the psychological wellbeing of care partners. However, few empirical studies have been completed on the benefits of early intervention for care partners of individuals with Alzheimer’s disease. ECLIPSE - a newly designed, weekly, small-group-based intervention - will be provided over a four-week period to care partners of individuals recently diagnosed with Alzheimer’s disease. This project aims to implement and evaluate the effectiveness of ECLIPSE to improve psychological wellbeing, and to empower and support care partners.

The aim of this study is to assess the efficacy and patient perceptions of an 8-week exercise and educational support program for women with metastatic breast cancer in improving disease-specific quality of life, symptoms of anxiety and depression, and exercise capacity, as well as reducing pain and fatigue. Who is it for? You may be eligible for this study if you are aged 18 years or older, and have a diagnosis of metastatic breast cancer. Study details All participants will take part in an 8-week program consisting of two 60-minute exercise sessions per week involving aerobic and strength-based exercises, as well as two 60-minute educational support sessions per week. Exercise sessions will be supervised and run at the Cabrini Exercise and Wellness Centre. Once the patient is safely established on a supervised exercise regime, an unsupervised home exercise program will be prescribed for them to complete at home. Educational support sessions will cover a range of topics including mindfulness, energy conservation, superannuation and services, sleep, nutrition and lymphoedema, with the option to ‘opt out’ of particular sessions or request additional one-on-one support sessions with the social worker or psychologist if desired. Participants will be required to fill out a number of questionnaires and perform brief tests of physical function before the start of the program and after completion of the 8-week program. It is hoped that this study will demonstrate that a combined exercise and educational support program is effective for managing undesirable side effects of metastatic breast cancer and its treatment, and at improving functional exercise capacity and quality of life in these patients.

Adults who were born prematurely and mothers who give birth to a preterm baby are at increased risk of cardiovascular disease but neither are included in New Zealand’s risk assessment guidelines. As part of a wider project investigating the impact of premature birth on cardiovascular health we will invite the New Zealand Very Low Birth Weight cohort (born <1500g) and their mothers to have their cardiovascular disease risk assessed and compared to a control group. We will compare cardiovascular risk factors, cardiovascular events, general health and reproductive history in the premature-born NZ VLBW cohort and controls at age 35 years (2021). Cardiovascular events and risk factor trajectory will be compared to cardiovascular risk estimations using health data collected as part of risk factor data collected at 28 years of age using validated calculators (such as NZ PREDICT guidelines). We will also compare cardiovascular disease event rate and all-cause mortality in mothers of the NZ VLBW cohort compared to mothers of controls and calculate and compare five year cardiovascular risk estimates using the NZ PREDICT equations. This will be compared to actual cardiovascular disease events as part of a comprehensive evaluation of cardiovascular health planned in five years’ time. Evaluation for cardiovascular risk in participants will be based upon medical history, blood pressure and anthropometric measurements and blood testing for diabetes and dyslipidemia. This study and our wider research project will help to inform recommendations around cardiovascular risk screening after preterm birth/delivery.

The primary purpose of this study is to evaluate the safety of a new cancer drug, ACT001. Part B will evaluate the combination treatment of ACT001 with pembrolizumab in patients with recurrent GBM (Glioblastoma Multiforme brain cancer) only. Who is it for? You may be eligible to participate in this study if you are aged 18 or over, and have been diagnosed with glioblastoma. Those who participated in Part A of the study (ACTRN12616000228482) may be eligible to also participate in this study, subject to principal investigator approval. Study details: Participants will receive oral ACT001 twice every day for 21 days, together with intravenous (IV) infusion of pembrolizumab on the first day. After 21 days, once the safety of this treatment is determined, all participants will be given the treatment in recurrent 21-day cycles until tumour progression or adverse event. Researchers will take a number of blood samples from the initial 3 participants in Day 1 of the first and second 21-day cycle, to examine the rate that the body processes the drug. MRI scans and assessments of treatment response will be taken before treatment and then every 9 weeks to look for changes in tumour growth. Participants will also be assessed for side effects throughout the study period. It is hoped that the findings of this trial will show whether the combination treatment of ACT001 with pembrolizumab can be safely given to cancer patients, and provide information on the rate of processing of ACT001 by the body when pembrolizumab is also given. Using this information, researchers hope to find if the combination of ACT001 and pembrolizumab is safe and effective.

Osteoporosis is a disease characterized by bone fragility resulting in bone fractures, which leads to increased morbidity and mortality. Following menopause, bone resorption exceeds bone formation, leading to net bone loss and bone fragility. There is an emerging body of evidence linking the gut microbiome and probiotic ingestion to skeletal, muscle, cognitive, and cardiometabolic function. The aim of this study is to investigate whether a taking a probiotic supplement .twice daily for 12 months positively impacts the rate of bone loss in recently psotmenopausal women The proposed study is a double-blind, placebo-controlled randomised trial, which will investigate whether consuming a probiotic supplement containing inulin (a prebiotic soluble fibre) twice daily for 12 months will improve bone health in early postmenopausal women, aged 40-65 years. In addition, secondary outcomes will measure the effect of the intervention on immune system modulation and cognition as well as musculoskeletal and metabolic function as potential mediators. It is hypothesised that the probiotic supplementation will improve markers of bone health, muscle health, and metabolic health in postmenopausal women.

We aim to identify complexities in the scale-up, spread and sustainability of interact-ABI-lity, an online intervention to provide scalable communication training to communication partners of people with acquired brain injury (ABI), including family, friends, partners, paid support workers, clinicians and the general public. We therefore seek to identify; 1. Who uses interact-ABI-lity and what are their characteristics? 2. In what geographical locations and healthcare and social contexts is interact-ABI-lity used? 3. Do users complete interact-ABI-lity as intended? Why/not? 4. How usable is the technology for those completing interact-ABI-lity? 5. What barriers, facilitators and workarounds do users experience when completing interact-ABI-lity? 6. How satisfied with interact-ABI-lity are the users? 7. What is the cost of delivering interact-ABI-lity? The direct evaluation of the implementation of interact-ABI-lity by end-users aims to ensure the course reaches and meets their needs in a feasible, scalable, sustainable and acceptable manner.

This study aims to compare bronchoscopic biopsy to CT-guided biopsy for the purposes of evaluating peripheral lung nodules. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have a lung lesion in the outer 1/3rd of the lung field measuring between 1-3cm clinically requiring a biopsy. Study details Participants will be randomised (i.e. allocated by chance) to receive either bronchoscopic sampling performed by a respiratory physician or CT-guided biopsy to be performed by an interventional radiologist. Bronchoscopic biopsy will involve the doctor planning the path based upon CT images you have already had, followed by insertion of a thin, flexible tube into the airway, confirmation of position with ultrasound and x-ray and sampling of the lesion using transbronchial needle aspiration as well as forceps and brush. CT-guided biopsy will involve having a needle passed through the chest wall to biopsy the lesion, with guidance of CT images taken immediately before and during the procedure. Diagnostic methods will be compared for accuracy, and all participants will be monitored for complications for 7 days post-procedure. Costs, human resource use, and timing of the procedure will also be evaluated. It is hoped that this research will show that bronchoscopic biopsy is safer, has a comparable diagnostic yield, and is cost-effective compared to CT-guided biopsy for the purposes of evaluating peripheral lung nodules.

While there is currently no cure for dementia, there is evidence that some health conditions and lifestyles may increase the risk of developing dementia. Some of these risk factors for dementia can exist in mid-life, well before a person may start to show signs or symptoms of dementia. HAPPI MIND is a multi-domain intervention that brings together the expertise of different health professional groups to help reduce dementia risk factors and subsequent development of dementia in at-risk middle-aged adults. This primary care based model involves dementia risk assessment led by the practice nurse and GP, motivational interviewing to drive behavioural change, multidisciplinary management of dementia risk factors and a smart-phone app supported self-management of dementia risk factors. The study aims to evaluate the effectiveness and cost-effectiveness of the HAPPI MIND program for assessing dementia risk and reducing dementia risk factors in middle-aged adults in the primary care setting. It is hypothesised that primary care-based dementia risk assessment will lead to increased awareness and detection of dementia risk factors, and the tailored interdisciplinary GP/nurse-coordinated health promotion program (HAPPI MIND) will lead to reduced dementia risk, compared usual care and dementia risk assessment alone (minimal intervention).

This study is aimed at evaluating the feasibility of an online program, Healthy Living after Cancer Online, aimed at supporting people who have completed cancer treatment in improving their quality of life. Who is it for? You may be eligible for this trial if you are aged 18 or over and have been diagnosed with localised (i.e., non-metastatic) potentially curative cancer of any type within the last five years, and have completed treatment for this (please note: people on hormonal treatment or Herceptin still eligible). Study details Participants will be asked to work through an online program for 12 weeks that addresses multiple areas of health, including physical activity, healthy eating, mental health, finding the new normal after cancer treatment, fatigue, and weight management. Questionnaires will be collected before and after the intervention. Information from this study will help inform post-cancer survivorship programs.