For adolescents living with higher body weight, changing lifestyle behaviours can be met with challenges due to psychosocial factors, such as mental health and emotional challenges. Few behavioural interventions have included skill development to manage these mental health and emotional challenges.

The feasibility of a dialectical behavioural therapy (DBT)–enhanced lifestyle intervention will be evaluated through a pilot randomised controlled trial. We will recruit 90 adolescents aged 14–17 years with a body mass index Z-score >1.4 and mild-to-moderate depressive symptoms to participate with a caregiver in the trial. Adolescents will be randomised 2:2:1 to one of the three study arms: (A) behavioural lifestyle intervention with DBT skills training, (B) behavioural lifestyle intervention alone (ie, without DBT skills training) or (C) control. The interventions will include two sessions weekly for 16 weeks that include (1) one modified DBT skills training with two facilitators, supervised by a clinical psychologist, combined with one behavioural lifestyle session delivered by a dietitian and/or a kinesiologist and (2) two behavioural lifestyle sessions alone. DBT skills training will consist of teaching mindfulness, emotion regulation, distress tolerance, interpersonal effectiveness and walking the middle path modules. Behavioural sessions will be guided by evidence-based practices for goal setting, dietary counselling, improving sleep, reducing screen time and structured physical activity. The main outcomes are enrolment rates, adherence to the intervention and retention rates for follow-up measurements. The secondary outcome will be changes in the quality of life (Pediatric Quality of Life Inventory) and daily physical activity levels between baseline and immediately post-intervention. Adolescents will participate in a focus group incorporating photo elicitation to explore satisfaction, acceptability and perceived benefits of the study arms.

This study has received ethical approval from the University of Manitoba’s Biomedical Research Ethics Committee (HS24295-H2020:427), Hamilton Health Sciences & McMaster University (HiREB 18159) and The Conjoint Health Research Ethics Board (CHREB), University of Calgary (REB24-1084). Results will be disseminated through publication in peer-reviewed journals and be relevant to researchers and clinicians involved in paediatrics and paediatric weight management.

NCT05338944.

To determine age-specific and age-standardised incidence trends of acute rheumatic fever (ARF) or rheumatic heart disease (RHD) among Indigenous Western Australians aged less than 35 years of age.

A population-based retrospective cohort study with linked data analysis.

Western Australian hospital admissions (1996–2022) and RHD notifications to the state-based register (2011–2015).

Patients, both Indigenous and non-Indigenous aged

Of 1746 incident ARF/RHD cases, 1526 (87%) were Indigenous peoples, with the highest rates observed in patients aged 5–14 years, with an annual estimated increase of 4.3% (95% CI 3.2% to 5.2%). The 0–4 years age group experienced an annual increase in incidence rates of 4.8% (95% CI 1.4% to 8.2%). Overall, Indigenous patients experienced an annual increase of 1.9% (95% CI 1.3% to 2.6%) from 1996 to 2022. However, most cases (n=894) were identified after multiple significant policy developments (2011–2022) with an annual increase of 5.7% (95% CI 3.7% to 7.5%) for this period.

Increasing trends of incident ARF/RHD were observed in Indigenous patients aged under 15 years, with the greatest annual increments observed after policy implementation for disease reporting and awareness in the period from 2011 to 2022. Improvement in case ascertainment of ARF/RHD may be contributing towards increasing trends with improved reporting and monitoring of incident cases in very young Indigenous Australians more recently.

Type 2 diabetes is a prevalent chronic disease, associated with health complications, premature morbidity and significant healthcare costs. Optimal lifestyle behaviour control and patient self-management are crucial for improving diabetes control; however, they are difficult to achieve in primary care. There is limited research on the use of information from wearable devices to encourage behaviour change. This study will examine the effectiveness and cost-effectiveness of a multi-component health behaviour intervention in achieving clinically significant reductions in haemoglobin A1c (HbA1c) among general practice patients with type 2 diabetes.

The study uses a cluster-randomised controlled design, with general practices randomly assigned to either the Wearables Integrated Technology (WEAR-IT) intervention (n=15) or usual care (n=15). To achieve a sample size of 375 participants, 12–13 patients per practice will be recruited. Patients diagnosed with type 2 diabetes will be eligible to participate if they are aged 18–75 years; have had poorly controlled diabetes (HbA1c≥7.5%), with the cognitive capacity and ability to access the intervention application via an iOS or Android smart device. The WEAR-IT self-management intervention combines information from wearable devices (physical activity, blood glucose and blood pressure) and the electronic medical record, with goal setting and coaching support. The intervention will be primarily delivered by the general practice nurse, with review and confirmation of goals by the general practitioner. Participants attending the usual care practices will receive standard care. Outcome measures, including HbA1c, lipids, blood pressure, quality of life, dietary and exercise behaviours and cost-effectiveness, will be collected at baseline, 6-month (primary endpoint) and 12-month post-randomisation. The primary analysis will compare the change in HbA1c between the intervention and control groups at 6-month follow-up, with long-term outcomes assessed at 12-month post-randomisation.

The study was approved by Bond University (BH00137). Results will be disseminated through peer-reviewed journal publications, conference presentations and summaries to participating sites and patients.

Australian New Zealand Clinical Trials Registry (ACTRN12624000957594).

Type 2 diabetes mellitus (T2DM) is a fast-growing chronic disease, with at least 1.3 million people diagnosed in Australia. In the Western Sydney Local Health District (WSLHD), an estimated 13.1% of all adults have T2DM. The condition significantly contributes to cardiovascular, heart and kidney diseases and causes a large disease burden. Lifestyle modifications, such as improved nutrition, increased physical activity and stress reduction, are recommended as first-line treatments for T2DM management. However, the current primary care system cannot meet the growing demands for diabetes care, necessitating the development of innovative, scalable, cost-effective solutions. Digital health technologies present a promising approach for promoting self-management in individuals with T2DM.

This cluster-randomised controlled trial aims to evaluate the feasibility and effectiveness of Gro-AUS, a localised version of the Gro Health app in Australia, to support T2DM management in Australian primary care settings. The trial will be conducted across multiple general practice clinics within the WSLHD, an area with a high prevalence of T2DM and significant cultural diversity in patient populations. Participants will be randomly assigned by clinic to either the intervention group (digital health programme) or control group (standard care). Primary outcomes include improvements in glycaemic control, cardiovascular risk factors and diabetes remission, with secondary outcomes such as weight loss, physical activity and mental well-being. Data will be collected using electronic and paper methods, with secure storage and de-identification ensuring participant privacy. The study’s mixed-method approach ensures inclusivity for patients with varying levels of digital literacy. Data will be securely stored, de-identified and used to assess the effectiveness of the intervention. Findings are expected to inform future models of diabetes care in Australia, providing evidence for the scalability of digital health technologies in chronic disease management.

This trial is by nature unblinded. The recruitment style for a stepped-wedge trial may also bias participant engagement. However, it has direct implications for clinical practice as an effectiveness implementation trial. The design also allows for a much larger sample and more statistical power to examine outcomes.

This trial has been prospectively registered with the Australian New Zealand Clinical Trials Registry. Ethical approval has been granted by the WSLHD Human Research Ethics Committee prior to data collection. Results will be disseminated through publication in a peer-reviewed medical journal and shared via the Agency for Clinical Innovation, the Primary Care Health Network and through community engagement initiatives.

ANZCTR388639.

This study validates the previously tested Screening for Poverty And Related social determinants to improve Knowledge of and access to resources (‘SPARK Tool’) against comparison questions from well-established national surveys (Post Survey Questionnaire (PSQ)) to inform the development of a standardised tool to collect patients’ demographic and social needs data in healthcare.

Cross-sectional study.

Pan-Canadian study of participants from four Canadian provinces (SK, MB, ON and NL).

192 participants were interviewed concurrently, completing both the SPARK tool and PSQ survey.

Survey topics included demographics: language, immigration, race, disability, sex, gender identity, sexual orientation; and social needs: education, income, medication access, transportation, housing, social support and employment status. Concurrent validity was performed to assess agreement and correlation between SPARK and comparison questions at an individual level as well as within domain clusters. We report on Cohen’s kappa measure of inter-rater reliability, Pearson correlation coefficient and Cramer’s V to assess overall capture of needs in the SPARK and PSQ as well as within each domain. Agreement between the surveys was described using correct (true positive and true negative) and incorrect (false positive and false negative) classification.

There was a moderate correlation between SPARK and PSQ (0.44, p60), SPARK correctly classified 90.5% (n=176/191).

SPARK provides a brief 15 min screening tool for primary care clinics to capture social and access needs. SPARK was able to correctly classify most participants within each domain. Related ongoing research is needed to further validate SPARK in a large representative sample and explore primary care implementation strategies to support integration.

Cystic fibrosis (CF) is a genetic condition of impaired membrane electrolyte transport and is characterised by defects in the production and function of the cystic fibrosis transmembrane conductance regulator (CFTR) protein. Ground-breaking CFTR modulator therapy has resulted in a notable shift in the clinical presentation and progressive nature of CF, across both pulmonary and extrapulmonary systems. Access to CFTR modulator therapies in people with CF is occurring in a staged, descending age process, with clinical trials focusing primarily on safety and efficacy. There is a lack of robust, real-world longitudinal data on CFTR modulator therapy in infants and young children where extrapulmonary outcomes such as growth, micronutrient status and pancreatic function are the key focus.

Pancreatic, nutritional and clinical outcomes in children 0–5 years with CF during the first 2 years of CFTR modulator therapy (PaNC) is a prospective cohort study involving all eight tertiary paediatric CF centres in Australia. Infants and children 4 months to 5 years of age who are eligible for elexacaftor/tezacaftor/ivacaftor (ETI) or ivacaftor (IVA) meet the inclusion criteria for PaNC, with a total eligible cohort of 303 children at the commencement of recruitment. The primary outcomes are change in weight-for-length/body mass index z score and change in serum micronutrient status, at 6–12 monthly intervals, during the first 2 years of treatment with ETI or IVA. Secondary outcomes include change in exocrine pancreatic function, measured by faecal elastase-1, change in the use and dose of pancreatic enzyme replacement therapy, nutritional and gastrointestinal therapies and change in sweat chloride levels. Linear mixed modelling will be used to analyse primary and secondary endpoints. This protocol is reported in accordance with ‘The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement’ reporting guidelines.

Overarching governance and ethics approval has been granted by Monash Health Human Research Ethics Committee, in addition to all eight sites receiving site-specific authorisation approvals prior to the commencement of recruitment. Opportunities for CF consumers to be involved in targeted dissemination plans will be initiated via CF Australia at the completion of the study period. Additionally, a summary of non-identifiable results will be provided to CF consumers and CF healthcare providers via scientific and lay conferences and via peer-reviewed journals.

ACTRN12624001185550; Pre-results.

Gestational diabetes is a common metabolic disorder in pregnancy which identifies a substantial increased risk of future diabetes. Despite this risk, many individuals are not screened for dysglycaemia in the postpartum period. Continuous glucose monitoring (CGM) is an evolving technology that provides details of an individual’s glucose levels throughout the day; however, it has not yet been evaluated as a screening tool for postpartum dysglycaemia. To address this gap, this prospective cohort study will examine the use of CGM in the early postpartum period to predict the risk of maternal dysglycaemia after delivery.

The Predicting Dysglycaemia in Individuals with Gestational Diabetes Immediately Postpartum using CGM (PREDISPOSE) study is a prospective cohort study designed to assess the ability of a CGM device (Freestyle Libre 2) worn in the postpartum period to detect persistent dysglycaemia in individuals with gestational diabetes. The study will recruit 240 individuals with gestational diabetes. Each participant will wear the CGM immediately postpartum and before attending routine postpartum diabetes screening, consisting of a 75-gram oral glucose tolerance test (OGTT) and related blood work (haemoglobin A1c (HbA1c), complete blood count and lipid profile). The primary outcome is the accuracy of the area under the curve for all glucose measurements from the first CGM wear to detect postpartum dysglycaemia. We will perform sensitivity and specificity analyses to determine optimal CGM cut-offs to diagnose diabetes or prediabetes. Secondary outcomes include the incidence of postpartum dysglycaemia (based on 75-gram OGTT and/or HbA1c), incidence of postpartum dyslipidaemia, patient acceptability of CGM testing, data variability from CGM and cardiometabolic health outcomes diagnosed in years one, two and five after delivery.

All participating sites have received ethics approval of the current protocol and have started recruitment of participants to the study. The ethics boards that approved this study are the Biomedical Research Ethics Board at the University of Manitoba, the Conjoint Health Research Ethics Board at the University of Calgary, the Mount Sinai Hospital Research Ethics Board at Mount Sinai Hospital and the Comité d'éthique de la Recherche at Université Laval. Study results will be disseminated through conference presentations and publication in a peer-reviewed journal, regardless of study findings.

NCT04972955. Registration date: 28 June 2021.