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Combining structured exercise with a low-energy diet to attenuate lean mass loss in South Asian adults living with type 2 diabetes: the COMBINE randomised trial protocol

Por: Arsenyadis · F. · Henson · J. · McCarthy · M. · Papamargaritis · D. · King · J. A. · Redman · E. · Whelehan · G. · Wilkinson · T. · Sargeant · J. · Rowlands · A. · Boule · N. · Dasgupta · K. · McCann · G. P. · Davies · M. J. · Khunti · K. · Choudhary · P. · Yates · T.
Introduction

The global prevalence of type 2 diabetes (T2D) is rising and disproportionately affects South Asian adults, including those in the United Kingdom. South Asians develop T2D at a higher rate and at a younger age than their white British counterparts, at a lower body mass index. Active efforts to reduce adiposity can improve glycaemic control and in some cases achieve T2D remission. However, a substantial proportion of lean mass is lost while achieving weight loss, which may have physiological and metabolic consequences, affecting long-term health outcomes and quality of life for people living with T2D and obesity. We are examining the impact of a combined low energy diet and supervised exercise intervention versus a low energy diet alone for the preservation of lean mass in an understudied South Asian population living with T2D and excess adiposity.

Methods and analysis

This prospective, randomised, two-arm parallel-group, open-label, blinded-endpoint trial is being conducted in Leicester, UK. 36 South Asian adults aged 40–65 years within 10 years of T2D diagnosis and not on insulin therapy will be enrolled. Both intervention arms will receive an 800–900 kcal/day low energy diet for 12 weeks. Those randomised to the exercise group will additionally receive a mixture of supervised and home-based resistance and aerobic exercise training three times per week. The primary outcome is the difference in the change of lean mass between groups measured using dual-energy X-ray absorptiometry at baseline and 12 weeks and will be analysed using linear regression modelling.

Ethics and dissemination

The trial was approved by the NHS research ethics service (23/WM/0201). All participants will provide informed consent prior to enrolment, and the study will be conducted in accordance with the Declaration of Helsinki. Findings will be shared widely (publications, presentations, press releases, social media platforms) and will inform an effectiveness trial.

Trial registration number

ISRCTN11175684.

Protocol for a multi-country retrospective observational paediatric sepsis epidemiological study (SENTINEL International)

Por: Long · E. · Williams · A. · George · S. · Hearps · S. · Yock-Corrales · A. · Pavlicich · V. · Krishnamurthy · K. · Seymour-Hanna · Y. · Raman · R. · Choudhary · B. · Kusuma · W. · Ribaya · V. · Mudithakumara · N. · Lertamornkitti · N. · David · A. · Mohamed · S. · Heye · T. B. · Njiramma
Introduction

Improving outcomes from sepsis in children is a WHO Global Health Priority, yet mortality from sepsis remains high, particularly in low- and middle-income countries (LMICs). This database from children with community-acquired childhood sepsis in LMICs and some high-income countries will allow analysis of the burden of disease, including incidence, severity and outcomes. Understanding these aspects of sepsis care is fundamental for the design and conduct of future international interventional trials to improve childhood sepsis outcomes.

Methods and analysis

This multicountry retrospective observational study will include children up to 18 years of age presenting to emergency departments with suspected sepsis, defined as admission to hospital for treatment with intravenous antibiotics plus (1) a provisional diagnosis of sepsis and/or (2) treatment for suspected sepsis (operationalised as the administration of one or more fluid bolus to treat impaired perfusion or vasoactive infusion). Presenting characteristics, management and outcomes will be collected. These will include vital signs, serum biomarkers, intravenous fluid administration for the first 24 hours of hospitalisation, organ support therapies delivered, antimicrobial use, microbiological diagnoses, hospital and intensive care unit length of stay, and mortality censored at hospital discharge or 30 days from enrolment (whichever occurs first).

Ethics and dissemination

Central ethics approval was received from the Royal Children’s Hospital of Melbourne, Australia Human Research Ethics Committee (HREC/100648/RCHM-2023). Each international site will be required to obtain local Institutional Research Ethics Board approval. The findings will be disseminated in peer-reviewed journals, at academic conferences and through lay media. A cleaned study database and individual site-level data will be made available to site investigators upon completion of the study.

Trial registration number

This study was registered with the Australian and New Zealand Clinical Trials Registry on 23 January 2024 prior to commencement of recruitment (ACTRN12624000052538).

Intensive outpatient interventions for youth with complex mental illness: a scoping review protocol

Por: Choudhary · W. · Morgan · R. · Szatmari · P. · Besa · R. · Selvachandran · J. · Aitken · M. · Kozloff · N.
Introduction

Mental illness typically onsets during the developmental stages from adolescence to emerging adulthood (ages 15–24 years), referred to as ‘youth’. A subset of youth with mental illness may be identified as having ‘complex’ mental health needs, defined based on requiring prolonged, extensive and resource-intensive services across multiple sectors, functional impairment, and comorbid challenges or multimorbidity . Effective early intervention for youth with complex mental illness is crucial to prevent the sequelae of long-term mental health problems. Several resource-intensive outpatient models have been developed to meet the needs of youth with complex mental illness; however, to the best of our knowledge, no scoping review has synthesised the available evidence on these interventions. A comprehensive synthesis of existing intensive outpatient interventions is needed to identify, target and inform future research and clinical efforts to better serve youth with complex mental illness. As such, the proposed scoping review will address the following research questions: (1) What intensive outpatient interventions have been evaluated for youth with complex mental illness? (2) To which populations are these interventions targeted? and (3) What outcomes have been examined within the context of these models?

Methods and analysis

This review will follow the Arksey and O’Malley framework for scoping reviews, and we will report the results following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) recommendations. We will conduct a comprehensive literature search across seven academic databases to identify relevant peer-reviewed material in English from 1990 to the present. Inclusion criteria will address evaluations of outpatient models of care with intensive components targeted to youth ages 15–24 with features of complex mental illness. Studies will be screened independently for eligibility by two reviewers in Covidence using clear inclusion criteria. We will then collate, summarise and present the findings to provide a comprehensive overview of the existing evidence.

Ethics and dissemination

Ethical approval will not be required, as no data will be collected for the proposed project. Results will be disseminated in peer-reviewed articles, presented at conferences and shared with stakeholders to inform the development, implementation and evaluation of comprehensive transdiagnostic services targeting youth with complex mental illness.

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