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AnteayerBMJ Open

Effectiveness and cost-effectiveness of a 12-month automated text message intervention for weight management in postpartum women with overweight or obesity: protocol for the Supporting MumS (SMS) multisite, parallel-group, randomised controlled trial

Por: Gallagher · D. · Spyreli · E. · Anderson · A. S. · Bridges · S. · Cardwell · C. R. · Coulman · E. · Dombrowski · S. U. · Free · C. · Heaney · S. · Hoddinott · P. · Kee · F. · McDowell · C. · McIntosh · E. · Woodside · J. V. · McKinley · M. C.
Introduction

The reproductive years can increase women’s weight-related risk. Evidence for effective postpartum weight management interventions is lacking and engaging women during this life stage is challenging. Following a promising pilot evaluation of the Supporting MumS intervention, we assess if theory-based and bidirectional text messages to support diet and physical activity behaviour change for weight loss and weight loss maintenance, are effective and cost-effective for weight change in postpartum women with overweight or obesity, compared with an active control arm receiving text messages on child health and development.

Methods and analysis

Two-arm, parallel-group, assessor-blind randomised controlled trial with cost-effectiveness and process evaluations. Women (n=888) with body mass index (BMI) ≥25 kg/m2 and within 24 months of giving birth were recruited via community and National Health Service pathways through five UK sites targeting areas of ethnic and socioeconomic diversity. Women were 1:1 randomised to the intervention or active control groups, each receiving automated text messages for 12 months. Data are collected at 0, 6, 12 and 24 months. The primary outcome is weight change at 12 months from baseline, compared between groups. Secondary outcomes include weight change (24 months) and waist circumference (cm), proportional weight gain (>5 kg), BMI (kg/m2), dietary intake, physical activity, infant feeding and mental health (6, 12 and 24 months, respectively). Economic evaluation examines health service usage and personal expenditure, health-related quality of life and capability well-being to assess cost-effectiveness over the trial and modelled lifetime. Cost–utility analysis examines cost per quality-adjusted life-years gained over 24 months. Mixed-method process evaluation explores participants’ experiences and contextual factors impacting outcomes and implementation. Stakeholder interviews examine scale-up and implementation.

Ethics and dissemination

Ethical approval was obtained before data collection (West of Scotland Research Ethics Service Research Ethics Committee (REC) 4 22/WS/0003). Results will be published via a range of outputs and audiences.

Trial registration number

ISRCTN16299220.

What Matters to Aboriginal and Torres Strait Islander Youth (WM2Y): a study protocol to develop a national youth well-being measure

Por: Garvey · G. · Howard · K. · Garvey · D. · Dickson · M. · Howell · M. · Butler · T. L. · Cadet-James · Y. · Cunningham · J. · Bainbridge · R. · McGorry · P. · Williamson · A. · Anderson · K. M.
Introduction

Adolescents face challenges associated with unprecedented environmental, social and technological changes. The impacts of colonisation, intergenerational trauma, racism and socioeconomic disadvantage intensify these challenges for many Aboriginal and Torres Strait Islander adolescents. However, Aboriginal and Torres Strait Islander adolescents also have cultural, spiritual, family and community capital that fosters their well-being.

To date, little research has focused on understanding and appropriately measuring the well-being of Aboriginal and Torres Strait Islander adolescents, a pivotal factor in informing and guiding programmes and interventions that support them. This study will identify the domains of well-being and develop a new preference-based well-being measure based on the values and preferences of Aboriginal and Torres Strait Islander youth (aged 12–17 years).

Methods and analysis

This project will be conducted across three research phases: (1) qualitative exploration of well-being using PhotoYarning and yarns with adult mentors to develop candidate items; (2) Think Aloud study, quantitative survey, psychometric analysis, validity testing of candidate items and finalisation of the descriptive system; and (3) scoring development using a quantitative preference-based approach. A multinomial (conditional) logit framework will be used to analyse responses and generate a scoring algorithm for the new preference-based well-being measure.

Ethics and dissemination

Ethics approvals have been obtained from: the Human Research Ethics Committees for each state and territory where data are being collected, the institutions where the research is being conducted and from the relevant Departments of Education. The new well-being measure will have wide applicability and can be used in assessing the effectiveness of programmes and services. This new national measure will ensure benefit and positive impact through the ability to identify and measure the aspects of well-being important to and valued by Aboriginal and Torres Strait Islander youth. Results will be published in international peer-reviewed journals and presented at conferences, and summaries will be provided to the study partner organisations and other relevant organisations.

What works for whom, how and why in mental health education for undergraduate health profession students? A realist synthesis protocol

Por: McCormack · Z. · Kerr · A. · Simpson · A. · Keating · D. · Strawbridge · J.
Introduction

It has been shown that mental health education can support positive attitudes of health profession students towards people with mental health challenges, which supports them to provide optimal healthcare to this group. There are many different approaches to designing and delivering mental health education to health profession students. Each has their own advantages and disadvantages, and often mental health education programmes incorporate a multimodal approach in order to reap the benefits of a variety of teaching and learning approaches. The aim of this study is to understand the current landscape of teaching and learning approaches to mental health education for undergraduate health profession students. We will examine the features of successful outcomes for health profession students for:

  • Learning environment.

  • Knowledge development and retention.

  • Confidence.

  • Motivation.

  • Preparedness for professional practice.

  • Methods

    For this, a realist synthesis has been chosen in order to review the literature. Realist synthesis lends itself to the review of complex interventions such as mental health education for undergraduate health profession curricula because it seeks to uncover the range of different mechanisms and context configurations that produce different outcomes. Health profession education and education practice, in general, is complex. A patient and public involvement (PPI) group is involved throughout this study and includes undergraduate health profession students, and members of the St John of Gods Hospital Consumers and Carers Council who are involved at every stage of the research. This study will engage with a stakeholder group who will support the refining of the programme theory.

    Ethics and dissemination

    Ethical approval has been sought and approved by Royal College of Surgeons, Ireland Ethical Committee (REC number: 212622783). We will aim to write up and publish the full synthesis as a journal article. We will also discuss ways of dissemination outside of academia with our PPI group.

    National cross-sectional cluster survey of tuberculosis prevalence in Timor-Leste: a study protocol

    Por: Lopes · C. · Joao · J. C. · Lowbridge · C. · Martins · N. · dos Santos · R. I. G. · da Silva · E. · Dias · J. · Ramalingam · S. · Amaral · S. · Oakley · T. · Ico · L. d. C. · Sarmento · N. · Yan · J. · Francis · J. R.
    Introduction

    Timor-Leste has one of the world’s highest estimated tuberculosis (TB) incidences, yet the data which informs this estimate is limited and the true burden of TB disease is not known. TB prevalence surveys offer the best means of determining robust estimates of disease burden. This study aims to provide an estimate of the prevalence of bacteriologically confirmed pulmonary TB in Timor-Leste and provide additional insights into diagnostic coverage and health-seeking behaviour of persons with symptoms suggestive of TB.

    Methods and analysis

    A national population-based cross-sectional cluster survey will be conducted in which participants aged 15 years and older will be screened for pulmonary TB using an algorithm consisting of symptom screening and digital X-ray of the chest with computer-aided detection software for X-ray interpretation. Xpert Ultra and liquid culture methods will be used to confirm survey TB cases. Additional data will be collected from persons reporting symptoms suggestive of TB to assess health-seeking behaviour and access to TB diagnosis and care. The survey aims to screen a target sample population of 20 068 people, living within 50 clusters, representing every municipality of Timor-Leste. Bacteriologically confirmed pulmonary TB prevalence will be estimated using WHO-recommended methods.

    Ethics and dissemination

    Research ethics approval has been granted by the human research ethics committee of the Northern Territory, Australia, and the Instituto Nacional da Saúde, Timor-Leste. The results will be published in a peer-reviewed scientific journal and disseminated with relevant stakeholders.

    Trial registration number

    ACTRN12623000718640.

    Advancing Suicide Intervention Strategies for Teens (ASSIST): study protocol for a multisite randomised controlled trial

    Por: Adrian · M. · McCauley · E. · Gallop · R. · Stevens · J. · Jobes · D. A. · Crumlish · J. · Stanley · B. · Brown · G. K. · Green · K. L. · Hughes · J. L. · Bridge · J. A.
    Introduction

    Brief interventions that reduce suicide risk following youth’s experience with acute care due to suicidality are needed.

    Methods and analysis

    The study will use a three-arm randomised controlled trial designed to test the effectiveness of the Safety Planning Intervention with structured follow-up (SPI+) and the Collaborative Assessment and Management of Suicidality (CAMS) compared with enhanced usual care. The primary outcomes measure will be suicidal events, defined as death by suicide, attempted suicide, preparatory acts toward imminent suicidal behaviour or suicidal ideation resulting in a change in emergency evaluation or inpatient admission. Secondary measures will be the number of suicide attempts and severity of suicidal ideation. The experimental interventions, SPI+ and CAMS, consist of up to eight sessions over approximately 8 weeks that are designed to manage (SPI+) or treat (CAMS) patient-identified ‘drivers’ of suicidal thoughts and behaviours. Mechanisms and moderators of change will be evaluated to understand treatment impacts.

    Ethics and dissemination

    This study has been approved by the Seattle Children’s Institutional Review Board and is monitored by external agencies including the University of Washington Institute for Translational Health Sciences, and a National Institute of Mental Health (NIMH)-appointed Data Safety and Monitoring Board. Trial results will help establish evidence towards safe and effective treatment strategies for youth transitioning from acute to outpatient care due to a suicidal crisis. The data will be shared with the NIMH Data Archives and disseminated through publications and conferences.

    Trial registration number

    NCT05078970.

    Clinician and patient perspectives on the barriers and facilitators to physical rehabilitation in intensive care: a qualitative interview study

    Por: Woodbridge · H. R. · Norton · C. · Jones · M. · Brett · S. J. · Alexander · C. M. · Gordon · A. C.
    Objectives

    The objective of this study is to explore patient, relative/carer and clinician perceptions of barriers to early physical rehabilitation in intensive care units (ICUs) within an associated group of hospitals in the UK and how they can be overcome.

    Design

    Qualitative study using semi-structured interviews and thematic framework analysis.

    Setting

    Four ICUs over three hospital sites in London, UK.

    Participants

    Former ICU patients or their relatives/carers with personal experience of ICU rehabilitation. ICU clinicians, including doctors, nurses, physiotherapists and occupational therapists, involved in the delivery of physical rehabilitation or decisions over its initiation.

    Primary and secondary outcomes measures

    Views and experiences on the barriers and facilitators to ICU physical rehabilitation.

    Results

    Interviews were carried out with 11 former patients, 3 family members and 16 clinicians. The themes generated related to: safety and physiological concerns, patient participation and engagement, clinician experience and knowledge, teamwork, equipment and environment and risks and benefits of rehabilitation in intensive care. The overarching theme for overcoming barriers was a change in working model from ICU clinicians having separate responsibilities (a multidisciplinary approach) to one where all parties have a shared aim of providing patient-centred ICU physical rehabilitation (an interdisciplinary approach).

    Conclusions

    The results have revealed barriers that can be modified to improve rehabilitation delivery in an ICU. Interdisciplinary working could overcome many of these barriers to optimise recovery from critical illness.

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