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Connecting families--randomised controlled trial of poverty screening and financial support navigation for families of young children in primary care: an internal pilot study informed protocol

Por: Bayoumi · I. · Parkin · P. C. · Tabassum · F. · Johnson · C. · Sherwood · M. · Mitchell · M. · Birken · C. S. · Bloch · G. · Carsley · S. · Cole · M. · Green · M. · Keown-Stoneman · C. D. G. · Maguire · J. L. · Purkey · E. · van den Heuvel · M. · Weir · S. · Wong · P. · Borkhoff · C. M.
Introduction

Poverty can have profound negative impacts on parent, child and family health. Primary care providers are in a unique position to address child poverty. Some team-based models have integrated community support workers (CSWs) for social service system navigation assistance. The overall aim of this study is to rigorously test a poverty reduction intervention (navigation of financial supports) embedded in primary care. The primary objective is to compare parenting stress between CSW-supported, structured review of financial supports and social system navigation (intervention) and receipt of written summary of local resources (usual care).

Methods and analysis

This is a multisite pragmatic superiority randomised controlled trial with a 1:1 allocation to the CSW-supported social system navigation versus no navigation. Parent–child dyads (80 parents of children aged Do you ever have difficulty making ends meet at the end of the month?’) will be recruited during a scheduled health supervision visit from primary care practices in Kingston, Ontario. Intervention group participants will have a structured review of financial supports with a trained CSW and will meet up to 6 times over 6 months. Outcomes are measured at baseline, 6 months and 12 months after randomisation. The primary outcome is the Parenting Stress Index Fourth Edition Short Form (PSI-4-SF) total score at 6 months. Secondary outcomes include household income, food insecurity, parent mental health (depression and anxiety) and child health. An internal pilot study was used to obtain more reliable estimates of the SD of PSI-4-SF at 6 months to recalculate the sample size (if needed) and assess randomisation and completion rates. Qualitative interviews conducted 9 months after enrolment explore parent experiences with the CSW intervention.

Ethics and dissemination

Research ethics approval by Queen’s University Health Sciences REB. Results will be shared with the College of Family Physicians of Canada, the Ontario SPOR SUPPORT Unit and academic forums.

Trial registration number

Connecting Families (Registered 12 October 2021 at www.clinicaltrials.gov; NCT05091957).

Strengthening active outdoor living among children residing in two disadvantaged neighbourhoods in Copenhagen, Denmark: a mixed methods study protocol for the Happy Healthy Active Children initiative

Por: Stougaard · M. · Termansen · T. · Stjernqvist · N. W. · Borring · A. S. · Villersholt · N. L. · Friis · N. · Müllertz · A. L. O. · Elsborg · P. · Mejsner · S. B. · Bloch · P.
Introduction

The Happy Healthy Active Children (HHAC) initiative is a multicomponent community-based initiative aimed at promoting physical activity, food literacy and nature literacy among children in early childhood kindergarten and primary school settings. Developed in collaboration between Activity Experts and Community Stakeholders, HHAC integrates thematic activities (Play, Nature, Food) across kindergartens, schools and the broader community. The initiative responds to growing concerns about declining physical activity levels, insufficient contact with nature and poor dietary habits in childhood, factors known to influence long-term health and well-being. This protocol outlines the design, implementation and planned evaluation of the HHAC initiative.

Methods and analysis

HHAC is carried out within the long-term strategic initiative Tingbjerg Changing Diabetes. Following the Supersetting approach, HHAC addresses inequity in health by mobilising resources across local settings (kindergartens, schools and the local community arenas) and population groups (children, parents, staff and other community members) to develop and implement contextually relevant activities promoting outdoor play, cooking and nature experiences. Activities are evaluated using a within-subject design in kindergartens, while in schools a quasi-experimental design with matched control groups is applied. Data is collected at baseline and follow-up through accelerometry, validated questionnaires and structured observations. Primary outcomes include physical activity levels, food literacy and nature literacy. Analyses apply linear mixed-effects models to account for repeated measures and clustering at the institutional level. The evaluation also investigates implementation processes and context-mechanism configurations through a comprehensive realist evaluation. This includes developing a programme theory, conducting interviews with children, parents, staff and other local stakeholders and participant observations aiming to explore experiences and the mechanisms through which the activities contribute to changes in behaviour and well-being. All data will be analysed and condensed for a model for transferability.

Ethics and dissemination

Findings will be disseminated through peer-reviewed journals, conference presentations and public engagement activities targeting educators, policymakers and health professionals. The intervention materials will also be made freely available to support broader implementation. The study procedures were registered and approved by The Capital Region’s centre for data reviews ‘Videnscenter for Dataanmeldelser’ (Reference: P-2023–14277). All procedures were carried out under relevant regulations and guidelines. Written information about the study was given to all school principals, teachers and parents/guardians before the start of the study, and written informed consent is obtained from all legal guardians of all participants in their native language prior to child enrolment.

Prognostic communication in heart failure: protocol for a systematic qualitative synthesis of experiences, attitudes and practices

Por: Chu · C. · Bloch · S. · Yardley · S.
Introduction

Being able to talk about the anticipated course of living with an illness is essential to delivering and receiving person-centred care. Despite clinical heart failure guidance encouraging these prognostic conversations at all stages of disease, they occur infrequently or very late in the disease course. This qualitative synthesis will use the Joanna Briggs Institute (JBI) meta-aggregation approach to explore how prognostic conversations are currently taking place, what people think about prognostic conversations, and how people experience them.

Methods and analysis

This systematically conducted qualitative synthesis, using JBI meta-aggregation, considers qualitative evidence that explores the prognostic communication experiences, attitudes or practices of people with heart failure and their healthcare professionals. Prognostic communication is defined as a verbal interaction about anticipated changes to symptoms or function, possibility of unpredictable events, potential future treatments or care, expression of wishes about the future, or estimates of life expectancy. It will include interactions occurring in any setting (inpatient, outpatient, community). Exclusion criteria include studies of carer perspectives, discussion about implantable cardiac defibrillator deactivation, assisted dying and/or euthanasia, and those not published in the English language. Medical Literature Analysis and Retrieval System Online (MEDLINE) (Ovid), Excerpta Medica Database (EMBASE) (Ovid), PsycInfo (Ovid), Cumulative Index to Nursing and Allied Health Literature (CINAHL) Plus (EBSCOhost), Web of Science Core, Overton, ProQuest Dissertations and Theses Global, and Google Scholar databases will be searched for eligible studies. Reference screening of relevant systematic reviews will also be conducted. Two independent reviewers will screen, quality assess included studies and perform data extraction. JBI tools will be used for quality appraisal, data extraction, synthesis and assessing confidence of summarised findings.

Ethics and dissemination

Ethical approval is not required for the study since it is based on available published literature. Findings from the review will be disseminated through publication in a peer-reviewed journal.

Trial registration number

International Prospective Register of Systematic Reviews (PROSPERO) CRD42024605240.

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