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Multicentre, randomised, double-blind, placebo-controlled, proof of concept study of LSALT peptide as prevention of acute respiratory distress syndrome and acute kidney injury in patients infected with SARS-CoV-2 (COVID-19)

Por: Somayaji · R. · Luke · D. R. · Lau · A. · Guner · R. · Tabak · O. F. · Hepokoski · M. · Gardetto · N. · Conrad · S. A. · Kumar · S. D. · Ghosh · K. · Robbins · S. M. · Senger · D. L. · Sun · D. · Lim · R. K. S. · Liu · J. · Eser · F. · Karaali · R. · Tremblay · A. · Muruve · D.
Objective

Dipeptidase-1 (DPEP-1) is a recently discovered leucocyte adhesion receptor for neutrophils and monocytes in the lungs and kidneys and serves as a potential therapeutic target to attenuate inflammation in moderate-to-severe COVID-19. We aimed to evaluate the safety and efficacy of the DPEP-1 inhibitor, LSALT peptide, to prevent specific organ dysfunction in patients hospitalised with COVID-19.

Design

Phase 2a randomised, placebo-controlled, double-blinded, trial.

Setting

Hospitals in Canada, Turkey and the USA.

Participants

A total of 61 subjects with moderate-to-severe COVID-19.

Interventions

Randomisation to LSALT peptide 5 mg intravenously daily or placebo for up to 14 days.

Primary and secondary outcome measures

The primary endpoint was the proportion of subjects alive and free of respiratory failure and/or the need for renal replacement therapy (RRT). Numerous secondary and exploratory endpoints were assessed including ventilation-free days, and changes in kidney function or serum biomarkers.

Results

At 28 days, 27 (90.3%) and 28 (93.3%) of subjects in the placebo and LSALT groups were free of respiratory failure and the need for RRT (p=0.86). On days 14 and 28, the number of patients still requiring more intensive respiratory support (O2 ≥6 L/minute, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation) was 6 (19.4%) and 3 (9.7%) in the placebo group versus 2 (6.7%) and 2 (6.7%) in the LSALT group, respectively (p=0.14; p=0.67). Unadjusted analysis of ventilation-free days demonstrated 22.8 days for the LSALT group compared with 20.9 in the placebo group (p=0.4). LSALT-treated subjects had a significant reduction in the fold expression from baseline to end of treatment of serum CXCL10 compared with placebo (p=0.02). Treatment-emergent adverse events were similar between groups.

Conclusion

In a Phase 2 study, LSALT peptide was demonstrated to be safe and tolerated in patients hospitalised with moderate-to-severe COVID-19.

Trial registration number

NCT04402957.

Youth, caregiver and healthcare professional perspectives on planning the implementation of a trauma‐informed care programme: A qualitative study

Abstract

Aims

To explore youth, caregiver and staff perspectives on their vision of trauma-informed care, and to identify and understand potential considerations for the implementation of a trauma-informed care programme in an inpatient mental health unit within a paediatric hospital.

Design and Methods

We applied the Interpretive Description approach, guided by complexity theory and the Implementation Roadmap, and used Applied Thematic Analysis methods.

Findings

Twenty-five individuals participated in individual or group interviews between March and June 2022, including 21 healthcare professionals, 3 youth and 1 caregiver. We identified two overarching themes. The first theme, ‘Understanding and addressing the underlying reasons for distress’, related to participants’ understanding and vision of TIC in the current setting comprising: (a) ‘Participants’ understanding of TIC’; (b) ‘Trauma screening and trauma processing within TIC’; (c) ‘Taking “a more individualized approach”’; (d) ‘Unit programming’; and (e) “Connecting to the community”. The second theme, ‘Factors that support or limit successful TIC implementation’ comprises: (a) ‘The need for a broad “cultural shift”’; (b) ‘The physical environment on the unit’; and (c) ‘Factors that may limit successful implementation’.

Conclusion

We identified five key domains to consider within trauma-informed care implementation: (a) the centrality of engagement with youth, caregivers and staff in trauma-informed care delivery and implementation, (b) trauma-informed care core programme components, (c) factors that may support or limit success in implementing trauma-informed care within the mental health unit and (d) hospital-wide and (e) the importance of intersectoral collaboration (partnering with external organizations and sectors).

Impact

When implementing TIC, there is an ongoing need to increase clarity regarding TIC interventions and implementation initiatives. Youth, caregiver and healthcare professional participants shared considerations important for planning the delivery and implementation of trauma-informed care in their setting. We identified five key domains to consider within trauma-informed care implementation: (a) the centrality of relational engagement, (b) trauma-informed care programme components, (c) factors that may support or limit successful implementation of trauma-informed care within the mental health unit and (d) hospital-wide and (e) the importance of intersectoral collaboration. Organizations wishing to implement trauma-informed care should consider ongoing engagement with all relevant knowledge user groups throughout the process.

Reporting Method

Standards for Reporting Qualitative Research (SRQR).

Patient or Public Contribution

The local hospital research institute's Patient and Family Advisory Committee reviewed the draft study methods and provided feedback.

Intervention to increase physical activity and healthy eating among under-represented adolescents: GOAL trial protocol

Por: Robbins · L. B. · Ling · J. · Pfeiffer · K. A. · Kerver · J. M. · Resnicow · K. · McCaffery · H. · Hilliard · A. · Hobbs · L. · Donald · S. · Kaciroti · N.
Introduction

To reduce obesity-related disparities, reaching economically disadvantaged and/or minority status adolescents to assist them in meeting physical activity (PA) and nutrition recommendations is important. To address the problem, a 16-week intervention called Guys/Girls Opt for Activities for Life (GOAL) was designed. The purpose of this randomised controlled trial is to evaluate any effect of the intervention, compared with a control condition, on improving: (1) adolescents’ % body fat (primary outcome), moderate-to-vigorous PA (MVPA), diet quality and cardiorespiratory fitness from 0 to 4 months; (2) body mass index (BMI), overweight/obesity percentage and quality of life from 0 to 4 months and to 13 months; and (3) perceived social support, self-efficacy and motivation from 0 to 4 months with evaluation of any mediating effect on adolescent PA and diet quality. An exploratory aim is to evaluate any effect of the intervention, compared with the control, on improving parents’/guardians’ home environment, MVPA and diet quality from 0 to 4 months; and BMI from 0 to 4 months and to 13 months.

Methods and analysis

Adolescents (fifth to eighth grade) in 14 schools located in underserved urban communities are randomly assigned to the intervention or usual school offerings. One parent per adolescent is enrolled (882 dyads total). Cohort 1 includes four schools (2022–2023). Cohorts 2 and 3 include 5 schools in 2023–2024 and 2024–2025, respectively. The 16-week intervention has three components: (1) after-school GOAL club for adolescents to engage in PA and healthy eating/cooking activities; (2) three parent–adolescent meetings to empower parents to assist adolescents; and (3) GOAL social networking website for parents to share how they helped their adolescent.

Ethics and dissemination

The Michigan State University Biomedical Institutional Review Board provided ethical approval for the study. Findings will be shared via the trial registration database, peer-reviewed publications, conferences and community-oriented strategies.

Trial registration number

NCT04213014.

Happy Family, Healthy Kids: A Healthy Eating and Stress Management Program in Low-Income Parent–Preschooler Dyads

imageBackground Substantial effort has been invested to combat childhood obesity, but overall effects are disappointing, especially in low-income racial minority children. One possible reason is a lack of focus on the important stress–eating connection. Stress can negatively influence eating behaviors, leading to an increased appetite for high-fat and energy-dense foods. Objective This study aimed to evaluate the preliminary effects of a healthy eating and stress management program targeting multiple theoretical variables on improving eating behavior (dyads’ fruit/vegetable intake, emotional eating), food insecurity, anthropometric characteristics (dyads’ body mass index, % body fat), cardiovascular health (dyads’ blood pressure), and mental well-being (parental stress). Methods A one-group, quasi-experimental pilot study was conducted among 107 low-income parent–preschooler dyads. The 14-week program included a parent component, a parent–preschooler learning component, and a day care-based preschooler component. Results The program had positive effects on improving dyads’ fruit/vegetable intake, food insecurity, body mass index, and blood pressure and parents’ nutrition knowledge, self-efficacy, support, food resource management behavior, problem-focused coping, and home eating environment. The overall satisfaction rate was 95.2%, and 88.1% stated that the program assisted their families with having a healthy lifestyle. Discussion Results support the preliminary effects of the program on improving health outcomes in rural and urban low-income families. Although warranting further investigation with a more rigorous randomized controlled trial, the healthy eating and stress management program provides a potential solution to the current coexistence of an obesity epidemic and mental health crisis.

The role of psychosocial factors and biological sex on rural Thai adolescents' drinking intention and behaviours: A structural equation model

Abstract

Aims

To examine the contributions of psychosocial factors (attitude towards drinking, perceived drinking norms [PDNs], perceived behavioural control [PBC]), and biological sex on drinking intention and behaviours among rural Thai adolescents.

Design

A cross-sectional study design.

Methods

In 2022, stratified by sex and grade, we randomly selected 474 rural Thai adolescents (M age = 14.5 years; SD = 0.92; 50.6% male) from eight public district schools in Chiang Mai Province, Thailand, to complete a self-administered questionnaire. Structural equation modelling with the weighted least square mean and variance adjusted was used for data analysis.

Results

All adolescents' psychosocial factors contributed significantly to the prediction of drinking intention, which subsequently influenced their drinking onset, current drinking and binge drinking pattern in the past 30 days. PDNs emerged as the strongest psychosocial predictor of drinking intention, followed by PBC. Rural adolescents' drinking intention significantly mediated the relationship between all psychosocial factors and drinking behaviours either fully or partially. The path coefficient between drinking attitude and drinking intention was significantly different between males and females.

Conclusion

Different from previous studies focus on adolescents' drinking attitude, rural Thai adolescents' PDNs play a significant role on their drinking intention and subsequently their drinking onset and patterns. This nuanced understanding supports a paradigm shift to target adolescents' perceived drinking norms as a means to delay their drinking onset and problematic drinking behaviours.

Impact

Higher levels of perceived drinking norms significantly led to the increase in drinking intention among adolescents. Minimizing adolescents' perceptions of favourable drinking norms and promoting their capacity to resist drinking, especially due to peer pressure, are recommended for nursing roles as essential components of health education campaigns and future efforts to prevent underage drinking.

Patient or Public Contribution

In this study, there was no public or patient involvement.

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