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Evaluation of an innovative family-centred care and prevention intervention for children with overweight and obesity: a mixed-methods study protocol of the randomised controlled fruehstArt study in Germany

Por: Hagemeier · A. · Oberste · M. · Rosenberger · K. D. · Roth · R. · Hellmich · M. · Fluegel · V. · Ruettger · K. · Dadaczynski · K. · Joisten · C. · Mause · L. · Scholten · N. · Glaubach · J. · Hehn · M. · Bernhard · I. · Aydemir · I. · Redaelli · M. · Simic · D. · Alayli · A. · Lemmen · C.
Introduction

Childhood overweight and obesity pose a growing public health problem with increasing prevalence both in Europe and globally. Reasons can be found in behavioural factors such as a sedentary lifestyle, eating habits or low exercise levels and to a lesser extent in a genetic predisposition or a metabolic disorder. Preventing children with obesity and overweight to grow into obese teenagers is therefore of high importance. However, there are currently no established care and prevention programmes in Germany for the early reduction of overweight and prevention of obesity in children aged 3–6 years. fruehstArt aims to close this gap with a cross-sector outreach and family-centred personal counselling approach, where parents receive support from paediatricians and trained coaches who conduct consultations in the home of the family. The main research question is whether the fruehstArt programme reduces overweight and obesity in children aged 3–6 years within 12 months, as measured by the body mass index-standard deviation score (BMI-SDS).

Methods and analysis

fruehstArt has been developed as a new form of care, which includes a family intervention with motivational interviews provided by paediatricians and individual home-based counselling provided by a trained coach on eating behaviour, exercising, sleeping behaviour and age-appropriate use of electronic devices. fruehstArt will be accompanied by an efficacy study (summative evaluation of change in BMI-SDS). In addition to German, the project is also offered in Turkish in order to reach families with a migration background and language barriers. 812 children with overweight or obesity and their families in the region North Rhine will be included and observed over 12 months. Recruitment of children occurred from December 2023 to April 2025 with the final visits scheduled for April 2026. The study is conducted as a randomised controlled trial with a social-ecological intervention approach, considering children in their living environment and conditions. Moreover, a formative evaluation at the process level, and the system level will be carried out and complemented by a health economic analysis. Those are carried out to provide information about the intervention’s success and relevant costs. Thus, fruehstArt is realised in the form of an effectiveness–implementation hybrid design that combines the analysis of effectiveness with an evaluation of the implementation process.

Ethics and dissemination

The study received ethics approval in a coordinated procedure from the ethics committee of the Medical Faculty University hospital of Cologne and the ethics committee of the North Rhine Medical Association. For all collected data, the relevant national and European data protection regulations will be considered. All personal data (contact details) will be removed for the data analysis in order to ensure pseudonymisation. Dissemination strategies include reports and quality workshops for organisations, peer-reviewed publications and the presentation of results at conferences.

Discussion

The aim of the unique form of care fruehstArt is to improve the care of preschool children with overweight or obesity through innovative home-based counselling, cross-sectoral service integration and to address the cultural needs of Turkish families.

Trial registration number

DRKS00030749 (29-09-2023)

Qualitative evaluation of the barriers and facilitators to a retrospective hepatitis C virus patient re-engagement exercise in England

Por: Stuart · A. · Hörst · C. · Etoori · D. · Lorencatto · F. · Rosenberg · W. · Lowndes · C. · Simmons · R. · Mandal · S. · Gillyon-Powell · M. · Desai · M.
Objectives

The UK Health Security Agency and the National Health Service England (NHSE) led a hepatitis C virus (HCV) patient re-engagement exercise beginning in 2018, which entailed sharing public health surveillance data with NHSE Operational Delivery Networks (ODNs) in England. The ODNs used the data to contact and offer testing and treatment to people historically diagnosed with HCV, but who did not have evidence of successfully clearing the virus. A quantitative evaluation found that of 55 329 individuals whose details were shared with ODNs, around 13% had treatment after the exercise commenced. This qualitative evaluation aims to identify the barriers and facilitators to the re-engagement exercise as reported by ODN staff.

Design

Semistructured interviews. The topic guide and analysis were guided by the Theoretical Domains Framework, using a combined deductive framework and inductive thematic analysis approach.

Setting and participants

21 staff from 13 ODNs. The sampling frame was designed to capture participants from all regions of England and with varied outcomes from the re-engagement exercise.

Results

Interviewees reported the most barriers in environmental context and resources (including staffing limitations, interruptions during COVID-19, restricted laboratory access), and social influences (with limited responses from general practitioners and patients). Interviewees discussed whether it was appropriate for ODNs and individual staff to be assigned the data validation work and reported some stress and memory/attention barriers due to the volume of the exercise. They had varied beliefs about the consequences of the exercise, with most believing it was worthwhile due to treatment yield, lessons learnt and confirmation that some people had cleared the virus. Further facilitators included the ODN goals fitting with the exercise, and regional resources such as patient databases. Interviewees also reported adaptations to the exercise that facilitated patient contact, and their ongoing work to re-engage patients emphasised outreach partnerships and peer support.

Conclusions

The evaluation revealed insights into methods for re-engaging patients and of sharing and using public health data to support clinical practice. Government support and funding provision for regionally tailored holistic re-engagement approaches, alongside enhancements to health surveillance data, could enable barriers to re-engagement to be overcome.

Randomised controlled study investigating standard dose continuous renal replacement therapy (CRRT) versus low-dose CRRT in critically ill patients with acute kidney injury (AKI): study protocol for a prospective, randomised, controlled, international, mu

Por: Strauss · C. · Sadjadi · M. · von Groote · T. · Booke · H. · Schöne · L. M. · Hegner · C. · Wempe · C. · Meersch · M. · Gerss · J. · Bernard · A. · Haeberle · H. A. · Rosenberger · P. · Rahmel · T. · Unterberg · M. · Adamzik · M. · Arndt · C. · Wulf · H. · Romagnoli · S. · Bonizzoli · M.
Introduction

The only supportive therapy for patients with severe acute kidney injury (AKI), a common complication among the critically ill, is dialysis. Based on the literature and current guidelines, continuous renal replacement therapy (CRRT) with a total effluent dose of 20–25 mL/kg/hour and adjustments to ensure such dose is delivered despite down time (eg, due to surgical procedures) is recommended. However, experimental and clinical studies suggest that azotaemia, which can be induced by lowering the effluent dose, may accelerate renal recovery. This clinical study investigates whether a lower effluent dose (10–15 mL/kg/hour) for a maximum of 7 days or until successful (>24 hours) liberation of CRRT in critically ill patients with a dialysis-dependent AKI accelerates renal recovery and reduces time on CRRT compared with guideline-directed standard dose (25–30 mL/kg/hour).

Methods and analysis

The Ketzerei trial is an international, multicentre randomised, controlled trial, designed to investigate if a lower effluent dose (10–15 mL/kg/hour) accelerates renal recovery and reduces the time on CRRT compared with the guideline directed standard effluent dose (25–30 mL/kg/hour). The study aims to enrol 150 critically ill patients with a dialysis-dependent AKI. Eligible patients will be randomised to receive either a standard effluent dose (control group, 25–30 mL/kg/hour) or lower effluent dose (interventional group, 10–15 mL/kg/hour). The primary endpoint is the number of days free from CRRT and alive (from randomisation through day 28). Key secondary endpoints include the number of (serious) adverse events due to potential uremia, the duration of RRT and intensive care unit survival.

Ethics and dissemination

The Ketzerei trial has been approved by the Ethics Committee of the Chamber of Physicians Westfalen-Lippe (2023–343 f-s), the University of Muenster and subsequently by the corresponding Ethics Committee of the participating sites. Results will be disseminated widely and published in peer-reviewed journals, presented at conferences and will guide patient care and further research.

Trial registration number

clinicaltrials.gov (NCT06021288).

Patterns and persistence of SARS-CoV-2 seropositivity among college students at Indiana University--Bloomington

Por: Chen · C. · Rosenberg · M. · Li · M. · Macy · J. T. · Ludema · C.
Objective

This study examined the patterns and persistence of SARS-CoV-2 seropositivity among college students from March to November 2020. Using data from a sample of students at Indiana University, we assessed (1) the duration and seropositivity following reverse transcription-PCR (RT-PCR)-confirmed SARS-CoV-2 infection and (2) persistence of seropositivity over 10 weeks between two laboratory antibody test visits.

Setting, design and participants

The longitudinal study was conducted at Indiana University from September to November 2020, with two laboratory antibody tests, and included self-reported RT-PCR results before the observational period from as early as 20 March 2020. This 6–9 month period contributes to our understanding of seropositivity dynamics. The study included 172 college students who had previously tested positive for SARS-CoV-2 and measured their seropositivity.

Results

Our results showed a notable decline (66.7%) in antibody positivity over the observed period. Additionally, 12 weeks postinfection, most students with a SARS-CoV-2 infection history (75%) were no longer seropositive.

Conclusions

These findings reveal a nuanced picture of antibody dynamics, highlighting the complex interplay of factors among college students. The study underscores the need for continued research on antibody levels among young adults to better understand the drivers of variations in antibody persistence.

Trial registration number

#NCT04620798.

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