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).

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.

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.

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.

DRKS00030749 (29-09-2023)

Early and balanced replacement of blood products appears to be the key factor in improving outcomes of major bleeding patients including acute trauma, cardiac, obstetric and transplant surgery patients. Definitive clinical guidance regarding the optimal ratio of blood products, including those containing fibrinogen, is still lacking. Therefore, we tested the hypothesis that increasing the fibrinogen content to erythrocyte suspension ratio improves the mortality and functional outcomes of patients undergoing surgeries with expected major bleeding.

The Approximate Dose-Equivalent of Fibrinogen-to-Erythrocyte Suspension (ADEFES) ratio is a multicentre, prospective, observational, cohort study of patients undergoing major surgical procedures with expected major perioperative bleeding (ie, requiring packed red blood cells (PRBC)>4U/24 hours). For 5U of cryoprecipitate and 1.5 U of fresh frozen plasma (FFP), the approximate dose-equivalent for fibrinogen is considered as 1 gram of fibrinogen. Association of the ADEFES ratio at 24 hours will be assessed on the primary objective, which will consist of the composite of 30-day all-cause mortality, 30-day bleeding-specific mortality and the ‘highly-dependent scores’ of Katz index of independence in activities of daily living.

The study protocol was approved by the Ethics Committee of Ankara Bilkent City Hospital (approval no. E2-23-4265, dated 07 June 2023; Chair: Prof. Dr. F.E. Canpolat) and by the institutional review boards of all participating centres. The study will be conducted in accordance with the principles of the Declaration of Helsinki and the Strengthening the Reporting of Observational Studies in Epidemiology guidelines, as well as in compliance with national regulations on data protection and Good Clinical Practice standards. Written informed consent will be obtained from all participants prior to inclusion in the study.

The results of this study will be disseminated through peer-reviewed scientific journals, presentations at national and international conferences, and communication with relevant stakeholders including clinical practitioners and healthcare institutions. If applicable, study outcomes will also be shared via institutional newsletters and digital platforms to reach a broader audience in the medical community.

NCT06021184.

Continuous glucose monitoring (CGM) provides real-time glucose data for people with diabetes. However, detailed knowledge of its use in daily life remains limited. We aim to investigate the interaction between people with type 1 diabetes (T1D) and their CGM data and the impact of the interaction on glycaemia and diabetes distress.

This is a two-centre observational study of adults (n=500) with T1D using FreeStyle Libre 2. Over a period of 14 days, participants will continue their regular CGM use, record insulin doses and timing with smart insulin pens, track activity and sleep with an activity tracker, log all food intake in the LibreLink app and answer questions about quality of life and hypoglycaemia two times per day. Before the study period, the participants will complete a survey of 11 validated questionnaires assessing diabetes distress, hypoglycaemia awareness and other patient-reported outcomes (PROs). After the study period, the participants will complete two additional questionnaires assessing diabetes distress and health literacy.

The collected data will be used in two substudies with the overall aims of:

Substudy 1: to investigate how CGM is used in practice and the impact of the interaction on diabetes distress and glycaemia.

Substudy 2: to investigate whether and how CGM functions as a technological substitute for impaired awareness of hypoglycaemia, focusing on alarm data.

Endpoints will include CGM metrics, alarm data and PROs.

The Danish Data Protection Agency approved the study (P-2024–15985), and the regional committee on health research ethics has granted an ethical waiver (H-24014662). All participants have signed written informed consent forms before participating. The results will be published in an international peer-reviewed scientific journal by the study investigators and shared via www.clinicaltrials.gov. Participants who agreed to receive information about the study will be sent the results after publication.

ClinicalTrials.gov (NCT06453434).

To assess the relation of exposure to cement dust and heavy metal (aluminium, cadmium and lead) exposures to pulmonary function among male cement plant workers. The study also aimed to evaluate dose–response relationships and prevalence and severity of respiratory symptoms among exposure categories compared with a control group.

Cross-sectional study.

Secondary-level occupational health clinic in Ankara, Türkiye.

461 male non-smoking cement plant employees were included in total. Participants were categorised into packaging (n=101), milling (n=162) and office unexposed workers (n=198). Inclusion criteria were more than 70% work history in the cement industry and exclusion of pre-existing respiratory disease and missing data from the participants.

Not applicable.

Pulmonary function tests (forced vital capacity (FVC), forced expiratory volume in 1 s (FEV1), FEV1/FVC and peak expiratory flow (PEF)) and urinary, cadmium and blood lead concentrations were measured. Lung function impairment was the primary outcome measure; secondary outcomes included metal exposure—pulmonary measure correlations.

Significant negative correlations existed between FEV1 and urine aluminium (r=–0.622, p

Occupational cement dust and heavy metal exposure is closely linked to impaired pulmonary function in cement plant employees, particularly those who work in higher exposure jobs. The implications are robust endorsement of targeted monitoring and preventive interventions. Long-term longitudinal research is necessary to identify long-term outcome and efficacy of exposure reduction approaches.