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PRECISION study: impact of personalised cardiac anaesthesia and cerebral autoregulation on neurological outcomes in patients undergoing cardiac surgery - protocol for an international, multicentre, prospective cohort study

Por: Gomes · N. V. · Edgar-Whelan · H. · Beqiri · E. · Young · J. · Schindler · C. · Gregor · M. · Erb · J. M. · Siegemund · M. · Kuhle · J. · Maleska Maceski · A. · Needham · E. · Cichon · S. · Burger · B. · Monsch · A. U. · Hasemann · W. · Wüest · A. · Fassl · J. · Kaiser · H. A. · Hight · D
Introduction

Adverse neurological complications, including postoperative delirium (POD) and stroke, remain one of the major risks after cardiac surgery. A lack of comprehensive knowledge about their causes and neuroprotective strategies has hindered the development of effective interventions to reduce these events. Personalised cerebral autoregulation (CA)-oriented blood pressure monitoring aims to identify blood pressure targets tailored to each individual patient, thereby reducing brain injury. The PRECISION study aims to assess whether perioperative duration and magnitude of mean arterial pressure (MAP) deviation from an individual’s CA limits are associated with adverse neurological complications.

Methods and analysis

This international, multicentre, prospective cohort study is conducted at two Swiss and one British hospital. Patients aged 65 years or older undergoing elective primary or re-operative coronary artery bypass graft and/or valvular and/or ascending aorta surgery requiring cardiopulmonary bypass are included. Preoperatively, the patient’s baseline of physical, cognitive and mental status is established. Intraoperatively, near-infrared spectroscopy (NIRS) and transcranial Doppler (TCD) are recorded in real-time to generate NIRS-derived and TCD-derived CA indices. The primary endpoint is POD, assessed daily on postoperative days 0 to 7 or up to discharge, whichever occurs earlier with the 3D-Confusion Assessment Method (3D-CAM) or CAM-Intensive Care Unit. Secondary endpoints include a composite neurological outcome of POD and overt stroke, postoperative neurocognitive disorders, major morbidity and mortality. Associations between neurologic outcomes, neurobiomarkers and genetic variation will be explored.

A total of 500 participants is required to achieve 90% power to find a statistically significant effect of the area under the curve MAP

Ethics and dissemination

Ethical approval has been obtained from all responsible ethics committees (Swiss lead ethics committee EKNZ 2022-01457 and Health Research Authority and Health and Care Research Wales, UK, REC 23/SW/0076). Results will be disseminated at national and international conferences and published in peer-reviewed journals.

Trial registration number

NCT05595954.

American Heart Associations Lifes Simple 7 for cardiovascular health assessment among Iranian adults: a national cross-sectional study from STEPwise approach to non-communicable diseases risk factor surveillance (STEPS) survey 2021

Por: Azadnajafabad · S. · Rezaei · S. · Almasi · G. · Ahmadi · N. · Golestani · A. · Rashidi · M.-M. · Abbasi-Kangevari · M. · Rezaei · N. · Rezaei · N. · Farzi · Y. · Ghasemi · E. · Yoosefi · M. · Haghshenas · R. · Nasserinejad · M. · Kazemi · A. · Abdolhamidi · E. · Saeedi Moghaddam · S.
Objective

To assess cardiovascular health (CVH) metrics using the American Heart Association’s Life’s Simple 7 (LS7) tool as a comprehensive measure of several metabolic and behavioural risk factors for cardiovascular diseases.

Design

Cross-sectional study, nationally representative Iran STEPwise approach to non-communicable diseases risk factor surveillance (STEPS) survey 2021.

Setting

Iran, 2020–2021.

Participants

25 202 adult individuals aged 25 years and older participated in the STEPS survey.

Outcome measures

Using the LS7 framework, seven factors were assessed: current smoking, body mass index (BMI), physical activity level, modified healthy diet score components, total cholesterol, blood pressure and fasting plasma glucose (FPG). Each factor was categorised into three levels of poor, intermediate and ideal, according to the LS7 methodology.

Results

The study participants had a sex distribution of 55.5% females. The findings revealed a high prevalence of ideal levels of smoking (80.1%; 95% CI 79.3 to 81.0), total cholesterol (69.4%; 95% CI 68.5 to 70.4) and FPG (61.0%; 95% CI 60.0 to 62.1). BMI and blood pressure were ideal in about one-third of the population (33.0%; 95% CI 32.1 to 34.0, and 30.5%; 95% CI 29.6 to 31.4, respectively). However, only 13.3% (95% CI 12.6 to 14.0) of participants achieved ideal levels of physical activity, and a mere 0.4% (95% CI 0.3 to 0.6) adhered to an ideal healthy diet. Modest disparities in CVH metrics were observed across provinces and between two sexes. Ideal CVH status was significantly associated with lower risks of major diseases such as ischaemic heart disease, diabetes and chronic kidney disease.

Conclusions

Despite favourable scores in some CVH metrics, critical gaps in diet and physical activity highlight the need for intensive public health efforts to enhance CVH in Iran. The study emphasises the urgency of implementing region- and sex-specific public health policies.

Designing an implementation strategy to improve referral from general practice to a National Diabetes Prevention Programme using a Delphi survey with healthcare professionals and the Behaviour Change Wheel

Por: Haseldine · C. · ODonoghue · G. · Kearney · P. M. · Riordan · F. · Humphreys · M. · Kirby · L. · Mc Hugh · S. M.
Objectives

While diabetes prevention programmes (DPPs) effectively reduce the risk of type 2 diabetes, optimising referral to these programmes is challenging. Our prior research (a qualitative study on the pilot of the National Diabetes Prevention Programme (NDPP) and a systematic review) identified a range of barriers and facilitators to referral from healthcare workers’ perspectives. This study aims to gain consensus on the main factors influencing referral to a newly established NDPP and using the Behaviour Change Wheel (BCW) to select behaviour change techniques (BCTs) for an implementation strategy to improve referral to the programme in the future.

Design

A two-round modified online Delphi survey prioritised 17 barriers and facilitators of the referral process, followed by a mapping exercise with the BCW, which guided the identification of techniques to change referral behaviour from general practice.

Setting

The survey took place online with healthcare professionals working in the primary care setting in Ireland (April to June 2024). The NDPP was in the pilot phase and was not available in all areas. This study sought to learn from this pilot phase to inform the referral process, which was not yet fully established.

Participants

Healthcare professionals eligible to refer or involved in referral to the NDPP in Ireland (general practitioners, practice nurses and dietitians delivering the NDPP) took part in the Delphi survey. Recruitment was through a number of gatekeepers, a health service manager and professional groups who shared invitations to participate with eligible healthcare professionals.

Outcome measures

In the Delphi survey round 1, respondents were asked to rate the importance of 17 factors (nine facilitators and eight barriers) influencing referral on a 5-point Likert scale (not important to very high importance) and an open text box captured other suggested important factors. Barriers included limited practical information about the availability of the programme, concerns about workload, competing priorities and concern about patient motivation, the time commitment for patients and referral delays. Facilitators included electronic referral and feedback, promotion of the programme by healthcare professionals and consultation with patients before referral. Consensus was defined as agreement of ≥70% for each factor in the combined categories of high importance/very high importance, low/moderate importance or not important. Factors not reaching consensus after the first round were included in round 2 with any new factors from round 1. Factors that did not reach consensus or reached consensus as not important or of low/moderate importance were excluded. Only factors reaching consensus as being of high importance/very high importance across the two rounds were included in the final prioritised list.

Results

The Delphi survey had 37 responses to round 1 and 23 (62%) responses to round 2. 12 factors reached consensus as being of high/very high importance to improve referral. The 12 factors are mapped to seven intervention functions in the BCW and to nine key BCTs (feedback on the outcome of the behaviour, social support, instruction on how to perform a behaviour, information about the health consequences, information about social and environmental consequences, demonstration of the behaviour, prompts/cues, credible source and restructuring the physical environment). The strategy to improve referrals should include education delivered by educators to referrers, educational materials on the DPP and practical support to facilitate referrals. The health service should continue to provide electronic referrals and electronic prompts to refer could be considered as part of the electronic health record.

Conclusion

This study systematically prioritises factors perceived to influence referral and identifies BCTs to improve referral to an NDPP. The BCTs are a starting point for a strategy to improve referral to DPPs. Further consultation with stakeholders is recommended to discuss the acceptability, feasibility and operationalisation of the BCTs in the Irish setting.

Prevalence and risk factors of chronic kidney disease among Iranian adults with and without diabetes: a cross-sectional study using STEPS 2021 national survey

Por: Ataei · S. M.-N. · Almasi · G. · Kazemi · A. · Ahmadi · N. · Golestani · A. · Rashidi · M.-M. · Rezaei · N. · Azadnajafabad · S. · Rezaei · N. · Dilmaghani-Marand · A. · Ghasemi · E. · Farzi · Y. · Yoosefi · M. · Rezaee · K. · Foroutan Mehr · E. · Nasserinejad · M. · Haghshenas · R. · Al
Objectives

Chronic kidney disease (CKD) is a global health concern and a major long-term complication of diabetes, yet its burden remains understudied in regions with limited epidemiological data. This study aimed to evaluate the prevalence of CKD and its associated risk factors in the Iranian adult population, stratified by diabetes status.

Design

Population-based cross-sectional study.

Setting

Nationally representative survey across Iran (STEPS 2021).

Participants

17 607 adults aged ≥25 years with complete kidney function and albuminuria data, selected through systematic sampling with weighting to ensure national representativeness.

Primary and secondary outcome measures

CKD was defined as an estimated glomerular filtration rate (eGFR)

Results

The national prevalence of CKD was 11.9% (95% CI 11.2% to 12.6%), with 9.1% (8.5% to 9.9%) among individuals without diabetes and 28.6% (26.2% to 31.1%) among those with diabetes. According to KDIGO classification, 88.1% (87.4% to 88.8%) were at low risk, 9.0% (8.4% to 9.6%) at moderate risk, 2.0% (1.6% to 2.4%) at high risk and 0.9% (0.7% to 1.1%) at very high risk. Albuminuria was more prevalent than low eGFR in both groups with (22.5% (20.4% to 24.8%) vs 10.3% (8.7% to 12.1%)) and without (5.7% (5.2% to 6.3%) vs 4.3% (3.8% to 4.8%)) diabetes. Diabetes was more strongly linked to albuminuria than low eGFR and was progressively associated with higher risk categories (adjusted ORs (aORs) 2.41 (2.03–2.86) for moderate, 2.63 (1.74–3.97) for high, 3.93 (2.56–6.07) for very high vs low-risk). CKD prevalence was highest in northwest Iran, increased significantly with age, with a stronger association observed for low eGFR than albuminuria, and was associated with hypertension (aOR 2.41 (2.07–2.82)), dyslipidaemia (1.60 (1.31–1.94)), obesity (1.94 (1.59–2.36)), ischaemic heart disease (1.53 (1.25–1.87)) and physical inactivity (1.40 (1.20–1.62)). Higher socioeconomic status and education were associated with lower odds of CKD.

Conclusions

CKD is a major burden, especially in individuals with diabetes, with regional and socioeconomic disparities. Addressing risk factors, integrating CKD into non-communicable disease surveillance and prioritising it in global health agendas, including the Sustainable Development Goals, are essential.

Clinical characteristics, treatments and outcomes of hospitalised COVID-19 patients across pandemic waves at a tertiary acute care hospital in Narita, Japan: a single-centre retrospective observational study

Por: Hase · R. · Kurata · R. · Niiyama · Y. · Matsuda · N. · Ueda · H. · Kikuchi · K. · Ishida · K. · Kubota · Y. · Fujii · M. · Kurita · T. · Muranaka · E. · Sasazawa · H. · Mito · H. · Yano · Y. · Oku · R. · Tateishi · Y. · Toishi · S. · Obata · S. · Noguchi · Y. · Nakanishi · K. · Sunami · S.
Objective

This study aims to describe the characteristics of hospitalised COVID-19 patients in a tertiary care hospital close to an international airport in Japan and to compare these characteristics among different waves during the pandemic.

Design

Retrospective observational study.

Setting

Tertiary care centre in Japan.

Participants

All patients diagnosed with COVID-19 who were hospitalised between January 2020 and April 2022 were included.

Measurements

Clinical characteristics, characteristics of admission, treatments and outcomes were investigated and compared among six pandemic waves.

Results

A total of 827 patients were included. The median age was 58.0 years. More than half of the patients (58.3%) had at least one comorbidity. The majority of patients (89.0%) were domestically infected patients admitted under the Infectious Diseases Law, while the remaining patients (11.0%) were those diagnosed during airport quarantine and admitted under the Quarantine Act. Hospital-acquired COVID-19 infection occurred in 7.0% of cases, and mainly during the sixth wave. Overall, some form of oxygen therapy, high-flow oxygen devices, invasive mechanical ventilation (IMV) and extracorporeal membrane oxygenation was provided in 46.3%, 10.4%, 4.5% and 1.5% of cases, respectively. Only 1.8% of patients were treated in the intensive care unit (ICU), and 59.5% of patients on IMV were managed in the non-ICU ward. The in-hospital mortality rate was 5.8%. Median age, percentages of some comorbidities, vaccination coverage, medications for COVID-19, types of supportive care and ICU admissions differed significantly among waves.

Conclusions

This study suggests that patient characteristics, vaccination coverage, standard of treatment and severity of illness changed across waves during the COVID-19 pandemic. Intensive care delivery in non-ICU wards was unavoidable due to limited ICU capacity, which may be a key consideration when preparing for future pandemics.

Developing consolidated guidelines for reporting and evaluation of studies using transcranial electrical stimulation (CoRE-tES): protocol for an international Delphi study and expert consensus process

Por: Suhood · A. Y. · Summers · S. · Pascual-Leone · A. · Nitsche · M. A. · Ziemann · U. · Bikson · M. · Lefaucheur · J.-P. · Brunoni · A. R. · Bestmann · S. · Chipchase · L. S. · Razza · L. B. · Cavaleri · R.
Introduction

In recent decades, transcranial electrical stimulation (tES) has become a widely used non-invasive method for modulating brain function in clinical and non-clinical populations. However, existing tES trials exhibit substantial methodological heterogeneity, often limiting the reproducibility and interpretability of findings. There currently exists a paucity of consensus-driven, standardised recommendations outlining the key factors that should be reported and/or controlled in tES studies. Accordingly, this project aims to develop Consolidated Guidelines for Reporting and Evaluation of studies using tES (CoRE-tES), a tool designed to assess the methodological quality and reporting of laboratory-based and home-based tES studies. These guidelines will support improved quality, consistency, replication and transparency in research involving tES modalities, including transcranial direct current stimulation, transcranial alternating current stimulation and transcranial random noise stimulation.

Methods and analysis

CoRE-tES will be developed and disseminated over five stages. Stage 1 will comprise a review of recent tES literature to assess methodological and reporting quality. Stage 2 will employ a Delphi process to seek agreement among international tES experts on a list of items for inclusion in CoRE-tES. In stage 3, a consensus meeting will be held to synthesise and prioritise the agreed items to form CoRE-tES. Stage 4 will involve production of the final CoRE-tES checklist and an accompanying evaluation and elaboration document. In stage 5, CoRE-tES will be disseminated via journal publication, conferences, professional meetings and social media campaigns.

Ethics and dissemination

Ethics approval has been obtained from the Western Sydney University Human Research Ethics Committee (approval number H16803). Findings will be disseminated through scientific conferences and peer-reviewed journal publications, and CoRE-tES will be indexed on the Enhancing the QUAlity and Transparency Of health Research Network website.

Cohort profile: a prenatal birth cohort study of intergenerational risk and resilience after conflict and forced displacement

Por: Wuermli · A. · Hiott · M. C. · Ugarte · E. · Rahman · M. S. · Elahi · M. · Rahim · A. · Dutta · G. K. · Ahamed · M. S. · Roy · B. R. · Akhter · R. M. · Hossain · E. · Michael · D. · Ayrin · T. K. · Haseen · S. H. · Alam · R. B. · Ratul · T. I. · Horaira · M. A. · Gladstone · M. · Sanin · K.
Purpose

As of 2024, 123.2 million people had been forcibly displaced as a result of persecution, armed conflict or climate-related catastrophes, and these numbers are predicted to rise. There is a growing awareness of possible intergenerational effects of trauma on life-course health and well-being, however few studies have followed individuals longitudinally starting prenatally. This paper describes the first large prenatal birth cohort study in a refugee context in a lower middle-income country. This study aims to investigate the potential lifespan health and developmental implications of being born into a protracted humanitarian context, and what factors can buffer from the adversity posed by conflict and displacement.

Participants

We outline our approach of recruiting, consenting and gathering data from pregnant Rohingya refugee and host community women (N=2888; 80% Rohingya) over the course of 12 months in Cox’s Bazar, Bangladesh.

Findings to date

A fifth wave of data collection, when children were 6 months old, was completed in April 2025. Rohingya women were substantially less literate; were marrying and having children at slightly younger ages, were more likely to live in crowded, resource-limited households and exhibited higher rates of clinically significant post-traumatic stress disorder and anxiety than host community women.

Future plans

There is a critical need for research in displaced populations in order to elucidate potentially lasting transgenerational impacts of experiencing conflict and displacement trauma, and the prenatal and postnatal factors that support health and development across the life span. The next follow-up is planned when the children turn 36 months of age (starting March 2026).

Factors influencing physician-to-physician teleconsultation: a scoping review

Por: Ghasemi · S. · Changiz · T. · Omid · A.
Background

Teleconsultation has gained significant traction due to advancements in information and communication technologies. While much attention has been given to physician-to-patient teleconsultation, the factors influencing physician-to-physician teleconsultation remain underexplored.

Objectives

This scoping review aims to map and synthesise the existing evidence on the factors influencing physician-to-physician teleconsultation.

Eligibility criteria

We included publications of all methodological designs that specifically addressed factors affecting physician-to-physician teleconsultation. Studies focusing primarily on physician-to-patient teleconsultation without sufficient detail on physician-to-physician components were excluded. The search was limited to articles published in English and Persian between 2014 and 2024.

Sources of evidence

Eight electronic databases (PubMed, Scopus, Web of Science, etc) were searched from January 2014 to June 2024.

Charting methods

Data extraction was performed by two independent reviewers using a standardised form. Extracted data included study characteristics, key factors influencing teleconsultation and main findings.

Results

From 12 included studies, five key influencing components were identified: ‘patient-related factors’, ‘medical team competencies’, ‘infrastructure and technology’, ‘timing factors’ and ‘planning and programme evaluation’. Among these, infrastructure and technology were the most frequently reported factors across the studies, while patient-related factors were less commonly addressed.

Conclusions

This review identifies a comprehensive set of factors that influence physician-to-physician teleconsultation. The findings provide a foundation for developing effective teleconsultation programmes and highlight the need for more research in diverse healthcare settings.

Prospective, multicentre trial on preoperative biliary drainage by endoscopic ultrasound-guided hepaticogastrostomy for resectable/borderline resectable pancreatic cancer with biliary obstruction: the PROLOGUE study - a study protocol

Por: Yagi · S. · Hijioka · S. · Nagashio · Y. · Harai · S. · Agarie · D. · Yamashige · D. · Okamoto · K. · Fukuda · S. · Kuwada · M. · Komori · Y. · Kurita · Y. · Hasegawa · S. · Kubota · K. · Ishida · Y. · Ushio · J. · Takeshita · K. · Yoshino · K. · Ishiwatari · H. · Okusaka · T.
Introduction

Preoperative biliary drainage (PBD) is often required for patients with pancreatic cancer accompanied by biliary obstruction to ensure the safe administration of neoadjuvant chemotherapy or to manage cholangitis and jaundice. Although endoscopic retrograde cholangiopancreatography (ERCP) is the standard approach for PBD, it carries a significant risk of post-ERCP pancreatitis. Endoscopic ultrasound-guided biliary drainage (EUS-BD), particularly via hepaticogastrostomy (EUS-HGS), offers a promising alternative that avoids papillary manipulation. However, the clinical utility of EUS-BD as primary drainage for PBD remains unclear due to a lack of prospective studies. This multicentre prospective trial aims to evaluate the safety and efficacy of EUS-HGS as primary drainage for PBD in patients with resectable or borderline resectable pancreatic cancer.

Methods and analysis

This multicentre prospective study involves seven institutions in Japan. Eligible patients will undergo EUS-HGS using a 7Fr plastic stent. The primary endpoint is clinical success, defined by improvements in bilirubin or liver enzyme levels within 14 days postprocedure. Secondary endpoints include technical success rate, adverse event incidence, stent patency and surgical outcomes. A total of 30 patients will be enrolled, considering an expected clinical success rate of 90% and a 10% dropout allowance.

Ethics and dissemination

This study has been approved by the National Cancer Center Institutional Review Board (Research No. 2024-084). The results of this study will be reported at an international conference and published in an international peer-reviewed journal.

Trial registration number

UMIN ID: 000055173.

Effect of curcumin on fatigue and musculoskeletal health in postmenopausal women: a double-blind randomised controlled trial

Por: Shabani · F. · Mashayekh-Amiri · S. · Mousavi · Z. · Shaseb · E. · Mirghafourvand · M.
Objectives

Considering the proven anti-inflammatory effects of curcumin, we aimed to investigate the effect of curcumin supplementation on fatigue and musculoskeletal health (primary outcomes) and depression and its side effects (secondary outcomes) in postmenopausal women.

Design

This was a parallel-group, double-blind, randomised placebo-controlled superiority trial.

Setting

The trial was conducted at two general clinics in Tabriz, Iran, in 2023.

Participants

A total of 74 postmenopausal women were enrolled. The participants were women aged between 40 years and 60 years with normal menopause and at least 1 year after amenorrhoea.

Intervention

They were randomly assigned (1:1 allocation ratio) using a block randomisation method to receive either 500 mg curcumin capsules (intervention group, n=37) or identical placebo capsules (control group, n=37) twice daily for 8 weeks. Both participants and researchers were blinded to the group assignments.

Primary and secondary outcome measures

Data were collected using the questionnaires of demographic characteristics, short form of the perimenopausal fatigue scale, musculoskeletal health, Beck Depression Inventory (BDI-13) and the side effects checklist. Independent t, ANCOVA and Mann-Whitney U tests were used to compare the results between the two groups.

Results

A total of 74 women were randomised, with 33 in the curcumin group and 31 in the placebo group completing the study and being included in the final analysis. After the 8-week intervention, ANCOVA adjusting for baseline values revealed that the curcumin group showed a statistically significant improvement in musculoskeletal health (mean difference (MD): 5.3; 95% CI: 3.3 to 7.4; p

Conclusion

In this trial, an 8-week supplementation with curcumin was more effective than placebo at improving musculoskeletal health and reducing fatigue score in postmenopausal women. The study was not able to demonstrate a significant effect on depression.

Trial registration number

Iranian Registry of Clinical Trials (IRCT): IRCT20120718010324N72. Last updated version: 18 October 2022. Actual start of recruitment: 23 January 2023.

Investigating the influence of adherence to dietary behaviour recommendations on percentage total weight loss after metabolic and bariatric surgery: study protocol for the OBSERVE study, a single-centre observational, prospective, longitudinal cohort stud

Por: Pehlke · B. · Michel · C. · Jansen · C. · Karunakaran · S. · Rentschler-Heckel · J. · Robitzsch · A. · Niedergethman · M. · Marsall · M. · Hasenberg · T. · Teufel · M. · Bäuerle · A.
Introduction

The long-term success of metabolic and bariatric surgery (MBS) depends largely on adherence to health-promoting behaviour following MBS. Especially, adherence to healthy dietary behaviour in line with guidelines appears to be of the utmost importance. The primary objective of the present study is to evaluate the effect of adherence to dietary behaviour recommendations and the percentage of total weight loss (%TWL) after MBS. Adherence is hypothesised to have a positive influence on the %TWL, 24 months after MBS. Furthermore, we investigate the association of various sociodemographic, organisational, psychological and behavioural factors prior to and after MBS and their effect on %TWL.

Methods and analysis

The present study is a single-centre observational, prospective, longitudinal cohort study conducted in Germany. Data are collected at nine measurement points (T0: 4 weeks prior to MBS; T1: 2 weeks after MBS, T2: 5 weeks after MBS; T3: 3 months after MBS; T4: 6 months after MBS; T5: 12 months after MBS; T6: 18 months after MBS; T7: 24 months after MBS; and T8: 36 months after MBS). Adherence to dietary behaviour recommendations is assessed using the Dietary Behavior Inventory-Surgery (DBI-S). N=325 patients applying for MBS will be included in the study. A regression analysis approach is chosen to answer the primary research question. The primary outcome %TWL is regressed at T7 (24 months after MBS) in a causal analysis on dietary adherence (DBI-S score) at T3–T7, with the covariates age, gender, marital status, educational attainment, employment status, Patient Health Questionnaire-4 score and body mass index at T0 and MBS method at T1. Stepwise hierarchical regression analyses are performed and analysed for significant model differences using 2 difference tests. Effect sizes are estimated by R2. Group differences are analysed using t-tests and Analyses of variance (ANOVAs). Bivariate correlations of continuous variables are examined using regression/correlation analyses.

Ethics and dissemination

The Ethics Committee of the Medical Faculty of the University of Essen-Duisburg has approved the conduct of the study (24-11969-BO). Results will be disseminated through manuscripts in clinical/academic peer-reviewed journals, presentations at academic conferences and communications with partners, participants and other stakeholders. Key findings will also be published in lay language on a publicly accessible website and disseminated via various (social) media channels.

Trial registration number

The study has been prospectively registered on 8 October 2024 in the German Clinical Trials Register (DRKS00034888).

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