Subjects with schizophrenia have a 2–3 fold higher mortality rate than the general population and a reduced life expectancy of 10–20 years. Approximately one-third of this excess mortality has been attributed to obesity-related type 2 diabetes (T2D) and to cardiovascular disease. Glucagon-like peptide-1 (GLP-1) analogues increase satiety and delay gastric emptying, thereby reducing food intake and weight. GLP-1 analogues also exert beneficial effects on cardiovascular outcomes in high-risk patients with T2D.

Our aim is to investigate whether 30 weeks add-on treatment with the GLP-1 analogue semaglutide can reduce HbA1c sufficiently to reverse pre-diabetes and the metabolic syndrome in overweight schizophrenic patients.

We will perform a 30 week, two-armed, multicentre, superiority, double-blinded, randomised trial investigating the effect of weekly injections of semaglutide versus placebo in mental health facilities in Region of Southern Denmark and Region of Zealand, Denmark. In total, 154 adults with schizophrenia spectrum disease, aged 18–60 years treated with second generation antipsychotic treatment, HbA1c 39–47 mmol/mol and body mass index >27 kg/m² will be randomised to injections of 1.0 mg semaglutide or placebo. The primary outcome is changes in HbA1c. Secondary outcomes encompass metabolic measures, psychotic symptoms and quality of life. Exploratory outcomes encompass insulin sensitivity, cardiovascular risk profile, medication adherence, general well-being and physical activity.

This study will be carried out in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. This research has obtained approval from both the Danish Medicines Agency and The Regional Committees on Health Research Ethics for Southern Denmark.

NCT05193578 European Clinical Trials Database Number (EudraCT) 2020-004374-22, Regional Ethical Committee number S-20200182.

Current choice models in healthcare (and beyond) can provide suboptimal predictions of healthcare users’ decisions. One reason for such inaccuracy is that standard microeconomic theory assumes that decisions of healthcare users are made in a social vacuum. Healthcare choices, however, can in fact be (entirely) socially determined. To achieve more accurate choice predictions within healthcare and therefore better policy decisions, the social influences that affect healthcare user decision-making need to be identified and explicitly integrated into choice models. The purpose of this study is to develop a socially interdependent choice framework of healthcare user decision-making.

A mixed-methods approach will be used. A systematic literature review will be conducted that identifies the social influences on healthcare user decision-making. Based on the outcomes of a systematic literature review, an interview guide will be developed that assesses which, and how, social influences affect healthcare user decision-making in four different medical fields. This guide will be used during two exploratory focus groups to assess the engagement of participants and clarity of questions and probes. The refined interview guide will be used to conduct the semistructured interviews with healthcare professionals and users. These interviews will explore in detail which, and how, social influences affect healthcare user decision-making. Focus group and interview transcripts will be analysed iteratively using a constant comparative approach based on a mix of inductive and deductive coding. Based on the outcomes, a social influence independent choice framework for healthcare user decision-making will be drafted. Finally, the Delphi technique will be employed to achieve consensus about the final version of this choice framework.

This study was approved by the Erasmus School of Health Policy and Management Research Ethics Review Committee (ESHPM, Rotterdam, The Netherlands; reference ETH2122-0666).

Preterm birth complications are the most common cause of death in children under 5 years. The presence of multiple microorganisms and genital tract inflammation could be the common mechanism driving early onset of labour. South Africa has high levels of preterm birth, genital tract infections and HIV infection among pregnant women. We plan to investigate associations between the presence of multiple lower genital tract microorganisms in pregnancy and gestational age at birth.

This cohort study enrols around 600 pregnant women at one public healthcare facility in East London, South Africa. Eligible women are ≥18 years and at Chlamydia trachomatis and Neisseria gonorrhoeae, with treatment if test results are positive. At these visits, additional vaginal specimens are taken for: PCR detection and quantification of Trichomonas vaginalis, Candida spp., Mycoplasma genitalium, M. hominis, Ureaplasma urealyticum and U. parvum; microscopy and Nugent scoring; and for 16S ribosomal RNA gene sequencing and quantification. Pregnancy outcomes are collected from a postnatal visit and birth registers. The primary outcome is gestational age at birth. Statistical analyses will explore associations between specific microorganisms and gestational age at birth. To explore the association with the quantity of microorganisms, we will construct an index of microorganism load and use mixed-effects regression models and classification and regression tree analysis to examine which combinations of microorganisms contribute to earlier gestational age at birth.

This protocol has approvals from the University of Cape Town Research Ethics Committee and the Canton of Bern Ethics Committee. Results from this study will be uploaded to preprint servers, submitted to open access peer-reviewed journals and presented at regional and international conferences.

NCT06131749; Pre-results.

Obesity is one of the main threats to public health in western countries and increases the risk of several diseases, overall morbidity and mortality. Sustained weight loss will reduce risk factors and improve several obesity comorbidities. Options are conservative treatment such as lifestyle changes, bariatric surgery or medications. Conservative treatment has a low success rate, and bariatric surgery is typically not reversible, with the risk of complications and recurrences. Treatment of obesity with medications has in recent years shown great promise, but the side effects are many, and the long-term effect is unknown. There is also a need for an option for patients where surgery has contraindications and conservative follow-up does not succeed.

The research on obesity and gut microbiota has yielded promising results regarding weight reduction and metabolic health, but more research is needed to better understand the relationship between gut microbiota and severe obesity. This study could show proof of concept that gut microbiota from a lean donor could, in addition to lifestyle intervention, contribute to weight reduction in people suffering from severe obesity.

This study aims to investigate if a fecal microbiota transplantation (FMT) from a lean donor leads to weight reduction in participants suffering from severe obesity. The study is a single-centre, double-blinded, placebo-controlled, parallel-group study with 60 participants. Participants will be randomised 1:1 for FMT from a lean donor or placebo. FMT or placebo will be delivered once by enema.

We will include participants from the outpatient clinic for severe obesity, at the Medical Department, University Hospital of North Norway, Harstad, by invitation only. The study has a follow-up period of 12 months, with study visits of 3, 6 and 12 months post FMT. The primary endpoint is a weight reduction of ≥10%, 12 months after intervention.

The results of the study will be published in open access journals. At the end of the study, the participants will receive information on which treatment group they belong to.

The Regional Ethical Committee in North Norway (REK) approved the study protocol (2017/1655/REK Nord). We plan to present the results from the study at (inter)national conferences and publish in open-access general peer-reviewed journals. The enema method for FMT administration used in this study was developed by our study team.

NCT03273855.

To compare the associations of COVID-19 preventive behaviours and depressive and anxiety symptoms with eHealth literacy and COVID-19 knowledge among Korean adults.

A cross-sectional online survey was conducted in April 2020.

Seoul metropolitan area in South Korea.

1057 Korean adults were recruited.

Associations between eHealth literacy, COVID-19 knowledge, COVID-19 preventive behaviours and psychological distress were computed using Pearson’s correlation and logistic regression analyses. eHealth literacy, COVID-19 knowledge, COVID-19 preventive behaviours and psychological distress were weighted by sex and age distribution of the general population in Seoul Metropolitan area.

68.40% (n=723) perceived high eHealth literacy level (eHEALS ≥26), while 57.43% (n=605) had high levels of COVID-19 knowledge (score ≥25). No significant association between eHealth literacy and COVID-19 knowledge was identified (r=0.05, p=0.09). eHealth literacy and COVID-19 knowledge were significantly associated with COVID-19 preventive behaviours (aOR=1.99, 95% CI 1.51 to 2.62 L; aOR=1.81, 95% CI 1.40 to 2.34, respectively). High eHealth literacy was significantly associated with anxiety symptom (aOR=1.71, 95% CI 1.18 to 2.47) and depressive symptom (aOR=1.69, 95% CI 1.24 to 2.30). COVID-19 knowledge had negative and no associations with the symptoms (aOR=0.62, 95% CI 0.46 to 0.86; aOR=0.79, 95% CI 0.60 to 1.03, respectively). High eHealth literacy with low COVID-19 knowledge was positively and significantly associated with COVID-19 preventive behaviours (aOR=2.30, 95% CI 1.52 to 3.43), and anxiety (aOR=1.81, 95% CI 1.09 to 3.01) and depressive symptoms (aOR=2.24, 95% CI 1.41 to 3.55). High eHealth literacy with high COVID-19 knowledge were significantly associated with more preventive behaviours (aOR=3.66, 95% CI 2.47 to 5.42) but no significant associations with anxiety and depressive symptoms.

We identified that eHealth literacy and COVID-19 knowledge were not associated each other, and differently associated with individuals’ COVID-19 preventive behaviours and psychological well-being. Public health strategies should pay attention to enhancing both eHealth literacy and COVID-19 knowledge levels in the public to maximise their COVID-19 preventive behaviours and mitigate their psychological distress during COVID-19 pandemic.