Conectar
Childhood obesity is an escalating crisis in the United States. Health policy may impact this epidemic which disproportionally affects underserved populations.
The aim was to use the reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) framework to assess health policy impact on preventing or treating school-aged children (5 > 18 years) with obesity in underserved populations.
A scoping review of 842 articles was conducted. Twenty-four articles met the inclusion criteria and underwent data extraction.
Twelve studies included subgroup analysis, with four suggesting an impact of policy on at-risk groups. None of the 24 studies fully applied the RE-AIM framework. Policies positively impacted childhood obesity in 12 studies across the sample.
Our review revealed inconsistent evidence for the effectiveness of policy on childhood obesity, perhaps due to the lack of focus on the social determinants of health. In addition, many studies did not evaluate the outcomes for underserved populations. Therefore, we propose more attention to social determinants in future legislation and evaluation of policy effectiveness on underserved populations. Findings identify an urgent need for the design, implementation, and evaluation of policies specifically directed to address the inequities of racism, social injustices, and social determinants of health that impact childhood obesity in the United States. Future work needs to identify who was reached by the policy, who benefitted from the policy, and how policies were implemented to address obesity-related health disparities. Nurses should advocate for the evaluation of childhood obesity policies, particularly in underserved populations, to determine effectiveness. Nurses, particularly those trained in population and community health and research, should advocate for policy research that considers inequities rather than controls for these variables. Multi-layered interventions can then be tailored to sub-populations and evaluated more effectively.
Surgical stress results in immune dysfunction, predisposing patients to infections in the postoperative period and potentially increasing the risk of cancer recurrence. Perioperative immunonutrition with arginine-enhanced diets has been found to potentially improve short-term and cancer outcomes. This study seeks to measure the impact of perioperative immunomodulation on biomarkers of the immune response and perioperative outcomes following hepatopancreaticobiliary surgery.
This is a 1:1:1 randomised, controlled and blinded superiority trial of 45 patients. Baseline and perioperative variables were collected to evaluate immune function, clinical outcomes and feasibility outcomes. The primary outcome is a reduction in natural killer cell killing as measured on postoperative day 1 compared with baseline between the control and experimental cohorts.
This trial has been approved by the research ethics boards at participating sites and Health Canada (parent control number: 223646). Results will be distributed widely through local and international meetings, presentation, publication and ClinicalTrials.gov (identifier: NCT04549662). Any modifications to the protocol will be communicated via publications and ClinicalTrials.gov.
ClinicalTrials.gov identifier: NCT04549662.
Providing comprehensible information is essential to the process of valid informed consent. Recruitment materials designed by sponsoring institutions in English-speaking, high-income countries are commonly translated for use in global health studies in other countries; however, key concepts are often missed, misunderstood or ‘lost in translation’. The aim of this study was to explore the language barriers to informed consent, focusing on the challenges of translating recruitment materials for maternal health studies into Zambian languages.
We used a qualitative approach, which incorporated a multistakeholder workshop (11 participants), in-depth interviews with researchers and translators (8 participants) and two community-based focus groups with volunteers from community advisory boards (20 participants). Content analysis was used to identify terms commonly occurring in recruitment materials prior to the workshop. The framework analysis approach was used to analyse interview data, and a simple inductive thematic analysis approach was used to analyse focus group data.
The study was based in Lusaka, Zambia.
The workshop highlighted difficulties in translating research terms and pregnancy-specific terms, as well as widespread concern that current templates are too long, use overly formal language and are designed with little input from local teams. Framework analysis of in-depth interviews identified barriers to participant understanding relating to design and development of recruitment materials, language, local context and communication styles. Focus group participants confirmed these findings and suggested potential solutions to ensure the language and content of recruitment materials can be better understood.
Our findings demonstrate that the way in which recruitment materials are currently designed, translated and disseminated may not enable potential trial participants to fully understand the information provided. Instead of using overly complex institutional templates, recruitment materials should be created through an iterative and interactive process that provides truly comprehensible information in a format appropriate for its intended participants.
Effective health care relies on person-centeredness and teamwork, which are known to improve outcomes. These two concepts have been defined individually, but we could not find a definition of the combined concept. A preliminary definition was developed through a concept analysis; however, consensus on the concept has not been reached.
The aim of this study was to reach consensus on the definition and attributes of person-centered teamwork.
A consensus design allowed experts to collaborate and share their experience and wisdom to refine and reach consensus on the definition and attributes of person-centered teamwork. An e-Delphi was used to engage the experts.
Three rounds of online engagement with 12 experts were needed to reach consensus on the definition and attributes of person-centered teamwork. The attributes reached consensus of 82% after the first round. The definition had 82% consensus after the three rounds. The definition had been adjusted and refined according to the expert input. The newly adjusted definition was established.
We successfully used the e-Delphi method to obtain consensus on the attributes and definition of person-centered teamwork. The definition of person-centered teamwork can be further developed and included in clinical practice to guide improved clinical outcomes. The consensus definition of person-centered teamwork provides a clear understanding of the meaning thereof, which may in turn enrich the usability thereof in clinical practice. Person-centered teams improve outcomes for persons receiving care in hospitals. Building person-centered teams are now better understood and the foundation of building these teams defined. We engaged with 12 experts in the academic and clinical field of person-centeredness and teamwork. The use and value of the Delphi method to obtain consensus is now better understood and can assist future research development.
Oral mucosa is an ideal model for studying scarless wound healing. Researchers have shown that the key factors which promote scarless wound healing already exist in basal state of oral mucosa. Thus, to identify the other potential factors in basal state of oral mucosa will benefit to skin wound healing. In this study, we identified eight gene modules enriched in wound healing stages of human skin and oral mucosa through co-expression analysis, among which the module M8 was only module enriched in basal state of oral mucosa, indicating that the genes in module M8 may have key factors mediating scarless wound healing. Through bioinformatic analysis of genes in module M8, we found IGF2 may be the key factor mediating scarless wound healing of oral mucosa. Then, we purified IGF2 protein by prokaryotic expression, and we found that IGF2 could promote the proliferation and migration of HaCaT cells. Moreover, IGF2 promoted wound re-epithelialization and accelerated wound healing in a full-thickness skin wound model. Our findings identified IGF2 as a factor to promote skin wound healing which provide a potential target for wound healing therapy in clinic.
This study explores the experiences of interprofessional collaboration of Canadian midwives and obstetricians from midwives' perspective.
A concurrent mixed-methods approach that combined a small validation study and qualitative thematic analysis was used to provide evidence of the nature and importance of collaboration between Registered Midwives (RMs) and obstetricians.
Eighteen RMs across Canada completed a demographic survey and the Midwifery-Obstetrician Collaboration (MOC) scale in 2023. The quantitative analyses were conducted to assess the reliability of the Midwifery-Obstetrician Collaboration (MOC) and accumulate preliminary evidence to support its validity. Semi-structured interviews were conducted with 13 participants. After completing the interviews, themes were identified using thematic analysis.
The primary themes identified were knowledge of midwifery scope affects collaboration, collaboration is necessary for effective patient care, midwife-physician collaboration is impacted by power differentials and hierarchies, and proposed methods to improve physician-midwife collaboration. Although a small sample size did not permit extensive statistical testing, the quantitative results supported the reliability of the MOC scale. In addition, a strong correlation between the MOC and the communication subscale of the Inter-Professional Collaboration (IPC) scale provided evidence of the MOC's concurrent validity as a measure of collaboration between midwives and physicians.
This study provides support for the Midwifery-Obstetrics Collaboration (MOC) Scale as an assessment tool to evaluate collaboration between midwives and OB/GYNs in obstetrics care. While the 18 RMs recruited for this study provided a fulsome analysis for the qualitative portion, a larger study is necessary to provide more extensive quantitative analysis to validate the MOC scale for continued use among RMs and OBs.
The implications of this study are to foster strong interprofessional relationships between midwives and OBs and to improve the health outcomes of pregnant women and newborns.
The authors adhered to Consolidated criteria for reporting qualitative research (COREQ).
There is a substantial lack of inter-facility referral systems for emergency obstetrical and neonatal care in rural areas of sub-Saharan Africa. Data on the costs and cost-effectiveness of such systems that reduce preventable maternal and neonatal deaths are scarce.
We aimed to determine the cost-effectiveness of a non-governmental organisation (NGO)-run inter-facility referral system for emergency obstetrical and neonatal care in rural Southern Madagascar by analysing the characteristics of cases referred through the intervention as well as its costs.
We used secondary NGO data, drawn from an NGO’s monitoring and financial administration database, including medical and financial records.
We performed a descriptive and a cost-effectiveness analysis, including a one-way deterministic sensitivity analysis.
1172 cases were referred over a period of 4 years. The most common referral reasons were obstructed labour, ineffective labour and eclampsia. In total, 48 neonates were referred through the referral system over the study period. Estimated cost per referral was US$336 and the incremental cost-effectiveness ratio (ICER) was US$70 per additional life-year saved (undiscounted, discounted US$137). The sensitivity analysis showed that the intervention was cost-effective for all scenarios with the lowest ICER at US$99 and the highest ICER at US$205 per additional life-year saved. When extrapolated to the population living in the study area, the investment costs of the programme were US$0.13 per person and annual running costs US$0.06 per person.
In our study, the inter-facility referral system was a very cost-effective intervention. Our findings may inform policies, decision-making and implementation strategies for emergency obstetrical and neonatal care referral systems in similar resource-constrained settings.
Mental Health Literacy (MHL) is important for improving mental health and reducing inequities in treatment. The Mental Health Literacy Scale (MHLS) is a valid and reliable assessment tool for MHL. This systematic review will examine and compare the measurement properties of the MHLS in different languages, enabling academics, clinicians and policymakers to make informed judgements regarding its use in assessments.
The review will adhere to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology for systematic reviews of patient-reported outcome measures and the Joanna Briggs Institute (JBI) Manual for Evidence Synthesis and will be presented following the Preferred Reporting Items for Systematic reviews and Meta-Analysis 2020 checklist. The review will be conducted in four stages, including an initial search confined to PubMed, a search of electronic scientific databases PsycINFO, CINAHL, Scopus, MEDLINE, Embase (Elsevier), PubMed (NLM) and ERIC, an examination of the reference lists of all papers to locate relevant publications and finally contacting the MHLS original author to identify validation studies that the searches will not retrieve. These phases will assist us in locating studies that evaluate the measurement properties of MHLS across various populations, demographics and contexts. The search will focus on articles published in English between May 2015 and December 2023. The methodological quality of the studies will be evaluated using the COSMIN Risk of Bias checklist, and a comprehensive qualitative and quantitative data synthesis will be performed.
Ethics approval is not required. The publication will be in peer-reviewed journals and presented at national and international conferences.
CRD42023430924.
To explore the role of nutritional support in nursing practice on postoperative surgical site wound healing in patients undergoing surgery at risk for pressure ulcers. This study adopted a retrospective experimental design and included a total of 60 patients at risk of pressure ulcers, divided into a nutritional support group and a control group, with 30 people in each group. The nutritional support group implemented specific nutritional support measures after surgery, while the control group received standard postoperative care. Outcome measures included redness and swelling scores, edema scores, anxiety assessments, pain scores, bleeding volume, recovery time and incidence of pressure ulcers. The result indicates that patients who received nutritional support exhibited lower postoperative wound redness and swelling scores compared to the control group (3.11 ± 0.45 vs. 4.85 ± 0.74, p < 0.05). Additionally, the nutritional support group showed significantly lower edema scores (2.75 ± 0.37 vs. 3.53 ± 0.62, p < 0.05). Anxiety levels, as measured by the anxiety assessment scale (SAS), were also lower in the nutritional support group (6.52 ± 1.19 vs. 7.60 ± 1.62, p < 0.05). Moreover, the average healing time was shorter for the nutritional support group (7.27 ± 1.36 days) compared to the control group (9.71 ± 1.84 days, p < 0.05). Postoperative pain scores were lower in the nutritional support group (4.13 ± 0.72 vs. 5.43 ± 0.62, p < 0.05), and patient satisfaction scores were higher (9.42 ± 0.76 vs. 7.25 ± 0.81, p < 0.05). Nutritional support has a positive effect on postoperative wound healing at surgical sites in patients at risk of pressure ulcers in nursing practice. It can significantly reduce redness, swelling, edema, anxiety, and pain scores, reduce bleeding, shorten recovery time, and reduce pressure ulcers. incidence rate.
Opioid use disorder often co-occurs with chronic pain but assessment and treatment of these co-occurring disorders is complex. This review aims to identify current treatments and delivery models for co-occurring chronic pain and opioid use disorder (OUD) documented in the scientific literature.
Scoping review.
The review was conducted in six databases in June 2022 (no time limit): CINAHL, PsycINFO, Web of Science, Cochrane, PubMed and Embase. The PRISMA-ScR checklist was used to guide reporting.
Forty-seven publications addressing the issue of co-occurring chronic pain and OUD management were included. Randomized controlled trials provide evidence for the effectiveness of opioid agonist treatments (OAT) such as methadone or buprenorphine/naloxone, as well as for combining OAT with Mindfulness-Oriented Recovery Enhancement or cognitive behavioural therapy. A number of other pharmacological treatments (opioid and nonopioid), nonpharmacological treatments (e.g. physiotherapy) and service delivery models (e.g. simultaneous treatment of comorbidities, interdisciplinary and interprofessional collaboration) are also underlined. In most cases, authors recommend a combination of strategies to meet patient needs.
The scoping review reveals gaps in evidence-based knowledge to effectively care for co-occurring chronic pain and OUD, but several experts recommend the uptake of known ‘best’ practices such as integrated treatment of the multiple biopsychosocial dimensions of the co-occurring disorders as well as collaborative interdisciplinary work.
Improving services is dependent on alleviating barriers such as working in silos, the costs associated with nonpharmacological treatments, and the double stigma associated with pain in people with a substance use disorder.
Clinical studies indicate antibiotic bone cement with propeller flaps improves diabetic foot wound repair and reduces amputation rates, but the molecular mechanisms, particularly key proteins' role remain largely unexplored. This study assessed the efficacy of antibiotic bone cement for treating diabetic foot wounds, focusing on molecular impact on ROCK1. Sixty patients were randomized into experimental (EXP, n = 40) and control (CON, n = 20) groups, treated with antibiotic bone cement and negative pressure. Wound healing rate, amputation rate, wound secretion culture and C-reactive protein (CRP) changes, were monitored. Comprehensive molecular investigations were conducted and animal experiments were performed to further validate the findings. Statistical methods were employed to verify significant differences between the groups and treatment outcomes. The EXP group showed significant improvements in wound healing (χ2$$ {\chi}^2 $$ = 11.265, p = 0.004) and reduced amputation rates. Elevated levels of ROCK1, fibroblasts and VGF were observed in the trauma tissue post-treatment in the experimental group compared to pre-treatment and the control group (all p < 0.05). Improved trauma secretion culture and CRP were also noted in the EXP group (all p < 0.05). The study suggests that antibiotic bone cement enhances diabetic foot wound healing, possibly via upregulation of ROCK1. Further research is needed to elucidate the underlying molecular mechanisms and broader clinical implications.
The aim of the study was to establish the feasibility of delivering a structured post-diagnosis information and support program to dyads (persons living with dementia or mild cognitive impairment and family carers) in two primary care settings.
A two-phase explanatory mixed-method approach guided by the Bowen Feasibility Framework focused on acceptability, implementation, adaptation, integration and efficacy of a five-part programme. In phase 1, the quantitative impact of the programme on the dyadic programme recipients' self-efficacy, quality of life, dyadic relationship and volume of care was measured. In phase 2, inductive content analysis focused on nurse and dyad participant experiences of the programme. Quantitative and qualitative data were reviewed to conclude each element of feasibility.
Four registered nurses working within the participating sites were recruited, trained as programme facilitators and supported to deliver the programme. Eligible dyads attending the respective primary health clinics were invited to participate in the programme and complete surveys at three time points: recruitment, post-programme and 3-month follow-up. Post-programme semi-structured interviews were conducted with dyads and programme facilitators.
Twenty-nine dyads completed the program; the majority were spousal dyads. The programme proved acceptable to the dyads with high retention and completion rates. Implementation and integration of the programme into usual practice were attributed to the motivation and capacity of the nurses as programme facilitators. Regarding programme efficacy, most dyads reported they were better prepared for the future and shared the plans they developed during the programme with family members.
Implementing a structured information and support programme is feasible, but sustainability requires further adaptation or increased staff resources to maintain programme fidelity. Future research should consider selecting efficacy measures sensitive to the unique needs of people living with dementia and increasing follow-up time to 6 months.
This study established the feasibility of registered nurses delivering a post-diagnosis information and support programme for people living with early-stage dementia or mild cognitive impairment and their informal carers in primary care settings. The motivation and capacity of nurses working as programme facilitators ensured the integration of the programme into usual work, but this was not considered sustainable over time. Family carer dyads reported tangible outcomes and gained confidence in sharing their diagnosis with family and friends and asking for assistance. Findings from this study can be used to provide direction for a clinical trial investigating the effectiveness of the structured information and support programme in the primary care setting.
The authors have adhered to the EQUATOR STROBE Statement.
A public hospital memory clinic and general medical practice participated in project design, study protocol development and supported implementation.
An estimated 20% of emergency department (ED) patients require respiratory support (RS). Evidence suggests that nasal high flow (NHF) reduces RS need.
This review compared NHF to conventional oxygen therapy (COT) or noninvasive ventilation (NIV) in adult ED patients.
The systematic review (SR) and meta-analysis (MA) methods reflect the Cochrane Collaboration methodology. Six databases were searched for randomized controlled trials (RCTs) comparing NHF to COT or NIV use in the ED. Three summary estimates were reported: (1) need to escalate care, (2) mortality, and (3) adverse events (AEs).
This SR and MA included 18 RCTs (n = 1874 participants). Two of the five MA conclusions were statistically significant. Compared with COT, NHF reduced the risk of escalation by 45% (RR 0.55; 95% CI [0.33, 0.92], p = .02, NNT = 32); however, no statistically significant differences in risk of mortality (RR 1.02; 95% CI [0.68, 1.54]; p = .91) and AE (RR 0.98; 95% CI [0.61, 1.59]; p = .94) outcomes were found. Compared with NIV, NHF increased the risk of escalation by 60% (RR 1.60; 95% CI [1.10, 2.33]; p = .01); mortality risk was not statistically significant (RR 1.23, 95% CI [0.78, 1.95]; p = .37).
Evidence-based decision-making regarding RS in the ED is challenging. ED clinicians have at times had to rely on non-ED evidence to support their practice. Compared with COT, NHF was seen to be superior and reduced the risk of escalation. Conversely, for this same outcome, NIV was superior to NHF. However, substantial clinical heterogeneity was seen in the NIV delivered. Research considering NHF versus NIV is needed. COVID-19 has exposed the research gaps and slowed the progress of ED research.
To determine the effectiveness of brief reminiscence-based psychosocial interventions in alleviating psychological distress in cancer patients.
Cancer patients suffer tremendous psycho-spiritual pain, which affects their quality of life. Brief reminiscence-based psychosocial interventions have demonstrated positive effects on the mental health of cancer patients; however, the efficacy of these interventions has been inconsistent.
A systematic review and meta-analysis.
This review was conducted and reported in accordance with the PRISMA 2020 checklist provided by the EQUATOR network. The Cochrane Library, Web of Science, PsycINFO, PubMed, Embase, CINAHL and Scopus databases were systematically searched from inception to 27 November 2022 to identify randomised controlled trials (RCTs) published in English.
Twenty studies involving 1744 cancer participants were included. The meta-analysis showed statistically significant effects of brief reminiscence-based psychosocial interventions on hope, anxiety and depression at post-intervention. A separate analysis revealed that brief reminiscence-based psychosocial interventions had a sustainable effect on hope, spiritual well-being, anxiety and depression at 1 month after the intervention. However, no statistically significant effect on quality of life was found in our study either immediately after the intervention or at 1 month.
Brief reminiscence-based psychosocial interventions can significantly reduce anxiety and depressive symptoms and improve hope and spiritual well-being in cancer patients.
This study further supports that brief reminiscence-based psychosocial interventions should be incorporated into the routine care of cancer patients to address their psychosocial distress.
All authors of this article contributed to the study conception and design. All authors of the included studies provided original data for this paper.
To assess the creative potential of surgeons and surgeon trainees, as measured by divergent thinking. The secondary objectives were to identify factors associated with divergent thinking, assess confidence in creative problem-solving and the perceived effect of surgical training on creative potential, and explore the value of creativity in surgery.
We used a mixed-methods design, conducting a survey of divergent thinking ability using a validated questionnaire followed by two semi-structured interviews with top-scoring participants.
Surgeons and surgeon trainees in the Department of Surgery at McMaster University.
The primary outcome was divergent thinking, assessed with the Abbreviated Torrance Test for Adults. Participants also self-assessed their confidence in creative problem-solving and the effect of surgical training on their creative potential. We performed descriptive analyses and multivariable linear regression to identify factors associated with divergent thinking. We conducted a thematic analysis of the interview responses.
82 surgeons and surgeon trainees were surveyed; 43 were junior trainees and 28 were senior trainees. General surgery, orthopaedic surgery and plastic surgery represented 71.9% of the participants. The median participant age was 28 years (range 24–73), 51.2% of whom were female. Participants demonstrated levels of divergent thinking that were higher but not meaningfully different from the adult norm (62.39 (95% CI 61.25, 63.53), p
The divergent thinking ability among surgeons and surgeon trainees was not meaningfully different from the adult normative score; however, their ability to generate original ideas was below average.
Satisfactory management of acute pain remains a major medical challenge despite the availability of multiple therapeutic options including the fixed-dose combination (FDC) drugs. Tramadol and dexketoprofen trometamol (TRAM/DKP) 75/25 mg FDC was launched in 2018 in Asia and is widely used in the management of moderate to severe acute pain. There are limited data on its effectiveness and safety in Asian patients, and therefore, a need to better understand its usage patterns in clinical practice. We aim to understand the usage pattern of TRAM/DKP FDC, its effectiveness and tolerability in patients with moderate to severe acute pain in Asia.
REKOVER is a phase-IV, multicountry, multicentre, prospective, real-world observational study. A total of 750 postsurgical and non-surgical patients (male and female, aged 18–80 years) will be recruited from 13 tertiary-care hospitals (15 sites) in Singapore, Thailand, the Philippines and Malaysia. All patients prescribed with TRAM/DKP FDC and willing to participate in the study will be enrolled. The recruitment duration for each site will be 6 months. The severity of pain will be collected using Numeric Pain Rating Scale through the treatment period from day 1 to day 5, while satisfaction with the treatment will be evaluated using Patient Global Evaluation Scale at the end of treatment. Any adverse event reported during the study duration will be recorded for safety analysis (up to day 6). The study data will be entered into the ClaimIt portal and mobile application (app) (ObvioHealth, USA). All the inpatient data will be entered into the portal by the study site and for outpatient it will be done by patients through an app.
The study has been approved by the local ethics committee from each study sites in Singapore, Thailand, the Philippines and Malaysia. Findings will be disseminated through local and global conference presentations, publications in peer-reviewed scientific journals and continuing medical education.
Schizophrenia is a chronic condition, of which the diagnosis and management require comprehensive care. The role mental health nurses play in this management cannot be overemphasised. In an effort to give their best, several challenges confront them which need to be sought and addressed. This study aimed to explore the factors that influence the management of schizophrenia by mental health nurses in the Upper East Region.
A descriptive phenomenology design was used in this study. Individual in-depth interviews were conducted among 18 purposively sampled mental health nurses using a semistructured interview guide. Audio-recorded interviews were transcribed verbatim and analysed thematically using Colaizzi’s approach.
The study was conducted in five primary and secondary-level health facilities in the Upper East Region of Ghana.
Five themes were deduced from the theoretical framework, which were as follows: individual factors, interpersonal factors, organisational factors, community-level factors, and policy-level factors. At the individual level, factors such as the condition of the patient at presentation, medication side effects, inadequate knowledge, and poor adherence were identified. Interpersonal factors identified were poor communication, lack of mutual respect, and poor communication, while organisational factors such as inadequate staff, inadequate infrastructure and logistics, and unavailability of antipsychotics were reported. Moreover, the study identified community-level factors such as stigma and cultural beliefs, while policy-level factors such as laws regarding suicide, patient rights, and non-inclusion of mental health services into the National Health Insurance Scheme were reported as factors influencing the management of schizophrenia by mental health nurses.
Addressing these factors is essential to ensure sustainable improvements and the effective management of schizophrenia. It is imperative to consider these factors when designing interventions and policies to optimise the management of schizophrenia by mental health nurses in Ghana.
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.
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