[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576169":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":25,"locations":31,"responsibleParty":115,"collaborators":117,"id":120,"slug":121,"hasResults":122,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":122,"sex":128,"minAge":129,"maxAge":12,"enrollmentInfo":130,"targetDuration":12,"studyType":133,"phases":134,"briefSummary":136,"conditions":137,"keywords":139,"overallStatus":34,"whyStopped":12,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},{"fullName":5,"class":6},"Vastra Gotaland Region","OTHER_GOV",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Control clinics (usual care)","NO_INTERVENTION","The \"usual care\" model in Gothenburg includes annual health checks for individuals with psychotic disorders. Patients attend two 60-minute visits for assessments such as blood tests, blood pressure, and weight checks, with results evaluated using standard benchmarks or risk algorithms like SCORE2. Physicians may suggest referrals to primary care or recommend lifestyle changes, including diet, exercise, or substance use adjustments. Identified issues may prompt simple advice or referrals to health promoters for support with smoking cessation, dietary guidance, or group activities.\n\nThe 36 ± 6-month clinical trial standardizes data collection at four outpatient clinics without altering care. Eligible patients sign consent, with rescreening allowed if a patient meets the exclusion criteria at one annual check but not at the next. Non-participants continue with regular care.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Intervention Clinics","EXPERIMENTAL","The annual health checks for the intervention group follow the same structure of two visits as in routine care as usual, with the primary difference being the content of the visits.",[18],"Other: Intervention",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"OTHER","Intervention","The intervention group follows a structured flowchart for annual health check-ups, focusing on assessing the cardiometabolic profile, considering sex and ethnicity. This assessment includes tracking changes in cardiometabolic parameters, alongside overall cardiometabolic risk using SCORE2 and if the criteria for metabolic syndrome are met.\n\nLifestyle habits are evaluated based on health status, illness, and benefits of quitting unhealthy behaviors. Education sessions educate participants and families on the link between psychotic disorders, lifestyle choices, and cardiometabolic health.\n\nGradual lifestyle changes are tailored to individual needs, addressing stress and cognitive challenges, and follow national health guidelines with personalized advice and motivational tools. Regular follow-ups assess progress, while motivational tools \"body composition analyzer and QRISK3\" enhance engagement. Contact with internal and external resources is based on the assessment and motivational work.",[14],[26],{"name":27,"role":28,"phone":29,"phoneExt":12,"email":30},"Hemen Najar, M.D., Ph.D.","CONTACT","0046 73 566 15 64","hemen.najar@vgregion.se",[32,52,64,76,88,100],{"facility":33,"status":34,"city":35,"state":12,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Psykosmottagning Centrum","RECRUITING","Gothenburg","411 13","Sweden","SE",{"type":40,"coordinates":41},"Point",[42,43],11.96679,57.70716,{"lat":43,"lon":42},[46,50],{"name":47,"role":28,"phone":48,"phoneExt":12,"email":49},"Eva Andreasson","0046 70 242 67 97","evaandreasson17@gmail.com",{"name":47,"role":51,"phone":12,"phoneExt":12,"email":12},"PRINCIPAL_INVESTIGATOR",{"facility":53,"status":34,"city":35,"state":12,"zip":54,"country":37,"countryCode":38,"cosmosGeoPoint":55,"geoPoint":57,"contacts":58},"Psykosmottagning Nordost","415 05",{"type":40,"coordinates":56},[42,43],{"lat":43,"lon":42},[59,63],{"name":60,"role":28,"phone":61,"phoneExt":12,"email":62},"Elin Saari-Bladmyr","0046 70 355 13 57","elin.bladmyr@vgregion.se",{"name":60,"role":51,"phone":12,"phoneExt":12,"email":12},{"facility":65,"status":34,"city":35,"state":12,"zip":66,"country":37,"countryCode":38,"cosmosGeoPoint":67,"geoPoint":69,"contacts":70},"Psykosmottagning Öster","416 72",{"type":40,"coordinates":68},[42,43],{"lat":43,"lon":42},[71,75],{"name":72,"role":28,"phone":73,"phoneExt":12,"email":74},"Lina Klysing","0046 72 145 83 73","lina.persson@vgregion.se",{"name":72,"role":51,"phone":12,"phoneExt":12,"email":12},{"facility":77,"status":34,"city":35,"state":12,"zip":78,"country":37,"countryCode":38,"cosmosGeoPoint":79,"geoPoint":81,"contacts":82},"Psykosmottagning Hisingen","417 52",{"type":40,"coordinates":80},[42,43],{"lat":43,"lon":42},[83,87],{"name":84,"role":28,"phone":85,"phoneExt":12,"email":86},"Christina Hagberg","0046 73 660 14 18","christina.i.hagberg@vgregion.se",{"name":84,"role":51,"phone":12,"phoneExt":12,"email":12},{"facility":89,"status":34,"city":35,"state":12,"zip":90,"country":37,"countryCode":38,"cosmosGeoPoint":91,"geoPoint":93,"contacts":94},"Psykosmottagning Väster","421 48",{"type":40,"coordinates":92},[42,43],{"lat":43,"lon":42},[95,99],{"name":96,"role":28,"phone":97,"phoneExt":12,"email":98},"Caroline Holmbom","0046 76 949 43 08","caroline.e.larsson@vgregion.se",{"name":96,"role":51,"phone":12,"phoneExt":12,"email":12},{"facility":101,"status":34,"city":102,"state":12,"zip":103,"country":37,"countryCode":38,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Psykosmottagning Mölndal","Mölndal","431 35",{"type":40,"coordinates":105},[106,107],12.01378,57.6554,{"lat":107,"lon":106},[110,114],{"name":111,"role":28,"phone":112,"phoneExt":12,"email":113},"Erik Wålinder","0046 76 940 29 76","erik.walinder@vgregion.se",{"name":111,"role":51,"phone":12,"phoneExt":12,"email":12},{"type":116,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR",[118],{"name":119,"class":21},"The Swedish Society of Medicine","100576169","improving-heart-and-metabolic-health-in-people-with-severe-mental-illness-through-a-long-term-clinical-trial-100576169",false,"NCT06781801","Improving Heart and Metabolic Health in People With Severe Mental Illness Through a Long-term Clinical Trial","Longitudinal Approach to Generate Positive Cardiometabolic Health Outcomes in Severe Mental Illness","LAGOM","Inclusion criteria\n\n1. Adults ≥18 years of age meeting the International Classification of Diseases, Tenth Revision (ICD-10) diagnostic criteria for any one of the schizophrenia spectrum disorders (F20-F25 or F28-F29)\n2. Ability to provide informed consent\n\nExclusion criteria\n\n1. Having an electrical medical implant such as a pacemaker or other mechanical implants\n2. Pregnancy\n3. Deemed unsuitable by the investigator: A person may be deemed unsuitable for participation if circumstances prevent safe or reliable participation in the trial. Examples include inability or unwillingness to maintain contact with the clinic (e.g., absence of a stable address or telephone number), planned relocation or transfer to another treatment facility, municipality, or country during the trial period, mobility limitations or other practical barriers preventing attendance at clinic visits, or administrative restrictions preventing appropriate documentation in medical records or trial databases (e.g., protected or anonymous identity status). Such decisions are made on an individual basis in consultation with the clinical team (case manager (CM), treating psychiatrist, and site principal investigator (PI)) to ensure patient safety and trial integrity.\n4. Prior participation in the LAGOM trial during a previous inclusion cycle (i.e., participants can only be included once during the trial period).\n5. Currently under compulsory care.","ALL","18 Years",{"count":131,"type":132},650,"ESTIMATED","INTERVENTIONAL",[135],"NA","Background Cardiometabolic conditions-including cardiovascular disease, type 2 diabetes, and obesity-are highly prevalent among individuals with psychotic disorders. These conditions contribute substantially to reduced life expectancy, diminished quality of life, and increased societal and economic burdens. Thus, effective, individualized interventions are urgently needed. Outpatient psychiatric clinics offer an ideal setting for such efforts owing to regular patient contact and access to multidisciplinary care. We have developed a comprehensive, clinically integrated trial aimed at improving cardiometabolic health, promoting healthier lifestyles, and enhancing quality of life for individuals with psychotic disorders receiving care in the Greater Gothenburg region.\n\nMethods LAGOM is a multicenter, naturalistic, quasi-experimental case-control trial conducted across six geographically separate outpatient psychosis clinics within the Department of Psychotic Disorders at Sahlgrenska University Hospital, a multi-site university hospital in the Greater Gothenburg region. A total of 650 adults with psychotic disorders will be recruited from these clinics. Two clinics will implement the LAGOM intervention, whereas four will serve as control sites delivering usual care. The intervention is embedded within routine psychiatric care and grounded in behavioral science. It includes comprehensive cardiometabolic risk assessments, two visual motivational tools (QRISK3 and a body composition analyzer), personalized follow-up plans, risk-oriented referrals to primary care, and structured education for patients, relatives, and staff. The intervention is designed to be scalable, sustainable, and tailored to individual patient needs.\n\nDiscussion If proven superior to usual care, this pragmatic, multicomponent intervention-delivered within routine psychiatric care-could improve cardiometabolic health and quality of life for individuals with psychotic disorders. Embedding the intervention within existing clinical structures enhances its scalability and feasibility and, if effective, could serve as a model for wider implementation.",[138],"Psychotic Disorders",[140,141,142,143,144,145,146,147,148,149],"Psychotic disorders","Quality of life","Cost-effectiveness","Cardiometabolic risk factors","Cardiovascular disease prevention","Metabolic syndrome","Pragmatic clinical trial","Integrated health care","Multicomponent intervention","Behavior change intervention","2026-08-06",{"date":152,"type":153},"2026-08-11","ACTUAL",{"date":155,"type":153},"2025-02-27",{"date":157,"type":132},"2029-12-31",{"name":5,"class":6},6]