[{"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 in the trial by the clinical investigation team member based on factors that may affect the ability to participate safely and reliably. These factors may include, but are not limited to, physical disabilities that hinder participation or practical challenges such as long travel distances to the trial site. The assessment is made on an individual basis and aims to ensure both 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},644,"ESTIMATED","INTERVENTIONAL",[135],"NA","Cardiometabolic diseases are prevalent among individuals with psychotic disorders, significantly contributing to their shorter lifespan, reduced quality of life, and economic impact on individuals and society. To improve cardiometabolic health, effective and individualized interventions are crucial. Psychosis outpatient clinics are ideal for these interventions due to regular patient visits and the availability of diverse health professionals. The investigators have developed and want to test a comprehensive intervention program to improve cardiometabolic health, enhance quality of life, and promote healthy lifestyles specifically for people with psychotic disorders at psychiatric outpatient clinics in Gothenburg.\n\nThis clinical trial aims to include 644 individuals with psychotic disorders from six outpatient clinics in the Department of Psychotic Disorders at Sahlgrenska University Hospital in Gothenburg. Two outpatient clinics will provide the LAGOM-intervention, while the other clinics will serve as controls, offering \"care as usual\". The intervention group will receive multidisciplinary support integrated into the routine clinical procedures. The intervention includes regular follow-ups and use of motivational tools, including body composition analyzer and cardiovascular risk prediction algorithm (QRISK3).\n\nIf the intervention effectively improves cardiometabolic health, enhances quality of life for this vulnerable group, and proves cost-effective, it can serve as a model program for implementation in Region Västra Götaland.",[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","2025-12-01",{"date":152,"type":153},"2025-12-09","ACTUAL",{"date":155,"type":153},"2025-02-27",{"date":157,"type":132},"2029-12-31",{"name":5,"class":6},6]