[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599548":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":31,"locations":40,"responsibleParty":58,"collaborators":18,"id":62,"slug":18,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":18,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":89,"overallStatus":43,"whyStopped":18,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"University of Oslo","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Lifestyle Intervention","EXPERIMENTAL","Participants in this arm receive a 6-month lifestyle program in addition to usual mental health care. The intervention includes monthly individual sessions with a clinical dietitian, omega-3 supplementation, monthly group-based physical activity sessions led by an instructor, and support to follow a personalized training plan.",[13],"Behavioral: Lifestyle Intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","NO_INTERVENTION","Participants in this arm receive treatment as usual (TAU) in mental health care. After the 6-month study period, they are offered the same lifestyle program without data collection, for ethical reasons.",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"BEHAVIORAL","The Lifestyle Program consists of monthly one-on-one dietary counselling sessions with a registered clinical dietitian, monthly group-based physical activity sessions led by an instructor, and support to follow a personalized exercise plan. The intervention focuses on cardioprotective dietary changes, weight reduction, and increasing physical activity at moderate-to-high intensity to meet recommended amount. Participants will receive dietary supplementation corresponding to a therapeutic dose of 1000 mg EPA+DHA per day from fish oil. During monthly visits with the dietitian, data will be collected to monitor progress and support adherence. Participants will be encouraged to monitor body weight at home between visits (bathroom scales are loaned as needed), and follow up is carried out biweekly via phone-calls. The intervention is designed to be feasible within routine mental health care and tailored to the needs of adults with severe mental illness.",[9],[25,26],"Dietary Counselling and Exercise","Lifestyle Program",[28],{"name":29,"affiliation":5,"role":30},"Professor Kjetil Retterstøl, Professor, MD","PRINCIPAL_INVESTIGATOR",[32,37],{"name":33,"role":34,"phone":35,"phoneExt":18,"email":36},"Madeleine E Angelsen, M.Sc. Clinical Nutrition","CONTACT","+4747234028","m.e.angelsen@studmed.uio.no",{"name":29,"role":34,"phone":38,"phoneExt":18,"email":39},"+47 90098393","kjetil.retterstol@medisin.uio.no",[41],{"facility":42,"status":43,"city":44,"state":18,"zip":45,"country":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Department for nutrition science, Domus Medica, University of Oslo","RECRUITING","Oslo","0372","Norway",{"type":48,"coordinates":49},"Point",[50,51],10.74609,59.91273,{"lat":51,"lon":50},[54,57],{"name":55,"role":34,"phone":56,"phoneExt":18,"email":36},"Madeleine E Angelsen, Ph.D candidate","47234028",{"name":29,"role":30,"phone":18,"phoneExt":18,"email":18},{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"SPONSOR_INVESTIGATOR","Madeleine Elisabeth Angelsen","PhD Fellow under the supervision of Professor Kjetil Retterstøl","100599548",false,"NCT07085923","Norwegian Mental Illness Heart Health Study","Dietary Counselling And Exercise To Combat Cardiovascular Disease Risk In Norwegian Patients With A Severe Mental Illness","NORMI-Heart","Inclusion Criteria:\n\n* Diagnosis of F20-29 (schizophrenia spectrum) or F31 (bipolar affective disorder)\n* Current use of antipsychotic medication (first- or second generation) or lithium\n* Body Mass Index \\> or = 27 kg\u002Fm\\^2\n\nExclusion Criteria:\n\nPsychiatric condition:\n\n* Inability to provide informed consent\\*\n* Acute psychiatric crisis\\*\n* Significant cognitive impairment\\* \\*These criteria will be evaluated and confirmed by the participant's primary mental health care provider before enrollment\n\nMedication initiated during the intervention period:\n\n* GLP-1 receptor agonists\n* Antihypertensive medication\n* Antidiabetic medication\n* Lipid-lowering medication\n\nAlcohol consumption:\n\n-More than 14 units per week (men) or more than 7 units per week (women)\n\nSomatic conditions:\n\n* Type 1 diabetes\n* Established cardiovascular disease\n* Body Mass Index (BMI) \\\u003C27 kg\u002Fm²\n* Pregnancy\n* Inability to perform physical exercise\n\nSomatic risk findings at baseline:\n\n* HbA1c \\>57 mmol\u002Fmol (7.4%)\n* LDL cholesterol \\>5.0 mmol\u002FL\n* Blood pressure \\>180\u002F100 mmHg\n* Active malignant disease",true,"ALL","25 Years","70 Years",{"count":74,"type":75},70,"ESTIMATED","INTERVENTIONAL",[78],"NA","Norwegian patients with severe mental illnesses (SMI), such as schizophrenia spectrum or bipolar disorder, lose on average 10 years of life compared to mentally healthy individuals. Much of this gap is due to heart disease. Unhealthy lifestyle habits, including poor diet and physical inactivity, contribute to higher levels of metabolic risk factors for heart disease in this population.\n\nThe goal of this clinical trial is to find out if a lifestyle program including dietary counselling and regular physical exercise can help people with SMI to improve their physical and mental health.\n\nThe main questions it aims to answer are:\n\n* Does adherence to a healthy lifestyle program lead to reduced estimated risk of heart disease?\n* Does it change lifestyle habits, body weight and composition, and metabolic risk markers over six months?\n* Can participants with severe mental illness complete a healthy lifestyle program, and do they find it acceptable?\n\nResearchers will compare two groups: one that receives the lifestyle program in addition to regular mental health care, and one that receives regular care only.\n\nDuring the six month program, participants in the lifestyle group will:\n\n* Meet with a clinical dietitian once a month for dietary counselling\n* Take part in group-based physical activity sessions once a month, and receive support to follow a personal training plan\n\nAround 70 adults will take part in the study. The results may help improve the way lifestyle support is offered to people living with severe mental illness and inform health care providers about strategies to improve physical health in this vulnerable group.",[81,82,83,84,85,86,87,88],"Cardio Vascular Disease","Metabolic Syndrome (MetS)","Severe Mental Disorder","Schizophrenia and Schizophrenia Spectrum Psychosis","Bipolar Disease Type I","Overweight and\u002For Obesity","CVD Risk Factors","Severe Mental Illness",[88,90,9,91,92,93,94,95,96,97,98],"Cardiovascular Disease","Healthy Diet","Exercise","CVD-risk","Schizophrenia","Antipsychotic Medication","Bipolar Disorder","Non-pharmacological intervention","Clinical Dietitian","2025-09-26",{"date":101,"type":102},"2025-10-02","ACTUAL",{"date":104,"type":102},"2025-09-16",{"date":106,"type":75},"2028-06-30",{"name":60,"class":6},1]