[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100531227":3},{"organization":4,"outcomesModule":7,"designInfo":47,"detailedDescription":54,"studyPopulation":40,"armGroups":40,"interventions":55,"overallOfficials":40,"centralContacts":60,"locations":70,"responsibleParty":108,"collaborators":110,"id":113,"slug":40,"hasResults":114,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":40,"eligibilityCriteria":118,"healthyVolunteers":114,"sex":119,"minAge":120,"maxAge":40,"enrollmentInfo":121,"targetDuration":40,"studyType":124,"phases":125,"briefSummary":127,"conditions":128,"keywords":133,"overallStatus":73,"whyStopped":40,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},{"fullName":5,"class":6},"Vestre Viken Hospital Trust","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":40},[9],{"measure":10,"description":11,"timeFrame":12},"Non-HDL cholesterol","HDL-cholesterol - total cholesterol, biochemical test","6 weeks",[14,17,19,21,23,25,27,29,31,33,36,38,41,44],{"measure":15,"description":16,"timeFrame":12},"total cholesterol","biochemical test",{"measure":18,"description":16,"timeFrame":12},"HDL-cholesterol",{"measure":20,"description":16,"timeFrame":12},"Triglycerids",{"measure":22,"description":16,"timeFrame":12},"HbA1c",{"measure":24,"description":16,"timeFrame":12},"ALT AST\u002FALT AST\u002FALT",{"measure":26,"description":16,"timeFrame":12},"fasting glucose",{"measure":28,"description":16,"timeFrame":12},"Vitamin D",{"measure":30,"description":16,"timeFrame":12},"Folate",{"measure":32,"description":16,"timeFrame":12},"LDL-cholesterol",{"measure":34,"description":35,"timeFrame":12},"Weight","anthropometric measurement",{"measure":37,"description":35,"timeFrame":12},"waist circumference",{"measure":39,"description":40,"timeFrame":12},"Bloodpressure",null,{"measure":42,"description":43,"timeFrame":12},"24-hour dietary recall","interview",{"measure":45,"description":46,"timeFrame":12},"Food frequency questionnaire","questionnaire",{"allocation":48,"interventionModel":49,"interventionModelDescription":50,"primaryPurpose":51,"observationalModel":40,"timePerspective":40,"maskingInfo":52},"RANDOMIZED","PARALLEL","the included patients will be randomized into two groups: one croup will receive nutritional counseling, while the other does not. All the participants will complete baseline and post-intervention measurements consisting of: mapping of diet, anthropometric measurements (weight, height, waist measurement), bloodpressure, biochemical measurements (total cholesterol, non-HDL cholesterol, LDL cholesterol, triglycerides, vitamin D, ferritin, fasting glucose, HbA1c, folate and AST\u002FALT. Then the two groups will be compared to reveal any differences.","PREVENTION",{"masking":53,"maskingDescription":40,"whoMasked":40},"NONE","People with severe mental illness have a shorter life expectancy compared to the general population. Individuals with schizophrenia or bipolar affective disorder have an estimated reduce life expectancy by an average of 10-20 years. Increased mortality is caused by many factors, but cardiovascular diseases contributes the most. Increased prevalence of cardiovascular disease is mainly due to a poor lifestyle, which includes smoking, physical inactivity and an unhealthy diet.\n\nIt is important to find treatment that can provide better quality of life and longer life expectancy in these patient groups. Few clinical studies have been conducted on the effect of nutritional counseling on biochemical and anthropometric measurements related to cardiovascular diseases. Therefore, we want to investigate this through a randomized controlled trial.",[56],{"type":57,"name":58,"description":59,"armGroupLabels":40,"otherNames":40},"BEHAVIORAL","Nutritional counseling","The intervention group will recieve 30 x 2 minutes with nutritonal counseling seperatet by a 15 minutes break. The participants will receive individually tailored guidance based on the information recieved at baseline measurments.\n\nThe couseling will be based on the Norwegian goverments dietary advices and the recommendation from the Directorate of Health for the prevention of cardiovascular diseases.",[61,66],{"name":62,"role":63,"phone":64,"phoneExt":40,"email":65},"Dawn E Peleikis, phD","CONTACT","+4799405812","dawn.peleikis@vestreviken.no",{"name":67,"role":63,"phone":68,"phoneExt":40,"email":69},"Camilla N Myrdal, Master","+4794814040","camilla.myrdal@studmed.uio.no",[71,84],{"facility":72,"status":73,"city":74,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":40,"geoPoint":40,"contacts":79},"Vestre Viken Health Trust","RECRUITING","Drammen","Akershus","3004","Norway","NO",[80],{"name":81,"role":63,"phone":82,"phoneExt":40,"email":83},"Siri Bråthen, MSc","+4745226100","sibraa@vestreviken.no",{"facility":85,"status":73,"city":74,"state":40,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":86,"geoPoint":91,"contacts":92},"Department of Research and Delvelopment, Mental health and Addiction, Vestre Viken Hospital Trust",{"type":87,"coordinates":88},"Point",[89,90],10.20449,59.74389,{"lat":90,"lon":89},[93,97,100,103,105],{"name":94,"role":63,"phone":95,"phoneExt":40,"email":96},"Wenche Ryberg, phd","004732803000","wenche.ryberg@vestreviken.no",{"name":98,"role":63,"phone":40,"phoneExt":40,"email":99},"Monica strand, phd","monica.strand@vestreviken.no",{"name":101,"role":102,"phone":40,"phoneExt":40,"email":40},"Roar Fosse, phd","SUB_INVESTIGATOR",{"name":104,"role":102,"phone":40,"phoneExt":40,"email":40},"Strand Monica, phd",{"name":106,"role":107,"phone":40,"phoneExt":40,"email":40},"Ryberg Wenche, phd","PRINCIPAL_INVESTIGATOR",{"type":109,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR",[111],{"name":112,"class":6},"University of Oslo","100531227",false,"NCT06197048","Effect of Nutritional Counseling on Anthropometry and Biomarkers in Patients Diagnosed With Schizophrenia\u002FPsychosis or Bipolar Affective Disorder","A Randomized Controlled Trial on the Effect of Nutritional Counseling on Anthropometry and Biomarkers in Patients Diagnosed With Schizophrenia\u002FPsychosis or Bipolar Affective Disorder Treated at Asker DPS as Outpatients or Inpatients at Blakstad Hospital","Inclusion Criteria:\n\n* \\> 18 years\n* Diagnosed with either schizophrenia\u002Fpsychosis or bipolar affective disorder\n* Patients treatet in Vestre Viken healthcare company, at either Asker district psychiatric center or Blakstad hospital\n\nExclusion Criteria:\n\n* none","ALL","18 Years",{"count":122,"type":123},40,"ESTIMATED","INTERVENTIONAL",[126],"NA","The goal of this clinical trial is to compare the effect of nutritional counseling versus no treatment in patients with schizophenia or bipolar affective disorder.\n\nThe main question it aims to answer are:\n\n• Can nutritional counseling have a preventive effect on the development of cardiovascular disease in patients with schizophenia or bipolar affective disorder?\n\nParticipants will meet a nutritionist at baseline to asess nutritional status, biochemical and anthropometric measurements. Then, half of the study population will receive nutritional counseling. After six weeks, the same baseline measurements will be repeated to examine any potential differences between the two groups. After the intervention, the control group will be offered the same counseling as the intervention group received during the study.",[129,130,131,132],"Cardiovascular Diseases","Schizophrenia","Psychosis","Bipolar Disorder",[134,58,135,130,136,137],"Severe mental disorders","Cardiovascular disease","Bipolar affective disorder","Randomzied controlled trial","2024-01-08",{"date":140,"type":141},"2024-01-09","ACTUAL",{"date":143,"type":141},"2023-09-25",{"date":145,"type":123},"2028-12-01",{"name":5,"class":6},2]