Effect of Nutritional Counseling on Anthropometry and Biomarkers in Patients Diagnosed With Schizophrenia/Psychosis or Bipolar Affective Disorder
- Sponsor
- Vestre Viken Hospital Trust
- Study ID
- NCT06197048
- Status
- Recruiting
Conditions
- Bipolar Disorder
- Cardiovascular Diseases
- Psychosis
- Schizophrenia
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Nutritional counseling — BEHAVIORALThe 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. The couseling will be based on the Norwegian goverments dietary advices and the recommendation from the Directorate of Health for the prevention of cardiovascular diseases.
Study Details
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. The main question it aims to answer are: • Can nutritional counseling have a preventive effect on the development of cardiovascular disease in patients with schizophenia or bipolar affective disorder? Participants 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.
Key Dates
- First listed
- Jan 9, 2024
- Start date
- Sep 25, 2023
- Status verified
- Dec 2023
- Primary completion
- May 15, 2024
- Completion
- Dec 1, 2028
Study Design
- Enrollment
- 40 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Primary Outcome Measure
Non-HDL cholesterol [ Time Frame: 6 weeks ]
Central Contacts
- Dawn E Peleikis, phD+4799405812
- Camilla N Myrdal, Master+4794814040
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