Bipolar Disorder, Cardiovascular Diseases, Psychosis, Schizophrenia
Conditions
Keywords
Severe mental disorders, Nutritional counseling, Cardiovascular disease, Schizophrenia, Bipolar affective disorder, Randomzied controlled trial
Brief summary
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.
Detailed description
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. It 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.
Interventions
BEHAVIORALNutritional 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. 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.
Sponsors
University of Oslo
Vestre Viken Hospital Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
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/ALT. Then the two groups will be compared to reveal any differences.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \> 18 years * Diagnosed with either schizophrenia/psychosis or bipolar affective disorder * Patients treatet in Vestre Viken healthcare company, at either Asker district psychiatric center or Blakstad hospital
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Non-HDL cholesterol | 6 weeks | HDL-cholesterol - total cholesterol, biochemical test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| total cholesterol | 6 weeks | biochemical test |
| HDL-cholesterol | 6 weeks | biochemical test |
| Triglycerids | 6 weeks | biochemical test |
| HbA1c | 6 weeks | biochemical test |
| ALT AST/ALT AST/ALT | 6 weeks | biochemical test |
| fasting glucose | 6 weeks | biochemical test |
| Food frequency questionnaire | 6 weeks | questionnaire |
| Folate | 6 weeks | biochemical test |
| LDL-cholesterol | 6 weeks | biochemical test |
| Weight | 6 weeks | anthropometric measurement |
| waist circumference | 6 weeks | anthropometric measurement |
| Bloodpressure | 6 weeks | — |
| 24-hour dietary recall | 6 weeks | interview |
| Vitamin D | 6 weeks | biochemical test |
Countries
Norway
Contacts
Primary ContactDawn E Peleikis, phD
Backup ContactCamilla N Myrdal, Master
Outcome results
None listed