Effect of Nutritional Counseling on Anthropometry and Biomarkers in Patients Diagnosed With Schizophrenia/Psychosis or Bipolar Affective Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nutritional counseling.
- Who it may be relevant to
- Registry conditions: Cardiovascular Diseases, Schizophrenia, Psychosis, Bipolar Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized Controlled Trial on the Effect of Nutritional Counseling on Anthropometry and Biomarkers in Patients Diagnosed With Schizophrenia/Psychosis or Bipolar Affective Disorder Treated at Asker DPS as Outpatients or Inpatients at Blakstad Hospital
Overview
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
- 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. 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.
Primary outcome measures
- Non-HDL cholesterol [Time frame: 6 weeks]
Secondary outcome measures (12)
- total cholesterol [Time frame: 6 weeks]
- HDL-cholesterol [Time frame: 6 weeks]
- Triglycerids [Time frame: 6 weeks]
- HbA1c [Time frame: 6 weeks]
- ALT AST/ALT AST/ALT [Time frame: 6 weeks]
- fasting glucose [Time frame: 6 weeks]
- Vitamin D [Time frame: 6 weeks]
- Folate [Time frame: 6 weeks]
- LDL-cholesterol [Time frame: 6 weeks]
- Weight [Time frame: 6 weeks]
- waist circumference [Time frame: 6 weeks]
- Bloodpressure [Time frame: 6 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Norway · 2 centers
- Vestre Viken Health Trust — Drammen
- Department of Research and Delvelopment, Mental health and Addiction, Vestre Viken Hospita — Drammen
Identifiers
NCT: NCT06197048 · Vestre viken