NCT Number: NCT06197048
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Vestre Viken Health Trust, Drammen, Akershus, Norway
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 6 weeks
HDL-cholesterol - total cholesterol, biochemical test
Time frame: 6 weeks
biochemical test
Time frame: 6 weeks
biochemical test
Time frame: 6 weeks
biochemical test
Time frame: 6 weeks
biochemical test
Time frame: 6 weeks
biochemical test
Time frame: 6 weeks
biochemical test
Time frame: 6 weeks
biochemical test
Time frame: 6 weeks
biochemical test
Time frame: 6 weeks
biochemical test
Time frame: 6 weeks
anthropometric measurement
Time frame: 6 weeks
anthropometric measurement
Time frame: 6 weeks
Time frame: 6 weeks
interview
Time frame: 6 weeks
questionnaire
Contact information is provided by the study sponsor or research team.
Camilla N Myrdal, Master
CONTACT
Dawn E Peleikis, phD
CONTACT
Vestre Viken Hospital Trust
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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