Effect of Nutritional Counseling on Anthropometry and Biomarkers in Patients Diagnosed With Schizophrenia/Psychosis or Bipolar Affective Disorder

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06197048
• Other study ID #: Vestre viken
• Status: Recruiting
• Phase: N/A
• Start date: September 25, 2023
• Est. completion date: December 1, 2028

Study information

• Verified date: December 2023
• Source: Vestre Viken Hospital Trust
• Contact: Dawn E Peleikis, phD
• Phone: +4799405812
• Email: dawn.peleikis[@]vestreviken.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 1, 2028
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Cardiovascular Diseases
• Mental Disorders
• Mood Disorders
• Psychosis
• Psychotic Disorders
• Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
Norway	Department of Research and Delvelopment, Mental health and Addiction, Vestre Viken Hospital Trust	Drammen
Norway	Vestre Viken Health Trust	Drammen	Viken

Sponsors (2)

Lead Sponsor	Collaborator
Vestre Viken Hospital Trust	University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-HDL cholesterol	HDL-cholesterol - total cholesterol, biochemical test	6 weeks
Secondary	total cholesterol	biochemical test	6 weeks
Secondary	HDL-cholesterol	biochemical test	6 weeks
Secondary	Triglycerids	biochemical test	6 weeks
Secondary	HbA1c	biochemical test	6 weeks
Secondary	ALT AST/ALT AST/ALT	biochemical test	6 weeks
Secondary	fasting glucose	biochemical test	6 weeks
Secondary	Vitamin D	biochemical test	6 weeks
Secondary	Folate	biochemical test	6 weeks
Secondary	LDL-cholesterol	biochemical test	6 weeks
Secondary	Weight	anthropometric measurement	6 weeks
Secondary	waist circumference	anthropometric measurement	6 weeks
Secondary	Bloodpressure		6 weeks
Secondary	24-hour dietary recall	interview	6 weeks
Secondary	Food frequency questionnaire	questionnaire	6 weeks