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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Schizophrenia; Bipolar Disorder; Psychosis
• Intervention / Treatment: Behavioral: Nutritional counseling

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dawn E Peleikis, phD; Phone Number: +4799405812; Email: dawn.peleikis@vestreviken.no
• Study Contact Backup: Name: Camilla N Myrdal, Master; Phone Number: +4794814040; Email: camilla.myrdal@studmed.uio.no

Study Locations

• Norway
  • Drammen, Norway, 3004
    • Recruiting
    • Department of Research and Delvelopment, Mental health and Addiction, Vestre Viken Hospital Trust
    • Contact: Wenche Ryberg, phd; Phone Number: 004732803000; Email: wenche.ryberg@vestreviken.no
    • Contact: Monica strand, phd; Email: monica.strand@vestreviken.no
    • Sub-Investigator: Roar Fosse, phd
    • Sub-Investigator: Strand Monica, phd
    • Principal Investigator: Ryberg Wenche, phd
  • Viken
    • Drammen, Viken, Norway, 3004
      • Recruiting
      • Vestre Viken Health Trust
      • Contact: Siri Bråthen, MSc; Phone Number: +4745226100; Email: sibraa@vestreviken.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-HDL cholesterol	HDL-cholesterol - total cholesterol, biochemical test	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total cholesterol	biochemical test	6 weeks
HDL-cholesterol	biochemical test	6 weeks
Triglycerids	biochemical test	6 weeks
HbA1c	biochemical test	6 weeks
ALT AST/ALT AST/ALT	biochemical test	6 weeks
fasting glucose	biochemical test	6 weeks
Vitamin D	biochemical test	6 weeks
Folate	biochemical test	6 weeks
LDL-cholesterol	biochemical test	6 weeks
Weight	anthropometric measurement	6 weeks
waist circumference	anthropometric measurement	6 weeks
Bloodpressure		6 weeks
24-hour dietary recall	interview	6 weeks
Food frequency questionnaire	questionnaire	6 weeks

Collaborators and Investigators

• Sponsor: Vestre Viken Hospital Trust
• Collaborators: University of Oslo

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2023
• Primary Completion (Estimated): May 15, 2024
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: December 25, 2023
• First Submitted That Met QC Criteria: January 8, 2024
• First Posted (Actual): January 9, 2024

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Cardiovascular disease; Schizophrenia; Nutritional counseling; Bipolar affective disorder; Severe mental disorders; Randomzied controlled trial
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Cardiovascular Diseases; Schizophrenia; Psychotic Disorders; Mental Disorders; Bipolar Disorder; Mood Disorders
• Other Study ID Numbers: Vestre viken

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The IPD will be stored at TSD- services for sensitive data. Only researchers in this prosject will have acsess

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No