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

NCT06197048 | Recruiting

• 1 other identifier: Vestre viken
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Cardiovascular Diseases; Schizophrenia; Psychosis; Bipolar Disorder

Keywords

Severe mental disorders; Nutritional counseling; Cardiovascular disease; Schizophrenia; Bipolar affective disorder; Randomzied controlled trial

Outcome Measures

Primary Outcomes (1)

• Non-HDL cholesterol

  HDL-cholesterol - total cholesterol, biochemical test

  6 weeks

Secondary Outcomes (14)

• total cholesterol

  6 weeks

• HDL-cholesterol

  6 weeks

• Triglycerids

  6 weeks

• HbA1c

  6 weeks

• ALT AST/ALT AST/ALT

  6 weeks

Interventions

Nutritional counseling BEHAVIORAL

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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

You may not qualify if:

• none

Sponsors & Collaborators

• Vestre Viken Hospital Trust: lead
• University of Oslo: collaborator

Study Sites (2)

Vestre Viken Health Trust

Drammen, Akershus, 3004, Norway

RECRUITING

Department of Research and Delvelopment, Mental health and Addiction, Vestre Viken Hospital Trust

Drammen, 3004, Norway

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases; Schizophrenia; Psychotic Disorders; Bipolar Disorder; Mental Disorders

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Mood Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Central Study Contacts

Dawn E Peleikis, phD

CONTACT

+4799405812; dawn.peleikis@vestreviken.no

Camilla N Myrdal, Master

CONTACT

+4794814040; camilla.myrdal@studmed.uio.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 25, 2023
• First Posted: January 9, 2024
• Study Start: September 25, 2023
• Primary Completion: May 15, 2024
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 9, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)