Clinical trial NCT06197048: Effect of Nutritional Counseling on Anthropometry and Biomarkers in Patients Diagnosed With Schizophrenia/Psychosis or Bipolar Affective Disorder
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Schizophrenia
Psychosis
Bipolar Disorder
Keywords: Severe mental disorders
Nutritional counseling
Cardiovascular disease
Schizophrenia
Bipolar affective disorder
Randomzied controlled trial
Lead sponsor: Vestre Viken Hospital Trust
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2024-01-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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.

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

Primary outcomes:
measure: Non-HDL cholesterol
timeFrame: 6 weeks
Secondary outcomes:
measure: total cholesterol
timeFrame: 6 weeks
measure: HDL-cholesterol
timeFrame: 6 weeks
measure: Triglycerids
timeFrame: 6 weeks
measure: HbA1c
timeFrame: 6 weeks
measure: ALT AST/ALT AST/ALT
timeFrame: 6 weeks
measure: fasting glucose
timeFrame: 6 weeks
measure: Vitamin D
timeFrame: 6 weeks
measure: Folate
timeFrame: 6 weeks
measure: LDL-cholesterol
timeFrame: 6 weeks
measure: Weight
timeFrame: 6 weeks
measure: waist circumference
timeFrame: 6 weeks
measure: Bloodpressure
timeFrame: 6 weeks
measure: 24-hour dietary recall
timeFrame: 6 weeks
measure: Food frequency questionnaire
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Drammen
country: Norway
facility: Vestre Viken Health Trust
state: Viken
city: Drammen
country: Norway
facility: Department of Research and Delvelopment, Mental health and Addiction, Vestre Viken Hospital Trust
Study officials:
References: