Cardiovascular DiseasesNCT06197048
Effect of Nutritional Counseling on Anthropometry and Biomarkers in Patients Diagnosed With Schizophrenia/Psychosis or Bipolar Affective Disorder
A study testing Nutritional counseling in people with Cardiovascular Diseases and Schizophrenia, run by Vestre Viken Hospital Trust at 2 sites in Norway.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Schizophrenia, Psychosis
- What is being tested?
- Nutritional counseling
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 2 sitesNorway
- Study dates
- 25 Sep 2023to 1 Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 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
Who cannot join
- none
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Norway2 sites, 2 recruiting
- Recruiting
Vestre Viken Health Trust
Drammen, Akershus, 3004
Siri Bråthen, MSc, +4745226100, sibraa@vestreviken.no
- Recruiting
Department of Research and Delvelopment, Mental health and Addiction, Vestre Viken Hospital Trust
Drammen, 3004
Wenche Ryberg, phd, 004732803000, wenche.ryberg@vestreviken.no
Monica strand, phd, monica.strand@vestreviken.no
About this study
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
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:
Read more
- 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.
Read the 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.
- Conditions
- Cardiovascular Diseases, Schizophrenia, Psychosis, Bipolar Disorder
- Being tested
- Nutritional counseling
- Keywords
- Severe mental disorders, Nutritional counseling, Cardiovascular disease, Schizophrenia, Bipolar affective disorder, Randomzied controlled trial
- Medical subject headings
- Cardiovascular Diseases, Schizophrenia, Psychotic Disorders, Bipolar Disorder, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional counselingBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-HDL cholesterol
HDL-cholesterol - total cholesterol, biochemical test
Measured: 6 weeks
Secondary outcomes (14)
total cholesterol
biochemical test
Measured: 6 weeks
HDL-cholesterol
biochemical test
Measured: 6 weeks
Triglycerids
biochemical test
Measured: 6 weeks
HbA1c
biochemical test
Measured: 6 weeks
ALT AST/ALT AST/ALT
biochemical test
Measured: 6 weeks
fasting glucose
biochemical test
Measured: 6 weeks
Vitamin D
biochemical test
Measured: 6 weeks
Folate
biochemical test
Measured: 6 weeks
LDL-cholesterol
biochemical test
Measured: 6 weeks
Weight
anthropometric measurement
Measured: 6 weeks
waist circumference
anthropometric measurement
Measured: 6 weeks
Bloodpressure
Measured: 6 weeks
24-hour dietary recall
interview
Measured: 6 weeks
Food frequency questionnaire
questionnaire
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start25 Sep 2023
- Primary completion15 May 2024 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vestre Viken Hospital Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06197048
- Sponsor's protocol ID
- Vestre viken
- Status last verified
- Dec 2023
- First submitted
- 25 Dec 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD will be stored at TSD- services for sensitive data. Only researchers in this prosject will have acsess