Идёт набор NCT06197048

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

Без фазы С лечением Cardiovascular Diseases Schizophrenia Psychosis Bipolar Disorder

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Nutritional counseling.
Кому может быть актуально: Состояния в реестре: Cardiovascular Diseases, Schizophrenia, Psychosis, Bipolar Disorder. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Норвегия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

Поведенческое 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.

Первичные конечные точки

Non-HDL cholesterol [Срок оценки: 6 weeks]

Вторичные конечные точки (12)

total cholesterol [Срок оценки: 6 weeks]
HDL-cholesterol [Срок оценки: 6 weeks]
Triglycerids [Срок оценки: 6 weeks]
HbA1c [Срок оценки: 6 weeks]
ALT AST/ALT AST/ALT [Срок оценки: 6 weeks]
fasting glucose [Срок оценки: 6 weeks]
Vitamin D [Срок оценки: 6 weeks]
Folate [Срок оценки: 6 weeks]
LDL-cholesterol [Срок оценки: 6 weeks]
Weight [Срок оценки: 6 weeks]
waist circumference [Срок оценки: 6 weeks]
Bloodpressure [Срок оценки: 6 weeks]

Критерии участия

Критерии включения

> 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