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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Non-HDL cholesterol
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 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
排除标准
- 未提供
结局指标
主要结局
Non-HDL cholesterol
时间窗: 6 weeks
HDL-cholesterol - total cholesterol, biochemical test
次要结局
- waist circumference(6 weeks)
- Bloodpressure(6 weeks)
- Vitamin D(6 weeks)
- Folate(6 weeks)
- Weight(6 weeks)
- 24-hour dietary recall(6 weeks)
- Food frequency questionnaire(6 weeks)
- Triglycerids(6 weeks)
- fasting glucose(6 weeks)
- HDL-cholesterol(6 weeks)
- HbA1c(6 weeks)
- total cholesterol(6 weeks)
- ALT AST/ALT AST/ALT(6 weeks)
- LDL-cholesterol(6 weeks)