Dietary Counselling And Exercise To Combat Cardiovascular Disease Risk In Norwegian Patients With A Severe Mental Illness
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change in Estimated Risk of Heart Disease (QRISK3)
研究概览
简要总结
Norwegian patients with severe mental illnesses (SMI), such as schizophrenia spectrum or bipolar disorder, lose on average 10 years of life compared to mentally healthy individuals. Much of this gap is due to heart disease. Unhealthy lifestyle habits, including poor diet and physical inactivity, contribute to higher levels of metabolic risk factors for heart disease in this population.
The goal of this clinical trial is to find out if a lifestyle program including dietary counselling and regular physical exercise can help people with SMI to improve their physical and mental health.
The main questions it aims to answer are:
- Does adherence to a healthy lifestyle program lead to reduced estimated risk of heart disease?
- Does it change lifestyle habits, body weight and composition, and metabolic risk markers over six months?
- Can participants with severe mental illness complete a healthy lifestyle program, and do they find it acceptable?
Researchers will compare two groups: one that receives the lifestyle program in addition to regular mental health care, and one that receives regular care only.
During the six month program, participants in the lifestyle group will:
- Meet with a clinical dietitian once a month for dietary counselling
- Take part in group-based physical activity sessions once a month, and receive support to follow a personal training plan
Around 70 adults will take part in the study. The results may help improve the way lifestyle support is offered to people living with severe mental illness and inform health care providers about strategies to improve physical health in this vulnerable group.
详细描述
People with severe mental illness (SMI) such as schizophrenia spectrum- or bipolar disorder face a markedly increased risk of early death compared to the general population, with cardiovascular disease (CVD) as the leading cause. This excess risk is partly explained by modifiable lifestyle-related risk factors such as physical inactivity, poor diet quality, and the metabolic side effects of antipsychotic medication. Despite this, people with SMI often receive less preventive somatic care and limited support to adopt healthier habits.
The scientific evidence for the effectiveness of lifestyle interventions in this population is still limited, and previous trials have yielded mixed results. The most promising studies have combined professional dietary counselling with physical activity at moderate to high intensity. This study builds on previous research and clinical experience with the patient group, and responds to a documented need for targeted, feasible interventions in mental health services.
The study aims to contribute to the evidence base by testing a feasible, multidisciplinary intervention integrated in routine mental health care. This randomized controlled trial (RCT) will evaluate the impact of a structured lifestyle program on the estimated CVD risk and associated metabolic and lifestyle outcomes in Norwegian adults with an SMI.
Participants will be randomized in a 1:1 ratio to either a 6-month lifestyle intervention or a control group receiving treatment as usual (TAU) in mental health care. The study will include approximately 70 overweight adults with schizophrenia spectrum (ICD-10 F20-29) or bipolar disorder (ICD-10 F31). For ethical reasons, the control group will be offered the same lifestyle program after the 6-month trial period, without accompanying data collection.
The intervention period lasts six months and consists of:
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
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of F20-29 (schizophrenia spectrum) or F31 (bipolar affective disorder)
- •Current use of antipsychotic medication (first- or second generation) or lithium
- •Body Mass Index > or = 27 kg/m^2
排除标准
- •Psychiatric condition:
- •Inability to provide informed consent*
- •Acute psychiatric crisis*
- •Significant cognitive impairment* *These criteria will be evaluated and confirmed by the participant's primary mental health care provider before enrollment
- •Medication initiated during the intervention period:
- •GLP-1 receptor agonists
- •Antihypertensive medication
- •Antidiabetic medication
- •Lipid-lowering medication
- •Alcohol consumption:
- •More than 14 units per week (men) or more than 7 units per week (women)
- •Somatic conditions:
- •Type 1 diabetes
- •Established cardiovascular disease
- •Body Mass Index (BMI) <27 kg/m²
- •Pregnancy
- •Inability to perform physical exercise
- •Somatic risk findings at baseline:
- •HbA1c >57 mmol/mol (7.4%)
- •LDL cholesterol >5.0 mmol/L
- •Blood pressure >180/100 mmHg
- •Active malignant disease
结局指标
主要结局
Change in Estimated Risk of Heart Disease (QRISK3)
时间窗: From baseline to 6 months
Compare the change in estimated cardiovascular disease risk between intervention and control (Treatment as Usual) groups over 6 months, using the validated QRISK3 algorithm.
Association Between Change in Lifestyle Adherence and Change in QRISK3 Score
时间窗: From baseline to 6 months
Explore whether change in adherence to a healthy lifestyle, measured with the DIGIKOST Lifestyle Index, predicts change in estimated cardiovascular disease risk (QRISK3).
次要结局
- Change in Objectively Measured Physical Activity (Accelerometer)(From baseline to 6 months)
- Change in lifestyle adherence score (DIGIKOST Lifestyle Index)(Baseline and 6 months)
- Change in Diet Quality (DIGIKOST Diet Index and 24-Hour Dietary Recall)(From baseline to 6 months)
- Presence and Change in Metabolic Syndrome (IDF and ATP-III Criteria)(Baseline, 3 months and 6 months)
- Change in Blood Biomarkers Related to Cardiometabolic Health(From baseline, at 3 months and after 6 months)
- Change in Body Weight(Baseline, 3 months, and 6 months)
- Change in Waist Circumference(Baseline, 3 months and 6 months)
- Change in Blood Pressure(Baseline, 3 months, and 6 months)
- Change in Body Composition (BIA)(Baseline, 3 months and 6 months)
研究者
Madeleine Elisabeth Angelsen
PhD Fellow under the supervision of Professor Kjetil Retterstøl
University of Oslo