Norwegian Mental Illness Heart Health Study
Dietary Counselling And Exercise To Combat Cardiovascular Disease Risk In Norwegian Patients With A Severe Mental Illness
Madeleine Elisabeth Angelsen
70 participants
Sep 16, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria3
- 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
Exclusion Criteria22
- 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
Interventions
The Lifestyle Program consists of monthly one-on-one dietary counselling sessions with a registered clinical dietitian, monthly group-based physical activity sessions led by an instructor, and support to follow a personalized exercise plan. The intervention focuses on cardioprotective dietary changes, weight reduction, and increasing physical activity at moderate-to-high intensity to meet recommended amount. Participants will receive dietary supplementation corresponding to a therapeutic dose of 1000 mg EPA+DHA per day from fish oil. During monthly visits with the dietitian, data will be collected to monitor progress and support adherence. Participants will be encouraged to monitor body weight at home between visits (bathroom scales are loaned as needed), and follow up is carried out biweekly via phone-calls. The intervention is designed to be feasible within routine mental health care and tailored to the needs of adults with severe mental illness.
Locations(1)
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NCT07085923