Diet and Exercise Program for Heart Health in Severe Mental Illness
Tests diet counselling and exercise in adults with severe mental illness.
Plain-language title generated from the registry record
Registry title: Norwegian Mental Illness Heart Health Study
Key facts
- Where
- Oslo, NorwaySee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 25 and 70 years old?
Source: NCT07085923, who can take part
Where in Norway
- Department for nutrition science, Domus Medica, University of OsloOslo, NorwayTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Madeleine Elisabeth Angelsen
- Trial code
- NCT07085923
- Record updated
- 2 October 2025
- Original description
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.Read full original descriptionShow less
Dietary Counselling And Exercise To Combat Cardiovascular Disease Risk In Norwegian Patients With A Severe Mental Illness
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.
Inclusion: 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: Antihypertensive medication; Antidiabetic medication; Psychiatric condition:; 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:; 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; Active malignant disease; HbA1c >57 mmol/mol (7.4%); LDL cholesterol >5.0 mmol/L; Inability to provide informed consent*; GLP-1 receptor agonists; Body Mass Index (BMI) <27 kg/m²; Pregnancy; Inability to perform physical exercise; Somatic risk findings at baseline:; Blood pressure >180/100 mmHg.