NCT07085923Recruiting
Norwegian Mental Illness Heart Health Study
Dietary Counselling And Exercise To Combat Cardiovascular Disease Risk In Norwegian Patients With A Severe Mental Illness
Source: ClinicalTrials.gov · Last updated 2 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 17 Jul 2025
- Start date
- 16 Sept 2025
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Madeleine Elisabeth Angelsen
- Diseases
- Schizophrenia, Obesity, Bipolar disorder
- NCT number
- NCT07085923
What you commit to
- Study type: Interventional
- Planned participants: 70
- From 16 Sept 2025 to the primary completion date, 30 Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Antihypertensive medication
- Antidiabetic medication
Other illness
- 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
Lab values
- HbA1c \>57 mmol/mol (7.4%)
- LDL cholesterol \>5.0 mmol/L
Other
- 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
Who the study is looking for
- 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
Age in the registry: 25 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department for nutrition science, Domus Medica, University of Oslo Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.