NCT07085923 Norwegian Mental Illness Heart Health Study
| NCT ID | NCT07085923 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Madeleine Elisabeth Angelsen |
| Condition | Cardio Vascular Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2025-09-16 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2025-09-16 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: 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
Contact & Investigator
Professor Kjetil Retterstøl, Professor, MD
PRINCIPAL INVESTIGATOR
University of Oslo
Frequently Asked Questions
Who can join the NCT07085923 clinical trial?
This trial is open to participants of all sexes, aged 25 Years or older, up to 70 Years, studying Cardio Vascular Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07085923 currently recruiting?
Yes, NCT07085923 is actively recruiting participants. Contact the research team at m.e.angelsen@studmed.uio.no for enrollment information.
Where is the NCT07085923 trial being conducted?
This trial is being conducted at Oslo, Norway.
Who is sponsoring the NCT07085923 clinical trial?
NCT07085923 is sponsored by Madeleine Elisabeth Angelsen. The principal investigator is Professor Kjetil Retterstøl, Professor, MD at University of Oslo. The trial plans to enroll 70 participants.