RecruitingNot ApplicableNCT07085923

Norwegian Mental Illness Heart Health Study

Dietary Counselling And Exercise To Combat Cardiovascular Disease Risk In Norwegian Patients With A Severe Mental Illness


Sponsor

Madeleine Elisabeth Angelsen

Enrollment

70 participants

Start Date

Sep 16, 2025

Study Type

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

Min Age: 25 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how to improve heart health in people living with schizophrenia or bipolar disorder who are overweight and taking antipsychotic medications or lithium. These medications can cause weight gain and raise the risk of heart disease, and this study aims to find solutions. **You may be eligible if...** - You have been diagnosed with schizophrenia spectrum disorder or bipolar disorder - You are currently taking antipsychotic medication or lithium - Your BMI is 27 or higher (overweight or obese) **You may NOT be eligible if...** - You are unable to provide informed consent or are in an acute psychiatric crisis - You have significant cognitive impairment (as determined by your mental health provider) - You have recently started GLP-1 medications, blood pressure medications, diabetes medications, or cholesterol-lowering medications - You drink more than a moderate amount of alcohol regularly Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALLifestyle Intervention

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)

Department for nutrition science, Domus Medica, University of Oslo

Oslo, Norway

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NCT07085923


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