Improving heart health in Norwegians with severe mental illness

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, controlled 1:1 trial compares a structured 6‑month multidisciplinary lifestyle program (professional dietary counselling plus supervised moderate‑to‑high intensity exercise) with treatment as usual in Norwegian adults with severe mental illness. Primary outcomes include change in estimated cardiovascular disease risk, weight and body composition, and metabolic markers measured at baseline and six months. The study will also measure adherence and participant acceptability to determine feasibility within routine mental health services. Participants must have a BMI ≥27 kg/m2 and be on antipsychotic medication or lithium, while those with established cardiovascular disease, type 1 diabetes, pregnancy, inability to exercise, or initiating certain cardiometabolic drugs during the intervention are excluded.

Why it matters

Who can join: the full rules

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

Where it's running

• Department for nutrition science, Domus Medica, University of Oslo
  Oslo, Norway Recruiting

Study contacts

• Principal investigator: Professor Kjetil Retterstøl, Professor, MD — University of Oslo
• Study coordinator: Madeleine E Angelsen, M.Sc. Clinical Nutrition
• Email: m.e.angelsen@studmed.uio.no
• Phone: +4747234028

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.