Improving heart health in Norwegians with severe mental illness
Dietary Counselling And Exercise To Combat Cardiovascular Disease Risk In Norwegian Patients With A Severe Mental Illness
This trial will test whether a 6‑month program of dietary counseling and regular exercise can lower estimated heart disease risk in adults with schizophrenia-spectrum or bipolar I disorder who are overweight and on antipsychotic medication or lithium.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 25 Years to 70 Years |
| Sex | All |
| Sponsor | University of Oslo Academic / other |
| Locations | 1 site (Oslo) |
| Trial ID | NCT07085923 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults in Norway with schizophrenia‑spectrum disorders or bipolar I disorder who are currently taking antipsychotic medication or lithium and have a BMI of 27 kg/m2 or higher, who can provide informed consent and participate in exercise.
Not a fit: People with established cardiovascular disease, type 1 diabetes, pregnancy, inability to exercise, heavy alcohol use above study limits, or those who must start GLP‑1 agonists, antihypertensives, antidiabetics, or lipid‑lowering drugs during the study are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the program could lower estimated cardiovascular risk and improve weight, metabolic health, and daily lifestyle habits for people with severe mental illness.
How similar studies have performed: Previous trials in severe mental illness have produced mixed results, though programs that combine professional dietary counselling with moderate‑to‑high intensity exercise have shown the most promising effects.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Oslo
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.