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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 25
Maximum Age: 70
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Norway
Department for nutrition science, Domus Medica, University of Oslo
RECRUITING
Oslo
Contact Information
Primary
Madeleine E Angelsen, M.Sc. Clinical Nutrition
m.e.angelsen@studmed.uio.no
+4747234028
Backup
Professor Kjetil Retterstøl, Professor, MD
kjetil.retterstol@medisin.uio.no
+47 90098393
Time Frame
Start Date: 2025-09-16
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 70
Treatments
Experimental: Lifestyle Intervention
Participants in this arm receive a 6-month lifestyle program in addition to usual mental health care. The intervention includes monthly individual sessions with a clinical dietitian, omega-3 supplementation, monthly group-based physical activity sessions led by an instructor, and support to follow a personalized training plan.
No_intervention: Control
Participants in this arm receive treatment as usual (TAU) in mental health care. After the 6-month study period, they are offered the same lifestyle program without data collection, for ethical reasons.
Sponsors
Leads: Madeleine Elisabeth Angelsen

This content was sourced from clinicaltrials.gov