Norwegian Mental Illness Heart Health Study

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.

Conditions

• Cardio Vascular Disease
• Metabolic Syndrome (MetS)
• Severe Mental Disorder
• Schizophrenia and Schizophrenia Spectrum Psychosis
• Bipolar Disease Type I
• Overweight and/or Obesity
• CVD Risk Factors
• Severe Mental Illness

Interventions

BEHAVIORAL

Lifestyle 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.

Sponsors & Collaborators

• Madeleine Elisabeth Angelsen

  lead OTHER

Principal Investigators

• Professor Kjetil Retterstøl, Professor, MD · University of Oslo

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

25 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-09-16

Primary Completion

2028-06-30

Completion

2028-06-30

Countries

• Norway

Study Locations