Actively Recruiting

Phase Not Applicable
Age: 25Years - 70Years
All Genders
Healthy Volunteers
NCT07085923

Norwegian Mental Illness Heart Health Study

Led by Madeleine Elisabeth Angelsen · Updated on 2025-10-02

70

Participants Needed

1

Research Sites

145 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Norwegian Mental Illness Heart Health Study

Who Can Participate

Age: 25Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of schizophrenia spectrum (F20-29) or bipolar affective disorder (F31)
  • Current use of antipsychotic medication (first- or second generation) or lithium
  • Body Mass Index (BMI) greater than or equal to 27 kg/m²
Not Eligible

You will not qualify if you...

  • Unable to give informed consent (confirmed by primary mental health care provider)
  • Experiencing an acute psychiatric crisis
  • Significant cognitive impairment
  • Starting new medication during the study: GLP-1 receptor agonists, antihypertensive, antidiabetic, or lipid-lowering drugs
  • Alcohol use exceeding 14 units/week for men or 7 units/week for women
  • Type 1 diabetes
  • Established cardiovascular disease
  • Body Mass Index (BMI) less than 27 kg/m²
  • Pregnancy
  • Unable to perform physical exercise
  • Baseline HbA1c greater than 57 mmol/mol (7.4%)
  • LDL cholesterol greater than 5.0 mmol/L
  • Blood pressure higher than 180/100 mmHg
  • Active malignant disease

AI-Screening

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Trial Site Locations

Total: 1 location

1

Department for nutrition science, Domus Medica, University of Oslo

Oslo, Norway, 0372

Actively Recruiting

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Research Team

M

Madeleine E Angelsen, M.Sc. Clinical Nutrition

CONTACT

P

Professor Kjetil Retterstøl, Professor, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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