Actively Recruiting

Phase Not Applicable
Age: 25Years - 70Years
All Genders
Healthy Volunteers
ID07085923

Dietary Counselling And Exercise To Reduce Cardiovascular Disease Risk In Norwegian Adults With Severe Mental Illness

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

70

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether a lifestyle program combining dietary counselling and regular physical exercise can improve physical and mental health in Norwegian adults with severe mental illnesses (SMI) such as schizophrenia spectrum or bipolar disorder. These individuals face a higher risk of early death, mainly due to heart disease, caused partly by unhealthy lifestyle habits and metabolic side effects of medications. The trial aims to test if this program can reduce estimated heart disease risk and improve lifestyle habits, body weight, and metabolic markers over six months. Participants will be randomly assigned to one of two groups: one receiving a 6-month lifestyle program plus usual mental health care, and the other receiving usual care only. The lifestyle program includes monthly individual sessions with a clinical dietitian focused on heart-healthy dietary changes and weight reduction, monthly group physical activity sessions led by an instructor, and support to follow a personalized moderate-to-high intensity training plan. Participants in the lifestyle group also receive omega-3 supplementation and are encouraged to monitor body weight at home, with biweekly phone support. During the study, researchers will assess changes in estimated 10-year cardiovascular disease risk, lifestyle adherence, physical activity measured by accelerometer, diet quality, body composition, waist circumference, weight, blood pressure, and relevant biomarkers. Measurements occur at baseline, 3 months, and 6 months, with statistical analysis to evaluate differences between groups. The study also evaluates feasibility and acceptability of the program for people with SMI. Around 70 adults aged 25 to 70 with schizophrenia spectrum or bipolar disorder will participate, with data collected over the six-month intervention period.

CONDITIONS

Brief 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)
  • Currently using antipsychotic medication or lithium
  • Body mass index (BMI) of 27 kg/m² or higher
  • Age between 25 and 70 years
Not Eligible

You will not qualify if you...

  • Unable to provide informed consent
  • Experiencing an acute psychiatric crisis
  • Significant cognitive impairment
  • New use of GLP-1 receptor agonists, antihypertensive, antidiabetic, or lipid-lowering medication during the study
  • Alcohol consumption exceeding 14 units per week for men or 7 units per week for women
  • Type 1 diabetes
  • Established cardiovascular disease
  • Body mass index (BMI) less than 27 kg/m²
  • Pregnancy
  • Unable to perform physical exercise
  • HbA1c over 57 mmol/mol (7.4%)
  • LDL cholesterol over 5.0 mmol/L
  • Blood pressure above 180/100 mmHg
  • Active malignant disease

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Lifestyle Intervention

Duration - 6 months

Participants receive a 6-month lifestyle program including monthly one-on-one dietary counselling sessions with a clinical dietitian, monthly group-based physical activity sessions led by an instructor, support to follow a personalized exercise plan, and omega-3 supplementation. Participants are encouraged to monitor body weight at home and receive biweekly phone calls for support and adherence monitoring.

Monthly individual sessions and group physical activity sessions, plus biweekly phone calls

Follow-up

Duration - Concurrent with intervention period at 3 and 6 months

Participants are assessed at 3 months and 6 months during the intervention for changes in cardiovascular risk, lifestyle adherence, physical activity, diet quality, metabolic health, and body composition.

Assessments occur at baseline, 3 months, and 6 months

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

P

Professor Kjetil Retterstøl, Professor, MD

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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Published Research Related To This Trial

Effectiveness of nutrition and dietary interventions for people with serious mental illness: systematic review and meta-analysis.

Tetyana Rocks, Scott B Teasdale, Caitlin Fehily...

https://pubmed.ncbi.nlm.nih.gov/36183316

Exercise, diet and educational interventions for metabolic syndrome in persons with schizophrenia: A systematic review.

Jothimani Gurusamy, Sailaxmi Gandhi, Dinakaran Damodharan...

https://pubmed.ncbi.nlm.nih.gov/29990631

Clinical dietitian-led nutrition counseling and exercise to reduce cardiovascular risk in adults living with a BMI above 27 and severe mental illness: the NORMI-Heart trial protocol.

Madeleine Elisabeth Angelsen, Hemen Najar, Mette Svendsen...

https://pubmed.ncbi.nlm.nih.gov/41769638