Norwegian Mental Illness Heart Health Study

NCT07085923 | Recruiting

• 1 other identifier: 108677
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Severe Mental Illness; Cardiovascular Disease; Lifestyle Intervention; Healthy Diet; Exercise; CVD-risk; Schizophrenia; Antipsychotic Medication; Bipolar Disorder; Non-pharmacological intervention; Clinical Dietitian

Outcome Measures

Primary Outcomes (2)

• Change in Estimated Risk of Heart Disease (QRISK3)

  Compare the change in estimated cardiovascular disease risk between intervention and control (Treatment as Usual) groups over 6 months, using the validated QRISK3 algorithm.

  From baseline to 6 months

• Association Between Change in Lifestyle Adherence and Change in QRISK3 Score

  Explore whether change in adherence to a healthy lifestyle, measured with the DIGIKOST Lifestyle Index, predicts change in estimated cardiovascular disease risk (QRISK3).

  From baseline to 6 months

Secondary Outcomes (9)

• Change in Objectively Measured Physical Activity (Accelerometer)

  From baseline to 6 months

• Change in lifestyle adherence score (DIGIKOST Lifestyle Index)

  Baseline and 6 months

• Change in Diet Quality (DIGIKOST Diet Index and 24-Hour Dietary Recall)

  From baseline to 6 months

• Presence and Change in Metabolic Syndrome (IDF and ATP-III Criteria)

  Baseline, 3 months and 6 months

• Change in Blood Biomarkers Related to Cardiometabolic Health

  From baseline, at 3 months and after 6 months

Other Outcomes (3)

• Change in Health-Related Quality of Life (PROMIS-29)

  Baseline, 3- and 6 months

• Feasibility and Acceptability of the Lifestyle Program (qualitative)

  Throughout the 6 month intervention period

• Predictors of adherence and effect heterogeneity

  Baseline to 6 months

Study Arms (2)

Lifestyle Intervention

EXPERIMENTAL

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.

Behavioral: Lifestyle Intervention

Control

NO INTERVENTION

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.

Interventions

Lifestyle Intervention BEHAVIORAL

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.

Also known as: Dietary Counselling and Exercise, Lifestyle Program

Lifestyle Intervention

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Madeleine Elisabeth Angelsen: lead

Study Sites (1)

Department for nutrition science, Domus Medica, University of Oslo

Oslo, 0372, Norway

RECRUITING

Related Publications (2)

• Rocks T, Teasdale SB, Fehily C, Young C, Howland G, Kelly B, Dawson S, Jacka F, Dunbar JA, O'Neil A. Effectiveness of nutrition and dietary interventions for people with serious mental illness: systematic review and meta-analysis. Med J Aust. 2022 Oct 2;217 Suppl 7(Suppl 7):S7-S21. doi: 10.5694/mja2.51680.

  PMID: 36183316 BACKGROUND

• Gurusamy J, Gandhi S, Damodharan D, Ganesan V, Palaniappan M. Exercise, diet and educational interventions for metabolic syndrome in persons with schizophrenia: A systematic review. Asian J Psychiatr. 2018 Aug;36:73-85. doi: 10.1016/j.ajp.2018.06.018. Epub 2018 Jun 30.

  PMID: 29990631 BACKGROUND

Related Links

• This page from the Norwegian Directorate of Health presents the recommended national care pathway for adults with mental illness, including guidance on somatic screening and treatment to ensure coordinated, high-quality, and equitable health services.

MeSH Terms

Conditions

Metabolic Syndrome; Mental Disorders; Schizophrenia; Cardiovascular Diseases; Motor Activity; Bipolar Disorder

Interventions

Exercise

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Schizophrenia Spectrum and Other Psychotic Disorders; Behavior; Bipolar and Related Disorders; Mood Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Professor Kjetil Retterstøl, Professor, MD

  University of Oslo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Madeleine E Angelsen, M.Sc. Clinical Nutrition

CONTACT

+4747234028; m.e.angelsen@studmed.uio.no

Professor Kjetil Retterstøl, Professor, MD

CONTACT

+47 90098393; kjetil.retterstol@medisin.uio.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD Fellow under the supervision of Professor Kjetil Retterstøl

Model Details: Parallel assignment of participants to intervention or control group in a 1:1 ratio, stratified by diagnosis. The initial control group is offered the intervention after 6 months, without outcome assessments, for ethical reasons.

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: July 25, 2025
• Study Start: September 16, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: October 2, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)