Norwegian Mental Illness Heart Health Study

NCT ID: NCT07085923

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-16
• Study Completion Date: 2028-06-30

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.

Detailed Description

People with severe mental illness (SMI) such as schizophrenia spectrum- or bipolar disorder face a markedly increased risk of early death compared to the general population, with cardiovascular disease (CVD) as the leading cause. This excess risk is partly explained by modifiable lifestyle-related risk factors such as physical inactivity, poor diet quality, and the metabolic side effects of antipsychotic medication. Despite this, people with SMI often receive less preventive somatic care and limited support to adopt healthier habits.

The scientific evidence for the effectiveness of lifestyle interventions in this population is still limited, and previous trials have yielded mixed results. The most promising studies have combined professional dietary counselling with physical activity at moderate to high intensity. This study builds on previous research and clinical experience with the patient group, and responds to a documented need for targeted, feasible interventions in mental health services.

The study aims to contribute to the evidence base by testing a feasible, multidisciplinary intervention integrated in routine mental health care. This randomized controlled trial (RCT) will evaluate the impact of a structured lifestyle program on the estimated CVD risk and associated metabolic and lifestyle outcomes in Norwegian adults with an SMI.

Participants will be randomized in a 1:1 ratio to either a 6-month lifestyle intervention or a control group receiving treatment as usual (TAU) in mental health care. The study will include approximately 70 overweight adults with schizophrenia spectrum (ICD-10 F20-29) or bipolar disorder (ICD-10 F31). For ethical reasons, the control group will be offered the same lifestyle program after the 6-month trial period, without accompanying data collection.

The intervention period lasts six months and consists of:

• Monthly one-on-one sessions with a registered clinical dietitian, focused on cardioprotective dietary changes, practical food strategies, and weight reduction.
• Monthly group-based physical activity sessions led by an instructor, tailored to the participants' physical capacity.
• Support to follow a personalized training plan meeting the recommended amount of physical activity on moderate-high intensity.

The intervention is designed to integrate into existing mental health services and accommodate the needs and challenges specific to people with SMI, such as medication side effects, low energy levels, and cognitive symptoms. User panels including patients with lived experiences are involved in tailoring the intervention. Fidelity and feasibility will be evaluated through structured feedback and attendance records.

The study will assess whether adherence to a healthy lifestyle, measured with the DIGIKOST Lifestyle Index, affects estimated 10-year CVD risk, using a validated risk prediction tool. Weight monitoring, blood pressure recordings and blood test results are incorporated in the risk prediction, and this data will be assessed regularly throughout the study period. Secondary outcomes include changes in objectively measured physical activity (accelerometer), adherence to national lifestyle recommendations and diet quality (measured with a validated food frequency questionnaire, DIGIKOST), body composition (Bioelectrical impedance), waist circumference, body weight, and relevant biomarkers including blood lipids and glucose, in the intervention group compared to TAU. The presence of metabolic syndrome will also be evaluated using IDF and ATP III criteria. Health-related quality of life will be measured using a simple and validated questionnaire (PROMIS-29).

Statistical analysis will follow the intention-to-treat principle and use linear mixed-effects models to evaluate between-group changes from baseline to 6 months. In addition, interim measurements at 3 months will be used for secondary analyses to assess early changes, explore the trajectory of intervention effects, and monitor adherence and retention. This mid-intervention timepoint is also collected in the control group to enable temporal comparisons and better understand the dynamics of lifestyle change in both groups. Exploratory analyses will investigate predictors of adherence, effect heterogeneity, and timing of response.

The trial is part of a PhD project and will contribute to improved understanding of how lifestyle interventions can be tailored and implemented to improve physical health in people with SMI. The findings may help inform future clinical practice and reduce somatic health disparities in this underserved population.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Lifestyle Intervention

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Dietary Counselling and Exercise; Lifestyle Program

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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
• Pregnancy
• Inability to perform physical exercise

Somatic risk findings at baseline:

• HbA1c >57 mmol/mol (7.4%)
• LDL cholesterol >5.0 mmol/L
• Blood pressure >180/100 mmHg
• Active malignant disease

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Madeleine Elisabeth Angelsen

OTHER

Sponsor Role: lead

Responsible Party

Madeleine Elisabeth Angelsen

PhD Fellow under the supervision of Professor Kjetil Retterstøl

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Professor Kjetil Retterstøl, Professor, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oslo

Locations

Department for nutrition science, Domus Medica, University of Oslo

Oslo, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Madeleine E Angelsen, M.Sc. Clinical Nutrition

Role: CONTACT

m.e.angelsen@studmed.uio.no

+4747234028

Professor Kjetil Retterstøl, Professor, MD

Role: CONTACT

kjetil.retterstol@medisin.uio.no

+47 90098393

Facility Contacts

Madeleine E Angelsen, Ph.D candidate

Role: primary

m.e.angelsen@studmed.uio.no

47234028

References

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.

Reference Type: BACKGROUND

PMID: 36183316 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29990631 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Related Links

https://www.helsedirektoratet.no/nasjonale-forlop/psykiske-lidelser-voksne/bakgrunn-metode-og-prosess

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.

Other Identifiers

108677

Identifier Type: -

Identifier Source: org_study_id