Cardio Vascular DiseaseNORMI-HeartNCT07085923
Norwegian Mental Illness Heart Health Study
A study testing Lifestyle Intervention in people with Cardio Vascular Disease and Metabolic Syndrome (MetS), run by Madeleine Elisabeth Angelsen at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardio Vascular Disease, Metabolic Syndrome (MetS), Severe Mental Disorder
- What is being tested?
- Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteNorway
- Study dates
- 16 Sep 2025to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Department for nutrition science, Domus Medica, University of Oslo
Oslo, 0372
Madeleine E Angelsen, Ph.D candidate, 47234028, m.e.angelsen@studmed.uio.no
Professor Kjetil Retterstøl, Professor, MD
About this study
Official title: Dietary Counselling And Exercise To Combat Cardiovascular Disease Risk In Norwegian Patients With A Severe Mental Illness
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.
Read more
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.
Read the 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
- Being tested
- Lifestyle Intervention
- Keywords
- Severe Mental Illness, Cardiovascular Disease, Lifestyle Intervention, Healthy Diet, Exercise, CVD-risk, Schizophrenia, Antipsychotic Medication, Bipolar Disorder, Non-pharmacological intervention, Clinical Dietitian
- Medical subject headings
- Metabolic Syndrome, Mental Disorders, Schizophrenia, Cardiovascular Diseases, Motor Activity, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle InterventionBehavioural
Also called Dietary Counselling and Exercise, Lifestyle Program
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: From baseline to 6 months
Secondary outcomes (9)
Change in Objectively Measured Physical Activity (Accelerometer)
Physical activity will be assessed using a thigh-worn accelerometer worn for 7 consecutive days at baseline and again after 6 months. The device captures activity intensity and duration, including time spent sedentary, standing, and in moderate-to-vigorous physical activity. Between-group differences will be analyzed to evaluate the impact of the lifestyle intervention.
Measured: From baseline to 6 months
Change in lifestyle adherence score (DIGIKOST Lifestyle Index)
Healthy lifestyle adherence will be measured using the DIGIKOST Lifestyle Index at baseline and 6 months. The index serves as a proxy for behavioral change. Between-group differences (intervention vs. control) in change from baseline will be evaluated after the intervention (6 months)
Measured: Baseline and 6 months
Change in Diet Quality (DIGIKOST Diet Index and 24-Hour Dietary Recall)
Assess changes in diet quality based on a validated food frequency questionnaire (DIGIKOST Diet Index) and nutritional composition measured with 24-hour dietary recalls (repeated by phone call for validity), relative to Norwegian dietary recommendations. Repeated at baseline and after 6 months
Measured: From baseline to 6 months
Presence and Change in Metabolic Syndrome (IDF and ATP-III Criteria)
Metabolic syndrome will be assessed at baseline, 3 months, and 6 months using both the International Diabetes Federation (IDF) and the Adult Treatment Panel III (ATP-III) diagnostic criteria. Between-group differences (intervention vs. control) in the prevalence and change in metabolic syndrome status from baseline will be evaluated at 3 and 6 months.
Measured: Baseline, 3 months and 6 months
Change in Blood Biomarkers Related to Cardiometabolic Health
Fasting blood samples will be collected at baseline, 3 months, and 6 months to evaluate changes in cardiometabolic and nutritional biomarkers. Participants will be instructed to fast for at least 8 hours and avoid alcohol and vigorous physical activity for 24 hours prior to sampling. Samples will be drawn by the PhD candidate. Biomarkers include total cholesterol, LDL, HDL, triglycerides, ApoB, Lp(a), glucose, HbA1c, ALAT, ferritin, folate, vitamin D, homocysteine, hs-CRP, hydroxybutyrate, and acetoacetate. Between-group differences (intervention vs. control) in changes from baseline will be assessed at 3 and 6 months. The 3-month time point enables evaluation of early physiological responses to the intervention. Data will also be used to determine the presence and change in metabolic syndrome based on standard criteria.
Measured: From baseline, at 3 months and after 6 months
Change in Body Weight
Body weight will be measured at baseline, 3 months, and 6 months in both groups to assess between-group changes (intervention vs. treatment as usual). In the intervention group, additional monthly measurements will be conducted to track individual progress throughout the intervention period. A calibrated digital scale validated for clinical and research use will be used. Participants will be instructed to wear light clothing, remove shoes, and avoid eating or drinking for at least 8 hours prior to measurement.
Measured: Baseline, 3 months, and 6 months
Change in Waist Circumference
Waist circumference will be measured with a measuring tape at the midpoint between the lowest rib and the iliac crest. Measurements will be conducted at baseline, 3 months, and 6 months in both groups to assess between-group differences (intervention vs. treatment as usual). In the intervention group, additional monthly measurements will be performed to monitor changes over time.
Measured: Baseline, 3 months and 6 months
Change in Blood Pressure
Systolic and diastolic blood pressure will be measured in a seated position using automated equipment. Measurements will be taken at baseline, 3 months, and 6 months in both groups to evaluate between-group changes (intervention vs. treatment as usual). In the intervention group, additional monthly measurements will be conducted to track individual progress throughout the intervention period.
Measured: Baseline, 3 months, and 6 months
Change in Body Composition (BIA)
Body composition will be assessed using a bioelectrical impedance analysis (BIA) device validated for research purposes, at baseline, 3 months, and 6 months in both groups to evaluate changes in fat mass, fat-free mass, and total body weight. In the intervention group, BIA will also be performed monthly to track individual changes throughout the intervention period.
Measured: Baseline, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start16 Sep 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardio Vascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Madeleine Elisabeth Angelsen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Madeleine Elisabeth Angelsen, University of Oslo
- Investigators
- Professor Kjetil Retterstøl, Professor, MD, Principal investigator, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07085923
- Sponsor's protocol ID
- 108677
- Acronym
- NORMI-Heart
- Status last verified
- Jul 2025
- First submitted
- 17 Jul 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36183316Gurusamy 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.
PubMed 29990631Angelsen ME, Najar H, Svendsen M, Thoresen M, Peleikis DE, Retterstol K. 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. Front Nutr. 2026 Feb 12;13:1700251. doi: 10.3389/fnut.2026.1700251. eCollection 2026.
PubMed 41769638
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Counselling And Exercise To Combat Cardiovascular Disease Risk In Norwegian Patients With A Severe Mental Illness
- ClinicalTrials.gov ID
- NCT07085923
- Acronym / sponsor ID
- NORMI-Heart / 108677
- Conditions
- Cardio Vascular Disease, Metabolic Syndrome (MetS), Severe Mental Disorder, Schizophrenia and Schizophrenia Spectrum Psychosis, Bipolar Disease Type I, Overweight and/or Obesity
- Keywords
- Severe Mental Illness, Cardiovascular Disease, Lifestyle Intervention, Healthy Diet, Exercise, CVD-risk, Schizophrenia, Antipsychotic Medication
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Madeleine Elisabeth AngelsenUniversity, hospital or other
- Study start
- 16 Sep 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 25 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Intervention | Experimental | Behavioral: Lifestyle InterventionParticipants 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. |
| 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. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (22 listed)
- 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
- GLP-1 receptor agonists
- Antihypertensive medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle InterventionAlso: Dietary Counselling and Exercise, Lifestyle ProgramThe 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. | Behavioural | Lifestyle Intervention |
Primary outcome
Change in Estimated Risk of Heart Disease (QRISK3)
Time frame: From baseline to 6 months
Compare the change in estimated cardiovascular disease risk between intervention and control (Treatment as Usual) groups over 6 months, using the validated QRISK3 algorithm.
Association Between Change in Lifestyle Adherence and Change in QRISK3 Score
Time frame: From baseline to 6 months
Explore whether change in adherence to a healthy lifestyle, measured with the DIGIKOST Lifestyle Index, predicts change in estimated cardiovascular disease risk (QRISK3).
9 secondary outcomes
Change in Objectively Measured Physical Activity (Accelerometer)
Time frame: From baseline to 6 months
Change in lifestyle adherence score (DIGIKOST Lifestyle Index)
Time frame: Baseline and 6 months
Change in Diet Quality (DIGIKOST Diet Index and 24-Hour Dietary Recall)
Time frame: From baseline to 6 months
Presence and Change in Metabolic Syndrome (IDF and ATP-III Criteria)
Time frame: Baseline, 3 months and 6 months
Change in Blood Biomarkers Related to Cardiometabolic Health
Time frame: From baseline, at 3 months and after 6 months
Change in Body Weight
Time frame: Baseline, 3 months, and 6 months
Change in Waist Circumference
Time frame: Baseline, 3 months and 6 months
Change in Blood Pressure
Time frame: Baseline, 3 months, and 6 months
Change in Body Composition (BIA)
Time frame: Baseline, 3 months and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Background: PubMed 36183316Rocks 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.
- Background: PubMed 29990631Gurusamy 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.
- Derived from this study: PubMed 41769638Angelsen ME, Najar H, Svendsen M, Thoresen M, Peleikis DE, Retterstol K. 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. Front Nutr. 2026 Feb 12;13:1700251. doi: 10.3389/fnut.2026.1700251. eCollection 2026.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Cardio Vascular Disease
Not yet recruiting
Community Health Worker Nutrition Self-Management Support for Cardio-Kidney-Metabolic Health
Hypertension (HTN), CKD - Chronic Kidney Disease
Not yet recruitingPhase 4
Effectiveness and Tolerability of a Treat-to-Target Versus Fixed-Dose Statin Strategy in Patients With Atherosclerotic Cardiovascular Disease
Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia, Stroke (CVA) or TIA
Not yet recruitingObservational study
Hemodynamic Evaluation of Left Atrial Pressure in Relationship to Pulmonary Capillary Wedge Pressure in Cardio Thoracic Patients
Cardiogenic Shock, Pulmonary Edema Cardiac Cause
Recruiting
Effect of Anifrolumab on Arterial Inflammation in Systemic Lupus Erythematosus Study
Systemic Lupus Erythematosus, Atherosclerosis Generalized
Not yet recruitingObservational study
PAtient Similarity for Decision-Making in Prevention of Cardiovascular Toxicity (PACT): A Feasibility Study
Heart Failure, Coronary Artery Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Professor Kjetil Retterstøl, Professor, MD principal investigator
University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Intervention in people with Cardio Vascular Disease and Metabolic Syndrome (MetS), run by Madeleine Elisabeth Angelsen at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Madeleine E Angelsen, M.Sc. Clinical Nutrition (+4747234028, m.e.angelsen@studmed.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Estimated Risk of Heart Disease (QRISK3) (time frame: From baseline to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07085923, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.