Improving Heart and Metabolic Health in People With Severe Mental Illness Through a Long-term Clinical Trial (LAGOM)

Longitudinal Approach to Generate Positive Cardiometabolic Health Outcomes in Severe Mental Illness

Cardiometabolic diseases are prevalent among individuals with psychotic disorders, significantly contributing to their shorter lifespan, reduced quality of life, and economic impact on individuals and society. To improve cardiometabolic health, effective and individualized interventions are crucial. Psychosis outpatient clinics are ideal for these interventions due to regular patient visits and the availability of diverse health professionals. The investigators have developed and want to test a comprehensive intervention program to improve cardiometabolic health, enhance quality of life, and promote healthy lifestyles specifically for people with psychotic disorders at psychiatric outpatient clinics in Gothenburg.

This clinical trial aims to include 644 individuals with psychotic disorders from six outpatient clinics in the Department of Psychotic Disorders at Sahlgrenska University Hospital in Gothenburg. Two outpatient clinics will provide the LAGOM-intervention, while the other clinics will serve as controls, offering "care as usual". The intervention group will receive multidisciplinary support integrated into the routine clinical procedures. The intervention includes regular follow-ups and use of motivational tools, including body composition analyzer and cardiovascular risk prediction algorithm (QRISK3).

If the intervention effectively improves cardiometabolic health, enhances quality of life for this vulnerable group, and proves cost-effective, it can serve as a model program for implementation in Region Västra Götaland.

Study Overview

• Status: Recruiting
• Conditions: Psychotic Disorders
• Intervention / Treatment: Other: Intervention

• Study Type: Interventional
• Enrollment (Estimated): 644
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hemen Najar, M.D., Ph.D.; Phone Number: 0046 73 566 15 64; Email: hemen.najar@vgregion.se

Study Locations

• Sweden
  • Gothenburg, Sweden, 411 13
    • Recruiting
    • Psykosmottagning Centrum
    • Contact: Eva Andreasson; Phone Number: 0046 70 242 67 97; Email: evaandreasson17@gmail.com
    • Principal Investigator: Eva Andreasson
  • Gothenburg, Sweden, 417 52
    • Recruiting
    • Psykosmottagning Hisingen
    • Contact: Christina Hagberg; Phone Number: 0046 73 660 14 18; Email: christina.i.hagberg@vgregion.se
    • Principal Investigator: Christina Hagberg
  • Gothenburg, Sweden, 421 48
    • Recruiting
    • Psykosmottagning Väster
    • Contact: Caroline Holmbom; Phone Number: 0046 76 949 43 08; Email: caroline.e.larsson@vgregion.se
    • Principal Investigator: Caroline Holmbom
  • Gothenburg, Sweden, 415 05
    • Recruiting
    • Psykosmottagning Nordost
    • Contact: Elin Saari-Bladmyr; Phone Number: 0046 70 355 13 57; Email: elin.bladmyr@vgregion.se
    • Principal Investigator: Elin Saari-Bladmyr
  • Gothenburg, Sweden, 416 72
    • Recruiting
    • Psykosmottagning Öster
    • Contact: Lina Klysing; Phone Number: 0046 72 145 83 73; Email: lina.persson@vgregion.se
    • Principal Investigator: Lina Klysing
  • Mölndal, Sweden, 431 35
    • Recruiting
    • Psykosmottagning Mölndal
    • Contact: Erik Wålinder; Phone Number: 0046 76 940 29 76; Email: erik.walinder@vgregion.se
    • Principal Investigator: Erik Wålinder

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria

1. Adults ≥18 years of age meeting the International Classification of Diseases, Tenth Revision (ICD-10) diagnostic criteria for any one of the schizophrenia spectrum disorders (F20-F25 or F28-F29)
2. Ability to provide informed consent

Exclusion criteria

1. Having an electrical medical implant such as a pacemaker or other mechanical implants
2. Pregnancy
3. Deemed unsuitable by the investigator (a person may be deemed unsuitable for participation in the trial by the clinical investigation team member based on factors that may affect the ability to participate safely and reliably. These factors may include, but are not limited to, physical disabilities that hinder participation or practical challenges such as long travel distances to the trial site. The assessment is made on an individual basis and aims to ensure both patient safety and trial integrity).
4. Prior participation in the LAGOM trial during a previous inclusion cycle (i.e., participants can only be included once during the trial period).
5. Currently under compulsory care.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control clinics (usual care); The "usual care" model in Gothenburg includes annual health checks for individuals with psychotic disorders. Patients attend two 60-minute visits for assessments such as blood tests, blood pressure, and weight checks, with results evaluated using standard benchmarks or risk algorithms like SCORE2. Physicians may suggest referrals to primary care or recommend lifestyle changes, including diet, exercise, or substance use adjustments. Identified issues may prompt simple advice or referrals to health promoters for support with smoking cessation, dietary guidance, or group activities. The 36 ± 6-month clinical trial standardizes data collection at four outpatient clinics without altering care. Eligible patients sign consent, with rescreening allowed if a patient meets the exclusion criteria at one annual check but not at the next. Non-participants continue with regular care.
Experimental: Intervention Clinics; The annual health checks for the intervention group follow the same structure of two visits as in routine care as usual, with the primary difference being the content of the visits.	Other: Intervention; The intervention group follows a structured flowchart for annual health check-ups, focusing on assessing the cardiometabolic profile, considering sex and ethnicity. This assessment includes tracking changes in cardiometabolic parameters, alongside overall cardiometabolic risk using SCORE2 and if the criteria for metabolic syndrome are met. Lifestyle habits are evaluated based on health status, illness, and benefits of quitting unhealthy behaviors. Education sessions educate participants and families on the link between psychotic disorders, lifestyle choices, and cardiometabolic health. Gradual lifestyle changes are tailored to individual needs, addressing stress and cognitive challenges, and follow national health guidelines with personalized advice and motivational tools. Regular follow-ups assess progress, while motivational tools "body composition analyzer and QRISK3" enhance engagement. Contact with internal and external resources is based on the assessment and motivational work.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body mass index	To evaluate whether the intervention is superior to usual care in reducing cardiometabolic risk indicators over the 36-month period. Primary endpoint: Differences in the mean changes in body mass index (BMI) (kg/m2).	At 12 months from baseline.
Change in body mass index	To evaluate whether the intervention is superior to usual care in reducing cardiometabolic risk indicators over the 36-month period. Primary endpoint: Differences in the mean changes in body mass index (BMI) (kg/m2).	At 24 months from baseline.
Change in body mass index	To evaluate whether the intervention is superior to usual care in reducing cardiometabolic risk indicators over the 36-month period. Primary endpoint: Differences in the mean changes in body mass index (BMI) (kg/m2).	At 36 months from baseline.
Change in waist-hip ratio	To evaluate whether the intervention is superior to usual care in reducing cardiometabolic risk indicators over the 36-month period. Primary endpoint: Differences in the mean changes in waist-hip ratio (WHR).	At 12 months from baseline.
Change in waist-hip ratio	To evaluate whether the intervention is superior to usual care in reducing cardiometabolic risk indicators over the 36-month period. Primary endpoint: Differences in the mean changes in waist-hip ratio (WHR).	At 24 months from baseline.
Change in waist-hip ratio	To evaluate whether the intervention is superior to usual care in reducing cardiometabolic risk indicators over the 36-month period. Primary endpoint: Differences in the mean changes in waist-hip ratio (WHR).	At 36 months from baseline.
Change in systolic blood pressure	To evaluate whether the intervention is superior to usual care in reducing cardiometabolic risk indicators over the 36-month period. Primary endpoint: Differences in the mean changes in systolic blood pressure (SBP) (mm Hg).	At 12 months from baseline.
Change in systolic blood pressure	To evaluate whether the intervention is superior to usual care in reducing cardiometabolic risk indicators over the 36-month period. Primary endpoint: Differences in the mean changes in systolic blood pressure (SBP) (mm Hg).	At 24 months from baseline.
Change in systolic blood pressure	To evaluate whether the intervention is superior to usual care in reducing cardiometabolic risk indicators over the 36-month period. Primary endpoint: Differences in the mean changes in systolic blood pressure (SBP) (mm Hg).	At 36 months from baseline.
Change in diastolic blood pressure	To evaluate whether the intervention is superior to usual care in reducing cardiometabolic risk indicators over the 36-month period. Primary endpoint: Differences in the mean changes in diastolic blood pressure (DBP) mm Hg.	At 12 months from baseline.
Change in diastolic blood pressure	To evaluate whether the intervention is superior to usual care in reducing cardiometabolic risk indicators over the 36-month period. Primary endpoint: Differences in the mean changes in diastolic blood pressure (DBP) mm Hg.	At 24 months from baseline.
Change in diastolic blood pressure	To evaluate whether the intervention is superior to usual care in reducing cardiometabolic risk indicators over the 36-month period. Primary endpoint: Differences in the mean changes in diastolic blood pressure (DBP) mm Hg.	At 36 months from baseline.
Change in triacylglycerol/high density lipoprotein-cholesterol ratio	To evaluate whether the intervention is superior to usual care in reducing cardiometabolic risk indicators over the 36-month period. Primary endpoint: Differences in the mean changes in triacylglycerol/high density lipoprotein-cholesterol ratio (TAG/HDL-C ratio).	At 12 months from baseline.
Change in triacylglycerol/high density lipoprotein-cholesterol ratio	To evaluate whether the intervention is superior to usual care in reducing cardiometabolic risk indicators over the 36-month period. Primary endpoint: Differences in the mean changes in triacylglycerol/high density lipoprotein-cholesterol ratio (TAG/HDL-C ratio).	At 24 months from baseline.
Change in triacylglycerol/high density lipoprotein-cholesterol ratio	To evaluate whether the intervention is superior to usual care in reducing cardiometabolic risk indicators over the 36-month period. Primary endpoint: Differences in the mean changes in triacylglycerol/high density lipoprotein-cholesterol ratio (TAG/HDL-C ratio).	At 36 months from baseline.
Change in total cholesterol/HDL-C ratio	To evaluate whether the intervention is superior to usual care in reducing cardiometabolic risk indicators over the 36-month period. Primary endpoint: Differences in the mean changes in total cholesterol/HDL-C ratio (TChol/HDL-C ratio).	At 12 months from baseline.
Change in total cholesterol/HDL-C ratio	To evaluate whether the intervention is superior to usual care in reducing cardiometabolic risk indicators over the 36-month period. Primary endpoint: Differences in the mean changes in total cholesterol/HDL-C ratio (TChol/HDL-C ratio).	At 24 months from baseline.
Change in total cholesterol/HDL-C ratio	To evaluate whether the intervention is superior to usual care in reducing cardiometabolic risk indicators over the 36-month period. Primary endpoint: Differences in the mean changes in total cholesterol/HDL-C ratio (TChol/HDL-C ratio).	At 36 months from baseline.
Change in plasma glucose	To evaluate whether the intervention is superior to usual care in reducing cardiometabolic risk indicators over the 36-month period. Primary endpoint: Differences in the mean changes in plasma glucose (mmol/L).	At 12 months from baseline.
Change in plasma glucose	To evaluate whether the intervention is superior to usual care in reducing cardiometabolic risk indicators over the 36-month period. Primary endpoint: Differences in the mean changes in plasma glucose (mmol/L).	At 24 months from baseline.
Change in plasma glucose	To evaluate whether the intervention is superior to usual care in reducing cardiometabolic risk indicators over the 36-month period. Primary endpoint: Differences in the mean changes in plasma glucose (mmol/L).	At 36 months from baseline.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cardiovascular disease (CVD) events or risk scores based on the SCORE2 algorithm	To assess whether the intervention is superior to usual care in reducing the risk of cardiovascular disease (CVD) at 36 months. Secondary endpoint: CVD outcomes: Hazard ratio of incident CVD events and/or differences in the mean change in the CVD risk score will be assessed using the Systematic COronary Risk Evaluation 2 (SCORE2), a tool designed to estimate the 10-year risk of cardiovascular events in individuals aged 40-89 years. SCORE2 ranges from a minimum value of 0% (indicating no risk) to a maximum value of 100% (indicating certainty of an event). Higher scores represent a worse outcome, as they reflect an increased likelihood of experiencing a cardiovascular event within the specified timeframe.	At 36 months from baseline.
Change in incident rate of type 2 diabetes mellitus events	To assess whether the intervention is superior to usual care in reducing type 2 diabetes mellitus at 36 months. Secondary endpoints: Diabetes mellitus outcomes: Hazard ratio of incident type 2 diabetes mellitus events.	At 36 months from baseline.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quality of life	To evaluate whether the intervention is superior to usual care in improving health-related quality of life over the 36-month period. Other endpoint: Difference in the mean change in the quality of life questionnaire (EQ-5D-5L)*. *Quality of life according to the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire, which measures five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Respondents indicate problems on each dimension at one of five levels: no problems, slight problems, moderate problems, severe problems, or extreme problems/unable to perform. The EQ-5D-5L classification system can describe 3,125 possible health states. Additionally, the EQ-5D-5L includes a visual analogue scale (EQ VAS), where respondents rate their current health on a scale from 0 (the worst health they can imagine) to 100 (the best health they can imagine).	At 12 months from baseline.
Change in quality of life	To evaluate whether the intervention is superior to usual care in improving health-related quality of life over the 36-month period. Other endpoint: Difference in the mean change in the quality of life questionnaire (EQ-5D-5L)*. *Quality of life according to the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire, which measures five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Respondents indicate problems on each dimension at one of five levels: no problems, slight problems, moderate problems, severe problems, or extreme problems/unable to perform. The EQ-5D-5L classification system can describe 3,125 possible health states. Additionally, the EQ-5D-5L includes a visual analogue scale (EQ VAS), where respondents rate their current health on a scale from 0 (the worst health they can imagine) to 100 (the best health they can imagine).	At 24 months from baseline.
Change in quality of life	To evaluate whether the intervention is superior to usual care in improving health-related quality of life over the 36-month period. Other endpoint: Difference in the mean change in the quality of life questionnaire (EQ-5D-5L)*. *Quality of life according to the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire, which measures five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Respondents indicate problems on each dimension at one of five levels: no problems, slight problems, moderate problems, severe problems, or extreme problems/unable to perform. The EQ-5D-5L classification system can describe 3,125 possible health states. Additionally, the EQ-5D-5L includes a visual analogue scale (EQ VAS), where respondents rate their current health on a scale from 0 (the worst health they can imagine) to 100 (the best health they can imagine).	At 36 months from baseline.
Change in high-sensitivity C-reactive protein	To assess whether the intervention reduces the levels of high-sensitivity C-reactive protein (hs-CRP) over the 36-month period. Other endpoints: Differences in the mean changes in hs-CRP (mg/L).	At 12 months from baseline.
Change in high-sensitivity C-reactive protein	To assess whether the intervention reduces the levels of high-sensitivity C-reactive protein (hs-CRP) over the 36-month period. Other endpoints: Differences in the mean changes in hs-CRP (mg/L).	At 24 months from baseline.
Change in high-sensitivity C-reactive protein	To assess whether the intervention reduces the levels of high-sensitivity C-reactive protein (hs-CRP) over the 36-month period. Other endpoints: Differences in the mean changes in hs-CRP (mg/L).	At 36 months from baseline.
Change in HbA1c	To assess whether the intervention reduces the levels of HbA1c over the 36-month period. Other endpoints: Differences in the mean changes in HbA1c (mmol/mol).	At 12 months from baseline.
Change in HbA1c	To assess whether the intervention reduces the levels of HbA1c over the 36-month period. Other endpoints: Differences in the mean changes in HbA1c (mmol/mol).	At 24 months from baseline.
Change in HbA1c	To assess whether the intervention reduces the levels of HbA1c over the 36-month period. Other endpoints: Differences in the mean changes in HbA1c (mmol/mol).	At 36 months from baseline.
Descriptive cost analysis	To conduct a cost analysis per participant and assess cost-effectiveness over the 36-month period, where cost neutrality is considered a positive outcome. Other endpoint: Descriptive cost analysis (average cost per participant) in SEK and EUR.	At 12 months from baseline.
Descriptive cost analysis	To conduct a cost analysis per participant and assess cost-effectiveness over the 36-month period, where cost neutrality is considered a positive outcome. Other endpoint: Descriptive cost analysis (average cost per participant) in SEK and EUR.	At 24 months from baseline.
Descriptive cost analysis	To conduct a cost analysis per participant and assess cost-effectiveness over the 36-month period, where cost neutrality is considered a positive outcome. Other endpoint: Descriptive cost analysis (average cost per participant) in SEK and EUR.	At 36 months from baseline.
Change in quality-Adjusted Life Years	To conduct a cost analysis per participant and assess cost-effectiveness over the 36-month period, where cost neutrality is considered a positive outcome. Other endpoints: Difference in the mean change in quality-adjusted life years (QALYs) between the intervention and control groups.	At 12 months from baseline.
Change in quality-Adjusted Life Years	To conduct a cost analysis per participant and assess cost-effectiveness over the 36-month period, where cost neutrality is considered a positive outcome. Other endpoints: Difference in the mean change in quality-adjusted life years (QALYs) between the intervention and control groups.	At 24 months from baseline.
Change in quality-Adjusted Life Years	To conduct a cost analysis per participant and assess cost-effectiveness over the 36-month period, where cost neutrality is considered a positive outcome. Other endpoints: Difference in the mean change in quality-adjusted life years (QALYs) between the intervention and control groups	At 36 months from baseline.
Incremental cost-effectiveness ratio based on CVD	To conduct a cost analysis per participant and assess cost-effectiveness over the 36-month period, where cost neutrality is considered a positive outcome Other endpoints: Incremental cost-effectiveness ratio (ICER) based on the number of CVD cases averted.	At 12 months from baseline.
Incremental cost-effectiveness ratio based on CVD	To conduct a cost analysis per participant and assess cost-effectiveness over the 36-month period, where cost neutrality is considered a positive outcome Other endpoints: Incremental cost-effectiveness ratio (ICER) based on the number of CVD cases averted.	At 24 months from baseline.
Incremental cost-effectiveness ratio based on CVD	To conduct a cost analysis per participant and assess cost-effectiveness over the 36-month period, where cost neutrality is considered a positive outcome Other endpoints: Incremental cost-effectiveness ratio (ICER) based on the number of CVD cases averted.	At 36 months from baseline.
Incremental cost-effectiveness ratio based on type 2 diabetes mellitus	To conduct a cost analysis per participant and assess cost-effectiveness over the 36-month period, where cost neutrality is considered a positive outcome Other endpoints: Incremental cost-effectiveness ratio (ICER) based on the number of type 2 diabetes mellitus cases averted.	At 12 months from baseline.
Incremental cost-effectiveness ratio based on type 2 diabetes mellitus	To conduct a cost analysis per participant and assess cost-effectiveness over the 36-month period, where cost neutrality is considered a positive outcome Other endpoints: Incremental cost-effectiveness ratio (ICER) based on the number of type 2 diabetes mellitus cases averted.	At 24 months from baseline.
Incremental cost-effectiveness ratio based on type 2 diabetes mellitus	To conduct a cost analysis per participant and assess cost-effectiveness over the 36-month period, where cost neutrality is considered a positive outcome Other endpoints: Incremental cost-effectiveness ratio (ICER) based on the number of type 2 diabetes mellitus cases averted.	At 36 months from baseline.
Incremental cost-effectiveness ratio based on QALYs	To conduct a cost analysis per participant and assess cost-effectiveness over the 36-month period, where cost neutrality is considered a positive outcome Other endpoints: Incremental cost-effectiveness ratio (ICER) based on the number of QALYs gained.	At 12 months from baseline.
Incremental cost-effectiveness ratio based on QALYs	To conduct a cost analysis per participant and assess cost-effectiveness over the 36-month period, where cost neutrality is considered a positive outcome Other endpoints: Incremental cost-effectiveness ratio (ICER) based on the number of QALYs gained.	At 24 months from baseline.
Incremental cost-effectiveness ratio based on QALYs	To conduct a cost analysis per participant and assess cost-effectiveness over the 36-month period, where cost neutrality is considered a positive outcome Other endpoints: Incremental cost-effectiveness ratio (ICER) based on the number of QALYs gained.	At 36 months from baseline.
Change in alcohol consumption	To evaluate whether the intervention improves targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) over the 36-month period. Other endpoints: Difference in the mean change in alcohol consumption (Alcohol Use Disorders Identification Test - Consumption (AUDIT-C)*, scale 0-12). *The AUDIT-C (Alcohol Use Disorders Identification Test-Consumption) is a brief screening tool consisting of three questions, with scores ranging from 0 to 12 points, used to identify risky alcohol use and potential alcohol use disorders.	At 12 months from baseline.
Change in alcohol consumption	To evaluate whether the intervention improves targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) over the 36-month period. Other endpoints: Difference in the mean change in alcohol consumption (Alcohol Use Disorders Identification Test - Consumption (AUDIT-C)*, scale 0-12). *The AUDIT-C (Alcohol Use Disorders Identification Test-Consumption) is a brief screening tool consisting of three questions, with scores ranging from 0 to 12 points, used to identify risky alcohol use and potential alcohol use disorders.	At 24 months from baseline.
Change in alcohol consumption	To evaluate whether the intervention improves targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) over the 36-month period. Other endpoints: Difference in the mean change in alcohol consumption (Alcohol Use Disorders Identification Test - Consumption (AUDIT-C)*, scale 0-12). *The AUDIT-C (Alcohol Use Disorders Identification Test-Consumption) is a brief screening tool consisting of three questions, with scores ranging from 0 to 12 points, used to identify risky alcohol use and potential alcohol use disorders.	At 36 months from baseline.
Change in tobacco smoking	To evaluate whether the intervention improves targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) over the 36-month period. Other endpoints: • Questionnaires Difference in the mean change in tobacco smoking* per week. *The tobacco smoking questionnaire assesses smoking behavior with targeted questions addressing current smoking status, past smoking history, age at smoking initiation or cessation, and smoking frequency (daily or weekly cigarette consumption). For smoking frequency: Daily smoking frequency: Minimum = 0 cigarettes/day; Maximum = unlimited (as self-reported by participants). Weekly smoking frequency: Minimum = 0 cigarettes/week; Maximum = unlimited (as self-reported by participants). Higher values for daily or weekly smoking frequency indicate worse outcomes (greater tobacco use).	At 12 months from baseline.
Change in tobacco smoking	To evaluate whether the intervention improves targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) over the 36-month period. Other endpoints: • Questionnaires Difference in the mean change in tobacco smoking* per week. *The tobacco smoking questionnaire assesses smoking behavior with targeted questions addressing current smoking status, past smoking history, age at smoking initiation or cessation, and smoking frequency (daily or weekly cigarette consumption). For smoking frequency: Daily smoking frequency: Minimum = 0 cigarettes/day; Maximum = unlimited (as self-reported by participants). Weekly smoking frequency: Minimum = 0 cigarettes/week; Maximum = unlimited (as self-reported by participants). Higher values for daily or weekly smoking frequency indicate worse outcomes (greater tobacco use).	At 24 months from baseline.
Change in tobacco smoking	To evaluate whether the intervention improves targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) over the 36-month period. Other endpoints: • Questionnaires Difference in the mean change in tobacco smoking* per week. *The tobacco smoking questionnaire assesses smoking behavior with targeted questions addressing current smoking status, past smoking history, age at smoking initiation or cessation, and smoking frequency (daily or weekly cigarette consumption). For smoking frequency: Daily smoking frequency: Minimum = 0 cigarettes/day; Maximum = unlimited (as self-reported by participants). Weekly smoking frequency: Minimum = 0 cigarettes/week; Maximum = unlimited (as self-reported by participants). Higher values for daily or weekly smoking frequency indicate worse outcomes (greater tobacco use).	At 36 months from baseline.
Change in dietary habits	To evaluate whether the intervention improves targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) over the 36-month period. Other endpoints: • Questionnaires Difference in the mean change in dietary habits (dietary index)* (scale 0-12). *The dietary habits questionnaire (Kostindex) assesses dietary patterns through questions on vegetable, fruit, fish, sweets, and breakfast consumption. Scores range from 0 to 12, categorizing habits as unhealthy, moderate, or healthy to guide nutritional advice.	At 12 months from baseline.
Change in dietary habits	To evaluate whether the intervention improves targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) over the 36-month period. Other endpoints: • Questionnaires Difference in the mean change in dietary habits (dietary index)* (scale 0-12). *The dietary habits questionnaire (Kostindex) assesses dietary patterns through questions on vegetable, fruit, fish, sweets, and breakfast consumption. Scores range from 0 to 12, categorizing habits as unhealthy, moderate, or healthy to guide nutritional advice.	At 24 months from baseline.
Change in dietary habits	To evaluate whether the intervention improves targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) over the 36-month period. Other endpoints: • Questionnaires Difference in the mean change in dietary habits (dietary index)* (scale 0-12). *The dietary habits questionnaire (Kostindex) assesses dietary patterns through questions on vegetable, fruit, fish, sweets, and breakfast consumption. Scores range from 0 to 12, categorizing habits as unhealthy, moderate, or healthy to guide nutritional advice.	At 36 months from baseline.
Change in physical activity	To evaluate whether the intervention improves targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) over the 36-month period. Other endpoints: Difference in the mean change in physical activity* (number of minutes per day). *The physical activity and inactivity questionnaire evaluates daily habits by measuring time spent on everyday activities, exercise, and sedentary time, including sleep. For physical activity: Higher values indicate better outcomes (more active time). For sedentary time: Higher values indicate worse outcomes (more inactive time).	At 12 months from baseline.
Change in physical activity	To evaluate whether the intervention improves targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) over the 36-month period. Other endpoints: Difference in the mean change in physical activity* (number of minutes per day). *The physical activity and inactivity questionnaire evaluates daily habits by measuring time spent on everyday activities, exercise, and sedentary time, including sleep. For physical activity: Higher values indicate better outcomes (more active time). For sedentary time: Higher values indicate worse outcomes (more inactive time).	At 24 months from baseline.
Change in physical activity	To evaluate whether the intervention improves targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) over the 36-month period. Other endpoints: Difference in the mean change in physical activity* (number of minutes per day). *The physical activity and inactivity questionnaire evaluates daily habits by measuring time spent on everyday activities, exercise, and sedentary time, including sleep. For physical activity: Higher values indicate better outcomes (more active time). For sedentary time: Higher values indicate worse outcomes (more inactive time).	At 36 months from baseline.
Requirements for achieving a change in targeted lifestyle	To explore the number, type, and average time interval between intervention sessions required annually to achieve a change in the targeted lifestyle over the 36-month period. Other endpoint: • For the intervention group, o Effect of the number and type of lifestyle sessions with healthcare professionals on the mean change in lifestyle outcomes.	At 12 months from baseline.
Requirements for achieving a change in targeted lifestyle	To explore the number, type, and average time interval between intervention sessions required annually to achieve a change in the targeted lifestyle over the 36-month period. Other endpoint: • For the intervention group, o Effect of the number and type of lifestyle sessions with healthcare professionals on the mean change in lifestyle outcomes.	At 24 months from baseline.
Requirements for achieving a change in targeted lifestyle	To explore the number, type, and average time interval between intervention sessions required annually to achieve a change in the targeted lifestyle over the 36-month period. Other endpoint: • For the intervention group, o Effect of the number and type of lifestyle sessions with healthcare professionals on the mean change in lifestyle outcomes.	At 36 months from baseline.
Effect of educational sessions	To investigate whether participation in educational sessions by participants and their relatives in the intervention group is associated with positive lifestyle changes over the 36-month period. Other endpoint: • For the intervention group, o Effect of participation in educational sessions (0-3 sessions) on the mean change in lifestyle outcomes.	At 12 months from baseline.
Effect of educational sessions	To investigate whether participation in educational sessions by participants and their relatives in the intervention group is associated with positive lifestyle changes over the 36-month period. Other endpoint: • For the intervention group, o Effect of participation in educational sessions (0-3 sessions) on the mean change in lifestyle outcomes.	At 24 months from baseline.
Effect of educational sessions	To investigate whether participation in educational sessions by participants and their relatives in the intervention group is associated with positive lifestyle changes over the 36-month period. Other endpoint: • For the intervention group, o Effect of participation in educational sessions (0-3 sessions) on the mean change in lifestyle outcomes.	At 36 months from baseline.

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region
• Collaborators: The Swedish Society of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: January 2, 2025
• First Submitted That Met QC Criteria: January 13, 2025
• First Posted (Actual): January 17, 2025

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Metabolic syndrome; Quality of life; Cost-effectiveness; Psychotic disorders; Cardiometabolic risk factors; Pragmatic clinical trial; Multicomponent intervention; Cardiovascular disease prevention; Behavior change intervention; Integrated health care
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Metabolic Diseases; Glucose Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Nutritional and Metabolic Diseases; Psychotic Disorders; Metabolic Syndrome; Investigative Techniques; Methods
• Other Study ID Numbers: CIV-24-09-049056

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: In accordance with the trial's CIP, individual participant data from this trial are not publicly available due to privacy and data protection regulations. All data are handled in compliance with the General Data Protection Regulation (EU 2016/679; GDPR) and relevant Swedish legislation, and are stored securely at Region Västra Götaland. Participants in the trial are coded with a specific record ID.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No