Background Cardiometabolic conditions-including cardiovascular disease, type 2 diabetes, and obesity-are highly prevalent among individuals with psychotic disorders. These conditions contribute substantially to reduced life expectancy, diminished quality of life, and increased societal and economic burdens. Thus, effective, individualized interventions are urgently needed. Outpatient psychiatric clinics offer an ideal setting for such efforts owing to regular patient contact and access to multidisciplinary care. We have developed a comprehensive, clinically integrated trial aimed at improving cardiometabolic health, promoting healthier lifestyles, and enhancing quality of life for individuals with psychotic disorders receiving care in the Greater Gothenburg region.
Methods LAGOM is a multicenter, naturalistic, quasi-experimental case-control trial conducted across six geographically separate outpatient psychosis clinics within the Department of Psychotic Disorders at Sahlgrenska University Hospital, a multi-site university hospital in the Greater Gothenburg region. A total of 650 adults with psychotic disorders will be recruited from these clinics. Two clinics will implement the LAGOM intervention, whereas four will serve as control sites delivering usual care. The intervention is embedded within routine psychiatric care and grounded in behavioral science. It includes comprehensive cardiometabolic risk assessments, two visual motivational tools (QRISK3 and a body composition analyzer), personalized follow-up plans, risk-oriented referrals to primary care, and structured education for patients, relatives, and staff. The intervention is designed to be scalable, sustainable, and tailored to individual patient needs.
Discussion If proven superior to usual care, this pragmatic, multicomponent intervention-delivered within routine psychiatric care-could improve cardiometabolic health and quality of life for individuals with psychotic disorders. Embedding the intervention within existing clinical structures enhances its scalability and feasibility and, if effective, could serve as a model for wider implementation.
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)
Ability to provide informed consent
Having an electrical medical implant such as a pacemaker or other mechanical implants
Pregnancy
Deemed unsuitable by the investigator: A person may be deemed unsuitable for participation if circumstances prevent safe or reliable participation in the trial. Examples include inability or unwillingness to maintain contact with the clinic (e.g., absence of a stable address or telephone number), planned relocation or transfer to another treatment facility, municipality, or country during the trial period, mobility limitations or other practical barriers preventing attendance at clinic visits, or administrative restrictions preventing appropriate documentation in medical records or trial databases (e.g., protected or anonymous identity status). Such decisions are made on an individual basis in consultation with the clinical team (case manager (CM), treating psychiatrist, and site principal investigator (PI)) to ensure patient safety and trial integrity.
Prior participation in the LAGOM trial during a previous inclusion cycle (i.e., participants can only be included once during the trial period).
Parallel
Intervention
Other interventionThe 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.
Estimated absolute ten-year cardiovascular risk based on the SCORE2 algorithm
Whether the intervention is superior to usual care in reducing the estimated absolute ten-year cardiovascular risk, assessed at 12, 24, and 36 months. Primary endpoint: The difference between the intervention and control groups in the mean change in estimated absolute cardiovascular risk, as 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.
Estimated absolute ten-year cardiovascular risk based on the SCORE2 algorithm
Whether the intervention is superior to usual care in reducing the estimated absolute ten-year cardiovascular risk, assessed at 12, 24, and 36 months. Primary endpoint: The difference between the intervention and control groups in the mean change in estimated absolute cardiovascular risk, as 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.
Estimated absolute ten-year cardiovascular risk based on the SCORE2 algorithm
Whether the intervention is superior to usual care in reducing the estimated absolute ten-year cardiovascular risk, assessed at 12, 24, and 36 months. Primary endpoint: The difference between the intervention and control groups in the mean change in estimated absolute cardiovascular risk, as 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.
Change in body mass index
To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in body mass index (BMI) (kg/m2).
Change in body mass index
To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in body mass index (BMI) (kg/m2).
Change in body mass index
To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in body mass index (BMI) (kg/m2).
Change in waist-hip ratio
To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in waist-hip ratio (WHR).
Requirements for achieving a change in targeted lifestyle
To assess how the number, type, and average interval between lifestyle-focused intervention sessions are associated with changes in lifestyle outcomes at 12, 24, and 36 months within the intervention group to examine factors related to engagement with the intervention.
Requirements for achieving a change in targeted lifestyle
To assess how the number, type, and average interval between lifestyle-focused intervention sessions are associated with changes in lifestyle outcomes at 12, 24, and 36 months within the intervention group to examine factors related to engagement with the intervention.
Requirements for achieving a change in targeted lifestyle
To assess how the number, type, and average interval between lifestyle-focused intervention sessions are associated with changes in lifestyle outcomes at 12, 24, and 36 months within the intervention group to examine factors related to engagement with the intervention.
Effect of educational sessions
To assess whether participation in educational sessions (0-3 sessions) by participants and their relatives is associated with changes in lifestyle outcomes at 12, 24, and 36 months within the intervention group to examine factors related to engagement with the intervention.
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Vastra Gotaland Region
Lead sponsor
The Swedish Society of Medicine
Collaborator
