RecruitingNot ApplicableNCT06781801

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

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


Sponsor

Vastra Gotaland Region

Enrollment

650 participants

Start Date

Feb 27, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether a structured exercise and heart health monitoring program can improve the physical and metabolic health of adults with schizophrenia spectrum disorders — conditions that often come with higher rates of heart disease and diabetes. Participants will use a wearable device to track activity and health metrics. **You may be eligible if...** - You are 18 or older - You have a diagnosis of schizophrenia or a related disorder (e.g., schizoaffective disorder) - You are able to give informed consent **You may NOT be eligible if...** - You have an implanted medical device (such as a pacemaker) - You are pregnant - You are currently under compulsory psychiatric care - You have participated in this specific trial before - Physical disabilities or travel difficulties make participation unsafe or impractical Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERIntervention

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.


Locations(6)

Psykosmottagning Centrum

Gothenburg, Sweden

Psykosmottagning Nordost

Gothenburg, Sweden

Psykosmottagning Öster

Gothenburg, Sweden

Psykosmottagning Hisingen

Gothenburg, Sweden

Psykosmottagning Väster

Gothenburg, Sweden

Psykosmottagning Mölndal

Mölndal, Sweden

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06781801


Related Trials