Improving Heart and Metabolic Health in People With Severe Mental Illness Through a Long-term Clinical Trial
NCT ID: NCT06781801
Last Updated: 2025-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
644 participants
INTERVENTIONAL
2025-02-27
2029-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
No interventions assigned to this group
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Ability to provide informed consent
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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The Swedish Society of Medicine
OTHER
Vastra Gotaland Region
OTHER_GOV
Responsible Party
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Locations
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Psykosmottagning Centrum
Gothenburg, , Sweden
Psykosmottagning Nordost
Gothenburg, , Sweden
Psykosmottagning Öster
Gothenburg, , Sweden
Psykosmottagning Hisingen
Gothenburg, , Sweden
Psykosmottagning Väster
Gothenburg, , Sweden
Psykosmottagning Mölndal
Mölndal, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CIV-24-09-049056
Identifier Type: -
Identifier Source: org_study_id
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