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

Study acronym: LAGOM
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoints removed 21 → 3 primary endpoints
See other at-risk trials from Vastra Gotaland Region

Record History

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  1. Notable Primary endpoint(s) modifiedv5 Show 4 more changesShow less
    • Enrollment target: 644 to 650
    • Eligibility criteria expanded, about 39 words
    • Secondary endpoints: 2 to 63
    • Publications: details revised at 1 of 1 entry
  2. Notable Primary endpoints: 7 to 21
    • Eligibility criteria expanded, about 92 words
    • Secondary endpoints: 1 to 2
    • Site details revised at 2 of 6 sites
    v4
  3. Minor Site contacts updated at 2 of 6 sitesv3
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 1, 2025 to Feb 27, 2025
    • Site details revised at 6 of 6 sites
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06781801
Lead Sponsor Vastra Gotaland Region
Collaborators: The Swedish Society of Medicine
Conditions
(from sponsor)
Psychotic Disorders
Related terms Metabolic Syndrome, Psychotic Disorders
Enrollment 650 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov