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

Last updated: December 1, 2025
Sponsor: Vastra Gotaland Region
Overall Status: Active - Recruiting

Phase

N/A

Condition

High Cholesterol (Hyperlipidemia)

Metabolic Disorders

Metabolic Syndrome

Treatment

Intervention

Clinical Study ID

NCT06781801
CIV-24-09-049056
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 Design

Total Participants: 644
Treatment Group(s): 1
Primary Treatment: Intervention
Phase:
Study Start date:
February 27, 2025
Estimated Completion Date:
December 31, 2029

Connect with a study center

  • Psykosmottagning Centrum

    Gothenburg, 411 13
    Sweden

    Active - Recruiting

  • Psykosmottagning Hisingen

    Gothenburg, 417 52
    Sweden

    Site Not Available

  • Psykosmottagning Nordost

    Gothenburg, 415 05
    Sweden

    Site Not Available

  • Psykosmottagning Väster

    Gothenburg, 421 48
    Sweden

    Active - Recruiting

  • Psykosmottagning Öster

    Gothenburg, 416 72
    Sweden

    Site Not Available

  • Psykosmottagning Centrum

    Gothenburg 2711537, 411 13
    Sweden

    Active - Recruiting

  • Psykosmottagning Hisingen

    Gothenburg 2711537, 417 52
    Sweden

    Active - Recruiting

  • Psykosmottagning Nordost

    Gothenburg 2711537, 415 05
    Sweden

    Active - Recruiting

  • Psykosmottagning Väster

    Gothenburg 2711537, 421 48
    Sweden

    Active - Recruiting

  • Psykosmottagning Öster

    Gothenburg 2711537, 416 72
    Sweden

    Active - Recruiting

  • Psykosmottagning Mölndal

    Mölndal, 431 35
    Sweden

    Site Not Available

  • Psykosmottagning Mölndal

    Mölndal 2691459, 431 35
    Sweden

    Active - Recruiting

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