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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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

Inclusion Criteria:

  1. Adults, ≥18 years, meeting ICD-10 diagnostic criteria for any one of the schizophrenia spectrum disorders (F20-F25 or F28-F29).
  2. Has the ability to sign informed consent.

Exclusion Criteria:

  1. Having an electrical medical implant like pacemaker or other mechanical implants.
  2. Pregnant women.
  3. Deemed unsuitable for inclusion at the discretion of the investigator.
  4. Previous participation in the clinical trial.
  5. Under treatment with compulsory care.

Study details
    Psychotic Disorders

NCT06781801

Vastra Gotaland Region

15 October 2025

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