Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06781801

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

Led by Vastra Gotaland Region · Updated on 2025-12-09

644

Participants Needed

6

Research Sites

252 weeks

Total Duration

On this page

Sponsors

V

Vastra Gotaland Region

Lead Sponsor

T

The Swedish Society of Medicine

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 18 years or older diagnosed with schizophrenia spectrum disorders (ICD-10 codes F20-F25 or F28-F29)
  • Ability to provide informed consent
Not Eligible

You will not qualify if you...

  • Having an electrical medical implant such as a pacemaker or other mechanical implants
  • Pregnancy
  • Deemed unsuitable by the investigator due to safety or participation challenges
  • Prior participation in the LAGOM trial during a previous inclusion cycle
  • Currently under compulsory care

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

Psykosmottagning Centrum

Gothenburg, Sweden, 411 13

Actively Recruiting

2

Psykosmottagning Nordost

Gothenburg, Sweden, 415 05

Actively Recruiting

3

Psykosmottagning Öster

Gothenburg, Sweden, 416 72

Actively Recruiting

4

Psykosmottagning Hisingen

Gothenburg, Sweden, 417 52

Actively Recruiting

5

Psykosmottagning Väster

Gothenburg, Sweden, 421 48

Actively Recruiting

6

Psykosmottagning Mölndal

Mölndal, Sweden, 431 35

Actively Recruiting

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Research Team

H

Hemen Najar, M.D., Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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