Actively Recruiting
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
Eligibility Criteria
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
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
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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
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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