NCT06781801

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

Longitudinal Approach to Generate Positive Cardiometabolic Health Outcomes in Severe Mental Illness

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 644 (estimated)
• Sponsor: Vastra Gotaland Region · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Psychotic Disorders

Interventions

Type	Name	Description
OTHER	Intervention	The intervention group follows a structured flowchart for annual health check-ups, focusing on assessing the cardiometabolic profile, considering sex and ethnicity. This assessment includes tracking changes in cardiometabolic parameters, alongside overall cardiometabolic risk using SCORE2 and if the criteria for metabolic syndrome are met. Lifestyle habits are evaluated based on health status, illness, and benefits of quitting unhealthy behaviors. Education sessions educate participants and families on the link between psychotic disorders, lifestyle choices, and cardiometabolic health. Gradual lifestyle changes are tailored to individual needs, addressing stress and cognitive challenges, and follow national health guidelines with personalized advice and motivational tools. Regular follow-ups assess progress, while motivational tools "body composition analyzer and QRISK3" enhance engagement. Contact with internal and external resources is based on the assessment and motivational work.

Timeline

• Start date: 2025-02-27
• Primary completion: 2029-12-31
• Completion: 2029-12-31
• First posted: 2025-01-17
• Last updated: 2025-12-09

Locations

6 sites across 1 country: Sweden