NCT06781801: LAGOM

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

Recruiting now NA Last updated 9 December 2025

What this trial tests

NA trial testing Intervention in Psychotic Disorders in 644 participants. Currently enrolling.

Timeline

27 February 2025

Primary endpoint
31 December 2029

31 December 2029

Quick facts

Lead sponsor	Vastra Gotaland Region
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	644
Start date	27 February 2025
Primary completion	31 December 2029
Estimated completion	31 December 2029
Sites	6 locations across Sweden

Drugs / interventions tested

• Intervention

Conditions studied

• Psychotic Disorders — all drugs for Psychotic Disorders →

Sponsor

Vastra Gotaland Region — full company profile →

Who can join

18 and older, any sex, with Psychotic Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Multicenter, cluster-based, superiority trial of a multicomponent lifestyle intervention versus usual care for reducing cardiometabolic risk in individuals with psychotic disorders over 36 months: the LAGOM protocol
   Najar H, Jedenius E, Fröberg A, Olofsson A, et al · · 2026 · DOI 10.21203/rs.3.rs-7972355/v1