RecruitingNot Applicable

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

Sweden644 participantsStarted 2025-02-27

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Adults ≥18 years of age meeting the International Classification of Diseases, Tenth Revision (ICD-10) diagnostic criteria for any one of the schizophrenia spectrum disorders (F20-F25 or F28-F29)
✓. Ability to provide informed consent

Exclusion criteria

✕. Having an electrical medical implant such as a pacemaker or other mechanical implants
✕. Pregnancy
✕. Deemed unsuitable by the investigator (a person may be deemed unsuitable for participation in the trial by the clinical investigation team member based on factors that may affect the ability to participate safely and reliably. These factors may include, but are not limited to, physical disabilities that hinder participation or practical challenges such as long travel distances to the trial site. The assessment is made on an individual basis and aims to ensure both patient safety and trial integrity).
✕. Prior participation in the LAGOM trial during a previous inclusion cycle (i.e., participants can only be included once during the trial period).
✕. Currently under compulsory care.

What they're measuring

Change in body mass index

Timeframe: At 12 months from baseline.

Change in body mass index

Timeframe: At 24 months from baseline.

Change in body mass index

Timeframe: At 36 months from baseline.

Change in waist-hip ratio

Timeframe: At 12 months from baseline.

Change in waist-hip ratio

Timeframe: At 24 months from baseline.

Change in waist-hip ratio

Timeframe: At 36 months from baseline.

Change in systolic blood pressure

Timeframe: At 12 months from baseline.

Change in systolic blood pressure

Timeframe: At 24 months from baseline.

Trial details

NCT IDNCT06781801

SponsorVastra Gotaland Region

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2029-12-31

Contact for this trial

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

0046 73 566 15 64 hemen.najar@vgregion.se

View on ClinicalTrials.gov More Psychotic Disorders trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Adults ≥18 years of age meeting the International Classification of Diseases, Tenth Revision (ICD-10) diagnostic criteria for any one of the schizophrenia spectrum disorders (F20-F25 or F28-F29)
✓. Ability to provide informed consent

Exclusion criteria

✕. Having an electrical medical implant such as a pacemaker or other mechanical implants
✕. Pregnancy
✕. Deemed unsuitable by the investigator (a person may be deemed unsuitable for participation in the trial by the clinical investigation team member based on factors that may affect the ability to participate safely and reliably. These factors may include, but are not limited to, physical disabilities that hinder participation or practical challenges such as long travel distances to the trial site. The assessment is made on an individual basis and aims to ensure both patient safety and trial integrity).
✕. Prior participation in the LAGOM trial during a previous inclusion cycle (i.e., participants can only be included once during the trial period).
✕. Currently under compulsory care.

What they're measuring

Change in body mass index

Timeframe: At 12 months from baseline.

Change in body mass index

Timeframe: At 24 months from baseline.

Change in body mass index

Timeframe: At 36 months from baseline.

Change in waist-hip ratio

Timeframe: At 12 months from baseline.

Change in waist-hip ratio

Timeframe: At 24 months from baseline.

Change in waist-hip ratio

Timeframe: At 36 months from baseline.

Change in systolic blood pressure

Timeframe: At 12 months from baseline.

Change in systolic blood pressure

Timeframe: At 24 months from baseline.