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

Official title

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

Overview

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.

Interventions

• 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 fam

Primary outcome measures

• Change in body mass index [Time frame: At 12 months from baseline.]
• Change in body mass index [Time frame: At 24 months from baseline.]
• Change in body mass index [Time frame: At 36 months from baseline.]
• Change in waist-hip ratio [Time frame: At 12 months from baseline.]
• Change in waist-hip ratio [Time frame: At 24 months from baseline.]
• Change in waist-hip ratio [Time frame: At 36 months from baseline.]
• Change in systolic blood pressure [Time frame: At 12 months from baseline.]
• Change in systolic blood pressure [Time frame: At 24 months from baseline.]
• Change in systolic blood pressure [Time frame: At 36 months from baseline.]
• Change in diastolic blood pressure [Time frame: At 12 months from baseline.]

Secondary outcome measures (2)

• Change in cardiovascular disease (CVD) events or risk scores based on the SCORE2 algorithm [Time frame: At 36 months from baseline.]
• Change in incident rate of type 2 diabetes mellitus events [Time frame: At 36 months from baseline.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

Sweden · 6 centers

• Psykosmottagning Centrum — Gothenburg
• Psykosmottagning Nordost — Gothenburg
• Psykosmottagning Öster — Gothenburg
• Psykosmottagning Hisingen — Gothenburg
• Psykosmottagning Väster — Gothenburg
• Psykosmottagning Mölndal — Mölndal

Publications

• Najar H, Jedenius E, Froberg A, Olofsson A, Holmbom C, Bjorlin CK, Hagberg C, Saari-Bladmyr E, Hantelius E, Walinder E, Andreasson E, Gustafsson J, Lundin L, Klysing L, Rundqvist L, Korvek N, Rydell P, Heder S, Zeebari Z, Holmberg C. Multicenter, cluster-based, superiority trial of a multicomponent lifestyle intervention versus usual care for reducing cardiometabolic risk in individuals with psych PMID 42337535

Identifiers

NCT: NCT06781801 · CIV-24-09-049056

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗