Improving heart and metabolic health in people with severe mental illness
Longitudinal Approach to Generate Positive Cardiometabolic Health Outcomes in Severe Mental Illness
This study is testing a new program to help people with severe mental illness, like schizophrenia, improve their heart and overall health by promoting healthier lifestyles.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 644 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vastra Gotaland Region Government |
| Locations | 6 sites (Gothenburg and 5 other locations) |
| Trial ID | NCT06781801 on ClinicalTrials.gov |
What this trial studies
This clinical trial focuses on enhancing cardiometabolic health in individuals with psychotic disorders, who often face significant health challenges. The study will involve 644 adults diagnosed with schizophrenia spectrum disorders, recruited from six outpatient clinics in Gothenburg. Participants will receive a comprehensive intervention program designed to promote healthy lifestyles and improve quality of life. The approach leverages the regular visits to outpatient clinics and the expertise of diverse health professionals to deliver individualized care.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with schizophrenia spectrum disorders.
Not a fit: Patients with electrical medical implants, pregnant women, or those deemed unsuitable by the investigator may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the cardiometabolic health and overall quality of life for individuals with severe mental illness.
How similar studies have performed: While there is ongoing research in this area, this specific comprehensive intervention approach is novel and has not been extensively tested in similar populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria 1. 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) 2. Ability to provide informed consent Exclusion criteria 1. Having an electrical medical implant such as a pacemaker or other mechanical implants 2. Pregnancy 3. 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). 4. Prior participation in the LAGOM trial during a previous inclusion cycle (i.e., participants can only be included once during the trial period). 5. Currently under compulsory care.
Where this trial is running
Gothenburg and 5 other locations
- Psykosmottagning Centrum — Gothenburg, Sweden (Recruiting)
- Psykosmottagning Nordost — Gothenburg, Sweden (Recruiting)
- Psykosmottagning Öster — Gothenburg, Sweden (Recruiting)
- Psykosmottagning Hisingen — Gothenburg, Sweden (Recruiting)
- Psykosmottagning Väster — Gothenburg, Sweden (Recruiting)
- Psykosmottagning Mölndal — Mölndal, Sweden (Recruiting)
Study contacts
- Study coordinator: Hemen Najar, M.D., Ph.D.
- Email: hemen.najar@vgregion.se
- Phone: 0046 73 566 15 64
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.