NCT06781801 Improving Heart and Metabolic Health in People With Severe Mental Illness Through a Long-term Clinical Trial
| NCT ID | NCT06781801 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vastra Gotaland Region |
| Condition | Psychotic Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 644 participants |
| Start Date | 2025-02-27 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 644 participants in total. It began in 2025-02-27 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06781801 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Psychotic Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06781801 currently recruiting?
Yes, NCT06781801 is actively recruiting participants. Contact the research team at hemen.najar@vgregion.se for enrollment information.
Where is the NCT06781801 trial being conducted?
This trial is being conducted at Gothenburg, Sweden, Gothenburg, Sweden, Gothenburg, Sweden, Gothenburg, Sweden and 2 additional locations.
Who is sponsoring the NCT06781801 clinical trial?
NCT06781801 is sponsored by Vastra Gotaland Region. The trial plans to enroll 644 participants.