NCT06781801Recruiting
Improving Heart and Metabolic Health in People With Severe Mental Illness Through a Long-term Clinical Trial
Longitudinal Approach to Generate Positive Cardiometabolic Health Outcomes in Severe Mental Illness
Source: ClinicalTrials.gov · Last updated 11 Aug 2026
Brief summary (registry, in English)
Background Cardiometabolic conditions-including cardiovascular disease, type 2 diabetes, and obesity-are highly prevalent among individuals with psychotic disorders. These conditions contribute substantially to reduced life expectancy, diminished quality of life, and increased societal and economic burdens. Thus, effective, individualized interventions are urgently needed. Outpatient psychiatric clinics offer an ideal setting for such efforts owing to regular patient contact and access to multidisciplinary care. We have developed a comprehensive, clinically integrated trial aimed at improving cardiometabolic health, promoting healthier lifestyles, and enhancing quality of life for individuals with psychotic disorders receiving care in the Greater Gothenburg region. Methods LAGOM is a multicenter, naturalistic, quasi-experimental case-control trial conducted across six geographically separate outpatient psychosis clinics within the Department of Psychotic Disorders at Sahlgrenska University Hospital, a multi-site university hospital in the Greater Gothenburg region. A total of 650 adults with psychotic disorders will be recruited from these clinics. Two clinics will implement the LAGOM intervention, whereas four will serve as control sites delivering usual care. The intervention is embedded within routine psychiatric care and grounded in behavioral science. It includes comprehensive cardiometabolic risk assessments, two visual motivational tools (QRISK3 and a body composition analyzer), personalized follow-up plans, risk-oriented referrals to primary care, and structured education for patients, relatives, and staff. The intervention is designed to be scalable, sustainable, and tailored to individual patient needs. Discussion If proven superior to usual care, this pragmatic, multicomponent intervention-delivered within routine psychiatric care-could improve cardiometabolic health and quality of life for individuals with psychotic disorders. Embedding the intervention within existing clinical structures enhances its scalability and feasibility and, if effective, could serve as a model for wider implementation.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 650 (estimated)
- First submitted
- 2 Jan 2025
- Start date
- 27 Feb 2025
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- Vastra Gotaland Region
- NCT number
- NCT06781801
What you commit to
- Study type: Interventional
- Planned participants: 650
- From 27 Feb 2025 to the primary completion date, 31 Dec 2029
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Having an electrical medical implant such as a pacemaker or other mechanical implants
- Prior participation in the LAGOM trial during a previous inclusion cycle (i.e., participants can only be included once during the trial period).
Other
- Pregnancy
- Deemed unsuitable by the investigator: A person may be deemed unsuitable for participation if circumstances prevent safe or reliable participation in the trial. Examples include inability or unwillingness to maintain contact with the clinic (e.g., absence of a stable address or telephone number), planned relocation or transfer to another treatment facility, municipality, or country during the trial period, mobility limitations or other practical barriers preventing attendance at clinic visits, or administrative restrictions preventing appropriate documentation in medical records or trial databases (e.g., protected or anonymous identity status). Such decisions are made on an individual basis in consultation with the clinical team (case manager (CM), treating psychiatrist, and site principal investigator (PI)) to ensure patient safety and trial integrity.
- Currently under compulsory care.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Psykosmottagning Väster Coordinator of this site? Confirm its status | Gothenburg | Sweden | Recruiting |
| Psykosmottagning Öster Coordinator of this site? Confirm its status | Gothenburg | Sweden | Recruiting |
| Psykosmottagning Nordost Coordinator of this site? Confirm its status | Gothenburg | Sweden | Recruiting |
| Psykosmottagning Hisingen Coordinator of this site? Confirm its status | Gothenburg | Sweden | Recruiting |
| Psykosmottagning Centrum Coordinator of this site? Confirm its status | Gothenburg | Sweden | Recruiting |
| Psykosmottagning Mölndal Coordinator of this site? Confirm its status | Mölndal | Sweden | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.