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

NCT06781801 | Recruiting

• 1 other identifier: CIV-24-09-049056
• Study Type: interventional
• Target: 650
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Psychotic Disorders

Keywords

Psychotic disorders; Quality of life; Cost-effectiveness; Cardiometabolic risk factors; Cardiovascular disease prevention; Metabolic syndrome; Pragmatic clinical trial; Integrated health care; Multicomponent intervention; Behavior change intervention

Outcome Measures

Primary Outcomes (3)

• Estimated absolute ten-year cardiovascular risk based on the SCORE2 algorithm

  Whether the intervention is superior to usual care in reducing the estimated absolute ten-year cardiovascular risk, assessed at 12, 24, and 36 months. Primary endpoint: The difference between the intervention and control groups in the mean change in estimated absolute cardiovascular risk, as assessed using the Systematic COronary Risk Evaluation 2 (SCORE2), a tool designed to estimate the 10-year risk of cardiovascular events in individuals aged 40-89 years. SCORE2 ranges from a minimum value of 0% (indicating no risk) to a maximum value of 100% (indicating certainty of an event). Higher scores represent a worse outcome, as they reflect an increased likelihood of experiencing a cardiovascular event within the specified timeframe.

  At 12 months from baseline.

• Estimated absolute ten-year cardiovascular risk based on the SCORE2 algorithm

  Whether the intervention is superior to usual care in reducing the estimated absolute ten-year cardiovascular risk, assessed at 12, 24, and 36 months. Primary endpoint: The difference between the intervention and control groups in the mean change in estimated absolute cardiovascular risk, as assessed using the Systematic COronary Risk Evaluation 2 (SCORE2), a tool designed to estimate the 10-year risk of cardiovascular events in individuals aged 40-89 years. SCORE2 ranges from a minimum value of 0% (indicating no risk) to a maximum value of 100% (indicating certainty of an event). Higher scores represent a worse outcome, as they reflect an increased likelihood of experiencing a cardiovascular event within the specified timeframe.

  At 24 months from baseline.

• Estimated absolute ten-year cardiovascular risk based on the SCORE2 algorithm

  Whether the intervention is superior to usual care in reducing the estimated absolute ten-year cardiovascular risk, assessed at 12, 24, and 36 months. Primary endpoint: The difference between the intervention and control groups in the mean change in estimated absolute cardiovascular risk, as assessed using the Systematic COronary Risk Evaluation 2 (SCORE2), a tool designed to estimate the 10-year risk of cardiovascular events in individuals aged 40-89 years. SCORE2 ranges from a minimum value of 0% (indicating no risk) to a maximum value of 100% (indicating certainty of an event). Higher scores represent a worse outcome, as they reflect an increased likelihood of experiencing a cardiovascular event within the specified timeframe.

  At 36 months from baseline.

Secondary Outcomes (63)

• Change in body mass index

  At 12 months from baseline.

• Change in body mass index

  At 24 months from baseline.

• Change in body mass index

  At 36 months from baseline.

• Change in waist-hip ratio

  At 12 months from baseline.

• Change in waist-hip ratio

  At 24 months from baseline.

Other Outcomes (6)

• Requirements for achieving a change in targeted lifestyle

  At 12 months from baseline.

• Requirements for achieving a change in targeted lifestyle

  At 24 months from baseline.

• Requirements for achieving a change in targeted lifestyle

  At 36 months from baseline.

Study Arms (2)

Control clinics (usual care)

NO INTERVENTION

The "usual care" model in Gothenburg includes annual health checks for individuals with psychotic disorders. Patients attend two 60-minute visits for assessments such as blood tests, blood pressure, and weight checks, with results evaluated using standard benchmarks or risk algorithms like SCORE2. Physicians may suggest referrals to primary care or recommend lifestyle changes, including diet, exercise, or substance use adjustments. Identified issues may prompt simple advice or referrals to health promoters for support with smoking cessation, dietary guidance, or group activities. The 36 ± 6-month clinical trial standardizes data collection at four outpatient clinics without altering care. Eligible patients sign consent, with rescreening allowed if a patient meets the exclusion criteria at one annual check but not at the next. Non-participants continue with regular care.

Intervention Clinics

EXPERIMENTAL

The annual health checks for the intervention group follow the same structure of two visits as in routine care as usual, with the primary difference being the content of the visits.

Other: Intervention

Interventions

Intervention OTHER

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 families on the link between psychotic disorders, lifestyle choices, and cardiometabolic health. Gradual lifestyle changes are tailored to individual needs, addressing stress and cognitive challenges, and follow national health guidelines with personalized advice and motivational tools. Regular follow-ups assess progress, while motivational tools "body composition analyzer and QRISK3" enhance engagement. Contact with internal and external resources is based on the assessment and motivational work.

Intervention Clinics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• The Swedish Society of Medicine: collaborator

Study Sites (6)

Psykosmottagning Centrum

Gothenburg, 411 13, Sweden

RECRUITING

Psykosmottagning Nordost

Gothenburg, 415 05, Sweden

RECRUITING

Psykosmottagning Öster

Gothenburg, 416 72, Sweden

RECRUITING

Psykosmottagning Hisingen

Gothenburg, 417 52, Sweden

RECRUITING

Psykosmottagning Väster

Gothenburg, 421 48, Sweden

RECRUITING

Psykosmottagning Mölndal

Mölndal, 431 35, Sweden

RECRUITING

Related Publications (1)

• 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 psychotic disorders over 36 months: the LAGOM protocol. BMC Psychiatry. 2026 Jun 23;26(1):487. doi: 10.1186/s12888-026-08315-3.

  PMID: 42337535 BACKGROUND

Related Links

• The published study protocol

MeSH Terms

Conditions

Psychotic Disorders; Metabolic Syndrome

Interventions

Methods

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

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

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: This is a longitudinal, multicenter, naturalistic, multicomponent, parallel-group, quasi-experimental cluster-based trial with a superiority framework. The trial uses a case-control clinical design with a 1:3 allocation ratio, assigning one participant at the intervention clinics for every three at the control clinics. Clusters are defined at the level of outpatient clinics, with two intervention clinics and four control clinics.

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 17, 2025
• Study Start: February 27, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: August 11, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (6)