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: 644
• Locations: 1 country
• Sites: 6

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.

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 (21)

• Change in body mass index

  To evaluate whether the intervention is superior to usual care in reducing cardiometabolic risk indicators over the 36-month period. Primary endpoint: Differences in the mean changes in body mass index (BMI) (kg/m2).

  At 12 months from baseline.

• Change in body mass index

  To evaluate whether the intervention is superior to usual care in reducing cardiometabolic risk indicators over the 36-month period. Primary endpoint: Differences in the mean changes in body mass index (BMI) (kg/m2).

  At 24 months from baseline.

• Change in body mass index

  To evaluate whether the intervention is superior to usual care in reducing cardiometabolic risk indicators over the 36-month period. Primary endpoint: Differences in the mean changes in body mass index (BMI) (kg/m2).

  At 36 months from baseline.

• Change in waist-hip ratio

  To evaluate whether the intervention is superior to usual care in reducing cardiometabolic risk indicators over the 36-month period. Primary endpoint: Differences in the mean changes in waist-hip ratio (WHR).

  At 12 months from baseline.

• Change in waist-hip ratio

  To evaluate whether the intervention is superior to usual care in reducing cardiometabolic risk indicators over the 36-month period. Primary endpoint: Differences in the mean changes in waist-hip ratio (WHR).

  At 24 months from baseline.

• Change in waist-hip ratio

  To evaluate whether the intervention is superior to usual care in reducing cardiometabolic risk indicators over the 36-month period. Primary endpoint: Differences in the mean changes in waist-hip ratio (WHR).

  At 36 months from baseline.

• Change in systolic blood pressure

  To evaluate whether the intervention is superior to usual care in reducing cardiometabolic risk indicators over the 36-month period. Primary endpoint: Differences in the mean changes in systolic blood pressure (SBP) (mm Hg).

  At 12 months from baseline.

• Change in systolic blood pressure

  To evaluate whether the intervention is superior to usual care in reducing cardiometabolic risk indicators over the 36-month period. Primary endpoint: Differences in the mean changes in systolic blood pressure (SBP) (mm Hg).

  At 24 months from baseline.

• Change in systolic blood pressure

  To evaluate whether the intervention is superior to usual care in reducing cardiometabolic risk indicators over the 36-month period. Primary endpoint: Differences in the mean changes in systolic blood pressure (SBP) (mm Hg).

  At 36 months from baseline.

• Change in diastolic blood pressure

  To evaluate whether the intervention is superior to usual care in reducing cardiometabolic risk indicators over the 36-month period. Primary endpoint: Differences in the mean changes in diastolic blood pressure (DBP) mm Hg.

  At 12 months from baseline.

• Change in diastolic blood pressure

  To evaluate whether the intervention is superior to usual care in reducing cardiometabolic risk indicators over the 36-month period. Primary endpoint: Differences in the mean changes in diastolic blood pressure (DBP) mm Hg.

  At 24 months from baseline.

• Change in diastolic blood pressure

  To evaluate whether the intervention is superior to usual care in reducing cardiometabolic risk indicators over the 36-month period. Primary endpoint: Differences in the mean changes in diastolic blood pressure (DBP) mm Hg.

  At 36 months from baseline.

• Change in triacylglycerol/high density lipoprotein-cholesterol ratio

  To evaluate whether the intervention is superior to usual care in reducing cardiometabolic risk indicators over the 36-month period. Primary endpoint: Differences in the mean changes in triacylglycerol/high density lipoprotein-cholesterol ratio (TAG/HDL-C ratio).

  At 12 months from baseline.

• Change in triacylglycerol/high density lipoprotein-cholesterol ratio

  To evaluate whether the intervention is superior to usual care in reducing cardiometabolic risk indicators over the 36-month period. Primary endpoint: Differences in the mean changes in triacylglycerol/high density lipoprotein-cholesterol ratio (TAG/HDL-C ratio).

  At 24 months from baseline.

• Change in triacylglycerol/high density lipoprotein-cholesterol ratio

  To evaluate whether the intervention is superior to usual care in reducing cardiometabolic risk indicators over the 36-month period. Primary endpoint: Differences in the mean changes in triacylglycerol/high density lipoprotein-cholesterol ratio (TAG/HDL-C ratio).

  At 36 months from baseline.

• Change in total cholesterol/HDL-C ratio

  To evaluate whether the intervention is superior to usual care in reducing cardiometabolic risk indicators over the 36-month period. Primary endpoint: Differences in the mean changes in total cholesterol/HDL-C ratio (TChol/HDL-C ratio).

  At 12 months from baseline.

• Change in total cholesterol/HDL-C ratio

  To evaluate whether the intervention is superior to usual care in reducing cardiometabolic risk indicators over the 36-month period. Primary endpoint: Differences in the mean changes in total cholesterol/HDL-C ratio (TChol/HDL-C ratio).

  At 24 months from baseline.

• Change in total cholesterol/HDL-C ratio

  To evaluate whether the intervention is superior to usual care in reducing cardiometabolic risk indicators over the 36-month period. Primary endpoint: Differences in the mean changes in total cholesterol/HDL-C ratio (TChol/HDL-C ratio).

  At 36 months from baseline.

• Change in plasma glucose

  To evaluate whether the intervention is superior to usual care in reducing cardiometabolic risk indicators over the 36-month period. Primary endpoint: Differences in the mean changes in plasma glucose (mmol/L).

  At 12 months from baseline.

• Change in plasma glucose

  To evaluate whether the intervention is superior to usual care in reducing cardiometabolic risk indicators over the 36-month period. Primary endpoint: Differences in the mean changes in plasma glucose (mmol/L).

  At 24 months from baseline.

• Change in plasma glucose

  To evaluate whether the intervention is superior to usual care in reducing cardiometabolic risk indicators over the 36-month period. Primary endpoint: Differences in the mean changes in plasma glucose (mmol/L).

  At 36 months from baseline.

Secondary Outcomes (2)

• Change in cardiovascular disease (CVD) events or risk scores based on the SCORE2 algorithm

  At 36 months from baseline.

• Change in incident rate of type 2 diabetes mellitus events

  At 36 months from baseline.

Other Outcomes (42)

• Change in quality of life

  At 12 months from baseline.

• Change in quality of life

  At 24 months from baseline.

• Change in quality of life

  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 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).
• 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

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: December 9, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (6)