Psychotic DisordersLAGOMNCT06781801
Improving Heart and Metabolic Health in People With Severe Mental Illness Through a Long-term Clinical Trial
A study testing Intervention in people with Psychotic Disorders, run by Vastra Gotaland Region at 6 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychotic Disorders
- What is being tested?
- Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 6 sitesSweden
- Study dates
- 27 Feb 2025to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
- Prior participation in the LAGOM trial during a previous inclusion cycle (i.e., participants can only be included once during the trial period).
- Currently under compulsory care.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Sweden6 sites, 6 recruiting
- Recruiting
Psykosmottagning Centrum
Gothenburg, 411 13
Eva Andreasson, 0046 70 242 67 97, evaandreasson17@gmail.com
Eva Andreasson
- Recruiting
Psykosmottagning Nordost
Gothenburg, 415 05
Elin Saari-Bladmyr, 0046 70 355 13 57, elin.bladmyr@vgregion.se
Elin Saari-Bladmyr
- Recruiting
Psykosmottagning Öster
Gothenburg, 416 72
Lina Klysing, 0046 72 145 83 73, lina.persson@vgregion.se
Lina Klysing
- Recruiting
Psykosmottagning Hisingen
Gothenburg, 417 52
Christina Hagberg, 0046 73 660 14 18, christina.i.hagberg@vgregion.se
Christina Hagberg
- Recruiting
Psykosmottagning Väster
Gothenburg, 421 48
Caroline Holmbom, 0046 76 949 43 08, caroline.e.larsson@vgregion.se
Caroline Holmbom
- Recruiting
Psykosmottagning Mölndal
Mölndal, 431 35
Erik Wålinder, 0046 76 940 29 76, erik.walinder@vgregion.se
Erik Wålinder
About this study
Official title: Longitudinal Approach to Generate Positive Cardiometabolic Health Outcomes in Severe Mental Illness
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
- Being tested
- Intervention
- 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
- Medical subject headings
- Psychotic Disorders, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At 36 months from baseline.
Secondary outcomes (63)
Change in body mass index
To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months.
Secondary endpoint:
Difference in the mean change in body mass index (BMI) (kg/m2).
Measured: At 12 months from baseline.
Change in body mass index
To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months.
Secondary endpoint:
Difference in the mean change in body mass index (BMI) (kg/m2).
Measured: At 24 months from baseline.
Change in body mass index
To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months.
Secondary endpoint:
Difference in the mean change in body mass index (BMI) (kg/m2).
Measured: At 36 months from baseline.
Change in waist-hip ratio
To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months.
Secondary endpoint:
Difference in the mean change in waist-hip ratio (WHR).
Measured: At 12 months from baseline.
Change in waist-hip ratio
To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months.
Secondary endpoint:
Difference in the mean change in waist-hip ratio (WHR).
Measured: At 24 months from baseline.
Change in waist-hip ratio
To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months.
Secondary endpoint:
Difference in the mean change in waist-hip ratio (WHR).
Measured: At 36 months from baseline.
Change in systolic blood pressure
To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months.
Secondary endpoint:
Difference in the mean change in systolic blood pressure (SBP) (mm Hg).
Measured: At 12 months from baseline.
Change in systolic blood pressure
To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months.
Secondary endpoint:
Difference in the mean change in systolic blood pressure (SBP) (mm Hg).
Measured: At 24 months from baseline.
Change in systolic blood pressure
To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months.
Secondary endpoint:
Difference in the mean change in systolic blood pressure (SBP) (mm Hg).
Measured: At 36 months from baseline.
Change in diastolic blood pressure
To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months.
Secondary endpoint:
Difference in the mean change in diastolic blood pressure (DBP) mm Hg.
Measured: At 12 months from baseline.
Change in diastolic blood pressure
To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months.
Secondary endpoint:
Difference in the mean change in diastolic blood pressure (DBP) mm Hg.
Measured: At 24 months from baseline.
Change in diastolic blood pressure
To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months.
Secondary endpoint:
Difference in the mean change in diastolic blood pressure (DBP) mm Hg.
Measured: At 36 months from baseline.
Change in plasma glucose
To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months.
Secondary endpoint:
Difference in the mean change in plasma glucose (mmol/L).
Measured: At 12 months from baseline.
Change in plasma glucose
To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months.
Secondary endpoint:
Difference in the mean change in plasma glucose (mmol/L).
Measured: At 24 months from baseline.
Change in plasma glucose
To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months.
Secondary endpoint:
Difference in the mean change in plasma glucose (mmol/L).
Measured: At 36 months from baseline.
Change in total cholesterol/HDL-C ratio
To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months.
Secondary endpoint:
Difference in the mean change in total cholesterol/HDL-C ratio (TChol/HDL-C ratio).
Measured: At 12 months from baseline.
Change in total cholesterol/HDL-C ratio
To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months.
Secondary endpoint:
Difference in the mean change in total cholesterol/HDL-C ratio (TChol/HDL-C ratio).
Measured: At 24 months from baseline.
Change in total cholesterol/HDL-C ratio
To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months.
Secondary endpoint:
Difference in the mean change in total cholesterol/HDL-C ratio (TChol/HDL-C ratio).
Measured: At 36 months from baseline.
Change in triacylglycerol/high density lipoprotein-cholesterol ratio
To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months.
Secondary endpoint:
Difference in the mean change in triacylglycerol/high density lipoprotein-cholesterol ratio (TAG/HDL-C ratio).
Measured: At 12 months from baseline.
Change in triacylglycerol/high density lipoprotein-cholesterol ratio
To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months.
Secondary endpoint:
Difference in the mean change in triacylglycerol/high density lipoprotein-cholesterol ratio (TAG/HDL-C ratio).
Measured: At 24 months from baseline.
Change in triacylglycerol/high density lipoprotein-cholesterol ratio
To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months.
Secondary endpoint:
Difference in the mean change in triacylglycerol/high density lipoprotein-cholesterol ratio (TAG/HDL-C ratio).
Measured: At 36 months from baseline.
Change in cardiovascular disease (CVD) events
To assess whether the intervention is superior to usual care in reducing the risk of cardiovascular disease (CVD) at 12, 24, and 36 months.
Secondary endpoint:
CVD outcomes: Hazard ratio of incident CVD events.
Measured: At 12 months from baseline.
Change in cardiovascular disease (CVD) events
To assess whether the intervention is superior to usual care in reducing the risk of cardiovascular disease (CVD) at 12, 24, and 36 months.
Secondary endpoint:
CVD outcomes: Hazard ratio of incident CVD events.
Measured: At 24 months from baseline.
Change in cardiovascular disease (CVD) events
To assess whether the intervention is superior to usual care in reducing the risk of cardiovascular disease (CVD) at 12, 24, and 36 months.
Secondary endpoint:
CVD outcomes: Hazard ratio of incident CVD events.
Measured: At 36 months from baseline.
Change in incident rate of type 2 diabetes mellitus events
To assess whether the intervention is superior to usual care in reducing type 2 diabetes mellitus at 36 months.
Secondary endpoint:
Diabetes mellitus outcomes: Hazard ratio of incident type 2 diabetes mellitus events.
Measured: At 12 months from baseline.
Change in incident rate of type 2 diabetes mellitus events
To assess whether the intervention is superior to usual care in reducing type 2 diabetes mellitus at 36 months.
Secondary endpoint:
Diabetes mellitus outcomes: Hazard ratio of incident type 2 diabetes mellitus events.
Measured: At 24 months from baseline.
Change in incident rate of type 2 diabetes mellitus events
To assess whether the intervention is superior to usual care in reducing type 2 diabetes mellitus at 36 months.
Secondary endpoint:
Diabetes mellitus outcomes: Hazard ratio of incident type 2 diabetes mellitus events.
Measured: At 36 months from baseline.
Change in quality of life
To assess whether the intervention is superior to usual care in improving health-related quality of life at 12, 24, and 36 months.
Secondary endpoint:
Difference in the mean change in the EQ-5D-5L score (quality of life)*.
*Quality of life according to the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire, which measures five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Respondents indicate problems on each dimension at one of five levels: no problems, slight problems, moderate problems, severe problems, or extreme problems/unable to perform. The EQ-5D-5L classification system can describe 3,125 possible health states. Additionally, the EQ-5D-5L includes a visual analogue scale (EQ VAS), where respondents rate their current health on a scale from 0 (the worst health they can imagine) to 100 (the best health they can imagine).
Measured: At 12 months from baseline.
Change in quality of life
To assess whether the intervention is superior to usual care in improving health-related quality of life at 12, 24, and 36 months.
Secondary endpoint:
Difference in the mean change in the EQ-5D-5L score (quality of life)*.
*Quality of life according to the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire, which measures five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Respondents indicate problems on each dimension at one of five levels: no problems, slight problems, moderate problems, severe problems, or extreme problems/unable to perform. The EQ-5D-5L classification system can describe 3,125 possible health states. Additionally, the EQ-5D-5L includes a visual analogue scale (EQ VAS), where respondents rate their current health on a scale from 0 (the worst health they can imagine) to 100 (the best health they can imagine).
Measured: At 24 months from baseline.
Change in quality of life
To assess whether the intervention is superior to usual care in improving health-related quality of life at 12, 24, and 36 months.
Secondary endpoint:
Difference in the mean change in the EQ-5D-5L score (quality of life)*.
*Quality of life according to the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire, which measures five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Respondents indicate problems on each dimension at one of five levels: no problems, slight problems, moderate problems, severe problems, or extreme problems/unable to perform. The EQ-5D-5L classification system can describe 3,125 possible health states. Additionally, the EQ-5D-5L includes a visual analogue scale (EQ VAS), where respondents rate their current health on a scale from 0 (the worst health they can imagine) to 100 (the best health they can imagine).
Measured: At 36 months from baseline.
Change in high-sensitivity C-reactive protein
To assess whether the intervention is superior to usual care in reducing the levels of high-sensitivity C-reactive protein (hs-CRP) at 12, 24, and 36 months.
Secondary endpoint:
Difference in the mean change in hs-CRP (mg/L).
Measured: At 12 months from baseline.
Change in high-sensitivity C-reactive protein
To assess whether the intervention is superior to usual care in reducing the levels of high-sensitivity C-reactive protein (hs-CRP) at 12, 24, and 36 months.
Secondary endpoint:
Difference in the mean change in hs-CRP (mg/L).
Measured: At 24 months from baseline.
Change in high-sensitivity C-reactive protein
To assess whether the intervention is superior to usual care in reducing the levels of high-sensitivity C-reactive protein (hs-CRP) at 12, 24, and 36 months.
Secondary endpoint:
Difference in the mean change in hs-CRP (mg/L).
Measured: At 36 months from baseline.
Change in HbA1c
To assess whether the intervention is superior to usual care in reducing the levels of HbA1c at 12, 24, and 36 months.
Secondary endpoint:
Difference in the mean change in HbA1c (mmol/mol).
Measured: At 12 months from baseline.
Change in HbA1c
To assess whether the intervention is superior to usual care in reducing the levels of HbA1c at 12, 24, and 36 months.
Secondary endpoint:
Difference in the mean change in HbA1c (mmol/mol).
Measured: At 24 months from baseline.
Change in HbA1c
To assess whether the intervention is superior to usual care in reducing the levels of HbA1c at 12, 24, and 36 months.
Secondary endpoint:
Difference in the mean change in HbA1c (mmol/mol).
Measured: At 36 months from baseline.
Descriptive cost analysis
To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome.
Secondary endpoint:
Descriptive cost analysis (average cost per participant) in SEK and EUR.
Measured: At 12 months from baseline.
Descriptive cost analysis
To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome.
Secondary endpoint:
Descriptive cost analysis (average cost per participant) in SEK and EUR.
Measured: At 24 months from baseline.
Descriptive cost analysis
To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome.
Secondary endpoint:
Descriptive cost analysis (average cost per participant) in SEK and EUR.
Measured: At 36 months from baseline.
Change in quality-Adjusted Life Years
To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome.
Secondary endpoint:
Difference in the mean change in quality-adjusted life years (QALYs) between the intervention and control groups.
Measured: At 12 months from baseline.
Change in quality-Adjusted Life Years
To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome.
Secondary endpoint:
Difference in the mean change in quality-adjusted life years (QALYs) between the intervention and control groups.
Measured: At 24 months from baseline.
Change in quality-Adjusted Life Years
To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome.
Secondary endpoint:
Difference in the mean change in quality-adjusted life years (QALYs) between the intervention and control groups.
Measured: At 36 months from baseline.
Incremental cost-effectiveness ratio based on CVD
To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome.
Secondary endpoint:
Incremental cost-effectiveness ratio (ICER) based on the number of CVD or type 2 diabetes mellitus cases averted and the number of QALYs gained.
Measured: At 12 months from baseline.
Incremental cost-effectiveness ratio based on CVD
To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome.
Secondary endpoint:
Incremental cost-effectiveness ratio (ICER) based on the number of CVD or type 2 diabetes mellitus cases averted and the number of QALYs gained.
Measured: At 24 months from baseline.
Incremental cost-effectiveness ratio based on CVD
To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome.
Secondary endpoint:
Incremental cost-effectiveness ratio (ICER) based on the number of CVD or type 2 diabetes mellitus cases averted and the number of QALYs gained.
Measured: At 36 months from baseline.
Incremental cost-effectiveness ratio based on type 2 diabetes mellitus
To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome.
Secondary endpoint:
Incremental cost-effectiveness ratio (ICER) based on the number of type 2 diabetes mellitus cases averted.
Measured: At 12 months from baseline.
Incremental cost-effectiveness ratio based on type 2 diabetes mellitus
To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome.
Secondary endpoint:
Incremental cost-effectiveness ratio (ICER) based on the number of type 2 diabetes mellitus cases averted.
Measured: At 24 months from baseline.
Incremental cost-effectiveness ratio based on type 2 diabetes mellitus
To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome.
Secondary endpoint:
Incremental cost-effectiveness ratio (ICER) based on the number of type 2 diabetes mellitus cases averted.
Measured: At 36 months from baseline.
Incremental cost-effectiveness ratio based on QALYs
To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome.
Secondary endpoint:
Incremental cost-effectiveness ratio (ICER) based on the number of QALYs gained.
Measured: At 12 months from baseline.
Incremental cost-effectiveness ratio based on QALYs
To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome.
Secondary endpoint:
Incremental cost-effectiveness ratio (ICER) based on the number of QALYs gained.
Measured: At 24 months from baseline.
Incremental cost-effectiveness ratio based on QALYs
To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome.
Secondary endpoint:
Incremental cost-effectiveness ratio (ICER) based on the number of QALYs gained.
Measured: At 36 months from baseline.
Change in alcohol consumption
To assess whether the intervention is superior to usual care in improving targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) at 12, 24, and 36 months.
Secondary endpoint:
Difference in the mean change in alcohol consumption (Alcohol Use Disorders Identification Test - Consumption (AUDIT-C)*, scale 0-12).
*The AUDIT-C (Alcohol Use Disorders Identification Test-Consumption) is a brief screening tool consisting of three questions, with scores ranging from 0 to 12 points, used to identify risky alcohol use and potential alcohol use disorders.
Measured: At 12 months from baseline.
Change in alcohol consumption
To assess whether the intervention is superior to usual care in improving targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) at 12, 24, and 36 months.
Secondary endpoint:
Difference in the mean change in alcohol consumption (Alcohol Use Disorders Identification Test - Consumption (AUDIT-C)*, scale 0-12).
*The AUDIT-C (Alcohol Use Disorders Identification Test-Consumption) is a brief screening tool consisting of three questions, with scores ranging from 0 to 12 points, used to identify risky alcohol use and potential alcohol use disorders.
Measured: At 24 months from baseline.
Change in alcohol consumption
To assess whether the intervention is superior to usual care in improving targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) at 12, 24, and 36 months.
Secondary endpoint:
Difference in the mean change in alcohol consumption (Alcohol Use Disorders Identification Test - Consumption (AUDIT-C)*, scale 0-12).
*The AUDIT-C (Alcohol Use Disorders Identification Test-Consumption) is a brief screening tool consisting of three questions, with scores ranging from 0 to 12 points, used to identify risky alcohol use and potential alcohol use disorders.
Measured: At 36 months from baseline.
Change in tobacco smoking
To assess whether the intervention is superior to usual care in improving targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) at 12, 24, and 36 months.
Secondary endpoint:
Difference in the mean change in tobacco smoking* per week.
*The tobacco smoking questionnaire assesses smoking behavior with targeted questions addressing current smoking status, past smoking history, age at smoking initiation or cessation, and smoking frequency (daily or weekly cigarette consumption).
For smoking frequency:
Daily smoking frequency: Minimum = 0 cigarettes/day; Maximum = unlimited (as self-reported by participants).
Weekly smoking frequency: Minimum = 0 cigarettes/week; Maximum = unlimited (as self-reported by participants).
Higher values for daily or weekly smoking frequency indicate worse outcomes (greater tobacco use).
Measured: At 12 months from baseline.
Change in tobacco smoking
To assess whether the intervention is superior to usual care in improving targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) at 12, 24, and 36 months.
Secondary endpoint:
Difference in the mean change in tobacco smoking* per week.
*The tobacco smoking questionnaire assesses smoking behavior with targeted questions addressing current smoking status, past smoking history, age at smoking initiation or cessation, and smoking frequency (daily or weekly cigarette consumption).
For smoking frequency:
Daily smoking frequency: Minimum = 0 cigarettes/day; Maximum = unlimited (as self-reported by participants).
Weekly smoking frequency: Minimum = 0 cigarettes/week; Maximum = unlimited (as self-reported by participants).
Higher values for daily or weekly smoking frequency indicate worse outcomes (greater tobacco use).
Measured: At 24 months from baseline.
Change in tobacco smoking
To assess whether the intervention is superior to usual care in improving targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) at 12, 24, and 36 months.
Secondary endpoint:
Difference in the mean change in tobacco smoking* per week.
*The tobacco smoking questionnaire assesses smoking behavior with targeted questions addressing current smoking status, past smoking history, age at smoking initiation or cessation, and smoking frequency (daily or weekly cigarette consumption).
For smoking frequency:
Daily smoking frequency: Minimum = 0 cigarettes/day; Maximum = unlimited (as self-reported by participants).
Weekly smoking frequency: Minimum = 0 cigarettes/week; Maximum = unlimited (as self-reported by participants).
Higher values for daily or weekly smoking frequency indicate worse outcomes (greater tobacco use).
Measured: At 36 months from baseline.
Change in dietary habits
To assess whether the intervention is superior to usual care in improving targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) at 12, 24, and 36 months.
Secondary endpoint:
Difference in the mean change in dietary habits (dietary index)* (scale 0-12).
*The dietary habits questionnaire (Kostindex) assesses dietary patterns through questions on vegetable, fruit, fish, sweets, and breakfast consumption. Scores range from 0 to 12, categorizing habits as unhealthy, moderate, or healthy to guide nutritional advice.
Measured: At 12 months from baseline.
Change in dietary habits
To assess whether the intervention is superior to usual care in improving targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) at 12, 24, and 36 months.
Secondary endpoint:
Difference in the mean change in dietary habits (dietary index)* (scale 0-12).
*The dietary habits questionnaire (Kostindex) assesses dietary patterns through questions on vegetable, fruit, fish, sweets, and breakfast consumption. Scores range from 0 to 12, categorizing habits as unhealthy, moderate, or healthy to guide nutritional advice.
Measured: At 24 months from baseline.
Change in dietary habits
To assess whether the intervention is superior to usual care in improving targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) at 12, 24, and 36 months.
Secondary endpoint:
Difference in the mean change in dietary habits (dietary index)* (scale 0-12).
*The dietary habits questionnaire (Kostindex) assesses dietary patterns through questions on vegetable, fruit, fish, sweets, and breakfast consumption. Scores range from 0 to 12, categorizing habits as unhealthy, moderate, or healthy to guide nutritional advice.
Measured: At 36 months from baseline.
Change in physical activity
To assess whether the intervention is superior to usual care in improving targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) at 12, 24, and 36 months.
Secondary endpoint:
Difference in the mean change in physical activity* (number of minutes per day).
*The physical activity and inactivity questionnaire evaluates daily habits by measuring time spent on everyday activities, exercise, and sedentary time, including sleep.
For physical activity:
Higher values indicate better outcomes (more active time).
For sedentary time:
Higher values indicate worse outcomes (more inactive time).
Measured: At 12 months from baseline.
Change in physical activity
To assess whether the intervention is superior to usual care in improving targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) at 12, 24, and 36 months.
Secondary endpoint:
Difference in the mean change in physical activity* (number of minutes per day).
*The physical activity and inactivity questionnaire evaluates daily habits by measuring time spent on everyday activities, exercise, and sedentary time, including sleep.
For physical activity:
Higher values indicate better outcomes (more active time).
For sedentary time:
Higher values indicate worse outcomes (more inactive time).
Measured: At 24 months from baseline.
Change in physical activity
To assess whether the intervention is superior to usual care in improving targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) at 12, 24, and 36 months.
Secondary endpoint:
Difference in the mean change in physical activity* (number of minutes per day).
*The physical activity and inactivity questionnaire evaluates daily habits by measuring time spent on everyday activities, exercise, and sedentary time, including sleep.
For physical activity:
Higher values indicate better outcomes (more active time).
For sedentary time:
Higher values indicate worse outcomes (more inactive time).
Measured: At 36 months from baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start27 Feb 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- The Swedish Society of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06781801
- Sponsor's protocol ID
- CIV-24-09-049056
- Acronym
- LAGOM
- Status last verified
- Oct 2025
- First submitted
- 2 Jan 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In accordance with the trial's CIP, individual participant data from this trial are not publicly available due to privacy and data protection regulations. All data are handled in compliance with the General Data Protection Regulation (EU 2016/679; GDPR) and relevant Swedish legislation, and are stored securely at Region Västra Götaland. Participants in the trial are coded with a specific record ID.
Publications
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.
PubMed 42337535
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Approach to Generate Positive Cardiometabolic Health Outcomes in Severe Mental Illness
- ClinicalTrials.gov ID
- NCT06781801
- Acronym / sponsor ID
- LAGOM / CIV-24-09-049056
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- The Swedish Society of Medicine
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 17 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: InterventionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
- Prior participation in the LAGOM trial during a previous inclusion cycle (i.e., participants can only be included once during the trial period).
- Currently under compulsory care.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionThe 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. | Other | Intervention Clinics |
Primary outcome
Estimated absolute ten-year cardiovascular risk based on the SCORE2 algorithm
Time frame: At 12 months from baseline.
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.
Estimated absolute ten-year cardiovascular risk based on the SCORE2 algorithm
Time frame: At 24 months from baseline.
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.
Estimated absolute ten-year cardiovascular risk based on the SCORE2 algorithm
Time frame: At 36 months from baseline.
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.
63 secondary outcomes
Change in body mass index
Time frame: At 12 months from baseline.
Change in body mass index
Time frame: At 24 months from baseline.
Change in body mass index
Time frame: At 36 months from baseline.
Change in waist-hip ratio
Time frame: At 12 months from baseline.
Change in waist-hip ratio
Time frame: At 24 months from baseline.
Change in waist-hip ratio
Time frame: At 36 months from baseline.
Change in systolic blood pressure
Time frame: At 12 months from baseline.
Change in systolic blood pressure
Time frame: At 24 months from baseline.
Change in systolic blood pressure
Time frame: At 36 months from baseline.
Change in diastolic blood pressure
Time frame: At 12 months from baseline.
Change in diastolic blood pressure
Time frame: At 24 months from baseline.
Change in diastolic blood pressure
Time frame: At 36 months from baseline.
Change in plasma glucose
Time frame: At 12 months from baseline.
Change in plasma glucose
Time frame: At 24 months from baseline.
Change in plasma glucose
Time frame: At 36 months from baseline.
Change in total cholesterol/HDL-C ratio
Time frame: At 12 months from baseline.
Change in total cholesterol/HDL-C ratio
Time frame: At 24 months from baseline.
Change in total cholesterol/HDL-C ratio
Time frame: At 36 months from baseline.
Change in triacylglycerol/high density lipoprotein-cholesterol ratio
Time frame: At 12 months from baseline.
Change in triacylglycerol/high density lipoprotein-cholesterol ratio
Time frame: At 24 months from baseline.
Change in triacylglycerol/high density lipoprotein-cholesterol ratio
Time frame: At 36 months from baseline.
Change in cardiovascular disease (CVD) events
Time frame: At 12 months from baseline.
Change in cardiovascular disease (CVD) events
Time frame: At 24 months from baseline.
Change in cardiovascular disease (CVD) events
Time frame: At 36 months from baseline.
Change in incident rate of type 2 diabetes mellitus events
Time frame: At 12 months from baseline.
Change in incident rate of type 2 diabetes mellitus events
Time frame: At 24 months from baseline.
Change in incident rate of type 2 diabetes mellitus events
Time frame: At 36 months from baseline.
Change in quality of life
Time frame: At 12 months from baseline.
Change in quality of life
Time frame: At 24 months from baseline.
Change in quality of life
Time frame: At 36 months from baseline.
Change in high-sensitivity C-reactive protein
Time frame: At 12 months from baseline.
Change in high-sensitivity C-reactive protein
Time frame: At 24 months from baseline.
Change in high-sensitivity C-reactive protein
Time frame: At 36 months from baseline.
Change in HbA1c
Time frame: At 12 months from baseline.
Change in HbA1c
Time frame: At 24 months from baseline.
Change in HbA1c
Time frame: At 36 months from baseline.
Descriptive cost analysis
Time frame: At 12 months from baseline.
Descriptive cost analysis
Time frame: At 24 months from baseline.
Descriptive cost analysis
Time frame: At 36 months from baseline.
Change in quality-Adjusted Life Years
Time frame: At 12 months from baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Background: PubMed 42337535Najar 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.
- The published study protocolLink provided by the sponsor.
- Individual participant dataSharing planned: No. In accordance with the trial's CIP, individual participant data from this trial are not publicly available due to privacy and data protection regulations. All data are handled in compliance with the General Data Protection Regulation (EU 2016/679; GDPR) and relevant Swedish legislation, and are stored securely at Region Västra Götaland. Participants in the trial are coded with a specific record ID.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Psychotic Disorders, run by Vastra Gotaland Region at 6 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hemen Najar, M.D., Ph.D. (0046 73 566 15 64, hemen.najar@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated absolute ten-year cardiovascular risk based on the SCORE2 algorithm (time frame: At 12 months from baseline.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06781801, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.