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| Name | Class |
|---|---|
| The Swedish Society of Medicine | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cardiovascular disease (CVD) events or risk scores based on the SCORE2 algorithm | To assess whether the intervention is superior to usual care in reducing the risk of cardiovascular disease (CVD) at 36 months. Secondary endpoint: CVD outcomes: Hazard ratio of incident CVD events and/or differences in the mean change in the CVD risk score will be 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in quality of life | To evaluate whether the intervention is superior to usual care in improving health-related quality of life over the 36-month period. Other endpoint: Difference in the mean change in the quality of life questionnaire (EQ-5D-5L)*. *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). |
Inclusion criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hemen Najar, M.D., Ph.D. | Contact | 0046 73 566 15 64 | hemen.najar@vgregion.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psykosmottagning Centrum | Recruiting | Gothenburg | 411 13 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42337535 | Derived | 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. doi: 10.1186/s12888-026-08315-3. Online ahead of print. |
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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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 21, 2025 | Oct 26, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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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.
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| 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. |
| 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 endpoints: Diabetes mellitus outcomes: Hazard ratio of incident type 2 diabetes mellitus events. | At 36 months from baseline. |
| At 12 months from baseline. |
| Change in quality of life | To evaluate whether the intervention is superior to usual care in improving health-related quality of life over the 36-month period. Other endpoint: Difference in the mean change in the quality of life questionnaire (EQ-5D-5L)*. *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). | At 24 months from baseline. |
| Change in quality of life | To evaluate whether the intervention is superior to usual care in improving health-related quality of life over the 36-month period. Other endpoint: Difference in the mean change in the quality of life questionnaire (EQ-5D-5L)*. *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). | At 36 months from baseline. |
| Change in high-sensitivity C-reactive protein | To assess whether the intervention reduces the levels of high-sensitivity C-reactive protein (hs-CRP) over the 36-month period. Other endpoints: Differences in the mean changes in hs-CRP (mg/L). | At 12 months from baseline. |
| Change in high-sensitivity C-reactive protein | To assess whether the intervention reduces the levels of high-sensitivity C-reactive protein (hs-CRP) over the 36-month period. Other endpoints: Differences in the mean changes in hs-CRP (mg/L). | At 24 months from baseline. |
| Change in high-sensitivity C-reactive protein | To assess whether the intervention reduces the levels of high-sensitivity C-reactive protein (hs-CRP) over the 36-month period. Other endpoints: Differences in the mean changes in hs-CRP (mg/L). | At 36 months from baseline. |
| Change in HbA1c | To assess whether the intervention reduces the levels of HbA1c over the 36-month period. Other endpoints: Differences in the mean changes in HbA1c (mmol/mol). | At 12 months from baseline. |
| Change in HbA1c | To assess whether the intervention reduces the levels of HbA1c over the 36-month period. Other endpoints: Differences in the mean changes in HbA1c (mmol/mol). | At 24 months from baseline. |
| Change in HbA1c | To assess whether the intervention reduces the levels of HbA1c over the 36-month period. Other endpoints: Differences in the mean changes in HbA1c (mmol/mol). | At 36 months from baseline. |
| Descriptive cost analysis | To conduct a cost analysis per participant and assess cost-effectiveness over the 36-month period, where cost neutrality is considered a positive outcome. Other endpoint: Descriptive cost analysis (average cost per participant) in SEK and EUR. | At 12 months from baseline. |
| Descriptive cost analysis | To conduct a cost analysis per participant and assess cost-effectiveness over the 36-month period, where cost neutrality is considered a positive outcome. Other endpoint: Descriptive cost analysis (average cost per participant) in SEK and EUR. | At 24 months from baseline. |
| Descriptive cost analysis | To conduct a cost analysis per participant and assess cost-effectiveness over the 36-month period, where cost neutrality is considered a positive outcome. Other endpoint: Descriptive cost analysis (average cost per participant) in SEK and EUR. | At 36 months from baseline. |
| Change in quality-Adjusted Life Years | To conduct a cost analysis per participant and assess cost-effectiveness over the 36-month period, where cost neutrality is considered a positive outcome. Other endpoints: Difference in the mean change in quality-adjusted life years (QALYs) between the intervention and control groups. | At 12 months from baseline. |
| Change in quality-Adjusted Life Years | To conduct a cost analysis per participant and assess cost-effectiveness over the 36-month period, where cost neutrality is considered a positive outcome. Other endpoints: Difference in the mean change in quality-adjusted life years (QALYs) between the intervention and control groups. | At 24 months from baseline. |
| Change in quality-Adjusted Life Years | To conduct a cost analysis per participant and assess cost-effectiveness over the 36-month period, where cost neutrality is considered a positive outcome. Other endpoints: Difference in the mean change in quality-adjusted life years (QALYs) between the intervention and control groups | At 36 months from baseline. |
| Incremental cost-effectiveness ratio based on CVD | To conduct a cost analysis per participant and assess cost-effectiveness over the 36-month period, where cost neutrality is considered a positive outcome Other endpoints: Incremental cost-effectiveness ratio (ICER) based on the number of CVD cases averted. | At 12 months from baseline. |
| Incremental cost-effectiveness ratio based on CVD | To conduct a cost analysis per participant and assess cost-effectiveness over the 36-month period, where cost neutrality is considered a positive outcome Other endpoints: Incremental cost-effectiveness ratio (ICER) based on the number of CVD cases averted. | At 24 months from baseline. |
| Incremental cost-effectiveness ratio based on CVD | To conduct a cost analysis per participant and assess cost-effectiveness over the 36-month period, where cost neutrality is considered a positive outcome Other endpoints: Incremental cost-effectiveness ratio (ICER) based on the number of CVD cases averted. | At 36 months from baseline. |
| Incremental cost-effectiveness ratio based on type 2 diabetes mellitus | To conduct a cost analysis per participant and assess cost-effectiveness over the 36-month period, where cost neutrality is considered a positive outcome Other endpoints: Incremental cost-effectiveness ratio (ICER) based on the number of type 2 diabetes mellitus cases averted. | At 12 months from baseline. |
| Incremental cost-effectiveness ratio based on type 2 diabetes mellitus | To conduct a cost analysis per participant and assess cost-effectiveness over the 36-month period, where cost neutrality is considered a positive outcome Other endpoints: Incremental cost-effectiveness ratio (ICER) based on the number of type 2 diabetes mellitus cases averted. | At 24 months from baseline. |
| Incremental cost-effectiveness ratio based on type 2 diabetes mellitus | To conduct a cost analysis per participant and assess cost-effectiveness over the 36-month period, where cost neutrality is considered a positive outcome Other endpoints: Incremental cost-effectiveness ratio (ICER) based on the number of type 2 diabetes mellitus cases averted. | At 36 months from baseline. |
| Incremental cost-effectiveness ratio based on QALYs | To conduct a cost analysis per participant and assess cost-effectiveness over the 36-month period, where cost neutrality is considered a positive outcome Other endpoints: Incremental cost-effectiveness ratio (ICER) based on the number of QALYs gained. | At 12 months from baseline. |
| Incremental cost-effectiveness ratio based on QALYs | To conduct a cost analysis per participant and assess cost-effectiveness over the 36-month period, where cost neutrality is considered a positive outcome Other endpoints: Incremental cost-effectiveness ratio (ICER) based on the number of QALYs gained. | At 24 months from baseline. |
| Incremental cost-effectiveness ratio based on QALYs | To conduct a cost analysis per participant and assess cost-effectiveness over the 36-month period, where cost neutrality is considered a positive outcome Other endpoints: Incremental cost-effectiveness ratio (ICER) based on the number of QALYs gained. | At 36 months from baseline. |
| Change in alcohol consumption | To evaluate whether the intervention improves targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) over the 36-month period. Other endpoints: 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. | At 12 months from baseline. |
| Change in alcohol consumption | To evaluate whether the intervention improves targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) over the 36-month period. Other endpoints: 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. | At 24 months from baseline. |
| Change in alcohol consumption | To evaluate whether the intervention improves targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) over the 36-month period. Other endpoints: 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. | At 36 months from baseline. |
| Change in tobacco smoking | To evaluate whether the intervention improves targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) over the 36-month period. Other endpoints: • Questionnaires 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). | At 12 months from baseline. |
| Change in tobacco smoking | To evaluate whether the intervention improves targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) over the 36-month period. Other endpoints: • Questionnaires 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). | At 24 months from baseline. |
| Change in tobacco smoking | To evaluate whether the intervention improves targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) over the 36-month period. Other endpoints: • Questionnaires 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). | At 36 months from baseline. |
| Change in dietary habits | To evaluate whether the intervention improves targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) over the 36-month period. Other endpoints: • Questionnaires 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. | At 12 months from baseline. |
| Change in dietary habits | To evaluate whether the intervention improves targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) over the 36-month period. Other endpoints: • Questionnaires 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. | At 24 months from baseline. |
| Change in dietary habits | To evaluate whether the intervention improves targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) over the 36-month period. Other endpoints: • Questionnaires 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. | At 36 months from baseline. |
| Change in physical activity | To evaluate whether the intervention improves targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) over the 36-month period. Other endpoints: 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). | At 12 months from baseline. |
| Change in physical activity | To evaluate whether the intervention improves targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) over the 36-month period. Other endpoints: 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). | At 24 months from baseline. |
| Change in physical activity | To evaluate whether the intervention improves targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) over the 36-month period. Other endpoints: 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). | At 36 months from baseline. |
| Requirements for achieving a change in targeted lifestyle | To explore the number, type, and average time interval between intervention sessions required annually to achieve a change in the targeted lifestyle over the 36-month period. Other endpoint: • For the intervention group, o Effect of the number and type of lifestyle sessions with healthcare professionals on the mean change in lifestyle outcomes. | At 12 months from baseline. |
| Requirements for achieving a change in targeted lifestyle | To explore the number, type, and average time interval between intervention sessions required annually to achieve a change in the targeted lifestyle over the 36-month period. Other endpoint: • For the intervention group, o Effect of the number and type of lifestyle sessions with healthcare professionals on the mean change in lifestyle outcomes. | At 24 months from baseline. |
| Requirements for achieving a change in targeted lifestyle | To explore the number, type, and average time interval between intervention sessions required annually to achieve a change in the targeted lifestyle over the 36-month period. Other endpoint: • For the intervention group, o Effect of the number and type of lifestyle sessions with healthcare professionals on the mean change in lifestyle outcomes. | At 36 months from baseline. |
| Effect of educational sessions | To investigate whether participation in educational sessions by participants and their relatives in the intervention group is associated with positive lifestyle changes over the 36-month period. Other endpoint: • For the intervention group, o Effect of participation in educational sessions (0-3 sessions) on the mean change in lifestyle outcomes. | At 12 months from baseline. |
| Effect of educational sessions | To investigate whether participation in educational sessions by participants and their relatives in the intervention group is associated with positive lifestyle changes over the 36-month period. Other endpoint: • For the intervention group, o Effect of participation in educational sessions (0-3 sessions) on the mean change in lifestyle outcomes. | At 24 months from baseline. |
| Effect of educational sessions | To investigate whether participation in educational sessions by participants and their relatives in the intervention group is associated with positive lifestyle changes over the 36-month period. Other endpoint: • For the intervention group, o Effect of participation in educational sessions (0-3 sessions) on the mean change in lifestyle outcomes. | At 36 months from baseline. |
| Psykosmottagning Nordost | Recruiting | Gothenburg | 415 05 | Sweden |
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| Psykosmottagning Öster | Recruiting | Gothenburg | 416 72 | Sweden |
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| Psykosmottagning Hisingen | Recruiting | Gothenburg | 417 52 | Sweden |
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| Psykosmottagning Väster | Recruiting | Gothenburg | 421 48 | Sweden |
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| Psykosmottagning Mölndal | Recruiting | Mölndal | 431 35 | Sweden |
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| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |