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

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.

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.

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.

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).

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).

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).

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).

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).

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).

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).

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).

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).

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.

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.

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.

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).

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).

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).

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).

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).

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).

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).

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).

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).

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.

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.

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.

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.

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.

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.

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).

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).

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).

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).

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).

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).

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).

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).

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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).

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).

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).

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.

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.

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.

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).

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).

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).

To assess how the number, type, and average interval between lifestyle-focused intervention sessions are associated with changes in lifestyle outcomes at 12, 24, and 36 months within the intervention group to examine factors related to engagement with the intervention.

To assess how the number, type, and average interval between lifestyle-focused intervention sessions are associated with changes in lifestyle outcomes at 12, 24, and 36 months within the intervention group to examine factors related to engagement with the intervention.

To assess how the number, type, and average interval between lifestyle-focused intervention sessions are associated with changes in lifestyle outcomes at 12, 24, and 36 months within the intervention group to examine factors related to engagement with the intervention.

To assess whether participation in educational sessions (0-3 sessions) by participants and their relatives is associated with changes in lifestyle outcomes at 12, 24, and 36 months within the intervention group to examine factors related to engagement with the intervention.

To assess whether participation in educational sessions (0-3 sessions) by participants and their relatives is associated with changes in lifestyle outcomes at 12, 24, and 36 months within the intervention group to examine factors related to engagement with the intervention.

To assess whether participation in educational sessions (0-3 sessions) by participants and their relatives is associated with changes in lifestyle outcomes at 12, 24, and 36 months within the intervention group to examine factors related to engagement with the intervention.