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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
644
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.
Psykosmottagning Centrum
Gothenburg, Sweden
RECRUITINGPsykosmottagning Nordost
Gothenburg, Sweden
RECRUITINGPsykosmottagning Öster
Gothenburg, Sweden
RECRUITINGPsykosmottagning Hisingen
Gothenburg, Sweden
RECRUITINGPsykosmottagning Väster
Gothenburg, Sweden
RECRUITINGPsykosmottagning Mölndal
Mölndal, Sweden
RECRUITINGChange 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: At 36 months from baseline.
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.
Time frame: 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.
Time frame: At 36 months from baseline.
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