Lifestyle Interventions for Severe Mentally Ill Outpatients in the Netherlands (LION)

Patients with severe mental illness (SMI) have an increased cardiometabolic risk. The prevalence of obesity is 4-5 times higher than in the general population, between 45-55%, and the prevalence of type diabetes is around 10-15%, which is up to four times higher than in the general population of comparable age. Although monitoring the somatic health of SMI patients is now obligatory in The Netherlands, most comorbidities are left untreated due to a lack of knowledge, and fear that medication will interact with antipsychotic medication. Lifestyle intervention in high risk individuals from the general population has been shown to be (cost-)effective, and even more effective than early pharmacological treatment, to prevent type 2 diabetes and reduce cardiometabolic risk. This non-pharmacological intervention to reduce cardiometabolic risk may also be effective in SMI patients. In spite of the much increased attention for their excessive cardiovascular risk, evidence based strategies that can be implemented on a large scale to prevent the burden of somatic disease in severe mentally ill (SMI) patients are still lacking, partly because RCT’s have been small and of short duration, or not feasible for large-scale implementation. The aim of the current proposal is to compare the (cost)effectiveness of a 12-month multidimensional lifestyle approach for SMI outpatients to usual care to reduce cardiometabolic risk factors in SMI patients. The intervention is based on a state-of-the-art intervention design, promoting active self-management using e-health tools and incorporating motivational techniques by nurses on top of exercise and other health promotion sessions and support from nurses. Secondary research questions include whether the intervention decreases depressive and negative symptoms, whether the multidimensional lifestyle approach is cost-effective, and whether the effectiveness is larger in men and at younger age. The self-management tools based on e-health are the Traffic Light website, and Heartville, a serious health game that was awarded the “Game for Health” on the TEDx 2012 in Maastricht, The Netherlands Several steps guide patient and nurse to better lifestyle habits. First, the Traffic Light method displays a risk profile with all lifestyle behaviors in green, orange or red, depending on the level of risk. The website-generated lifestyle profile provides insight for patient and nurse. Second, the patient decides which behavior he/she wants to change. The nurses use motivational interviewing (MI) techniques and the stages of change model to assist the patient in this process. Third, the Traffic Light is used to create a lifestyle plan, in which patients set their own goals on the chosen lifestyle areas, including what the patient’s needs are to achieve the goals, such as family involvement. The nurse’s role is to support patients in setting realistic goals. Finally, the Traffic Light model is used to sustain change: nurses support patients in the various phases of trial and error, and nurses will use MI and Stages of Change techniques at every step. In addition, the Traffic Light method contains features to support the role of the nurse in ensuring the availability of payable exercise and health promotion activities, and up to date lifestyle knowledge in the team. In this multicenter study, it is foreseen that 16 teams from 5 locations will deliver 32 nurses and 640 SMI outpatients. It is a cluster randomized trial, since teams will be randomized, and data analysis will be clustered. The primary outcome measure is waist circumference. Secondary outcomes include readiness to change (motivation), weight and height to calculate BMI, and other risk factors including all the components of the metabolic syndrome. These include blood pressure, plasma triglycerides, cholesterol (LDL, HDL, and total cholesterol) and fasting glucose and HbA1c. Furthermore, the measurements include depressive symptoms (Calgary Depression Scale for Schizophrenia), negative symptoms (PANSS), quality of life (SF 6D), and registration of antipsychotic medication. These measures are part of standard Routine Outcome Monitoring measurements and are taken at baseline, after 6 and after 12 months. Additional assessment of weight, waist circumference and lifestyle is taken at 3 and 9 months for intervention participants to evaluate lifestyle progress. Cost-effectiveness analysis (CEA) takes into account care consumption, waist circumference and quality of life. A budget impact analysis is performed by extrapolating CEA results to yearly intervention costs.