Cost-effectiveness of a lifestyle intervention for people with a serious mental illness (SMILE): design of a pragmatic cluster-randomised controlled trial

BackgroundCardiovascular disease is the leading cause of the estimated 11-25years reduced life expectancy for persons with serious mental illness (SMI). This excess cardiovascular mortality is primarily attributable to obesity, diabetes, hypertension, and dyslipidaemia. Obesity is associated with a sedentary lifestyle, limited physical activity and an unhealthy diet. Lifestyle interventions for persons with SMI seem promising in reducing weight and cardiovascular risk. The aim of this study is to evaluate the effectiveness and cost-effectiveness of a lifestyle intervention among persons with SMI in an outpatient treatment setting.MethodsThe Serious Mental Illness Lifestyle Evaluation (SMILE) study is a cluster-randomized controlled trial including an economic evaluation in approximately 18 Flexible Assertive Community Treatment (FACT) teams in the Netherlands. The intervention aims at a healthy diet and increased physical activity. Randomisation takes place at the level of participating FACT-teams. We aim to include 260 outpatients with SMI and a body mass index of 27 or higher who will either receive the lifestyle intervention or usual care. The intervention will last 12months and consists of weekly 2-h group meetings delivered over the first 6months. The next 6months will include monthly group meetings, supplemented with regular individual contacts. Primary outcome is weight loss. Secondary outcomes are metabolic parameters (waist circumference, lipids, blood pressure, glucose), quality of life and health related self-efficacy. Costs will be measured from a societal perspective and include costs of the lifestyle program, health care utilization, medication and lost productivity. Measurements will be performed at baseline and 3, 6 and 12months.DiscussionThe SMILE intervention for persons with SMI will provide important information on the effectiveness, cost-effectiveness, feasibility and delivery of a group-based lifestyle intervention in a Dutch outpatient treatment setting.Trial registrationDutch Trial Registration NL6660, registration date: 16 November 2017.