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Background: Cardiovascular disease is the leading cause of the estimated 11–25 years 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.
Methods: The 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 12 months and
consists of weekly 2-h group meetings delivered over the first 6 months. The next 6 months 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
Discussion: The 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
Trial registration: Dutch Trial Registration NL6660, registration date: 16 November 2017.