Strengths and Limitations
RECRUITMENT, BLIND
This study has several strengths. It was performed in a pragmatic, real-world setting in 21 FACT teams at 8 Dutch mental health centers. This improved its external validity because we made use of the available time, resources, and staff of FACT teams comparable in scope with Dutch care outside this experimental context. This may positively influence the implementation of lifestyle intervention following this study. FACT care is being adopted in many other countries, with a comprehensive focus on symptomatic, functional, and personal recovery. Therefore, the FACT team setting offers ample opportunities for lifestyle interventions. To better understand our findings, we performed a process evaluation (reported separatelyOur trial has limitations. The sample size was smaller than planned (224 participants instead of the anticipated 260). Despite a smaller-than-anticipated recruitment, we found a statistically significant difference in the primary outcome. A larger sample size would have resulted in a more precise effect estimate (smaller 95% CIs) but would probably not have changed the estimate itself. The SMILE study was an ambitious trial in this population, with the inclusion of 224 people with SMI within 1 year, with an almost complete range of sessions offered by professionals (98%) and with a patient participation rate of 52%.Another limitation is the limited validity of the lifestyle behavior measurements. We chose not to measure lifestyle behavior using extensive questionnaires or objective measures because we wanted to avoid the risk of overburdening participating clients. Further, as it was not possible to blind participants to the intervention allocation and not feasible to blind measurement assessors, it is possible this may have biased results.