Research Design
RECRUITMENT
A pragmatic cluster randomized clinical trial with 1-year follow-up was performed to test the effectiveness of the lifestyle intervention compared with TAU, with recruitment from January 2018 to January 2019. A total of 21 flexible assertive community treatment (FACT) teams from 8 mental health care centers in the Netherlands participated in the trial. Ethical approval was from the Medical Ethical Committee of the VU University Medical Center in Amsterdam. The Severe Mental Illness Lifestyle Evaluation (SMILE) study protocol has been previously published