Structured lifestyle education for people with schizophrenia, schizoaffective disorder and first-episode psychosis (STEPWISE):randomised controlled trial

Abstract Background: Obesity is a major challenge for people with schizophrenia. Aim: We assessed whether STEPWISE, a theory-based, group structured lifestyle education programme could support weight reduction in people with schizophrenia. Methods: In this randomised controlled trial, we recruited adults with schizophrenia, schizoaffective disorder or first episode psychosis from ten mental health organisations in England. Participants were randomly allocated to the STEPWISE intervention or treatment as usual. The 12-month intervention comprised four 2.5 hour weekly group sessions, followed by two-weekly maintenance contact and group sessions at 4, 7 and 10 months. The primary outcome was weight change after 12 months. Key secondary outcomes included diet, physical activity, biomedical measures and patient related outcome measures. Cost-effectiveness was assessed and a mixed-methods process evaluation was included. Results: Between 10 March 2015 and 31 March 2016, we recruited 414 people (intervention 208, usual care 206) with 341 (84.4%) participants completing the trial. At 12 months, weight reduction did not differ between groups (mean difference 0.0 Kg, 95% CI -1.6 to 1.7, p=0.963); physical activity, dietary intake and biochemical measures were unchanged. STEPWISE was well-received by participants and facilitators. The healthcare perspective incremental cost-effectiveness ratio was £246,921 per quality-adjusted life-year gained. Conclusions: Participants were successfully recruited and retained, indicating a strong interest in weight interventions; however, the STEPWISE intervention was neither clinically nor cost-effective. Further research is needed to determine how to manage overweight and obesity in people with schizophrenia. Declaration of Interest: None relevant to the trial; full disclosure is available in the paper. Study registration: ISRCTN19447796. Funding details: National Institute for Health Research (NIHR) Heath Technology Assessment (HTA) programme (HTA 12/28/05)