Holt, Richard, Gossage-Worrall, Rebecca, Hind, Daniel, Bradburn, Michael, McCrone, Paul, Morris, Tiyi, Edwardson, Chartlotte, Barnard, Katharine, Carey, Maria E., Davies, Melanie J., Dickens, Chris M., Doherty, Yvonne, Etherington, Angela, French, Paul, Gaughran, Fiona, Greenwood, Kathryn E., Kalidindi, Sridevi, Khunti, Kamlesh, Laugharne, Richard, Pendlebury, John, Rathod, Shanaya, Saxon, David, Shiers, David, Siddiqi, Najma, Swaby, Elizabeth A., Waller, Glenn and Wright, Stephen (2019) Structured lifestyle education for people with schizophrenia, schizoaffective disorder and first-episode psychosis (STEPWISE): randomised controlled trial. The British Journal of Psychiatry, 214 (2), 63-73. (doi:10.1192/bjp.2018.167).
Abstract
Background
Obesity is a major challenge for people with schizophrenia.
Aims
We assessed whether STEPWISE, a theory-based, group structured lifestyle education programme could support weight reduction in people with schizophrenia.
Method
In this randomised controlled trial (study registration: ISRCTN19447796), 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 h weekly group sessions, followed by 2-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.
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