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

Abstract

BackgroundObesity is a major challenge for people with schizophrenia.AimsWe assessed whether STEPWISE, a theory-based, group structured lifestyle education programme could support weight reduction in people with schizophrenia.MethodIn 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.ResultsBetween 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.ConclusionsParticipants 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 interestR.I.G.H. received fees for lecturing, consultancy work and attendance at conferences from the following: Boehringer Ingelheim, Eli Lilly, Janssen, Lundbeck, Novo Nordisk, Novartis, Otsuka, Sanofi, Sunovion, Takeda, MSD. M.J.D. reports personal fees from Novo Nordisk, Sanofi-Aventis, Lilly, Merck Sharp & Dohme, Boehringer Ingelheim, AstraZeneca, Janssen, Servier, Mitsubishi Tanabe Pharma Corporation, Takeda Pharmaceuticals International Inc.; and, grants from Novo Nordisk, Sanofi-Aventis, Lilly, Boehringer Ingelheim, Janssen. K.K. has received fees for consultancy and speaker for Novartis, Novo Nordisk, Sanofi-Aventis, Lilly, Servier and Merck Sharp & Dohme. He has received grants in support of investigator and investigator-initiated trials from Novartis, Novo Nordisk, Sanofi-Aventis, Lilly, Pfizer, Boehringer Ingelheim and Merck Sharp & Dohme. K.K. has received funds for research, honoraria for speaking at meetings and has served on advisory boards for Lilly, Sanofi-Aventis, Merck Sharp & Dohme and Novo Nordisk. D.Sh. is expert advisor to the NICE Centre for guidelines; board member of the National Collaborating Centre for Mental Health (NCCMH); clinical advisor (paid consultancy basis) to National Clinical Audit of Psychosis (NCAP); views are personal and not those of NICE, NCCMH or NCAP. J.P. received personal fees for involvement in the study from a National Institute for Health Research (NIHR) grant. M.E.C. and Y.D. report grants from NIHR Health Technology Assessment, during the conduct of the study; and The Leicester Diabetes Centre, an organisation (employer) jointly hosted by an NHS Hospital Trust and the University of Leicester and who is holder (through the University of Leicester) of the copyright of the STEPWISE programme and of the DESMOND suite of programmes, training and intervention fidelity framework that were used in this study. S.R. has received honorarium from Lundbeck for lecturing. F.G. reports personal fees from Otsuka and Lundbeck, personal fees and non-financial support from Sunovion, outside the submitted work; and has a family member with professional links to Lilly and GSK, including shares. F.G. is in part funded by the National Institute for Health Research Collaboration for Leadership in Applied Health Research & Care Funding scheme, by the Maudsley Charity and by the Stanley Medical Research Institute and is supported by the by the Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King's College London.

Challenges in the design, planning and implementation of trials evaluating group interventions

“…REPOSE [4] Relative Effectiveness of Pumps Over Structured Education. STEPWISE [5] STructured lifestyle Education for People WIth SchizophrEnia.…”

“…A case-based approached was adopted to present the challenges of implementing group interventions in five RCTs [1][2][3][4][5] evaluating group interventions (Table 1) managed by Sheffield CTRU [45]-a UK Clinical Research Collaboration (UKCRC)-registered clinical trial unit managing phase III RCTs of a range of interventions across varied research areas. The CTRU has managed a number of evaluations of complex interventions, including five completed group intervention trials.…”

“…Relative Effectiveness of Pumps Over Structured Education [4] (REPOSE) was an eight-centre cluster RCT assessing an existing group educational course for use with multiple daily injections compared to the same intervention adapted for use with a pump for adults aged ≥ 18 years with type 1 diabetes. The STructured lifestyle Education for People WIth SchizophrEnia [5] (STEPWISE) RCT ran in 10 mental health organisations and evaluated a group structured weight management lifestyle education intervention in adults aged ≥ 18 years with schizophrenia, schizoaffective disorder or first episode psychosis. Journeying through Dementia [1] (JtD) was a 13-centre RCT assessing a group intervention designed to support people in the early stages of dementia to maintain independence.…”

“…Various methods for recruitment were used in these trials and some studies used more than one method [1][2][3], including: mail-outs via general practitioners (GPs)/ NHS care teams [1][2][3][4]; mail-outs to the research cohort [1,3]; referrals via NHS care teams [1,4,5]; and selfreferral [1,2].…”

“…Individual randomisation was used in four of the trials [1][2][3]5] and cluster randomisation [4] was used in one. Randomisation was delayed from the point of consent in two trials [1,4] to ensure that the groups were filled and could be run in the time frame required.…”