STEPWISE: STructured lifestyle Education for People WIth SchizophrEnia, schizoaffective disorder and first episode psychosis

The STEPWISE research study is exploring a lifestyle intervention to reduce weight gain in people with schizophrenia, schizoaffective disorder or first episode psychosis prescribed antipsychotic medication. The study includes two phases, the Intervention Development Study, and the Trial. The Intervention Development Study is now complete, and further information about this can be found using the link on the right hand side of this page.

STEPWISE Trial

STEPWISE is an individually randomised controlled trial (RCT) exploring the extent to which a structured lifestyle education programme can support weight loss for adults with schizophrenia and first episode psychosis, in a community mental health setting.

The trial started in March 2015 and will compare the adapted version of the DESMOND™ intervention to usual care. We plan to invite approximately 5000 patients with schizophrenia, schizoaffective disorder or first episode psychosis to participate through clinics run by 10 UK Mental Health NHS Trusts.

We aim to recruit 396 participants over a period of 15 months. Those randomised to receive the STEPWISE intervention will receive an initial period of group-based structured education sessions run by trained educators followed by ‘booster’ sessions, along with routine advice and information about diet and physical activity. Those randomised to the control arm will receive usual care and the routine advice and information about diet and physical activity.

All participants will be assessed by researchers at baseline and followed-up at 3 and 12 months post-randomisation to the trial. The primary outcome is weight change (kg) at 12 months. Acceptability and accessibility of the intervention will be explored through qualitative interviews with service users who received the intervention and healthcare professionals who delivered it to patients during the study.

Study Update 3 August 2016:

Recruitment to the STEPWISE Trial started on 2 March 2015, with the first participant randomised on 12 March 2015. All sites have now closed to recruitment, most of which met or exceeded their site target. All sites have completed all the foundation courses and are continuing to deliver booster sessions and maintenance contact.

The study met the overall recruitment target of 396 on 14 March 2016.  The protocol was revised to allow two sites to continue to recruit to their final wave and the trial closed to recruitment on 31 March 2016. A total of 423 people consented to join the study and of these, 414 participants have been randomised. Researchers at the University of Sheffield have completed interviews with a sample of participants receiving the intervention and Facilitators delivering the intervention. Over 40 people have take part in the qualitative sub-study. Observation of a sample of education sessions, being undertaken by researchers at University Hospitals of Leicester, is almost complete and will explore whether the intervention is being delivered as intended. All sites have now completed 3 month follow up assessments, and twelve month follow ups have started at nine of the ten participating sites.

Project Team

Professor Richard Holt Chief Investigator

University of Southampton

r.i.g.holt@soton.ac.uk

+44 (0)23 8079 4665

Dr Daniel Hind Assistant Director, CTRU CTRU, University of Sheffield

d.hind@sheffield.ac.uk

+44 (0)114 222 0707

Rebecca Gossage-Worrall Trial Manager CTRU, University of Sheffield

r.gossage-worrall@sheffield.ac.uk

+44 (0)114 222 5206

Lizzie Swaby Research Assistant CTRU, University of Sheffield

e.a.swaby@sheffield.ac.uk

+44 (0)114 222 4023

Heather Dakin Trials Support Officer CTRU, University of Sheffield

h.dakin@sheffield.ac.uk

+44 (0)114 222 6385

Mike Bradburn Senior Medical Statistician CTRU, University of Sheffield

m.bradburn@sheffield.ac.uk

+44 (0)114 222 0706

Oscar Bortolami Statistician CTRU, University of Sheffield

o.bortolami@sheffield.ac.uk

+44 (0)114 222 5450

Amanda Loban, Kirsty Pemberton & Emily Turton

Data Management Team CTRU, University of Sheffield

stepwise-data@sheffield.ac.uk

+44 (0)114 222 0861

+44 (0)114 222 0685

Participating Sites:

Site Principal Investigator

Sheffield Health and Social Care NHS Foundation Trust

Prof. Glenn Waller

Leeds & York Partnership NHS Foundation Trust

Dr Stephen Wright

Bradford District Care Trust

Dr Najma Siddiqi

Greater Manchester West Mental Health NHS Foundation Trust

Prof. Paul French

South London & Maudsley NHS Foundation Trust

Dr Fiona Gaughran

Dr Sri Kalidindi

Sussex Partnership NHS Foundation Trust

Dr Kathy Greenwood

Southern Health NHS Foundation Trust

Dr Shanaya Rathod

Devon Partnership NHS Trust

Prof. Chris Dickens

Somerset Partnership NHS Foundation Trust

Prof. Chris Dickens

Dr Mike Campbell

Cornwall Partnership NHS Foundation Trust

Dr Richard Laugharne

Funder:

This project is funded by the National Institute for Health Research Health Technology Assessment (NIHR HTA) Programme (project number 12/28/05). Any views or opinions expressed are those of the authors and do not necessarily reflect those of the HTA programme, NIHR, NHS or the Department of Health.

Sponsor:

Sheffield Health and Social Care NHS Foundation Trust