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

The STEPWISE research study aimed to explore a lifestyle intervention to reduce weight gain in people with schizophrenia, schizoaffective disorder or first episode psychosis prescribed antipsychotic medication. The study included two phases, the Intervention Development Study (IDS), and the Trial. Both studies are now complete. Further information about the trial is below. If you want to find out more about the IDS please use 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, in a community mental health setting. We planned to recruit 396 service users with schizophrenia, schizoaffective disorder and first episode psychosis to participate through clinics run by 10 UK Mental Health NHS Trusts.

Interventions

The trial started in March 2015 and compared the intervention, based on the DESMOND™ (Diabetes Education and Self Management for Ongoing and Newly Diagnosed) philosophy and tailored for people taking antipsychotics, to usual care (control). All participants received routine written information about diet and physical activity prior to being randomised. Those randomised to receive the intervention received an initial period of group-based structured education sessions run by trained facilitators followed by ‘booster’ sessions. Those randomised to the control arm received their usual health and social care.

Outcomes

All participants were assessed by researchers at baseline and followed-up at 3 and 12 months post-randomisation to the trial. The primary outcome was weight change (kg) at 12 months. We also assessed levels of physical activity, dietary intake, psychiatric symptoms, medication and quality of life.

Acceptability and accessibility of the intervention were explored through qualitative interviews with service users who received the intervention and healthcare professionals who delivered it to patients during the study.

Project Update 27 November 2017

The STEPWISE trial randomised 414 (104%) participants between 12 March 2015 and 31 March 2016. Across the ten NHS Trusts that took part, 33 STEPWISE (intervention) courses were delivered during the trial.

We aimed to successfully follow-up at least 80% of participants at 12 months post-randomisation. A total of 338 (81.6%) participants contributed their weight (primary outcome) at 12 months, exceeding this target.

Researchers at the University of Sheffield completed over 50 interviews with a sample of participants receiving the intervention, with course facilitators and intervention developers. Researchers at University Hospitals of Leicester observed a sample of sessions to see whether courses were delivered as planned. This work helped us to understand how the intervention was delivered and whether it was acceptable to service users and healthcare professionals.

The results were presented at the World Psychiatric Association XVII World Congress of Psychiatry in Berlin on 11 October 2017. The project team submitted a draft final report to the funder which will be published in full in the NIHR Journal. Further information is available at https://www.journalslibrary.nihr.ac.uk/programmes/hta/122805/#/.

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

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 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