CTRU staff co-applicants in successful £1.9 million research grant to reduce weight gain in people with schizophrenia

weighing scales

Mike Bradburn and Danny Hind of the CTRU in partnership with colleagues from the Sheffield Health and Social Care Consortium and the Chief Investigator Professor Richard Holt (from the University of Southampton) were successful in being awarded a prestigious £1.9 million grant from the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme.

The STEPWISE (STructured Education for People WIth SchizophrEnia) study is exploring a lifestyle intervention to reduce weight gain in people with schizophrenia prescribed antipsychotic medication. The study has two phases:

Phase 1: Intervention development study

The first phase of the research study will adapt the DESMOND™ intervention, developed for people with diabetes or at risk of diabetes, to make it more appropriate for and acceptable to mental health service users and health care professionals and to provide a greater focus on weight loss. The intervention development study will include qualitative research with service users, carers and healthcare professionals before a modified intervention is finalised for the next phase of the research.

Phase 2: STEPWISE Trial

STEPWISE is an individually randomised control 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 is scheduled to start in December 2014 and will compare the adapted version of the DESMOND™ intervention to usual care. The investigators plan to invite approximately 5000 patients with schizophrenia or first episode psychosis to participate through clinics run by 10 UK Mental Health NHS Trusts.

The trial team aim to recruit 412 participants over a period of 15 months. Those randomised to receive the STEPWISE intervention will receive an initial period of group-based structured education run by trained educators followed by ‘booster’ sessions. Those randomised to the control arm will receive 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 (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.

Other CTRU staff involved in running the STEPWISE study are Rebecca Gossage-Worrall, the Trial Manager and Munya Dimairo, Medical Statistician.