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STEPWISE - STructured lifestyle Education for People WIth SchizophrEnia: a study protocol for a randomised controlled trial.

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posted on 14.11.2016, 09:26 by R. Gossage-Worrall, R. I. Holt, K. Barnard, Marian E. Carey, Melanie J. Davies, C. Dickens, Yvonne Doherty, Charlotte Edwardson, P. French, F. Gaughran, K. Greenwood, S. Kalidindi, D. Hind, Kamlesh Khunti, P. McCrone, J. Mitchell, J. Pendlebury, S. Rathod, D. Shiers, N. Siddiqi, L. Swaby, S. Wright
BACKGROUND: People with schizophrenia are two to three times more likely to be overweight than the general population. The UK National Institute of Health and Care Excellence (NICE) recommends an annual physical health review with signposting to, or provision of, a lifestyle programme to address weight concerns and obesity. The purpose of this randomised controlled trial is to assess whether a group-based structured education programme can help people with schizophrenia to lose weight. METHODS: Design: a randomised controlled trial of a group-based structured education programme. SETTING: 10 UK community mental health trusts. PARTICIPANTS: 396 adults with schizophrenia, schizoaffective, or first-episode psychosis who are prescribed antipsychotic medication will be recruited. Participants will be overweight, obese or be concerned about their weight. INTERVENTION: participants will be randomised to either the intervention or treatment as usual (TAU). The intervention arm will receive TAU plus four 2.5-h weekly sessions of theory-based lifestyle structured group education, with maintenance contact every 2 weeks and 'booster' sessions every 3 months. All participants will receive standardised written information about healthy eating, physical activity, alcohol and smoking. OUTCOMES: the primary outcome is weight (kg) change at 1 year post randomisation. Secondary outcomes, which will be assessed at 3 and 12 months, include: the proportion of participants who maintained or reduced their weight; waist circumference; body mass index; objectively measured physical activity (wrist accelerometer); self-reported diet; blood pressure; fasting plasma glucose, lipid profile and HbA1c (baseline and 1 year only); health-related quality of life (EQ-5D-5L and RAND SF-36); (adapted) brief illness perception questionnaire; the Brief Psychiatric Rating Scale; the Client Service Receipt Inventory; medication use; smoking status; adverse events; depression symptoms (Patient Health Questionnaire-9); use of weight-loss programmes; and session feedback (intervention only). Outcome assessors will be blind to trial group allocation. Qualitative interviews with a subsample of facilitators and invention-arm participants will provide data on intervention feasibility and acceptability. Assessment of intervention fidelity will also be performed. DISCUSSION: The STEPWISE trial will provide evidence for the clinical and cost-effectiveness of a tailored intervention, which, if successful, could be implemented rapidly in the NHS. TRIAL REGISTRATION: ISRCTN19447796 , registered on 20 March 2014.

Funding

This project was funded by the National Institute for Health Research Health Technology Assessment programme (project number 12/28/05). The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Health Technology Assessment programme, the NIHR, the NHS or the Department of Health. The study is also supported by the NIHR Clinical Research Network.

History

Citation

Trials, 2016, 17:475

Author affiliation

/Organisation/COLLEGE OF MEDICINE, BIOLOGICAL SCIENCES AND PSYCHOLOGY/School of Medicine/Department of Cardiovascular Sciences

Version

VoR (Version of Record)

Published in

Trials

Publisher

BioMed Central

issn

1745-6215

eissn

1745-6215

Acceptance date

25/08/2016

Available date

14/11/2016

Publisher version

http://trialsjournal.biomedcentral.com/articles/10.1186/s13063-016-1572-1

Language

en