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


METHODS
10 UK community mental health trusts.


METHODS
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.


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.


BACKGROUND
ISRCTN19447796 , registered on 20 March 2014.
The University of Sheffield, Sheffield, UK. r.gossage-worrall@sheffield.ac.uk.
Rebecca
http://orcid.org/0000-0002-1435-9474
R
Gossage-Worrall
Human Development and Health Academic Unit, University of Southampton Faculty of Medicine, Southampton, SO16 6YD, UK.
Richard I G
RI
Holt
Human Development and Health Academic Unit, University of Southampton Faculty of Medicine, Southampton, SO16 6YD, UK.
Katharine
K
Barnard
Leicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester, UK.
Marian
M
E Carey
Diabetes Research Centre, University of Leicester, Leicester, UK.|University Hospitals of Leicester NHS Foundation Trust, Leicester, UK.
Melanie
M
J Davies
University of Exeter Medical School and NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) for the South West Peninsula, Exeter, UK.
Chris
C
Dickens
Leicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester, UK.
Yvonne
Y
Doherty
Diabetes Research Centre, University of Leicester, Leicester, UK.
Charlotte
C
Edwardson
Greater Manchester West NHS Foundation Trust, Manchester, UK.
Paul
P
French
South London and Maudsley NHS Foundation Trust, London, UK.|Kings College London, London, UK.
Fiona
F
Gaughran
R&D, Sussex Partnership NHS Foundation Trust; and, School of Psychology, University of Sussex, Brighton, UK.
Kathryn
K
Greenwood
South London and Maudsley NHS Foundation Trust, London, UK.
Sridevi
S
Kalidindi
The University of Sheffield, Sheffield, UK.
Daniel
D
Hind
Diabetes Research Centre, University of Leicester, Leicester, UK.
Kamlesh
K
Khunti
Kings College London, London, UK.
Paul
P
McCrone
Sheffield Health and Social Care NHS Foundation Trust, Sheffield, UK.
Jonathan
J
Mitchell
Greater Manchester West NHS Foundation Trust, Manchester, UK.
John
J
Pendlebury
Southern Health NHS Foundation Trust, Southampton, UK.
Shanaya
S
Rathod
Carer; former GP, North Staffordshire; Honorary Reader in the Division of Psychology and Mental Health at the University of Manchester, Manchester, UK.
David
D
Shiers
Bradford District Care Trust, Bradford, UK.
Najma
N
Siddiqi
The University of Sheffield, Sheffield, UK.
Lizzie
L
Swaby
Leeds and York Partnership NHS Foundation Trust, Leeds, UK.
Stephen
S
Wright
Antipsychotic medication; Behaviour change; Education; First-episode psychosis; Lifestyle; Obesity; Overweight; Schizophrenia
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