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

STEPWISE - STructured lifestyle Education for People WIth SchizophrEnia: a study protocol for a randomised controlled trial
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.
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.Design: a randomised controlled trial of a group-based structured education programme.
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.
1745-6215
Gossage-Worrall, R.
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Holt, R.
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Barnard, K.
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Carey, Marian E.
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Davies, Melanie J.
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Dickens, C.
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Doherty, Y.
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Edwardson, C.
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French, P.
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Gaughran, F.
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Greenwood, K.
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Kalidindi, S.
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Hind, D.
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Khunti, K.
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McCrone, P.
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Mitchell, J.
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Pendlebury, J.
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Rathod, S.
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Shiers, D.
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Siddiqi, N.
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Swaby, L.
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Wright, S.
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Gossage-Worrall, R.
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Holt, R.
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Barnard, K.
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Carey, Marian E.
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Davies, Melanie J.
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Dickens, C.
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Doherty, Y.
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Edwardson, C.
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French, P.
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Gaughran, F.
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Greenwood, K.
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Kalidindi, S.
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Hind, D.
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Khunti, K.
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McCrone, P.
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Mitchell, J.
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Pendlebury, J.
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Rathod, S.
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Shiers, D.
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Siddiqi, N.
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Swaby, L.
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Wright, S.
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Gossage-Worrall, R., Holt, R., Barnard, K., Carey, Marian E., Davies, Melanie J., Dickens, C., Doherty, Y., Edwardson, C., French, P., Gaughran, F., Greenwood, K., Kalidindi, S., Hind, D., Khunti, K., McCrone, P., Mitchell, J., Pendlebury, J., Rathod, S., Shiers, D., Siddiqi, N., Swaby, L. and Wright, S. (2016) STEPWISE - STructured lifestyle Education for People WIth SchizophrEnia: a study protocol for a randomised controlled trial. Trials, 17, [475]. (doi:10.1186/s13063-016-1572-1). (PMID:27681572)

Record type: Article

Abstract

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.Design: a randomised controlled trial of a group-based structured education programme.
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.

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Accepted/In Press date: 25 August 2016
e-pub ahead of print date: 29 September 2016
Published date: 29 September 2016
Organisations: Faculty of Medicine

Identifiers

Local EPrints ID: 402127
URI: http://eprints.soton.ac.uk/id/eprint/402127
ISSN: 1745-6215
PURE UUID: bbc551a6-28ee-4724-8343-e41195c54296
ORCID for R. Holt: ORCID iD orcid.org/0000-0001-8911-6744

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Date deposited: 01 Nov 2016 10:38
Last modified: 18 Feb 2021 16:56

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Contributors

Author: R. Gossage-Worrall
Author: R. Holt ORCID iD
Author: K. Barnard
Author: Marian E. Carey
Author: Melanie J. Davies
Author: C. Dickens
Author: Y. Doherty
Author: C. Edwardson
Author: P. French
Author: F. Gaughran
Author: K. Greenwood
Author: S. Kalidindi
Author: D. Hind
Author: K. Khunti
Author: P. McCrone
Author: J. Mitchell
Author: J. Pendlebury
Author: S. Rathod
Author: D. Shiers
Author: N. Siddiqi
Author: L. Swaby
Author: S. Wright

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