National Institute of Health Research

HTA - 12/28/05: STEPWISE: STructured lifestyle Education for People WIth Schizophrenia

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Project title STEPWISE: STructured lifestyle Education for People WIth Schizophrenia
Research type Primary Research
Status Research in progress
Start date October 2013
Publication date

April 2018

This is the estimated publication date for this report, but please note that delays in the editorial review process can cause the forecast publication date to be delayed.

Cost £ 2,010,679.64
Chief Investigator Professor Richard Holt
Co-investigators Professor Katharine Barnard (Bournemouth University), Mr Mike Bradburn (University of Sheffield), Dr Marian Carey (University Hospitals of Leicester NHS Trust), Professor Melanie Davies (University of Leicester), Professor Paul French (Greater Manchester West Mental Health NHS Foundation Trust), Dr Daniel Hind (University of Sheffield), Professor Kamlesh Khunti (University of Leicester), Dr Richard Laugharne (Cornwall Partnership NHS Trust), Professor Paul McCrone (King's College London), Dr Shanaya Rathod (Southern Health NHS Foundation Trust), Dr David Shiers (Manchester University), Professor Chris Dickens (University of Exeter), Dr Thomas Yates (University of Leicester), Dr Jonathan Mitchell (Sheffield Health & Social Care NHS Foundation Trust), Professor Tim Kendall (NHS England), Dr Helen Millar (NHS Tayside), Dr Fiona Gaughran (South London and Maudsley NHS Foundation Trust), Dr Alex Mitchell (University of Leicester), Dr Stephen Wright (Leeds Partnership NHS FT), Mr John Pendlebury (Greater Mancher West Health NHS FT), Ms Angela Etherington (University of Southampton)
Contractor Sheffield Health & Social Care NHS Foundation Trust
Plain English summary Obesity and overweight occur 2-3 times more commonly among people with schizophrenia. In addition to a wide range of adverse physical health consequences, such as diabetes and heart disease, weight gain may be an important factor that stops people from taking their medication. In turn, this increases the risk of relapse of the schizophrenia and worse mental health. There is an urgent need to develop interventions to help people with schizophrenia manage their weight. Contrary to expectation, several short term studies have indicated that it is possible for people with schizophrenia to change their diet and exercise habits with appropriate support. A recent review of the current literature found that people with schizophrenia were able to lose an average of 3.12 kg over a period of 8-24 weeks after a lifestyle clinic. While this is encouraging, we need to investigate whether these interventions are effective in promoting further weight loss in the longer term. This project will develop and assess a lifestyle education programme that meets the needs of people with schizophrenia. We will also include people during their first episode of psychosis as this is frequently a prelude to a diagnosis of schizophrenia. We will adapt the programme from a highly successful NICE approved education programme, called DESMOND, which was developed in Leicester for people with diabetes or at risk of diabetes. We know that this programme has helped people to change their lifestyle by eating more healthily and exercising more. The programme has already been modified for use in minority ethnic groups and people with learning disabilities, suggesting that it will be feasible to make it acceptable to the needs of people with schizophrenia. We will also build on our own clinical experience of managing obesity and weight gain in people with schizophrenia. This development phase is vital to discover any problems about the format of the programme before embarking on a larger study. Finding the problems early on can also save a lot of money. Once we have developed the lifestyle programme, we will test the programme in a randomised controlled trial in people with schizophrenia, including those with first episode psychosis. It is important to find out if people with schizophrenia can change their lifestyle and lose weight as a result of the education programme. We will also assess whether the programme leads to changes in diet and physical activity as these can lead to health benefits irrespective of changes in weight. We know that obesity increases the risk of diabetes and heart disease. So as well as measuring body weight during the trial, we will also measure blood glucose and cholesterol to assess whether the lifestyle programme affects any of these important measurements. We need to find out if the programme is acceptable to people with schizophrenia, their carers and health care professionals. The best way of doing this is to talk to the people who have been involved in the trial to ask them about their experiences. We are planning to recruit about 400 people with schizophrenia who live in one of 10 Mental Health Trusts covering a wide geographical area and including both rural and urban settings in the UK. At present there are over 5,000 people living with schizophrenia in these areas. We will invite these people to take part during their routine clinic visits at community mental health establishments. We hope that this trial will go a long way to helping finding a solution for the challenging problem of obesity in people with schizophrenia.
Scientific summary Aim: Obesity & overweight occur 2-3 times more commonly among people with schizophrenia receiving antipsychotics. It causes a wide range of adverse physical health consequences & may be an important factor in non-adherence which increases the risk of relapse. There is an urgent need to develop interventions to reduce overweight & obesity in people with schizophrenia, including those with first episode psychosis. Both short-term randomised controlled trials & observational studies suggest that non-pharmacological interventions may aid weight loss. This project will adapt a structured lifestyle education programme, based on the NICE approved Diabetes Education & Self-Management for On-going & Newly Diagnosed (DESMOND) approach that can help people with schizophrenia to lose weight. We will then undertake a randomised controlled trial with an internal pilot in community mental health settings to evaluate the extent to which the lifestyle programme, when delivered to people with schizophrenia or first episode psychosis, can support weight loss. Design: A multicentre open-labelled individually randomised trial of a group lifestyle education programme in people with schizophrenia including those with first episode psychosis. Setting: The study will be run in 10 UK Mental Health Trusts in a variety of different community mental health locations that are convenient and familiar to participants including hospitals & primary care or community venues. Target population: We will invite ~5000 adults with schizophrenia or first episode psychosis to participate through clinics run by the Mental Health Trusts. We will also seek the views of carers, advocates & mental healthcare professionals to assess the acceptability of the intervention. Health technologies being assessed: We will deliver a structured lifestyle education programme that encourages increased physical activity, improved diet & weight reduction in people with schizophrenia. The programme will be based on the DESMOND approach, which provides person-centred structured group self-management education for people with, or at risk of, type 2 diabetes, & which uses a described philosophy & psychological theories of adult learning. The adapted programme is likely to include the following sessions: the patient story, healthcare professional story, consequences & personal risk, diet & weight loss, physical activity, emotion management & goal setting. The programme will be supported by specially developed resources which may include: a patient diary, goal setting sheets & other materials. Our programme will focus on 5 key lifestyle targets: weight reduction, moderate dietary intake of total fat, low dietary saturated fat intake, high dietary fibre intake, regular physical activity. It is envisaged that the programme will comprise a foundation programme (4 x 1-hr sessions) followed by booster sessions every 3 months. The programme will be delivered by 2 trained community mental health facilitators (educators) to groups of 6-8 people. The final structure will be informed by participants in the development phase. Measurement of outcomes: The primary outcome measure will be weight at 1 year after entry to the trial. All secondary outcome measures will be assessed at baseline & after 3 & 12 months except where stated. Weight; the proportion who maintained or reduced weight; % weight change Waist circumference Body mass index Wrist worn accelerometry (GeneActiv) Dietary intervention in primary care questionnaire Blood pressure Fasting glucose, lipid profile, HbA1c (baseline & 1 year only) Health-related quality of life (EQ-5D & RAND SF36) Illness Beliefs Questionnaire revised (IPQ-R) Brief Psychiatric Rating Scale Changes in medication Smoking status Adverse events Client Service Receipt Inventory Sample size: The primary outcome is weight (kg) at 12 months after randomisation. Previous data on UK patients with severe mental illness showed the mean baseline weight was 90.1 Kg & standard deviation (SD) of weight at 12 months after a lifestyle intervention was 16.4 Kg. A 5% difference in weight at 1 year from baseline is the minimum clinically important change equivalent to a weight change of 4.5 Kg. Assuming a SD of 10 Kg, 95% study power & two-sided significance level of 5%, 130 people per arm (260 in total) are required. Since the intervention is delivered in groups, the outcomes within the same group may be correlated in the intervention arm. Assuming on average 7 participants per group, & an intra class correlation of 5%, the sample size will be inflated by a design effect of 1.3 in the intervention arm in order to allow for this, which yields revised sample sizes of 169 & 130 in the intervention & control arms respectively (total 299). To maintain a 1:1 allocation, 158 per arm are required to reproduce this power. We anticipate a dropout rate of ~20% (higher than in similar studies), giving a final total of 198 participants per arm. With 10 centres, this requires 40-50 participants per centre, 20-25 of whom will receive the intervention in 3 or 4 groups. Project timetable: The project's duration is 48 month. The first 12 months will involve the adaptation of the DESMOND course in Leicester to make it more acceptable to & appropriate for people with schizophrenia & more focussed on weight loss. This work will involve a brief feasibility assessment in 2 trusts. Parallel to this, the Sheffield CTRU will maintain all essential documentation, convene the Trial Steering Committee, submit documentation for REC approval & commence the contracting. Based on prior experience of setting up trials involving new staff & services, 12-14 months is needed for the set-up of the 10 centres. The revised training course will be available from month 13. Centre initiation will be staggered. Recruitment will take place for an average of 12 months at each centre between months 15 & 30, with the last randomised participant being followed up until month 42. We have allowed 6 months for closedown, analysis & write-up. Expertise in team: The research team has an impressive array of complementary skills & a track record in diabetes prevention, schizophrenia & multi-disciplinary working. There is expertise in successfully running & recruiting to large randomised clinical trials. The project is supported by the MHRN and DRN.

Protocol (PDF File - 1.1 MB)


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