Title: STEPWISE: STructured lifestyle Education for People WIth Schizophrenia
Funder: Department of Health (England)

Abstract: 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 InventorySample 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 projects 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.


Research activity codes: 6.7 PHYSICAL;3.3 NUTRITION AND CHEMOPREVENTION
Health categories: MENTAL HEALTH;METABOLIC AND ENDOCRINE