Title: Motiv8: A randomized feasibility trial of a weight management intervention for adults on secure forensic mental health inpatient units
Funder: Department of Health and Social Care

Abstract: Research question: Is a weight management intervention feasible to implement for adults on secure forensic mental health inpatient units within a randomised wait-list control trial? Background: People with severe mental illness typically experience a 25-year reduction in life expectancy, mainly from physical disorders. This arises from factors such as side-effects of medication (weight gain), unhealthy lifestyles and poor physical healthcare. This is particularly compromised in secure services, where additional risk factors include restrictions on movement, confinement due to risk to self or others, reduced access to outdoor space and increased dosages of medication. Motiv8 is a 9-week weight management programme seeking to address this issue. It is coproduced with service users, and includes guided exercise sessions, cooking classes, and physical health sessions. Motiv8 has been piloted internally with promising results, however it has not been formally evaluated in a randomised trial. Aims and Objectives: The aim of this study is to conduct a randomised waitlist-controlled trial to assess the feasibility of a weight management intervention (Motiv8)+treatment as usual for individuals on secure mental health units. Our objectives are to assess feasibility and acceptability via recruitment/retention rates, adherence, engagement with the intervention, attendance/drop-out rates, completion of assessments, and qualitative interviews. The overall aim is to use this to refine a protocol and procedure for a definitive trial. Methods: We will conduct a randomised waitlist-controlled trial of Motiv8+TAU compared with TAU alone. This will be conducted on secure forensic services in Greater Manchester Mental Health NHS FT. We aim to run 4 cohorts of Motiv8 (with 8 people in each group) randomised to either Motiv8+TAU or TAU alone. Mental health, physical health and lifestyle assessments will be completed before the intervention, immediately after (10weeks) and 3 months later. Qualitative interviews will be conducted to explore participant experiences. Individuals will be placed on a waitlist and those in the control group will receive the intervention after the assessments. Timelines for Delivery: The study will be conducted over 24 months, with a view to conducting a definitive trial. Months 1-6 will be for study set up, staff recruitment/training and ethical approvals. Month 6-7 will be for recruitment of the study cohorts. Month 7-20 will be for intervention delivery, follow up at 10weeks and 3months, and the qualitative sub-study. Month 20-24 will be for analysis/dissemination. Anticipated Impact and Dissemination: Planned outputs include: evidence for the acceptability for a weight management intervention to inform a definitive trial; development of a protocol and manualised intervention; a minimum of three high quality academic publications; local, national and international dissemination of findings at conferences and through social networks. Our results will be used to inform a funding application to the NIHR HTA Programme, within the immediate months following the end of the study. This will be done with a view to establishing effectiveness. If Motiv8 is found to be beneficial, this will have an important impact on service development within secure services, with a view to be incorporated in NICE guidelines.

Lay abstract: We want to improve the poor physical health of people who use forensic mental health services. These services provide treatment for people with serious mental illness who have committed (or risk committing) a criminal offence. These individuals are likely to have a shorter life than the general population, and are more likely to have physical health problems. This includes heart disease, stroke and diabetes which can be caused by side-effects of medication, unhealthy eating, not exercising enough, smoking and not getting the best healthcare. People who use forensic services are even more at risk, because they often have longer stays in hospitals (5-15 years), less freedom to exercise, higher medication doses with more side effects. Being overweight is a big health issue, and leads to many health problems. The NHS offers evidence-based interventions (treatments), for those who are overweight. Evidence-based means they work well and are helpful, but sometimes we need to think of new treatments. At Greater Manchester Mental Health NHS, service users worked with staff to create a new intervention, Motiv8. It is a 9-week programme to help reduce weight-gain, using cooking classes, physical health education, and group exercise sessions, all provided by skilled staff in inpatient units. We have tested this out in a small study and found patients lost weight, got fitter, felt confident and their mood improved. We now need to test this out in a larger study, to show that it can be run properly in the NHS, so we can then see if it is useful. We have worked with service users/staff to develop this proposal using PPI consultations and have named PPI co-applicants. We will recruit four groups of people in secure units to take part in this. We will do a randomised trial where half of the participants will get Motiv8 straight away and half will get their usual treatment (but will get Motiv8 at the end of the study, to make it fair). This is so we can see if there are any differences between the two groups and be able to see how useful Motiv8 might be for inpatient care, compared with usual treatment. Participants will complete questionnaires about mental health, physical health and diet/exercise before and after the intervention, and will be compared to the group who just get their usual treatment. They will do questionnaires 12-weeks after the intervention to see if they have carried on exercising/eating well. We hope to show Motiv8 can be run within NHS services. If so, we will conduct a larger study to see how helpful it is. We will share our results in conferences, publications and talks at events for researchers, mental health providers and members of the public.

Research activity codes: 6.7 PHYSICAL
Health categories: GENERIC HEALTH RELEVANCE;MENTAL HEALTH