Motiv8: A randomized feasibility trial of a weight management intervention for adults on secure forensic mental health inpatient units

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.