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Table 1 Aims, objectives and outcomes

From: Motiv8: a study protocol for a cluster-randomised feasibility trial of a weight management intervention for adults with severe mental illness in secure forensic services

Research question/aim(s)

Objectives

Outcomes

Primary

To assess the acceptability and feasibility of the research trial, associated processes including the intervention, and assessments

Measured by:

- Recruitment rates

- Follow-up retention and questionnaire/outcome response rates

- Attendance at sessions

- Experience of involvement in the trial

- Assessment of safety (SAEs)

- Development of a manualised intervention

Secondary

Physical Health:

Body composition, blood pressure, cardiovascular fitness, health status

Mental Health:

Wellbeing, depression, anxiety, negative symptoms

Behavioural:

Physical activity, occupational functioning, diet, sleep

Physical health measures:

- BMI

- BP

- Hip/waist/chest/neck circumference

- Fitness test

Mental health measures:

- WEMWBS

- HADS

- SNS

Behavioural measures:

- SIMPAQ

- MOHOST

- 24-h diet recall

- PROMIS SD Short-Form

- PROMIS SRI Short Form

Measures to support economic evaluation:

- EQ-5D-5L

- ReQoL

- Engagement in care

- LUNSERS

- Ward activity

Tertiary

Clarify training needs for delivering Motiv8 via a MDT care team, prior to the commencement of a definitive trial

- Qualitative interview

- Adherence checklists

- Feedback forms and interviews with facilitators

- M-BacK Assessment and ESSEN-CES with clinical staff

  1. BMI body max index, BP blood pressure, ESSEN-CES ESSEN Climate Evaluation Schema, HADS Hospital Anxiety and Depression Scale, LUNSERS Liverpool University Neuroleptic Side Effect Rating Scale, M-Back Metabolic-Barriers, Attitudes, Confidence and Knowledge Questionnaire, MDT multi-disciplinary team, MOHOST Model Of Human Occupation Screening Tool, PROMIS SD Patient Reported Outcome Measurement Information Centre Sleep Disturbance, PROMIS SRI Patient Reported Outcome Measurement Information Centre Sleep-Related Impairment, ReQoL Recovering Quality of Life, SAEs Serious Adverse Event, SIMPAQ Simple Physical Activity Questionnaire, SNS Self-evaluation of Negative Symptoms, WEMWBS Warwick Edinburgh Mental Wellbeing Scale