Supporting physical activity through co-production in people with severe mental illness (SPACES): study protocol for a pragmatic parallel group randomised controlled trial

Introduction

Life expectancy is reduced by around 15–20 years for people with severe mental illness (SMI) compared with those without this condition. Many early deaths stem from preventable physical health problems linked to behaviours such as poor diet, smoking and low physical activity. Increasing physical activity can improve overall health. People with SMI are typically less active than the general population and supporting them to increase activity could help reduce the life expectancy gap. This study aims to explore the clinical and cost-effectiveness of a co-produced physical activity programme tailored to people with SMI (the SPACES intervention).

Methods and analysis

This two-arm, multi-site, pragmatic, parallel-group randomised controlled superiority trial will assess the clinical and cost-effectiveness of a co-produced physical activity intervention across National Health Service (NHS) mental health trusts in England and health boards in Wales. A total of 550 participants (275 per arm) will be randomised 1:1 into the intervention or usual care arms. The usual care arm will receive treatment as usual, while the intervention arm will receive treatment as usual plus an 18-week physical activity programme comprising walking sessions, indoor activities and community taster sessions. The intervention group will also receive six one-to-one sessions: four long-form consultations (entry, midpoint and one either side of the exit) and two shorter check-ins (between the entry and midpoint and between midpoint and the first exit consultation). The primary outcome is objective accelerometer-derived minutes per day of moderate to vigorous physical activity at 6 months post randomisation. Secondary outcomes are light physical activity, sedentary behaviour, self-reported physical activity and sedentary behaviour, body mass index, depression, anxiety, loneliness, health-related quality of life, healthcare resource use, predictive behaviour and adverse events. Measures will be taken at baseline and at 3, 6 and 12 months post randomisation.

Ethics and dissemination

This trial was provided ethical approval by the West of Scotland NHS Research Ethics Committee and the Health Research Authority on 14 May 2024 (ref: 24/WS0040). All participants will provide written informed consent before participation. Findings from this study will be shared publicly and disseminated through publication in peer-reviewed journals, conference presentations and social media outlets.

Trial registration number

ISRCTN23019026.