Individual health trainers to support health and well-being for people under community supervision in the criminal justice system: the STRENGTHEN pilot RCT

Abstract

Background Little is known about the effectiveness and cost-effectiveness of interventions, such as Health Trainer support, to improve the health and wellbeing of people recently released from prison or serving a community sentence, due to the challenges in recruiting participants and following them up. Objectives This pilot study aimed to assess the acceptability and feasibility of the trial methods and intervention (and associated costs) for a randomised trial to assess the effectiveness and costeffectiveness of Health Trainer support versus usual care. Design This involved a pilot multicentre parallel two group randomised controlled trial recruiting 120 participants with 1:1 individual allocation to receive support from a Health Trainer and usual care or usual care alone, with mixed methods process evaluation, in 2017-2018. Setting Participants were identified, screened and recruited in Community Rehabilitation Companies in Plymouth and Manchester or National Probation Service in Plymouth. The intervention was delivered in the community. Participants We invited those who had been out of prison for at least 2 months (to allow community stabilisation) with at least 7 months of a community sentence remaining, and excluded those who may have posed an unacceptable risk to the researchers and Health Trainers, or weren’t interested in the trial or intervention support. Interventions The intervention group received, in addition to usual care, our person-centred Health Trainer support in one-to-one sessions for up to 14 weeks, either in person or via telephone. 3 Health Trainers aimed to empower participants to make healthy lifestyle changes (particularly in alcohol use, smoking, diet and physical activity), take on the 5 Ways to Wellbeing, and signpost to other options for support. The control group received treatment as usual, defined by available community and public service options for improving health and wellbeing. Main outcome measures The measures included the Warwick and Edinburgh Mental Well-being Scale (WEMWBS), alcohol use, smoking, dietary behaviour, physical activity, substance use, resource use, quality of life, intervention costs, quality of life, intervention engagement, and feasibility and acceptability of trial methods and the intervention. Results We learned a great deal about recruitment and achieved our target of 120 participants. We met our minimum trial retention target at 6 months (60%). Among those offered Health Trainer support, 62% had at least two sessions. Our mixed-methods process evaluation generally supported the trial methods and intervention acceptability and feasibility. Data from the proposed primary outcome, the WEMWBS, provided us with valuable data to estimate the sample size for a full trial in which to test the effectiveness and cost-effectiveness of the intervention. Limitations We identified and discussed several limitations concerned with recruitment, retention, intervention engagement and blinding. Conclusions Based on the findings from this pilot trial, a full trial (with some modifications) seems justified with a sample size of around 900 participants to detect between-group differences in the WEMWBS scores at 6-month follow-up. Future work We identified a number of recruitment, trial retention, intervention engagement and blinding issues in this pilot and make recommendations in preparation of and within a full trial.