PT  - JOURNAL ARTICLE
AU  - Tom P Thompson
AU  - Lynne Callaghan
AU  - Emma Hazeldine
AU  - Cath Quinn
AU  - Samantha Walker
AU  - Richard Byng
AU  - Gary Wallace
AU  - Siobhan Creanor
AU  - Colin Green
AU  - Annie Hawton
AU  - Jill Annison
AU  - Julia Sinclair
AU  - Jane Senior
AU  - Adrian H Taylor
TI  - Health trainer-led motivational intervention plus usual care for people under community supervision compared with usual care alone: a study protocol for a parallel-group pilot randomised controlled trial (STRENGTHEN)
AID  - 10.1136/bmjopen-2018-023123
DP  - 2018 Jun 01
TA  - BMJ Open
PG  - e023123
VI  - 8
IP  - 6
4099  - http://bmjopen.bmj.com/content/8/6/e023123.short
4100  - http://bmjopen.bmj.com/content/8/6/e023123.full
SO  - BMJ Open2018 Jun 01; 8
AB  - Introduction People with experience of the criminal justice system typically have worse physical and mental health, lower levels of mental well-being and have less healthy lifestyles than the general population. Health trainers have worked with offenders in the community to provide support for lifestyle change, enhance mental well-being and signpost to appropriate services. There has been no rigorous evaluation of the effectiveness and cost-effectiveness of providing such community support. This study aims to determine the feasibility and acceptability of conducting a randomised trial and delivering a health trainer intervention to people receiving community supervision in the UK.Methods and analysis A 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. Participants receive community supervision from an offender manager in either a Community Rehabilitation Company or the National Probation Service. If they have served a custodial sentence, then they have to have been released for at least 2 months. The supervision period must have at least 7 months left at recruitment. Participants are interested in receiving support to change diet, physical activity, alcohol use and smoking and/or improve mental well-being. The primary outcome is mental well-being with secondary outcomes related to smoking, physical activity, alcohol consumption and diet. The primary outcome will inform sample size calculations for a definitive trial.Ethics and dissemination The study has been approved by the Health and Care Research Wales Ethics Committee (REC reference 16/WA/0171). Dissemination will include publication of the intervention development process and findings for the stated outcomes, parallel process evaluation and economic evaluation in peer-reviewed journals. Results will also be disseminated to stakeholders and trial participants.Trial registration numbers ISRCTN80475744; Pre-results.