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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)
  1. Tom P Thompson1,
  2. Lynne Callaghan1,
  3. Emma Hazeldine1,
  4. Cath Quinn1,
  5. Samantha Walker1,
  6. Richard Byng1,
  7. Gary Wallace2,
  8. Siobhan Creanor1,
  9. Colin Green3,
  10. Annie Hawton3,
  11. Jill Annison4,
  12. Julia Sinclair5,
  13. Jane Senior6,
  14. Adrian H Taylor1
  1. 1 Plymouth University Peninsula Schools of Medicine and Dentistry, Plymouth, UK
  2. 2 Plymouth City Council, Plymouth, UK
  3. 3 University of Exeter Medical School, Exeter, UK
  4. 4 School of Law, Criminology, and Government (Faculty of Business), Plymouth University, Plymouth, UK
  5. 5 University of Southampton, Southampton, UK
  6. 6 Division of Psychology & Mental Health, University of Manchester, Manchester, UK
  1. Correspondence to Dr Tom P Thompson; tom.thompson{at}plymouth.ac.uk

Abstract

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.

  • offenders
  • community supervision
  • lifestyle support
  • health behaviour change
  • mental wellbeing
  • complex intervention

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

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Footnotes

  • Contributors TPT led the drafting and development of the study protocol. LC, TPT, EH, SW, CQ, GW and AHT led the development of procedures in the southwest location. LC, JaS, TPT, CQ and AHT led the development of the procedures in the northwest. LC, RB, JaS, JuS, CQ and JA led on specific issues of working with the target population. SC led on the development of the statistical analysis plan. CG and AH led on the economic analysis plan. All authors contributed to drafting and approving the final manuscript.

  • Funding This manuscript is an independent research funded by the National Institute for Health Research PHR Programme (project number 14/54/19). This research was supported by the NIHR Collaboration for Leadership in Applied Health Research and Care South West Peninsula.

  • Disclaimer The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the PHR Programme, NIHR, NHS or the Department of Health.

  • Competing interests None declared.

  • Patient consent Not required.

  • Ethics approval The study has been approved by the Health and Care Research Wales Ethics Committee (REC reference 16/WA/0171).

  • Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.

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