Title: Improving health, under community supervision, with the support of a Health Trainer: Developing and evaluating a pilot randomised controlled trial
Funder: Department of Health and Social Care

Abstract: Target population: People under community supervision who express a desire to receive support, from a Health Trainer, to do things that make them feel better about themselves and improve their health, supported by the ‘5 Ways to Wellbeing’(5WWB)(19,32) and/or working towards one of the four target health behaviour changes (smoking reduction, alcohol consumption reduction, increasing physical activity or improving healthy eating). The proposed study will involve a developmental Phase 1, and a pilot RCT in Phase 2 with a focus on exploring the feasibility and acceptability of the intervention and trial methods to support progression to a definitive trial. Intervention: In Phase 1 we will develop and manualise an intervention building on existing training for Health Trainers (HTs) and for promoting the 5WWB to people receiving community supervision. HT support will be up to a maximum of 12 client centred one-to-one sessions: But we have planned for a mean of 6 sessions which could be sufficient to impact on the planned outcome measures and allow us to assess the possible mechanisms and component interactions through process evaluation. HTs will draw on motivational interviewing techniques and principles to support engagement in positive behaviours (e.g. such as physical activity, volunteering, creative pastimes) and growth in core human needs (competence, autonomy and relatedness). HTs will also help participants to self-monitor and set goals to achieve health behaviour change and link participants to other existing community resources and services. In Phase 2 we will further assess the acceptability and feasibility of the intervention (vs usual care) in a pilot randomised controlled trial, through indicators of engagement, interviews with health trainers, and assessing intervention fidelity from recorded sessions. Outcomes: In Phase 1, we will develop the methods for delivering a pilot trial, including refining our planned recruitment and randomisation procedures and assessments. In the pilot trial we will assess recruitment and retention rates at 3 and 6 months post-baseline. At the end of the study we will assess the trial procedures against proposed progression rules to support a bid for completing a definitive trial. Our primary interest will be in assessing subjective well-being (WEMWBS), with assessment of other behavioural outcomes (e.g. self-reported alcohol consumption, smoking, diet, physical activity, substance use), quality of life (SF36 and EQ-5D-5L), depression (PHQ-9), and various process measures and health care and related utilisation costs. We will also estimate the resource use and costs associated with delivery of the intervention, and pilot methods for determining future cost-effectiveness analyses. Process evaluations: Mixed methods (1:1 interviews with HTs, participants, decliners and justice staff; audio recorded intervention sessions; participant case report forms; and engagement monitoring database). Formative evaluation (1-8 months) to ensure components of the intervention work together coherently and understand how to deliver intervention components effectively, for the target population and setting. Process evaluation (months 9-21) to identify mechanisms by which things did, and did not change for participants. We will also explore the utility of our logic model underpinning the intervention. Sample size: In the pilot trial we aim to recruit 60 participants per arm (i.e. 30 in each arm per site).

Lay abstract: People receiving community supervision, and those released from prison, in the UK have greater healthcare needs and lower levels of healthcare access than the general population. Mental health and substance misuse problems are particularly prevalent and co-morbidity (having both) is common. People subject to the criminal justice system are also more likely to face social inequalities, such as homelessness and unemployment, particularly those just released from prison. Harmful health behaviours and social inequalities lead to long term poorer health outcomes. Little is known about the effectiveness of interventions to improve the physical and mental health, and mental well-being of people recently released from prison or serving community sentences when compared with interventions for those in prison. This is due to a lack of routine data collection and the challenges in following people up. Some research has been conducted on the effects of brief counselling interventions to reduce alcohol consumption with people receiving supervision from the Probation service. Health Trainers, with a good understanding of the challenges faced by people receiving community supervision and basic training in effective behaviour change techniques, may be able to support clients on a regular basis by helping to build motivation and confidence to make important changes without telling clients directly what they should or shouldn’t do. They can also provide information about other options to receive support and be there to provide encouragement, share successes and support recovery from relapses. Working in partnership with people who have lived experience of the criminal justice system, we propose to conduct a study in which people receiving community supervision are offered a chance to receive support from a Health Trainer for up to 12 sessions, which follow a clear structure but also offer flexibility. When we begin to offer this, people receiving community supervision will probably include all prison leavers, as well as those with community sentences. The aim will be to ensure that clients gain a sense of achievement and competence, a sense of control over choosing which behaviours to change and when and how, and a chance to relate to and receive support from others. People receiving community supervision, who want to do things that make them feel better about themselves and improve their health, through addressing one of four target health behaviours (alcohol reduction, smoking reduction, increased physical activity, improved diet), will be offered ideas on a number of ways to achieve this, based on others’ experiences, while also developing a shared understanding of how this can impact on health and well-being, and other behaviours. The Health Trainer will help the client to identify personal goals to set and monitor. The proposed research be the first step towards finding out if this additional support leads to improvement towards the target health behaviours and improvements in wellbeing and health related quality of life. To do this, participants entering the study will be assigned (with an equal chance) to either the additional support from a Health Trainer or usual support, and followed up at 3 & 6 months by a researcher. We will also investigate whether the extra costs associated with the Health Trainer and extra support provided ‘offer value for money’ in terms of improved health behaviours and resultant reduction in health care costs.

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: GENERIC HEALTH RELEVANCE