The Supply chain Health INitiative Evaluation (SHINE) study protocol: Evaluating health and wellbeing services delivered through the supply chain.
| ISRCTN | ISRCTN17324653 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17324653 |
| NIHR Work and Health Research Award | NIHR208251 |
| Sponsor | Guy's and St Thomas' NHS Foundation Trust |
| Funder | National Institute for Health and Care Research |
- Submission date
- 23/03/2026
- Registration date
- 31/03/2026
- Last edited
- 31/03/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Work provides financial security, a sense of purpose and confidence. Poor health can negatively impact a person’s ability to work effectively, or to work at all. Health and wellbeing services (HWS) are important as they help prevent illnesses and provide support to help people remain at work. However, many small and medium size enterprises (SMEs) lack access to HWS and attempts to encourage them to buy in services have fallen short. Government initiatives to subsidise HWS for SMEs may face obstacles beyond cost, like reluctance to buy services from independent providers and/or uncertainty about what is on offer. Three quarters of SMEs operate within supply chains providing goods and services to Large Enterprise Organisations (LEOs). Offering support through familiar and trusted supply chains could enhance accessibility and effectiveness of HWS for the SME workforce.
This study will assess and better understand how providing HWS to SMEs through their LEOs affects employee work and health outcomes. It will also explore SMEs willingness to fund HWS for their employees to then help us understand how this delivery model could work on a national scale.
Who can participate?
The study team are working with three LEOs (Jaguar Land Rover, Hampshire and Isle of White Healthcare NHS Foundation Trust, and Transport for London).
What does the study involve?
Each of the LEOs has helped to recruit 6 SMEs that they work with, 18 in total. The SMEs have been randomly placed into either the intervention arm or the control arm of the study. The intervention SMEs are co-designing an HWS with their affiliated LEO and then receive this HWS package for one year. Likely components include promoting workplace health, including mental health, and training workplace managers in wellbeing conversations. Trained study ‘champions’ in each SME will support the delivery of the intervention. The champions will work with qualified health and work advisors to promote the services and coordinate HWS activities. Control SMEs will not receive the HWS intervention and will operate under business as usual.
To examine if the intervention is effective, data will be collected about a variety of things from staff in each company using four surveys. The first survey will be distributed before the intervention begins (baseline). Then three follow-up surveys will be shared at 6-months (in the middle of the intervention), 12-months (at the end of the intervention) and at 18-months (six months after the end of the intervention). The primary outcome will be work engagement, and secondary outcomes include different aspects of physical and mental health and general wellbeing. Changes will be examined in these between our first baseline survey and the follow-up surveys to examine if the intervention had a positive impact on staff in the intervention group. Any changes will be compared to those observed in the staff in the control group. Data collected by the survey will also be used to conduct an economic evaluation of the intervention to assess if it can save the SME or the LEOs money in the future. The study team will also talk to champions and stakeholders to understand what is working well with delivering HWS this way and what could be improved. To understand the value SMEs place on HWS, decision makers (e.g. company managers) from different SMEs will be asked for their thoughts on paying for HWS. In these ways, they will learn if offering HWS through LEOs can have a positive impact on SMEs and their employees in terms of improving/maintaining health and wellbeing, and employee engagement. A planned schedule of patient and public involvement and engagement activities has been embedded throughout. This work will be undertaken with help from of an Expert Stakeholder and Patient/Public Group that was assembled especially for the study.
What are the possible benefits and risks of participating?
Despite some potential risks, it is anticipated that participants, in both the intervention and control arms, are likely to experience positive benefits from taking part in this study. Taking part can increase their knowledge of effective strategies and actions they can take to promote good health and wellbeing. In addition, this is an important research study because it aims to assess whether it is feasible and acceptable to deliver an effective health and wellbeing intervention from large enterprise organisations to SME employees who work in their supply chain. More broadly, the findings from this study are likely to make an important contribution to future Government policy and strategies regarding worker health and wellbeing and will make a valuable contribution to the emerging evidence base. Staff may also win a voucher if they complete all four surveys.
This study is considered to be a potentially high-risk study in terms of its potential to cause any harm or distress to research participants. There is a risk that some participants may experience distress when reflecting on their health and wellbeing, either while completing the survey or accessing the health and wellbeing offers in their company. They are free to stop completing the survey or to skip any questions if they would prefer not to answer them. If participants become distressed at any point while accessing the health and wellbeing supports, the session facilitators will follow their LEO’s standard operating procedures to ensure that the individual receives support. This may mean that confidentiality is broken to provide pathways to support.
Where is the study run from?
South London Guys and St Thomas NHS Foundation Trust, UK
When is the study starting and how long is it expected to run for?
January 2026 to November 2027.
Who is funding the study?
National Institute for Health and Care Research (NIHR), Work and Health Research Award, UK.
Who is the main contact?
Dr Brendan Dempsey, brendan.dempsey@nhs.net
Contact information
Scientific, Public
75 York Rd, 4th Floor
Waterloo
London
SE1 7NJ
United Kingdom
 ORCID ID |
0000-0002-7659-7398 |
|---|---|
| brendan.dempsey@nhs.net |
Principal investigator
75 York Rd, 4th Floor
Waterloo
London
SE1 7NJ
United Kingdom
| ORCID ID |
0000-0003-0523-3770 |
|---|---|
| brendan.dempsey@nhs.net |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Uncontrolled |
| Assignment | Parallel |
| Purpose | Prevention |
| Scientific title | A prospective matched control cluster study to assess the effectiveness of health and wellbeing services (HWS) delivered by large enterprise organisations (LEOs) to small and medium sized enterprises (SME) on employees’ work engagement, and exploration of SME decision makers’ willingness and capacity to purchase different types of HWS from their LEO. |
| Study acronym | The SHINE Study |
| Study objectives | The study has five overarching objectives, which are to: A. Establish what HWS can be delivered by LEOs to SMEs in their supply chain. B. Evaluate the effectiveness and influential factors of HWS delivered by LEOs to SMEs in their supply chain, compared to control arm SMEs. C. Conduct an economic evaluation using cost-consequence and social return on investment (SROI) frameworks to compare the intervention benefits and costs. D. Monitor implementation and the perceptions of stakeholders in SMEs and LEOs. E. Assess the willingness and capacity of SMEs to engage and pay for HWS through this model. |
| Ethics approval(s) |
Approved 05/12/2025, King's College London Health Faculties (Blue) Research Ethics Subcommittee (3rd Floor, 5-11 Lavington Street, London, SE1 0NZ, United Kingdom; -; rec@kcl.ac.uk), ref: RESCM-25/26-40064 |
| Health condition(s) or problem(s) studied | General health and wellbeing. No specific health condition(s) or problem(s) to be studied in this study. |
| Intervention | This is a prospective matched cluster randomised controlled trial. All SMEs have been randomly sorted into either the intervention or control arm of the study. Randomisation was conducted via a computer programme. The workforce of each intervention SME will receive the intervention over a 12-month period, while staff in the control SMEs will not receive the intervention and will operate as usual. The intervention will be co-designed by the SMEs and their LEO. SME leaders will have the chance to highlight certain health and wellbeing concerns and then the LEO can devise specific supports for these. The intervention is co-designed to ensure it is relevant and appropriate for SMEs and their staff. At a minimum, the intervention will include supports seeking to raise health promotion activities (e.g., webinars and fact sheets about various topics in health and wellbeing, health checks in the workplace), prevention of mental health ill health (e.g., training days about mental health, signposting documents to mental health support) and training managers to have work and health conversations. The individual components included in the HWS intervention for each supply chain SME will be developed based on: (1) a review of the existing HWS within each participating LEO to ensure that the individual components are designed and delivered in accordance to good practice and can be delivered safely and with fidelity in an SME context and (2) the needs of each supply chain SME, appreciating that each SME may have some existing HWS in place. SMEs will also have input in deciding how these supports are delivered to staff, ensuring they are appropriate and accessible. Several delivery channels will be incorporated, including: • access to self-guided resources, accessed via web, intranets or in hard copy • all staff webinars with question-and-answer opportunities • recorded sessions that staff can watch back on demand • tailored expert-led training sessions facilitated by work and health experts, delivered to all staff or specific staff groups (eg. Hand arm vibration for estates workers, male mental health for men, leaders) In line with SME preference, the supports (e.g., fact sheets and recorded sessions) will either be stored electronically or in paper format. Where the resources are stored will vary by each SME, ensuring that they are easily accessible for staff. For example, some SMEs will store the resources in a designated folder in a SharePoint that is accessible to all staff. Other SMEs do not have a SharePoint or only make their SharePoint accessible to managers and will store the resources elsewhere. The timeline for delivery of the intervention will vary by SME and LEO, but there will generally not be more than one offering a week. Each LEO will map their intervention on a calendar to ensure its delivery is consistent over the one-year period. Throughout the year long intervention period, SMEs will be able to provide feedback on the intervention and to suggest changes, for example, that certain topics be covered or that the delivery channels be changed as they are not accessible. All supports will be delivered by trained professionals from each LEO (or acting on behalf of the LEO where third-party providers are involved). All individuals are trained to provide these services and deliver these supports to staff in their LEO. The SHINE study champions will help to advertise the supports within the company and will encourage staff to access them. The champions will also provide feedback to the LEOs and the research team about what aspects of the delivery are working well and what are not. Together, the champions, LEO and research team will come up with strategies to increase engagement with the supports if they are low. The champions will also suggest if certain topics should be covered and will explore with their LEO if any new resources can be added over the 12-month intervention. The champions receive a half-day of training (delivered by the research team) to support them in their role. They will also have a monthly meeting with a trained work and health advisor to support them in their role. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 30/11/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 16 Years |
| Upper age limit | 101 Years |
| Sex | All |
| Target sample size at registration | 1170 |
| Key inclusion criteria | For the SMEs (or clusters): 1. UK-based company with between 10 and 249 staff 2. Operate independently, i.e. not be managed by a larger parent company or conglomerate. Within the participating SMEs, the study will be implemented at an organisational-level: 1. All employees will be eligible to take part in the study 2. Salaried employees and others that SMEs deem appropriate to involve, e.g. those undertaking apprenticeships, contactors, or volunteers. 3. All participants will be of working age, i.e. 16+ years. |
| Key exclusion criteria | For the SMEs (or clusters): 1. Any companies that were not solely based in the UK 2. Companies that had nine or fewer employees, or 250 or more employees. 3. Companies that operated and were managed by a larger conglomerate. We acknowledge that while many companies have nine or fewer employees and may also benefit from HWS delivered by LEOs with whom they work, we have not included them due to statistical concerns related to small sample sizes. Companies with 250 or more employees are not classed as an SME in the UK. Companies that operated as a conglomerate were excluded because the large parent company may offer health and wellbeing services to the SMEs that they work with, hence contaminating any effect we might observe from the LEO-delivered intervention. Employees: 1. If they were not currently working with one of the participating sites 2. If they were 15 years of age or younger |
| Date of first enrolment | 27/01/2026 |
| Date of final enrolment | 30/06/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
London
SE1 7NJ
England
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in publicly available repository |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be stored in a publicly available repository - the Open Science Framework (https://doi.org/10.17605/OSF.IO/PRW6F). Data will only be uploaded to the OSF where consent has been given by participants. This has been covered in the consent forms for all components of the study, and the publicly available datasets will only contain data from those who consented to this. All datasets will be fully anonymised, and any identifiable data will be deleted prior to uploading to the OSF. This will include the results of the surveys, along with transcripts generated by the qualitative interviews and focus groups required by the process evaluation. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 2.1 | 28/10/2025 | 24/03/2026 | No | No |
Additional files
- 49257_Protocol_v2.1_28Oct2025.pdf
- Protocol file
Editorial Notes
24/03/2026: Study’s existence confirmed by the King's College London Health Faculties (Blue) Research Ethics Subcommittee, UK.
