Hand in Hand - a work environment intervention for improved employee health in early education and care
| ISRCTN | ISRCTN81684777 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81684777 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 878385 |
| Sponsor | National Institute of Occupational Health |
| Funder | Statens arbeidsmiljøinstitutt |
- Submission date
- 26/09/2025
- Registration date
- 06/10/2025
- Last edited
- 03/10/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Of all sectors in Norway, the Early Education and Care (ECEC) sector not only has the highest sickness absence, it has the highest work-related sickness absence. With near 50% of the sickness absences in the ECEC being work-related, there is substantial potential to intervene and improve employee health. The most common sickness absence diagnoses among ECEC employees are musculoskeletal disorders and common mental disorders, i.e., anxiety and depression. Hence, improvements to the work environment should target known factors that are related to these disorders. The improvements include optimising physical workload and emotional work.
This study builds on and extends previous interventions, the TOY-project (where ergonomics and pedagogics go hand in hand) and Goldi-Daycare project (improving employee health by increase high intensity physical activity). Where these interventions aimed to address ergonomics in ECEC, this intervention extends the concepts from these interventions to the psychosocial work domain by addressing emotional work. The intervention aims to enhance the health of ECEC staff by promoting a better ergonomic and emotional work environment, particularly in areas where the work environment and quality of (ECEC) intersect.
Who can participate?
All employees directly involved in childcare who work in the participating childcare centres during the intervention period.
What does the study involve?
Employees will wear wearable sensors (accelerometers and heart rate monitors) for 7 days, they will be observed by a researcher, and they will be asked to answer a questionnaire about their psychosocial work environment, their health and their perception of the quality of care provided by the daycare center. Further, the employees will participate in a workshop that will provide them with tools to prioritise issues related to the work environment and to come to solution. Additionally, the employees will receive two workplace visits to evaluate how the solutions have been implemented and whether adjustments need to be made.
What are the possible benefits and risks of participating?
The study aims to improve ECEC staff health as well as quality of care provided by them. Other than a potential skin irritation as a reaction to the adhesive used to attach the wearable sensors, there are no risks to participating.
Where is the study run from?
The study is run from the National Institute of Occupational Health in Norway. The intervention will take place in 19 daycare centres in Norway.
When is the study starting, and how long is it expected to run for?
February 2025 to December 2026
Who is funding the study?
National Institute of Occupational Health (Norway)
Who is the main contact?
Suzanne Merkus, suzanne.merkus@stami.no
Contact information
Public, Scientific, Principal investigator
Pb 5330 Majorstuen
Oslo
0304
Norway
| Phone | +47 (0)23 19 52 65 |
|---|---|
| suzanne.merkus@stami.no |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicenter interventional cluster-randomised wait-list controlled trial |
| Secondary study design | Cluster randomised trial |
| Study type | Participant information sheet |
| Scientific title | Hand in Hand - Improved occupational health by considering quality of care in early education and care: a Goldilocks Works inspired cluster-randomised controlled |
| Study acronym | Hand in Hand |
| Study objectives | The overall aim of the Hand-in-Hand project is to implement and evaluate the effectiveness and implementation process of a participatory tailored work environment intervention that aims to promote a better work environment by considering quality in early education and care (ECEC). The intervention aims to optimise emotional work and optimise physical workload, and thereby reduce work-related fatigue, musculoskeletal discomfort, and depression and anxiety symptoms of ECEC staff. |
| Ethics approval(s) |
Approved 19/05/2025, Regional committees for medical and health research ethics (REK) South-East C (Postboks 1130, Blindern, Oslo, 0318, Norway; +47 (0)228 45 511; rek-sorost@medisin.uio.no), ref: 878385 |
| Health condition(s) or problem(s) studied | Occupational health among ECEC staff |
| Intervention | The aim of the intervention is to enhance the health of ECEC staff by promoting a better work environment, particularly in areas where the work environment and quality of (ECEC) intersect. The trail is a tailored organizational intervention with a participatory approach and is inspired by the Goldilocks Works-principle. The participatory approach ensures worker involvement, ownership of the intervention process, and tailoring to the needs of each workplace, which is essential for intervention effectiveness. The participating ECEC centres will be randomised to either the intervention or a waitlisted control group. The control group will a report of the results from the workplace mapping and the employees will receive an individualised report of their ergonomic demands. The participating ECEC centres will be informed of their group allocation by researchers before the start of baseline measurements. At baseline and 1-year follow-up, ECEC staff will participate in a workplace mapping that will assess the work environment, perceived quality of care, and staff health. Every 3 months throughout the 1-year intervention, ECEC will be asked to respond to questionnaires that assess the primary outcomes of the trial. The intervention components will consist of the workplace mapping, a workshop during working hours in which the results from the workplace mapping will be integrated, and two workplace visits. During the workplace mapping ergonomic factors will be assessed with wearable sensors (accelerometers and heart rate monitors for 7 days) and by observation, while psychosocial work factors, quality of care and staff health will be assessed by questionnaire. In the workshop, based on the results from the workplace mapping, the employees will choose between two packages: one related to ergonomics or one related to emotional work. Throughout the workshop, the employees will gain experience in using tools to prioritise areas for improvement within the work environment (either ergonomics or emotional work) and quality of care, and on how to find solutions to their issues based on the Hand in Hand approach. Hence, during the workshop, the intervention will be tailored to the needs of each ECEC centre. During two workplace visits, employees will reflect on whether solutions have been implemented and whether changes need to be made to the suggested solutions. The workshop and workplace visits will be led by consultants from the local NAV-Arbeidslivssenter with assistance from Human Resources (HR) staff as well as union representatives of the participating municipalities. The consultants and assistants will all receive training in how to deliver the workshop and workplace visits. Throughout the intervention year, information from the consultants, meetings with the municipality representatives, questionnaires answered by the employees, and a focus group interview among employees will contribute to evaluate the implementation of the intervention. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
1. Physical workload is measured using wearable sensors at baseline and 1 year follow-up |
| Key secondary outcome measure(s) |
1. Awareness of how the work environment and ECEC quality go hand-in-hand is measured using questionnaire at baseline and 1 year follow-up |
| Completion date | 30/12/2026 |
Eligibility
| Participant type(s) | Employee |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | All |
| Target sample size at registration | 210 |
| Key inclusion criteria | All employees directly involved in childcare from the recruited institutions who consent to participate in the scientific evaluation |
| Key exclusion criteria | 1. From the ergonomic evaluation: Pregnant women 2. Allergy to tape or tape adhesive |
| Date of first enrolment | 26/09/2025 |
| Date of final enrolment | 30/11/2025 |
Locations
Countries of recruitment
- Norway
Study participating centre
Oslo
0304
Norway
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
26/09/2025: Study's existence confirmed by the Regional committees for medical and health research ethics (REK) South-East C.
