Journal Article

Copen-SCALE: scaling-up an effective intervention to childcare institutions in Copenhagen – a stepped wedge type II hybrid effectiveness-implementation trial. A study protocol

Holtermann, Andreas, Lindberg, Line, Stilling, Mia Nyvang, Sørensen, Ole Henning, Rasmussen, Charlotte Diana Nørregaard, Tuck, Laura Downs

2025

Overview

Background This study protocol describes the evaluation of the scale-up of an effective intervention to potentially all 350 childcare institutions in Copenhagen. This project represents a unique opportunity previously unseen in occupational health and safety – namely the scale-up of an effective workplace intervention (TOY) to hundreds of workplaces. The aim of the project is to evaluate the scale-up of the TOY intervention, titled “Copen-SCALE.” Methods The study is a 4-year type II hybrid stepped-wedge trial that will evaluate the effectiveness, cost-effectiveness, and implementation of an intervention across up to 350 childcare institutions in Copenhagen Municipality. The original TOY intervention included three participatory ergonomic workshops at childcare institutions, facilitated by external ergonomic consultants. The intervention had high feasibility and demonstrated a significant reduction in pain-related sickness absence among the childcare workers. Copen-SCALE’s target population now includes childcare workers in both day nurseries (ages 0–3) and pre-schools (ages 3–6), expanding beyond the original TOY RCT trial group. Moreover, there has been further development of the intervention by including best practices and research findings to the TOY concept, leading to the development of Copen-SCALE. Copen-SCALE includes four evidence-based components: child self-reliance, ergonomics, pain management education, and health-promoting activities. Copen-SCALE aims to include up to eighty-seven childcare institutions each year from 2024 to the end of 2027. Mixed methods will be employed to investigate effectiveness, cost-effectiveness, adaptation, and implementation of Copen-SCALE. Discussion Scaling up effective interventions is crucial for achieving widespread benefits. Yet, this is underexplored in occupational health. The TOY intervention, being cost-effective and scalable, has the potential to contribute with valuable evidence, informing policies to enhance childcare workers’ health, well-being, and work environment. We anticipate that the findings from this project will inform wider dissemination of the intervention to childcare workers in more municipalities in Denmark. Trial registration The study was prospectively registered in a clinical trial register (ISRCTN14831585). Registered 04 January 2024, ISRCTN - ISRCTN14831585.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Adaptation / Age / Analysis / Best practice / Biostatistics / Care and treatment / Child / Child Day Care Centers / Child, Preschool / Childcare worker / Cost analysis / Cost effectiveness / Cost-Benefit Analysis / Day care centers / Denmark / Development and progression / Education / Environmental Health / Epidemiology / Ergonomics / Exercise / Health aspects / Health promotion / Humans / Implementation / Incomplete stepped wedged cluster trial / Infant / Institutions / Intervention / Medicine / Medicine & Public Health / Motor ability / Municipalities / Musculoskeletal diseases / Musculoskeletal pain / Occupational Health / Occupational safety / Pain / Participatory ergonomics / Prevalence studies (Epidemiology) / Prevention / Program Evaluation / Public Health / Risk factors / Scale-up / Schools / Sick leave / Study Protocol / Vaccine / Work environment / Workers / Working conditions / Workplace / Workplaces / Workshops