Hand-in-Hand–improving occupational health and quality of care in early education and care: study protocol for a cluster-randomized controlled trial

IntroductionIn Norway, the early education and care (ECEC) sector has the highest rate of work-related fatigue and sickness absence across all sectors. Work in ECEC can be characterized as physically and emotionally demanding, which may lead to fatigue and the two most common causes of sickness absence in the ECEC sector, i.e., musculoskeletal and mental health issues. Improvements to the work environment can lead to better health for ECEC employees and improve ECEC quality. Therefore, work environment, employee health, and ECEC quality go Hand-in-Hand. This paper presents the protocol for conducting a trial to evaluate the effectiveness and implementation of the tailored participatory Hand-in-Hand workplace intervention.Methods and analysisThe study is a 1-year pragmatic cluster-randomized controlled trial with a wait-listed control group. Nineteen ECEC centers were recruited from two Norwegian municipalities, with an estimated 350 employees. The intervention is facilitated by external consultants and includes one workshop and two workplace visits. This includes training the employees in the Hand-in-Hand toolbox, a systematic method for developing workplace measures. Data collection will consist of accelerometer and heart rate measurements, questionnaires, diaries, interviews and registry data; baseline measurements were conducted in October/November 2025. The primary outcome of the effect evaluation will be work-related fatigue. The effectiveness of the intervention will be analyzed using multilevel analyses. In addition, a process evaluation will assess intervention implementation to help understand why the intervention is effective (or not), and for whom and under which circumstances.DiscussionThe intervention adopts an interdisciplinary approach, integrating emotion work, sensor-based measurements of physical workload, and quality in early childhood education and care. The study aims to provide theoretical, methodological, and practical insights into how to design and implement a complex intervention in an ECEC setting.Trial registrationhttps://www.isrctn.com/ISRCTN81684777, identifier: ISRCTN81684777.