Abstract
BACKGROUND: A high prevalence of child overweight and obesity worldwide calls for innovative multi-setting intervention approaches, and thorough evaluation. This paper describes the protocol for the process evaluation of the Generation Healthy Kids (GHK) program-a school- and community-based intervention to promote healthy weight and wellbeing among 6-11-year-old children in Denmark. The process evaluation will explore (1) implementation, impact mechanisms and contextual factors influencing intervention outcomes and (2) potential ethical issues and unintended outcomes. METHODS: GHK aims to promote healthy weight and wellbeing through regular physical activity, healthy eating, improved sleep and balanced screen media behaviour among children in 1st-3rd grade. Intervention development was informed by United Kingdom Medical Research Council guidelines, previous evidence, theory, context knowledge, stakeholder input and a feasibility study. Intervention activities are designed to develop food, digital and physical literacy; awareness of sleep and screen media practices; social cohesion in the school class; and a supportive healthy environment. Pre-defined components in schools include a free lunch program 4 days a week; compulsory 40-min high-intensity physical activity sessions 3 days a week; equipment for active recess; classroom exercises on food literacy, screen media use, and sleep; and workshops and guidelines for parents on children's sleep and screen media behaviour. Local community interventions promoting child health and well-being will be co-created with community stakeholders. The 'Supersetting Approach' will be used to develop coordinated interventions across relevant settings. The 2-school year intervention will be tested in a cluster-randomized controlled trial with 12 intervention schools and 12 control schools, assessed at baseline (autumn 2023), and approximately 6 and 18 months later. The process evaluation will be guided by the project's program theory, process evaluation- and implementation science concepts and system approaches. It will include quantitative and qualitative methods and perspectives of children, parents, school staff and community stakeholders. DISCUSSION: The process evaluation will facilitate (1) interpretation of intervention effects; (2) understanding of context, impact mechanisms, synergies, implementation issues and evaluation approaches related to combining pre-defined components with system approaches and co-created activities; and (3) refinement of intervention and implementation strategies prior to potential scale-up. TRIAL REGISTRATION: ClinicalTrials.gov: NCT05940675. Registered on 4 July 2023.