Author:
Rossau Henriette Knold,Nilsson Ingrid Maria Susanne,Busck-Rasmussen Marianne,Ekstrøm Claus Thorn,Gadeberg Anne Kristine,Hirani Jonas Cuzulan,Strandberg-Larsen Katrine,Villadsen Sarah Fredsted
Abstract
AbstractBackgroundBreastmilk is the ideal nutrition for infants, and breastfeeding protects infants and mothers from a range of adverse health outcomes. In Denmark, most mothers initiate breastfeeding but many cease within the first months resulting in just 14% reaching the World Health Organization recommendation of six months of exclusive breastfeeding. Furthermore, the low breastfeeding proportion at six months is characterised by a marked social inequality. A previous intervention tested in a hospital setting succeeded in increasing the proportion of mothers breastfeeding exclusively at six months. However, most breastfeeding support is provided within the Danish municipality-based health visiting programme. Therefore, the intervention was adapted to fit the health visiting programme and implemented in 21 Danish municipalities. This article reports the study protocol, which will be used to evaluate the adapted intervention.MethodsThe intervention is tested in a cluster-randomised trial at the municipal level. A comprehensive evaluation approach is taken. The effectiveness of the intervention will be evaluated using survey and register data. Primary outcomes are the proportion of women who breastfeed exclusively at four months postpartum and duration of exclusive breastfeeding measured as a continuous outcome. A process evaluation will be completed to evaluate the implementation of the intervention; a realist evaluation will provide an understanding of the mechanisms of change characterising the intervention. Finally, a health economic evaluation will assess the cost-effectiveness and cost-utility of this complex intervention.DiscussionThis study protocol reports on the design and evaluation of the Breastfeeding Trial – a cluster-randomised trial implemented within the Danish Municipal Health Visiting Programme from April 2022 to October 2023. The purpose of the programme is to streamline breastfeeding support provided across healthcare sectors. The evaluation approach is comprehensive using a multitude of data to analyse the effect of the intervention and inform future efforts to improve breastfeeding for all.Trial registrationProspectively registered with Clinical Trials NCT05311631https://clinicaltrials.gov/ct2/show/NCT05311631
Publisher
Springer Science and Business Media LLC
Subject
Public Health, Environmental and Occupational Health
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