Effectiveness of a Community-based Support Programme to Reduce Social Inequality in Exclusive Breastfeeding: Study Protocol for a Cluster-randomised Trial

Overview

Journal BMC Public Health

Publisher Biomed Central

Specialty Public Health

Date 2023 Mar 8

PMID 36890478

Authors

Henriette Knold Rossau

Ingrid Maria Susanne Nilsson

Marianne Busck-Rasmussen

Claus Thorn Ekstrom

Anne Kristine Gadeberg

Jonas Cuzulan Hirani

Katrine Strandberg-Larsen

Sarah Fredsted Villadsen

Affiliations

Soon will be listed here.

Abstract

Background: Breastmilk 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.

Methods: The 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.

Discussion: This 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 Registration: Prospectively registered with Clinical Trials NCT05311631 https://clinicaltrials.gov/ct2/show/NCT05311631.

Citing Articles

Establishing trust through home visits during pregnancy: a realist evaluation of a Danish breastfeeding support intervention.

Gadeberg A, Nilsson I, Christensen U, Jacobsen M, Rossau H, Villadsen S Arch Public Health. 2025; 83(1):9.

PMID: 39800745 PMC: 11727675. DOI: 10.1186/s13690-024-01488-x.

Process evaluation of a breastfeeding support intervention to promote exclusive breastfeeding and reduce social inequity: a mixed-methods study in a cluster-randomised trial.

Rossau H, Gadeberg A, Strandberg-Larsen K, Nilsson I, Villadsen S Int J Equity Health. 2024; 23(1):204.

PMID: 39380053 PMC: 11463148. DOI: 10.1186/s12939-024-02295-0.

Development of a complex intervention to strengthen municipality-based breastfeeding support to reduced social inequity in breastfeeding.

Nilsson I, Busck-Rasmussen M, Villadsen S Arch Public Health. 2024; 82(1):174.

PMID: 39358759 PMC: 11447984. DOI: 10.1186/s13690-024-01401-6.

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