Effectiveness of a community-based support programme to reduce social inequality in exclusive breastfeeding: study protocol for a cluster-randomised trial
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 Organizati...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2023-03-01
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| Series: | BMC Public Health |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12889-023-15256-z |
| _version_ | 1827982477782679552 |
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| author | Henriette Knold Rossau Ingrid Maria Susanne Nilsson Marianne Busck-Rasmussen Claus Thorn Ekstrøm Anne Kristine Gadeberg Jonas Cuzulan Hirani Katrine Strandberg-Larsen Sarah Fredsted Villadsen |
| author_facet | Henriette Knold Rossau Ingrid Maria Susanne Nilsson Marianne Busck-Rasmussen Claus Thorn Ekstrøm Anne Kristine Gadeberg Jonas Cuzulan Hirani Katrine Strandberg-Larsen Sarah Fredsted Villadsen |
| author_sort | Henriette Knold Rossau |
| collection | DOAJ |
| description | 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 |
| first_indexed | 2024-04-09T22:33:42Z |
| format | Article |
| id | doaj.art-362bc7afef3e48c285e718d1d1933715 |
| institution | Directory Open Access Journal |
| issn | 1471-2458 |
| language | English |
| last_indexed | 2024-04-09T22:33:42Z |
| publishDate | 2023-03-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Public Health |
| spelling | doaj.art-362bc7afef3e48c285e718d1d19337152023-03-22T12:35:36ZengBMCBMC Public Health1471-24582023-03-0123111410.1186/s12889-023-15256-zEffectiveness of a community-based support programme to reduce social inequality in exclusive breastfeeding: study protocol for a cluster-randomised trialHenriette Knold Rossau0Ingrid Maria Susanne Nilsson1Marianne Busck-Rasmussen2Claus Thorn Ekstrøm3Anne Kristine Gadeberg4Jonas Cuzulan Hirani5Katrine Strandberg-Larsen6Sarah Fredsted Villadsen7Section of Social Medicine, Department of Public Health, University of CopenhagenThe Danish Committee for Health EducationThe Danish Committee for Health EducationSection of Biostatistics, Department of Public Health, University of CopenhagenSection of Social Medicine, Department of Public Health, University of CopenhagenThe Danish Center for Social Science ResearchSection of Epidemiology, Department of Public Health, University of CopenhagenSection of Social Medicine, Department of Public Health, University of CopenhagenAbstract 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/NCT05311631https://doi.org/10.1186/s12889-023-15256-zBreast feedingCommunity healthComplex interventionsCross-sectoral consistencyDelivery of health careHealth care sector |
| spellingShingle | Henriette Knold Rossau Ingrid Maria Susanne Nilsson Marianne Busck-Rasmussen Claus Thorn Ekstrøm Anne Kristine Gadeberg Jonas Cuzulan Hirani Katrine Strandberg-Larsen Sarah Fredsted Villadsen Effectiveness of a community-based support programme to reduce social inequality in exclusive breastfeeding: study protocol for a cluster-randomised trial BMC Public Health Breast feeding Community health Complex interventions Cross-sectoral consistency Delivery of health care Health care sector |
| title | Effectiveness of a community-based support programme to reduce social inequality in exclusive breastfeeding: study protocol for a cluster-randomised trial |
| title_full | Effectiveness of a community-based support programme to reduce social inequality in exclusive breastfeeding: study protocol for a cluster-randomised trial |
| title_fullStr | Effectiveness of a community-based support programme to reduce social inequality in exclusive breastfeeding: study protocol for a cluster-randomised trial |
| title_full_unstemmed | Effectiveness of a community-based support programme to reduce social inequality in exclusive breastfeeding: study protocol for a cluster-randomised trial |
| title_short | Effectiveness of a community-based support programme to reduce social inequality in exclusive breastfeeding: study protocol for a cluster-randomised trial |
| title_sort | effectiveness of a community based support programme to reduce social inequality in exclusive breastfeeding study protocol for a cluster randomised trial |
| topic | Breast feeding Community health Complex interventions Cross-sectoral consistency Delivery of health care Health care sector |
| url | https://doi.org/10.1186/s12889-023-15256-z |
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