The intervention was developed based on a previous successful study [27 (link)] and on a needs assessment [30 (link)] in a co-creation design with one to two health visitor representatives from each of the intervention clusters. The development was conducted in an iterative manner where health visitors tested aspects of the intervention in their real-world setting after having attended each meeting. The intervention was developed within a two-step approach: first, the contents and major outlines of the intervention were developed (January 2021 – April 2021). Next, co-creation with health visitor representatives from the intervention clusters was conducted following the described iterations (April 2021 – December 2021).
To be able to reduce social inequality in breastfeeding, it is important to investigate how the Breastfeeding Trial works in families who carry a high risk of early breastfeeding cessation, i.e., conceptualised in this study as families in which the mother is young or has a low educational attainment. These characteristics are in many ways stigmatised in high-income settings like Denmark [56 (link), 57 (link)]. Therefore, it is essential that the intervention supports relationship built on trust and provides a sense of security between the health visitor and the family. In an effort to avoid this stigma, recruitment videos developed and employed as part of the intensified intervention were tested among mothers in the target group and revised according to their feedback. Additionally, parents in the risk group participated during the questionnaire development phase with testing of questionnaires, which generated valuable input for the process.
A reference group of parent organisations, practitioners and decision makers will be established in order to contribute knowledge and experience, qualifying the project and in the long term facilitating and ensuring the dissemination of the project and ensuring that the knowledge produced will be targeted the audience including relevant decision makers.
During monthly dialogue meetings, health visitors will have the opportunity to disclose information about any harms or adverse effects. As the intervention aims to strengthen existing standard care, it is not expected to induce harm to the study population, and no data monitoring committee has been established.
To be able to reduce social inequality in breastfeeding, it is important to investigate how the Breastfeeding Trial works in families who carry a high risk of early breastfeeding cessation, i.e., conceptualised in this study as families in which the mother is young or has a low educational attainment. These characteristics are in many ways stigmatised in high-income settings like Denmark [56 (link), 57 (link)]. Therefore, it is essential that the intervention supports relationship built on trust and provides a sense of security between the health visitor and the family. In an effort to avoid this stigma, recruitment videos developed and employed as part of the intensified intervention were tested among mothers in the target group and revised according to their feedback. Additionally, parents in the risk group participated during the questionnaire development phase with testing of questionnaires, which generated valuable input for the process.
A reference group of parent organisations, practitioners and decision makers will be established in order to contribute knowledge and experience, qualifying the project and in the long term facilitating and ensuring the dissemination of the project and ensuring that the knowledge produced will be targeted the audience including relevant decision makers.
During monthly dialogue meetings, health visitors will have the opportunity to disclose information about any harms or adverse effects. As the intervention aims to strengthen existing standard care, it is not expected to induce harm to the study population, and no data monitoring committee has been established.
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