Section of Social Medicine, Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, 1353, Copenhagen, Denmark.
The Danish Committee for Health Education, Classensgade 71, 5th floor, 2100, Copenhagen, Denmark.
BMC Public Health. 2023 Mar 8;23(1):450. doi: 10.1186/s12889-023-15256-z.
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.
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.
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.
Prospectively registered with Clinical Trials NCT05311631 https://clinicaltrials.gov/ct2/show/NCT05311631.
母乳是婴儿最理想的营养来源，母乳喂养可以保护婴儿和母亲免受一系列不良健康后果的影响。在丹麦，大多数母亲都会开始母乳喂养，但许多母亲在头几个月就停止了，只有 14%的母亲达到了世界卫生组织推荐的六个月纯母乳喂养。此外，六个月时母乳喂养比例低的特点是明显的社会不平等。之前在医院环境中进行的一项干预措施成功地提高了六个月时纯母乳喂养的母亲比例。然而，大多数母乳喂养支持是在丹麦基于市的健康访视计划中提供的。因此，该干预措施进行了调整以适应健康访视计划，并在 21 个丹麦市实施。本文报告了将用于评估该调整后干预措施的研究方案。
该干预措施在市一级进行了一项基于群组的随机试验。采用综合评估方法。将使用调查和登记数据评估干预措施的效果。主要结果是产后四个月纯母乳喂养的女性比例和纯母乳喂养的持续时间（作为连续结果进行测量）。将完成一个过程评估以评估干预措施的实施情况；一个现实主义评估将提供对构成干预措施的变化机制的理解。最后，将进行健康经济评估以评估这种复杂干预措施的成本效益和成本效用。
本研究方案报告了母乳喂养试验的设计和评估 - 这是一项在丹麦市健康访视计划中实施的基于群组的随机试验，从 2022 年 4 月至 2023 年 10 月进行。该计划的目的是简化整个医疗保健部门提供的母乳喂养支持。评估方法全面，使用多种数据来分析干预措施的效果，并为未来努力改善所有人的母乳喂养提供信息。
前瞻性注册于临床试验 NCT05311631 https://clinicaltrials.gov/ct2/show/NCT05311631。
