The CRIAA Program complex intervention in primary care to support women and their families in breastfeeding: Study protocol for a pilot trial

Aim To report a pilot study protocol to assess the feasibility of a complex intervention, in the primary healthcare context, to support women and their families in breastfeeding. Design A pilot/feasibility trial with control and intervention groups. Methods The study will be conducted in two primary healthcare centres with 40 childbearing women (20 control group; 20 intervention group), with their partner/meaningful person and their respective healthcare professionals. Intervention group participants will receive the intervention: (a) in a breastfeeding workshop during their third trimester of pregnancy; and (b) via virtual breastfeeding support for six months postpartum. Health professionals will be trained to deliver the intervention. The control group will receive standard care in the outpatient clinic. The pilot will help determine the intervention's feasibility. Data collected pre‐intervention, 10‐days postpartum and two‐, four‐, and six‐months postpartum will provide estimates of the intervention's preliminary effects on self‐efficacy and main outcomes. Research Ethics Committee approval was obtained in April 2019. Discussion Breastfeeding support is a complex reality influenced by multiple factors. Therefore, approaches to breastfeeding are also, requiring interventions that address its multidimensional nature, including all actors involved. The proposed intervention will be applied by an interdisciplinary professional health team, allowing for its incorporation into standard practice and its perpetual maintenance. Impact The study will produce an original, comprehensive, complex intervention addressing contextual, and organizational factors to promote breastfeeding support using an interdisciplinary and family‐based approach; breastfeeding self‐efficacy is the core concept. The program evaluation and feasibility study will permit exploration of the integration of the intervention's novel aspects into the daily work of professionals and reveal how to better use existing resources in a full‐scale clinical trial. Trial registration ClinicalTrials.gov ID: NCT03944642. 摘要 目的 报告一项预试验研究方案,旨在评估在初级保健范围内支持产妇及其家庭母乳喂养的复杂干预措施的可行性。 设计 对照组和干预组的预试验/可行性试验。 方法 将在两个初级保健中心进行这项研究,有40名育龄女性(对照组:20人;干预组:20人)及其伴侣/重要人员和她们各自的保健专业人员参与。干预组的受试者将接受干预:(a)在怀孕三个月期间参加母乳喂养讲习班;(b)在产后六个月内通过虚拟母乳喂养支持。医护人员将接受培训以提供干预措施。对照组将在门诊接受标准护理。预试验将有助于确定干预的可行性。干预前、产后10天、产后2个月、4个月和6个月收集的数据将提供干预对自我效能和主要预后的初步影响的评估。2019年4月获得了研究伦理委员会的批准。 讨论 母乳喂养支持十分复杂,受到多种因素的影响。因此,母乳喂养方法也需要采取干预措施,解决其多面性问题,包括所有相关行为者。将由一个跨学科