Substance Use, Gender and Applied Research, RTI International, Research Triangle Park, North Carolina, USA
College of Public Health, Temple University, Philadelphia, Pennsylvania, USA.
BMJ Open. 2020 Jun 16;10(6):e034510. doi: 10.1136/bmjopen-2019-034510.
National breastfeeding rates have improved in recent years, however, disparities exist by socioeconomic and psychosocial factors. Suboptimal breastfeeding overburdens the society by increasing healthcare costs. Existing breastfeeding supports including education and peer support have not been sufficient in sustaining breastfeeding rates especially among low-income women. The preliminary outcomes of contingent incentives for breastfeeding in addition to existing support show promising effects in sustaining breastfeeding among mothers in the Special Supplemental Nutrition Programme for women, infants and children (WIC).
This trial uses a parallel randomised controlled trial. This trial is conducted at two sites in separate states in the USA. Mothers who were enrolled in WIC and initiated breastfeeding are eligible. Participants (n=168) are randomised into one of the two study groups: (1) standard care control (SC) group consisting of WIC breastfeeding services plus home-based individual support or (2) SC plus breastfeeding incentives (SC +BFI) contingent on demonstrating successful breastfeeding. All participants receive standard breastfeeding services from WIC, home-based individual support and assessments. Participants in SC receive financial compensation based on the number of completed monthly home visits, paid in a lump sum at the end of the 6-month intervention period. Participants in SC +BFI receive an escalating magnitude of financial incentives contingent on observed breastfeeding, paid monthly during the intervention period, as well as bonus incentives for selecting full breastfeeding food packages at WIC. The primary hypothesis is that monthly incentives contingent on breastfeeding in SC +BFI will significantly increase rates of any breastfeeding compared with SC. The primary outcome is the rate of any breastfeeding over 12 months. Randomisation is completed in an automated electronic system. Staff conducting home visits for support and assessments are blinded to study groups.
The Advarra Institutional Review Board has approved the study protocol (Pro00033168). Findings will be disseminated to our participants, scientific communities, public health officials and any other interested community members.
NCT03964454.
近年来，全国母乳喂养率有所提高，但仍存在社会经济和心理社会因素造成的差异。母乳喂养不足会增加医疗保健成本，给社会带来负担。现有的母乳喂养支持措施，包括教育和同伴支持，在维持母乳喂养率方面还不够充分，尤其是在低收入妇女中。除了现有的支持措施外，对母乳喂养的附带激励措施的初步结果表明，在补充营养特别计划（WIC）中，这种激励措施对维持母亲的母乳喂养率有积极影响。
本试验采用平行随机对照试验。该试验在美国两个不同州的两个地点进行。参加 WIC 并开始母乳喂养的母亲符合条件。参与者（n=168）随机分为两组之一：（1）标准护理对照组（SC），包括 WIC 母乳喂养服务和家庭为基础的个体支持，或（2）SC 加母乳喂养激励（SC+BFI），取决于成功母乳喂养的表现。所有参与者都接受 WIC 的标准母乳喂养服务、家庭为基础的个体支持和评估。SC 组的参与者根据完成的每月家访次数获得经济补偿，在 6 个月干预期结束时一次性支付。SC+BFI 组的参与者根据观察到的母乳喂养情况获得递增金额的经济激励，在干预期间每月支付，以及在 WIC 选择全母乳喂养食品套餐的奖金激励。主要假设是，SC+BFI 中基于母乳喂养的每月激励将显著提高任何母乳喂养率，与 SC 相比。主要结果是 12 个月内任何母乳喂养的比例。随机化在自动化电子系统中完成。进行支持和评估家访的工作人员对研究组不知情。
Advarra 机构审查委员会已经批准了研究方案（Pro00033168）。研究结果将传播给我们的参与者、科学界、公共卫生官员和任何其他感兴趣的社区成员。
NCT03964454。
