为一项针对低收入女性产后体重滞留干预措施的试验做准备：基于社区组织的方案可行性
Preparing for a trial to test a postpartum weight retention intervention among low income women: feasibility of a protocol in a community-based organization.
作者信息
Wright Charmaine, Mogul Marjie, Acevedo Glamarys, Aysola Jaya, Momplaisir Florence, Schwartz Sandy, Shea Judy
机构信息
Division of General Internal Medicine, Blockley Hall, 423 Guardian Dr, Philadelphia, PA, 19104, USA.
Maternity Care Coalition, 2000 Hamilton Avenue, Suite 205, Philadelphia, PA, 19130, USA.
出版信息
BMC Womens Health. 2018 Jan 25;18(1):27. doi: 10.1186/s12905-018-0517-0.
BACKGROUND
Postpartum weight retention (PPWR) causes intergenerational harm, negatively affecting a mother's cardiovascular health and ability to have future healthy pregnancies. Low-income minority women are at highest risk for PPWR with little guidance concerning timeline or strategy to lose weight after delivery. An academic-community partnership conducted observational and focus group work to develop an intervention for PPWR among low-income mothers. This study's objective is to determine the feasibility of implementing a PPWR intervention trial in partnership with a community-based organization (CBO) serving low-income families with social service support.
METHODS
We analyzed five implementation outcomes in this feasibility study: acceptability, adoption, appropriateness, penetration, and sustainability. Other secondary outcomes were the change in psychosocial and clinical outcomes from baseline to one year following the intervention delivery.
RESULTS
An academic-community partnership developed and piloted a postpartum weight retention intervention among 17 participants that included 1) six weeks of interactive daily health texting, 2) exercise assistance with baby carrier, home exercise program, and pedometer provision, 3) two live healthy eating and baby feeding workshops, and 4) two 45-min home visits over one year to provide social support and acquire followup data. Implementation outcomes demonstrate an intervention supported by the organization and accepted by end-users, with increased capacity of the CBO to test and deliver an effective intervention. Weight loss was achieved by the majority of participants at one year (Md - 5 pounds (IQR = - 14.5 - 0.3).
CONCLUSION
We made protocol enhancements to the developed intervention based on the analysis of this study, and now prepare for a funded randomized controlled trial (RCT) in a community-based setting. Our central hypothesis is that low-income women who participate in a multi-component, low cost-intervention delivered by a CBO will have less postpartum weight retention than those women who do not participate in the program.
TRIAL REGISTRATION
The trial was retrospectively registered, ID NCT02867631, 8/11/16.
背景
产后体重滞留（PPWR）会造成代际危害，对母亲的心血管健康以及未来孕育健康胎儿的能力产生负面影响。低收入少数族裔女性产后体重滞留的风险最高，且在产后减肥的时间安排或策略方面几乎没有指导。一个学术-社区合作项目开展了观察性研究和焦点小组工作，以开发针对低收入母亲产后体重滞留问题的干预措施。本研究的目的是确定与一个为有社会服务支持的低收入家庭提供服务的社区组织（CBO）合作开展产后体重滞留干预试验的可行性。
方法
在这项可行性研究中，我们分析了五个实施结果：可接受性、采用率、适宜性、渗透率和可持续性。其他次要结果是从基线到干预实施后一年心理社会和临床结果的变化。
结果
一个学术-社区合作项目为17名参与者开发并试点了一项产后体重滞留干预措施，包括：1）为期六周的每日互动健康短信提醒；2）借助婴儿背带提供运动辅助、家庭锻炼计划并提供计步器；3）举办两场关于健康饮食和婴儿喂养的现场工作坊；4）在一年时间内进行两次45分钟的家访，以提供社会支持并获取随访数据。实施结果表明该干预措施得到了该组织的支持并为最终用户所接受，同时增强了社区组织测试和实施有效干预措施的能力。大多数参与者在一年后实现了体重减轻（中位数-5磅（四分位距=-14.5-0.3））。
结论
基于本研究的分析，我们对已开发的干预措施进行了方案改进，现在准备在社区环境中开展一项获得资助的随机对照试验（RCT）。我们的核心假设是，参与由社区组织提供的多组分、低成本干预措施的低收入女性，产后体重滞留情况将少于未参与该项目的女性。
试验注册
该试验进行了回顾性注册，注册号为NCT02867631，注册时间为2016年8月11日。
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