Cluster randomized trial of a mobile health intervention to achieve appropriate gestational weight gain in overweight/obese women

妊娠期体重增加过多（GWG），定义为GWG高于当前医学研究所（IOM） GWG指南与女性及其患者的短期和长期不良健康并发症相关。 婴儿。超重和肥胖的妇女由于体重增加，已经处于并发症的高风险之中， 并且过量的GWG进一步加剧了它们的高并发症风险。因此，迫切需要帮助 减少高风险人群中过量的GWG。传统的高强度干预措施，以改善GWG 在超重和肥胖妇女中取得了成功，但对一些妇女来说时间太长。在 此外，研究表明，女性认为改变行为的建议更有说服力，如果它来自他们的 临床医生，但临床医生没有足够的训练，体重咨询。因此，旨在减少 超重和肥胖妇女中过量的GWG对妇女和临床医生都是实用的， needed.新出现的证据和我们的试点工作表明，移动的健康（mHealth）干预体重 管理可以有效的怀孕，但在现实世界的临床环境中的大规模随机试验， 是必要的。我们将对56名临床医生（2040名孕妇）进行一项随机分组对照试验， 超重/肥胖女性）随机接受常规护理或常规护理加移动健康干预。我们提出 适应性干预，根据患者的GWG与IOM的关系增加强度 指南基于技术的工具-包括一个移动的应用程序，无线“智能”秤，可穿戴活动跟踪器， 和饮食跟踪应用程序-将使方便的自我监测，反馈和目标设定。这些工具将 通过短信向患者提供大部分自动化的实时反馈，并将实时传输GWG， 身体活动和饮食数据提供给生活方式教练和产科医生。临床医生的所有患者， 干预，接收基于技术的工具，自动短信和每周核心生活方式的电子邮件 干预会议（步骤1）。步骤2是添加个性化短信;步骤3是添加 个性化的1：1电话辅导课程，后两个步骤为需要的患者保留 他们参与干预的临床医生还接受了EHR中嵌入的培训和工具，以促进讨论 GWG与患者。我们的主要目的是评估一种适应性的移动健康干预措施， 帮助超重/肥胖妇女及其临床医生管理GWG将改善GWG， 在乎我们的第二个目标是评估移动健康干预是否能改善产后体重保持 在6周时，具有适当出生体重的婴儿比例（<10th and >第90百分位数）和婴儿 从出生到12个月的成长轨迹。我们将评估移动健康干预措施的成本效益 并可能采用RE-AIM框架。如果这种mHealth干预措施被证明是有效的， 成为临床护理的补充部分，为母亲及其婴儿带来更好的结果。

Excessive gestational weight gain (GWG), defined as GWG above the current Institute of Medicine (IOM) GWG guidelines is associated with adverse short and long-term health complications for women and their infants. Overweight and obese women are at already at high risk of complications due to their elevated weight, and excessive GWG further exacerbates their high risk of complications. Thus, there is an urgent need to help reduce excessive GWG in this high-risk population. Traditional high-intensity interventions to improve GWG among overweight and obese women have achieved success but are too time intensive for some women. In addition, studies show women consider behavior change advice to be more persuasive if it comes from their clinician, but clinicians have insufficient training on weight counseling. Thus, interventions aimed at reducing excess GWG among overweight and obese women that are practical for both women and clinicians are needed. Emerging evidence and our pilot work suggest that mobile health (mHealth) interventions for weight management can be effective in pregnancy, but a large-scale randomized trial in the real-world clinical setting is needed. We will conduct a cluster randomized controlled trial of 56 clinicians (caring for 2040 pregnant overweight/obese women) randomized to usual care or usual care plus an mHealth intervention. We propose an adaptive intervention that increases in intensity according to patients’ GWG in relation to the IOM guidelines. Technology-based tools—including a mobile app, wireless “smart” scale, wearable activity tracker, and diet tracking app—will enable convenient self-monitoring, feedback, and goal setting. These tools will provide largely automated, real-time feedback to patients via text messaging and will transmit real-time GWG, physical activity and diet data to a lifestyle coach and obstetric clinician. All patients of clinicians in the intervention, receive the technology-based tools, automated text messages and weekly e-mails of core lifestyle intervention sessions (Step 1). Step 2 is the addition of personalized text messages; and Step 3 is the addition of personalized 1:1 telephone coaching sessions, with these latter 2 Steps reserved for patients who need them. Clinicians in the intervention also receive training and tools embedded in the EHR to facilitate discussing GWG with their patients. Our primary aim is to evaluate whether an adaptive mHealth intervention designed to help overweight/obese women and their clinicians manage GWG will improve GWG in comparison to usual care. Our secondary aim will evaluate whether an mHealth intervention improves postpartum weight retention at 6 weeks, the proportion of infants with appropriate birthweight (<10th and >90th percentile) and infant growth trajectory from birth to 12 months. We will evaluate the cost-effectiveness of the mHealth intervention and possible adoption using a RE-AIM framework. If this mHealth intervention is proven effective, it could become a complementary part of clinical care, leading to better outcomes for mothers and their infants.