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

妊娠期体重过度增加(GWG)，定义为超过当前医学研究所(IOM)的GWG GWG指南与女性及其女性的短期和长期健康不良并发症有关 婴儿。超重和肥胖的女性由于体重增加而出现并发症的风险已经很高， 而过量的GWG进一步加剧了他们发生并发症的高风险。因此，迫切需要提供帮助。 在这一高危人群中减少过多的GWG。改善GWG的传统高强度干预 在超重和肥胖中，女性已经取得了成功，但对一些女性来说，时间过于密集。在……里面 此外，研究表明，女性认为改变行为的建议更有说服力，如果它来自她们的 临床医生，但临床医生在体重咨询方面培训不足。因此，旨在减少 超重和肥胖女性中超重的GWG对女性和临床医生都是实用的 需要的。新出现的证据和我们的试点工作表明，移动健康(MHealth)对体重的干预 管理在怀孕期间可能是有效的，但在现实世界的临床环境中进行大规模随机试验 是必要的。我们将对56名临床医生(护理2040名孕妇)进行整群随机对照试验 超重/肥胖妇女)随机接受常规护理或常规护理加mHealth干预。我们建议 根据患者的GWG增加强度的适应性干预与IOM的关系 指导方针。基于技术的工具--包括移动应用程序、无线智能秤、可穿戴活动跟踪器、 和饮食跟踪应用程序-将支持方便的自我监控、反馈和目标设置。这些工具将 通过文本消息向患者提供基本上自动化的实时反馈，并将实时传输GWG， 向生活方式教练和产科临床医生提供体力活动和饮食数据。所有临床医生的患者都在 干预，接收基于技术的工具、自动短信和核心生活方式的每周电子邮件 干预会议(步骤1)。步骤2是添加个性化短信；步骤3是添加 个性化的一对一电话辅导课程，后两个步骤为有需要的患者保留 他们。参与干预的临床医生还接受EHR中嵌入的培训和工具，以便于讨论 GWG和他们的病人。我们的主要目标是评估适应性移动健康干预措施是否旨在 帮助超重/肥胖女性和她们的临床医生管理GWG将比平时改善GWG 关心。我们的次要目标是评估移动健康干预是否能改善产后体重保留 在6周时，具有适当出生体重(第10和第90百分位数)的婴儿和婴儿的比例 从出生到12个月的生长轨迹。我们将评估移动健康干预的成本效益 以及使用RE-AIM框架的可能采用。如果这种移动健康干预被证明是有效的，它可能 成为临床护理的补充部分，为母亲及其婴儿带来更好的结局。

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.