Healthy for 2/Healthy for U: A Pragmatic Randomized Clinical Trial to Limit Gestational Weight Gain and Prevent Obesity in the Prenatal Care Setting

肥胖和糖尿病的发病率继续上升，种族和性别差异持续存在。23%的 女性在青年期体重增加≥ 20 kg，这与以下发育有关： 糖尿病和更高的死亡率。由于许多妇女经历怀孕，过度 妊娠期体重增加（GWG）和产后体重保持（PPWR）可能是 在妇女和她们的孩子中，未来肥胖和糖尿病的可变因素。目的 这项R-18实用随机对照试验（RCT）的目的是测试 Healthy for Two / Healthy for You（H42/H4 U）是一项创新的循证医学研究。 远程提供的妊娠/产后健康指导干预（电话指导 + 基于网络的平台+移动的电话行为跟踪），旨在促进健康的GWG 产后体重减轻我们将把H42/H4 U嵌入产前护理诊所，为孕妇提供服务 种族和经济多样化的人口，利用现有的工作人员作为训练有素的健康教练 和社区卫生工作者，并测试其有效性和实施务实 RCT。我们的目标是1）比较H42/H4 U远程提供健康的有效性 在380名孕妇中，将辅导干预纳入产前护理与产后护理的比较 从6个产前诊所登记的孕妇和产后妇女; 2）评估组织 影响产前护理诊所实施干预措施的因素，包括 提供干预措施的成本以及提供者和工作人员的满意度，以便为今后的传播提供信息。 主要结局为GWG。母婴次要结局包括 GWG，GDM发病率，PPWR，婴儿出生体重和4个月和6个月，孕产妇健康 行为（饮食，体育活动，母乳喂养）和产妇健康（抑郁，睡眠， 应力）。这项研究将推进一个潜在的强大的，产前护理为基础的战略，以减少 肥胖症在育龄妇女中的影响及其对子女的代际影响。我们 团队汇集了学术和社区为基础的产科医生，人口健康 计划，并在开发，测试和实施行为经验的研究人员 在真实的世界环境中对怀孕和非怀孕成年人进行干预， 传播。最终，我们的目标是减少肥胖、糖尿病和其他与肥胖有关的疾病。 确保提供高质量的护理， 通过人口健康方法进行产前护理，减少肥胖和糖尿病。

Obesity and diabetes rates continue to rise, and racial and gender disparities persist. 23% of women gain ≥ 20 kg through young adulthood, which is associated with development of diabetes and greater mortality. Because many women experience pregnancy, excessive gestational weight gain (GWG) and post-partum weight retention (PPWR) are potentially modifiable contributors to future obesity and diabetes in both women and their children. The aim of this R-18 Pragmatic Randomized Controlled Trial (RCT) is to test the effectiveness of Healthy for Two / Healthy for You (H42/H4U), an innovative evidence-based pregnancy/postpartum health coaching intervention that is remotely-delivered (phone coaching + web-based platform + mobile phone behavioral tracking), aimed at promoting healthy GWG and postpartum weight loss. We will embed H42/H4U into prenatal care clinics that serve a racially and economically diverse population, leverage existing staff as trained health coaches and community health workers, and test its effectiveness and implementation in a pragmatic RCT. We aim to 1) Compare the effectiveness of the H42/H4U remotely-delivered health coaching intervention integrated into prenatal care compared with Usual Care among 380 pregnant and postpartum women enrolled from 6 prenatal clinics and; 2) Assess organizational factors that impact the implementation of the intervention into prenatal care clinics, including costs of intervention delivery and provider and staff satisfaction to inform future dissemination. The primary outcome will be GWG. Maternal and infant secondary outcomes include excess GWG, GDM incidence, PPWR, infant birth weight and at 4 and 6 months, maternal health behaviors (diet, physical activity, breastfeeding) and maternal wellness (depression, sleep, stress). This study will advance a potentially powerful, prenatal care-based strategy to reduce obesity in childbearing women and thereby the intergenerational effects on their children. Our team brings together academic and community-based obstetricians, a population health program, and researchers with experience in developing, testing and implementing behavioral interventions in both pregnant and non-pregnant adults in real world settings to enable wide dissemination. Ultimately, we aim to reduce obesity, diabetes and other obesity-related complications in mothers and their children, and ensure high quality care delivery that prevents obesity and diabetes through a population health approach to prenatal care.