PREPARE: A randomized trial of a pre-pregnancy weight loss intervention

描述（由申请人提供）：在美国，几乎一半的孕妇在怀孕开始时肥胖或超重，超过一半的孕妇经历了妊娠期体重过度增加。这些妇女患并发症的风险增加，如妊娠糖尿病、妊娠高血压和先兆子痫。肥胖妇女在分娩时需要更多的手术干预，并遭受更多的产后感染。越来越多的证据表明，母亲在怀孕初期的体重，以及怀孕期间的超重，与她的孩子变得肥胖和面临与肥胖相关的健康问题的风险增加有关。我们已经成功地帮助妇女在怀孕的前三个月开始一个项目，以避免过度的体重增加。然而，器官发生和代谢程序早在妊娠头三个月就开始了，早在第一次产前检查之前。因此，等待解决母亲的体重，身体活动和饮食并不是最佳选择。我们建议进行一项随机临床试验，以评估一项全面的孕前计划，以帮助肥胖和超重妇女改善饮食和体育活动习惯，在怀孕前减肥，并在怀孕期间不增加过多的体重。由于考虑怀孕的妇女对她们的时间有很多要求，我们在成功的远程但频繁的接触干预后模拟了我们的干预。1-3我们将与个人健康教练进行面对面的咨询，然后与同一教练进行24个月的频繁电话咨询，并访问一个支持网站。该研究将在Kaiser Permanente Northwest （KPNW）的综合健康计划中进行。在KPNW随机抽样的妇女对孕前生活方式计划表现出很高的兴趣。我们将使用KPNW广泛的电子医疗记录来识别极有可能怀孕的妇女，并邀请她们参与。我们将实施一项随机临床试验，以测试个性化体重管理干预措施，并与常规护理对照比较，针对计划在未来两年内怀孕的BMI为28的女性。我们认为，通过改善母亲的体重、饮食质量和活动水平，与对照组母亲的后代出生体重高于正常值相比，干预将导致后代出生体重较低（接近国家标准）。我们相信，通过电话和网站进行的干预将会被育龄妇女高度接受。如果我们证明帮助女性以更健康的体重开始怀孕可以改善她们自己和孩子的健康，那么这个项目可以在各种环境中迅速实施，并且可能具有巨大的潜力来减少肥胖并改善后代的公共健康。

DESCRIPTION (provided by applicant): Almost half of pregnant women in the US begin their pregnancies obese or overweight and more than half experience excessive gestational weight gain. These women are at increased risk for complications such as gestational diabetes, gestational hypertension, and pre-eclampsia. Obese women require more operative interventions at delivery and suffer more postpartum infections. Growing evidence suggests that a mother's weight at pregnancy onset, and excessive weight during pregnancy, are associated with an increased risk that her child will become obese and face obesity-related health issues. We have successfully helped women avoid excessive weight gain during pregnancy with a program started in the first trimester. However, organogenesis and metabolic programming begin early in the first trimester, well before the first prenatal visit. Therefore, waiting to addess mothers' weight, physical activity, and diet is not optimal. We propose to conduct a randomized clinical trial to evaluate a comprehensive pre-conception program to help obese and overweight women improve diet and physical activity habits and lose weight prior to becoming pregnant, and to not gain excessive weight during pregnancy. Because women considering pregnancy have many demands on their time, we modeled our intervention after successful remote, yet frequent contact interventions.1-3 We will use face-to-face counseling with a personal health coach followed by 24 months of frequent phone counseling with the same coach and access to a supportive website. The study will be conducted in an integrated health plan, Kaiser Permanente Northwest (KPNW). A random sample of women in KPNW have expressed high interest in a preconception lifestyle program. We will use KPNW's extensive electronic medical records to identify women with a high likelihood of pregnancy, and invite them to participate. We will implement a randomized clinical trial to test a personalized weight management intervention in comparison to usual care control for women with a BMI e 28 who are planning a pregnancy in the next two years. We believe that by improving mothers' weights, diet quality, and activity levels, the intervention will lead to offspring with lower birth weight (closer to national norms) compared to birth weights above norms in offspring of control mothers. We believe the intervention, delivered via telephone and website, will be highly acceptable to reproductive aged women. If we demonstrate that helping women start pregnancy at a healthier weight improves their own health and that of their children, this program could be quickly implemented in a variety of settings, and could have enormous potential to reduce obesity and improve public health for generations to come.