Weight management for improved pregnancy outcomes

描述(申请人提供)：从历史上看，营养不良一直是一个主要的健康问题。然而，最近在美国和其他工业化国家，营养过剩也成为一个严重的公共卫生问题。随着新的肥胖症流行，我们看到发病率、死亡率和公共卫生负担不断增加，特别是在育龄妇女中。虽然病态肥胖曾经在孕妇中很少见，但现在迅速增加的产科患者肥胖水平极大地增加了他们严重怀孕并发症的风险。这些并发症包括流产、死产、胎儿过大导致剖腹产或阴道分娩对母婴造成产伤的风险增加，以及新生儿死亡。在美国，超过三分之一的女性现在开始怀孕时的体重指数为30或更高，这种情况在50年前是罕见的。考虑到肥胖女性在怀孕期间体重增加的严重后果，如妊娠期糖尿病、先兆子痫或剖腹产，最好的策略可能是在怀孕期间保持稳定的体重，而不是增加15磅或更多。不幸的是，很少有关于减少怀孕期间体重增加的有效性和可行性的研究。这项研究就是为了解决这个问题。200名怀孕时体重指数在30或以上的妇女将被招募参加这项可行性测试。所有参与者都将是一个提供高质量产科护理的非营利性管理保健组织的成员。自愿参与的患者将被随机分配到体重维持干预或常规护理中。被分配到干预措施的参与者将参加一个体重维持计划，该计划旨在帮助他们吃营养均衡的饮食，并控制能量摄入，以最大限度地减少怀孕期间的体重增加。两组的参与者(和他们的婴儿)将在产后2周、产后6个月和产后一年参加随访评估。主要的结果衡量标准将是母亲在怀孕期间的体重增加，分娩后保留的体重，以及胎龄较大婴儿的比例。次要结果将包括母亲及其婴儿的多种安全措施。除了安全措施外，我们的二次分析还将探讨肥胖孕妇体重管理干预的可行性和可接受性。公共卫生相关性：怀孕期间肥胖和体重过度增加会增加高血压、妊娠期糖尿病、大婴儿和剖腹产的风险。这项研究将测试一项针对肥胖孕妇的强化体重管理计划，以防止体重增加过多，并降低怀孕并发症的风险。鉴于怀孕是妇女寻求医疗的主要原因之一，防止怀孕期间体重过度增加的干预措施可能会通过防止肥胖症恶化及其对母亲和婴儿的长期影响而对公共健康产生重大影响。

DESCRIPTION (provided by applicant): Historically, under nutrition has been a major health concern. Recently however, over nutrition has also become a serious public health problem in the United States and other industrialized countries. With the new obesity epidemic we see increasing morbidity, mortality, and public health burden, particularly among reproductive-aged women. Whereas morbid obesity was once rare among pregnant women, a rapidly increasing proportion of obstetrics patients now have levels of obesity which dramatically increase their risk of serious pregnancy complications. These complications include increased risk of miscarriage, stillbirth, having a fetus that is too large leading to cesarean section or birth injuries for mom and baby from vaginal delivery, and death of the infant in the newborn period. More than 1/3 of women in the U.S. are now starting their pregnancies with a body mass index or 30 or greater, a condition that was unusual to rare 50 years ago. Given the serious consequences of added weight gain during pregnancy for obese women, such as gestational diabetes, pre-eclampsia, or cesarean delivery, the best strategy during their pregnancy may be to maintain a steady weight rather than gaining 15 pounds or more. Unfortunately, there is little research on the efficacy and feasibility of minimizing weight gain during pregnancy. This study is designed to address that problem. Two hundred women with BMIs of 30 or greater at the start of their pregnancy will be recruited for this feasibility test. All participants will be members of a non-profit managed care organization that provides high-quality obstetrics care. Patients who volunteer to participate will be randomly assigned to either a weight maintenance intervention or to usual care. Participants assigned to the intervention will participate in a weight maintenance program designed to help them eat a nutritionally balanced diet and to also control energy intake to minimize weight gain during their pregnancy. Participants (and their babies) in both groups will participate in follow- up assessments at 2 weeks postpartum, 6 months postpartum and one year postpartum. The primary outcome measures will be mothers' weight gain during pregnancy, the amount of weight retained after delivery, and the proportion of large for gestational age infants. Secondary outcomes will include multiple safety measures of the mothers and their babies. In addition to measures of safety, our secondary analyses will address the feasibility and acceptability of a weight management intervention among obese pregnant women. PUBLIC HEALTH RELEVANCE: Obesity and excessive weight gain during pregnancy lead to increased risks of high blood pressure, gestational diabetes, large infants, and cesarean section. This study will test an intensive, weight management program for obese pregnant women to prevent too much weight gain and reduce risk of pregnancy complications. Given that pregnancy is one of the primary reasons women seek medical care, interventions that prevent excessive weight gain during pregnancy could have significant public health impact by preventing worsening obesity and its long-term effects on mothers and their babies.