Promoting fat loss during pregnancy in women with grade 2 and 3 obesity

项目摘要 孕妇肥胖和怀孕期间体重过度增加是导致孕妇和胎儿发病的主要原因。 在肥胖妇女中进行的随机试验表明，在怀孕期间进行生活方式干预， 减少妊娠期体重增加，但不幸的是，未能产生临床显着改善， 母婴健康状况如预期。一些明确的前瞻性队列研究表明， 肥胖的妇女，怀孕期间体重维持-特别是脂肪量减少-可能是 减少对孕产妇和儿童的不利影响。然而，没有随机对照试验 测试怀孕期间体重维持和母体脂肪量显著减少对健康的影响， 肥胖的女性我们新的初步能量平衡和身体成分数据显示，体重 怀孕期间的维持可以通过在第二次怀孕期间仔细定时限制热量来实现。 在怀孕的第三个三个月期间的三个月和eucaloric目标。根据这些和我们其他初步的 数据，我们提出了一个高度严格的原则证明试验，以确定6个月的妊娠 通过限制热量和提供食物进行干预，促进产妇体重维持和脂肪减少， 2级和3级肥胖的女性。2级和3级肥胖孕妇（N = 100; 30%西班牙裔; 30%黑人）将被随机分配到常规护理或妊娠期脂肪量减少（FML）干预。校长 目的是确定妊娠期间FML对以下变化的影响：1）母体体重，脂肪量， 心脏代谢风险因素; 2）安全性措施，包括胎儿和新生儿生长。所有的女人都会 在基线（13-16周）、妊娠27-29周和35-37周以及产后2周进行评估; 在整个试验期间每4周收集一次安全性测量。该项目意义重大，因为调查结果 有可能为修订目前鼓励体重的国家建议奠定基础 严重肥胖的女性在怀孕期间获得;研究结果可能会导致新的指导方针，鼓励 医生不要推迟对肥胖妇女的强化体重管理治疗， 怀孕，目前正在接受医疗保健。这项研究也是创新的;没有随机对照 评估干预措施效果的试验强度足以实际实现体重维持 并提供急需的安全性和有效性数据，以告知实践建议， 不同的严重肥胖妇女缺乏有效的治疗选择。

PROJECT SUMMARY Maternal obesity and excess weight gain in pregnancy are the leading causes of maternal and fetal morbidity. Randomized trials in women with obesity have shown that lifestyle interventions in pregnancy produce modest reductions in gestational weight gain, yet unfortunately fail to produce clinically significant improvements in maternal and child outcomes as long hoped. Several well-defined prospective cohort studies suggest that for women with obesity, weight maintenance during pregnancy – and specifically loss in fat mass – may be required to reduce adverse maternal and child outcomes. However, there are no randomized controlled trials testing the health effects of weight maintenance and significant maternal fat mass loss during pregnancy in women with obesity. Our novel preliminary energy balance and body composition data showed that weight maintenance during pregnancy could be achieved with careful timing of caloric restriction during the second trimester and eucaloric goals during the 3rd trimester of pregnancy. Based on these and our other preliminary data, we propose a highly rigorous proof-of-principle trial to determine the effects of a 6-month gestational intervention with calorie restriction and food provision to promote maternal weight maintenance and fat loss in women with grades 2 and 3 obesity. Pregnant women with grades 2 and 3 obesity (N = 100; 30% Hispanic; 30% Black) will be randomized to usual care or a gestational fat mass loss (FML) intervention. The principal aims are to determine the effects of FML during pregnancy on changes in 1) maternal weight, fat mass, and cardiometabolic risk factors; and, 2) safety measures, including fetal and neonatal growth. All women will be assessed at baseline (13-16 weeks), 27-29 weeks, and 35-37 weeks gestation and at 2 weeks postpartum; safety measures are collected every 4 weeks throughout the trial. This project is significant because findings have the potential to set the stage for a revision in national recommendations that currently encourage weight gain during pregnancy in women with severe obesity; findings may lead to new guidelines that encourage practitioners to not delay intensive weight management treatment in women with obesity who become pregnant and present for healthcare. The study is also innovative; there have been no randomized controlled trials evaluating the effects of a an intervention intensive enough to actually achieve weight maintenance during pregnancy and provide much needed safety and efficacy data to inform practice recommendations for diverse women with severe obesity who lack effective treatment options.