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

项目总结 孕妇肥胖和孕期超重是导致孕产妇和胎儿发病的主要原因。 对肥胖妇女的随机试验表明，怀孕期间的生活方式干预产生的效果不大 减少妊娠体重增加，但不幸的是，未能在临床上产生显著改善 产妇和儿童的结局正如人们长期以来所希望的那样。几项定义明确的前瞻性队列研究表明， 肥胖、怀孕期间保持体重--特别是脂肪量减少--的女性可能 减少不利的孕产妇和儿童结局所需的。然而，目前还没有随机对照试验 测试孕期体重维持和母亲显著减脂对健康的影响 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 孕期的维持可以通过在第二次怀孕期间仔细控制卡路里的时间来实现 妊娠三个月和妊娠第三个三个月期间的发热量目标。基于这些和我们的其他初步调查 数据，我们建议一项高度严格的原则证明试验来确定6个月妊娠的影响 通过限制卡路里和食物供应的干预措施促进母亲体重维持和脂肪减少 2级和3级肥胖的女性。2级和3级肥胖的孕妇(N=100；30%西班牙裔； 30%黑人)将随机接受常规护理或妊娠期脂肪减量(FML)干预。校长 目的是确定怀孕期间FML对1)母亲体重、脂肪量和 心脏代谢危险因素；和2)安全措施，包括胎儿和新生儿生长。所有的女人都会 在基线(13-16周)、27-29周、35-37周和产后2周进行评估； 在整个试验过程中，每4周收集一次安全措施。这个项目意义重大，因为研究结果 有可能为修订目前鼓励体重的国家建议奠定基础 严重肥胖妇女在怀孕期间的增加；研究结果可能导致新的指南，鼓励 从业者不得推迟肥胖女性的强化体重管理治疗 怀有身孕，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AN干预效果的试验，其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，以提供实践建议 患有严重肥胖症的多样化女性，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.