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

促进 2 级和 3 级肥胖女性孕期减脂

• 批准号: 10164778
• 负责人: Suzanne Phelan
• 金额: $ 60.5万
• 依托单位: LSU PENNINGTON BIOMEDICAL RESEARCH CTR
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-05-15 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10164778
• 关键词: 37 weeks gestation; Adherence; Adverse event; Agreement; Behavior Control; Birth; Birth Weight; Blood Pressure; Body Composition; Body Water; Body Weight Changes; Body Weight decreased; Breast Feeding; Caloric Restriction; Cesarean section; Child; Data; Desire for food; Dietary intake; Ethnic Origin; Fatigue; Fatty acid glycerol esters; Fetal Growth; Fetal Growth Retardation; Food; Gestational Diabetes; Glucose; Goals; Growth; Guidelines; Health; Healthcare; Hispanics; Hunger; Hypertension; Incidence; Infant; Insulin; Intake; Intervention; Lead; Lipids; Measurement; Measures; Mediator of activation protein; Modeling; Monitor; Morbid Obesity; Morbidity - disease rate; Neonatal; Obesity; Outcome; Pattern; Physical activity; Placenta; Postpartum Period; Pre-Eclampsia; Pregnancy; Pregnancy Complications; Pregnancy Trimesters; Pregnant Women; Prospective cohort study; Race; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Recommendation; Reporting; Research Project Grants; Risk Factors; Safety; Second Pregnancy Trimester; Small for Gestational Age Infant; Testing; Third Pregnancy Trimester; Translating; Weight; Weight Gain; Weight maintenance regimen; Woman; base; cardiometabolic risk; cardiometabolism; clinical care; clinically significant; depressive symptoms; dieting; effective therapy; efficacy testing; energy balance; epidemiologic data; epidemiology study; excessive weight gain; experience; fetal; gestational weight gain; improved; innovation; lifestyle intervention; maternal obesity; maternal weight; novel; obstetric outcomes; parity; pregnant; preservation; prevent; programs; randomized trial; restraint; therapy design; treatment as usual; weight maintenance

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.

项目摘要 孕产妇肥胖症并超过怀孕的体重是孕产妇和胎儿发病率的主要原因。 肥胖女性的随机试验表明，怀孕生产中的生活方式干预措施适中 妊娠体重增加的减少，但不幸的是无法在临床上显着改善 孕产妇和孩子的结果一直希望如此。一些定义明确的前瞻性队列研究表明 肥胖症的妇女，怀孕期间的体重维持 - 特别是脂肪质量损失 - 可能是 减少不良母校和儿童的结果所需。但是，没有随机对照试验 测试体重维持的健康影响和怀孕期间明显的母子脂肪质量损失 肥胖的妇女。我们新颖的初步能量平衡和身体组成数据表明重量 在第二次仔细的热量限制时，可以在怀孕期间进行维护 三个月怀孕的三个月和欧生目标。基于这些和我们的其他初步 数据，我们提出了一项高度严格的原始试验，以确定6个月妊娠的影响 干预卡路里限制和食物提供，以促进材料的体重维持和脂肪减少 2年级和3年级的妇女。具有2年级和3年级的孕妇（n = 100; 30％西班牙裔； 30％黑色）将被随机分配给通常的护理或妊娠脂肪质量损失（FML）干预措施。校长 目的是确定怀孕期间FML对1）MATER重量，脂肪质量和 心脏代谢危险因素； 2）安全措施，包括胎儿和新生儿生长。所有女人都会 在基线（13-16周），27-29周和35-37周妊娠以及产后2周评估； 在整个试验期间，每4周收集一次安全措施。这个项目很重要，因为发现 有可能为当前鼓励体重的国家建议中的修订奠定基础 患有严重肥胖的女性怀孕期间获得;调查结果可能会导致新准则，以鼓励 从业者不要延迟肥胖女性的体重管理治疗 怀孕并为医疗保健。这项研究也是创新的。没有随机控制 试验评估大量干预措施的影响以实际维持体重的影响 怀孕期间，并提供急需的安全性和效率数据，以告知实践建议 缺乏有效治疗选择的严重肥胖症的多样化女性。