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

基本信息

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
项目类别：
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

项目摘要

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.

项目概要孕产妇肥胖和妊娠期体重过度增加是孕产妇和胎儿发病的主要原因。对肥胖女性的随机试验表明，怀孕期间的生活方式干预会产生适度的影响。妊娠期体重增加减少，但不幸的是未能产生临床上显着的改善几项明确的前瞻性队列研究表明，孕产妇和儿童的结局符合人们长期以来的期望。肥胖女性在怀孕期间维持体重，特别是减少脂肪量可能会需要减少不良的孕产妇和儿童结局然而，尚无随机对照试验。测试怀孕期间维持体重和显着减少母亲脂肪量对健康的影响我们新颖的初步能量平衡和身体成分数据显示，肥胖女性的体重怀孕期间的维持可以通过在第二次怀孕期间仔细限制热量来实现基于这些和我们的其他初步研究，确定了妊娠第三个月的妊娠和健康目标。根据数据，我们提出了一项高度严格的原理验证试验，以确定 6 个月妊娠的影响通过热量限制和食物供应进行干预，以促进孕产妇体重维持和减脂 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少 (FML) 干预。目的是确定怀孕期间 FML 对以下变化的影响：1) 母亲体重、脂肪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。在基线（13-16 周）、27-29 周和 35-37 周妊娠以及产后 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，该项目的研究结果非常重要。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女性在怀孕期间体重增加的研究结果可能会导致新的指导方针鼓励护理人员不要推迟对肥胖女性进行强化体重管理治疗该研究也具有创新性；尚未进行随机对照研究。评估干预措施强度足以实际实现体重维持效果的试验怀孕期间提供急需的安全性和有效性数据，为实践建议提供信息患有严重肥胖症的不同女性缺乏有效的治疗选择。