Pregnancy and EARly Lifestyle improvement Study (PEARLS)

描述（由申请人提供）：妊娠期肥胖和高血糖症通过营养过剩影响胎儿生长，并可能对胎儿胰腺造成压力。这种宫内编程事件会影响出生体重，并增加后代未来肥胖、2型糖尿病、心血管疾病和过早死亡的风险轨迹。这一恶性循环使患糖尿病母亲的女性后代更有可能在分娩前患上糖尿病，将发病负担从一代传给下一代。这种悲剧性但可预防的趋势可能是妊娠期和2型糖尿病惊人增加的基础。我们建议在400名超重或肥胖的波多黎各孕妇（无糖尿病）及其婴儿中进行随机对照试验，以有利地影响母亲和婴儿的代谢健康。在妊娠20周之前出现的妇女将被随机分为生活方式改变干预组或标准护理对照组。波多黎各是一个以西班牙裔为主的美国领土，是体力活动和水果水平最低的地区之一， 蔬菜和全谷物摄入量最高，糖尿病、儿童肥胖和婴儿死亡率最高;然而，这里的研究招募率高于美国其他地方。干预将在孕妇及其婴儿中进行，重点是改善：（1）身体活动水平，（2）饮食质量和卡路里摄入量，（3）行为印记和（4）产前护理。干预措施将通过 六次密集的核心小组会议（每组10名参与者），然后是助推器会议和电话会议，并将在哺乳期间持续到产后第一年。我们将评估联合干预是否会：（1）增加妊娠期体重适当增加的妇女比例，（2）优化早期婴儿生长，（3）实现适当的保留和依从性。作为次要目标，我们将评估干预措施是否改善了妇女的胰岛素敏感性和β细胞功能以及婴儿的空腹胰岛素浓度。这项研究还将帮助我们克服后勤和其他障碍， 制定更有效的方法在怀孕期间进行干预，以最大限度地减少后代的心脏代谢风险轨迹。在波多黎各进行这项研究将解决美国许多地区常见的主要健康差距，同时也将促进有关如何影响早期生命危险因素以降低年轻女性及其后代代谢风险的知识。

DESCRIPTION (provided by applicant): Obesity and hyperglycemia in pregnancy impact fetal growth through over-nutrition and may stress the feta pancreas. Such intrauterine programming events affect birth weight and raise the offspring's risk trajectory for future obesity, type 2 diabetes, cardiovascular disease and premature death. This vicious cycle, through which female offspring of mothers with diabetes are themselves more likely to develop diabetes prior to delivery, transmits the burden of morbidity from one generation to the next. This tragic but preventable trend likely underlies the alarming increase in gestational and type 2 diabetes. We propose to conduct a randomized controlled trial in 400 overweight or obese pregnant Puerto Rican women (free of diabetes) and their infants, to favorably impact metabolic health in mothers and infants. Women presenting before 20 gestational weeks will be block randomized to a lifestyle modification intervention or standard care control group. Puerto Rico is a predominantly Hispanic U.S. territory with among the lowest levels of physical activity and fruit, vegetable and whole grain intake, and the highest rates of diabetes, childhood obesity and infant mortality of all U.S. jurisdictions; nevertheless, recruitment rates for research studies ae higher here than elsewhere in the U.S.. The intervention will be conducted in pregnant women and their infants, focusing on improving: (1) physical activity levels, (2) diet quality and calori intake, (3) behavioral imprinting and (4) prenatal care. The intervention will be delivered through six intensive core group sessions (10 participants per group), followed by booster sessions and phone calls, and will continue during lactation through the first postpartum year. We will evaluate whether the combined intervention will: (1) increase the percent of women with adequate gestational weight gain, (2) optimize early infant growth and (3) achieve adequate retention and compliance. As secondary aims, we will evaluate whether the interventions improve insulin sensitivity and beta-cell function in the women and fasting insulin concentrations in their infants. This study will also help us to work through the logistical and other barriers to develop more effective ways to intervene during pregnancy to maximally reduce cardio-metabolic risk trajectories of future generations. Undertaking this study in Puerto Rico will address a major health disparity common to many parts of the US, whilst also advancing knowledge about how early life risk factors could be influenced to reduce metabolic risk in young women and their offspring.