A Randomized Control Trial to improve metabolic outcomes in African American pregnant women

包括妊娠期糖尿病(GDM)在内的母亲高血糖不成比例地影响5%-11%的 非裔美国孕妇(AAPW)。妊娠期糖尿病甚至非糖尿病高血糖与 先兆子痫、初次剖宫产、巨大儿、短期内的分娩创伤以及增加的风险。 从长远来看，肥胖、2型糖尿病和心血管疾病是母亲和子女的主要危险因素。国民医疗 即使是短期后果，全球生产总值的成本也很高，每年高达18亿美元。超重/肥胖AAPW有 在任何种族中，妊娠期糖尿病、妊娠期糖尿病复发和非糖尿病高血糖的风险最高。沉睡 差距也是存在的。AAPW睡眠时间较短，睡眠时间中点较晚，睡眠连续性较差 比白人女性更有质量。我们和其他人都表现出睡眠时间短、睡眠质量差和睡眠晚 时机选择与妊娠期糖尿病风险增加有关。在怀孕期间普遍存在的睡眠障碍可能代表着 母亲高血糖的可改变的危险因素。虽然认知/行为方法已经产生了强大的 在普通人群中改善睡眠时间和质量，我们是唯一一组测试 非药物睡眠干预改善早产儿母体糖代谢。我们的前期工作 建议睡眠B.E.T.T.E.R.解决清醒-睡眠卫生的6个原则(卧室、锻炼、紧张、 在床上的时间、饮食和节奏)，以24小时的行为和多种生活方式为目标 改善孕妇的睡眠。这项随机对照试验的目的是建立 我们的文化针对性和个性化更好的干预措施的有效性，以促进孕产妇 AAPW中的葡萄糖代谢。我们将招募150名18-40岁超重/肥胖的未分娩AAPW。他们将会是 随机(每组75人)：1)睡得更好或2)注意力控制(备胎)。数据将于16-16收集 20周(基线)、28-30周(治疗结束)和34-36周(治疗后)妊娠周(GW)，使用有效和 在自由生活条件下使用最先进的血糖评估方法监测睡眠的可靠仪器 水平和胰岛素敏感性。我们的具体目标是：(1)定义更好的与备胎相比的影响 糖耐量(空腹血糖-主要结果)和胰岛素敏感性，以及(2)决定 比生育准备更好地改善参与者的睡眠持续时间、睡眠质量和时间安排，以及(3)确定 其他因素在多大程度上代表关键的影响因素，包括经济困难、心理社会 压力和种族歧视的干预(探索性目的)。我们研究的长期目标是 1)开发低成本和有效的方法，以优化产妇的新陈代谢和福祉 易于在医院或社区诊所的产前护理中使用；2)整合睡眠卫生 改善低收入非洲母亲糖代谢的主流产前教育原则 美国女性。这有助于改善母亲及其后代和下一代的健康状况。 这项提案支持NIMHD改善少数群体健康和消除健康差距的使命。

Maternal hyperglycemia including Gestational Diabetes Mellitus (GDM) disproportionately affects 5-11% of African American Pregnant Women (AAPW). GDM and even nondiabetic hyperglycemia are linked to preeclampsia, primary cesarean section, macrosomia, birth trauma in the short-term, and increased risks of obesity, Type 2 diabetes and cardiovascular disease in mothers and offspring in the long-term. National medical costs of GDM even for short-term consequences are high at $1.8 billion yearly. Overweight/obese AAPW have the highest increased risk of GDM, GDM recurrence and nondiabetic hyperglycemia of any race. Sleep disparities also exist. AAPW have shorter sleep, later midpoints of sleep (timing), worse sleep continuity and quality than White women. We and others have shown short sleep duration, poor sleep quality and later sleep timing are associated with increased GDM risk. Sleep disturbances, ubiquitous in pregnancy, may represent MODIFIABLE risk factors for maternal hyperglycemia. While cognitive/behavioral methods have yielded robust improvement in sleep duration and quality in general population, we are the only group to test the effects of a nonpharmacologic sleep intervention to improve maternal glucose metabolism in AAPW. Our preliminary work suggests that sleep B.E.T.T.E.R. addressing 6 principles of wake-sleep hygiene (Bedroom, Exercise, Tension, Time in bed, Eating, and Rhythm), targeting 24-hr behaviors and multiple lifestyle components can successfully improve sleep in pregnant women. The purpose of this randomized controlled trial is to establish the effectiveness of our culturally targeted and individually tailored BETTER intervention to promote maternal glucose metabolism in AAPW. We will enroll 150 overweight/obese nulliparous AAPW aged 18-40. They will be randomized (75 per group) to: 1) sleep BETTER or 2) attention control (Birth-Prep). Data will be collected at 16- 20 (baseline), 28-30 (end of treatment) and 34-36 (post treatment) gestational weeks (GWs) using valid and reliable instruments monitoring sleep in free-living conditions with state-of-the-art methods assessing glucose levels and insulin sensitivity. Our specific aims are to: (1) Define the impact of BETTER versus Birth-Prep on glucose tolerance (fasting glucose-primary outcome) and insulin sensitivity, and (2) Determine the efficacy of BETTER versus Birth-Prep to improve sleep duration, sleep quality and timing in participants, and (3) Determine the extent to which other factors represent key effect modifiers including economic hardships, psychosocial stress and racial discrimination for the intervention (exploratory aim). The long-term goals of our research are 1) to develop low-cost and effective approach on optimizing maternal metabolism and well-being that can be easily employed in prenatal care from hospital- or community-based clinics, and 2) to integrate sleep hygiene principles in mainstream prenatal education to improve maternal glucose metabolism in low income African American women. This can contribute to better health outcomes in mothers, their offspring and next generations. This proposal supports NIMHD’s mission of improving minority health and eliminating health disparities.