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

改善非裔美国孕妇代谢结果的随机对照试验

• 批准号: 10471915
• 负责人: Bilgay Izci Balserak
• 金额: $ 64.89万
• 依托单位: UNIVERSITY OF ILLINOIS AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-20 至 2026-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10471915
• 关键词: Address; Adverse effects; Affect; African American; African American population; Aftercare; Appetite Regulation; Area Under Curve; Beds; Behavior; Behavioral; Birth; Birth trauma; Caffeine; Cardiovascular Diseases; Cesarean section; Child; Clinic; Cognitive; Communities; Data; Eating; Economics; Education; Educational Curriculum; Educational Intervention; Effectiveness; Enrollment; Exercise; Future; General Population; Gestational Diabetes; Glucose; Goals; Health; Hospitals; Household; Hyperglycemia; Individual; Interdisciplinary Study; Intervention; Knowledge; Lead; Life Cycle Stages; Life Style; Light Exercise; Link; Low income; Mainstreaming; Measures; Medical Care Costs; Mental Depression; Meta-Analysis; Metabolic; Metabolism; Methods; Mission; Mothers; National Institute on Minority Health and Health Disparities; Noise; Non-Insulin-Dependent Diabetes Mellitus; Nulliparity; Obesity; Outcome; Overweight; Participant; Patient Self-Report; Personal Satisfaction; Pilot Projects; Polysomnography; Population; Pre-Eclampsia; Pregnancy; Pregnancy Complications; Pregnant Women; Prenatal care; Preparation; Psychosocial Stress; Race; Randomized; Randomized Controlled Trials; Recurrence; Reduce health disparities; Research; Risk; Risk Factors; Role; Science; Sleep; Sleep disturbances; Social status; Social support; Stress; Telephone; Testing; Thinking; Time; Woman; Work; aged; attentional control; base; cost; cost effective; fasting glucose; fetal; fitbit; food security; glucose metabolism; glucose tolerance; glycemic control; health disparity; healthy lifestyle; improve minority health; improved; innovation; instrument; insulin sensitivity; maternal hyperglycemia; modifiable behavior; modifiable risk; motivational enhancement therapy; next generation; non-diabetic; novel; obesity risk; offspring; poor sleep; post intervention; prenatal; primary outcome; racial and ethnic disparities; racial discrimination; sleep health; sleep quality; tool

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.

母亲高血糖（包括妊娠期糖尿病 (GDM)）不成比例地影响 5-11% 非裔美国孕妇 (AAPW)。 GDM 甚至非糖尿病高血糖都与 先兆子痫、初次剖宫产、巨大儿、短期产伤以及增加的风险 从长远来看，母亲和后代会患上肥胖症、2型糖尿病和心血管疾病。国民医疗 即使是短期后果，GDM 的成本也高达每年 18 亿美元。超重/肥胖 AAPW 有 在所有种族中，GDM、GDM 复发和非糖尿病高血糖的风险增加最高。睡觉 差距也存在。 AAPW 的睡眠时间较短，睡眠中点（时间）较晚，睡眠连续性较差， 品质高于白人女性。我们和其他人都表现出睡眠时间短、睡眠质量差、睡眠晚 时机与 GDM 风险增加有关。怀孕期间普遍存在的睡眠障碍可能代表 母亲高血糖的可改变危险因素。虽然认知/行为方法已经产生了稳健的结果 改善一般人群的睡眠时间和质量，我们是唯一测试睡眠效果的小组 非药物睡眠干预可改善 AAPW 中母亲的葡萄糖代谢。我们的前期工作 建议睡眠 B.E.T.T.E.R.解决睡醒卫生的 6 项原则（卧室、运动、紧张、 就寝时间、饮食和节奏）、针对 24 小时行为和多种生活方式组成部分可以成功 改善孕妇的睡眠。这项随机对照试验的目的是确定 我们针对文化和个性化定制的 BETTER 干预措施的有效性，以促进孕产妇健康 AAPW 中的葡萄糖代谢。我们将招募150名18-40岁的超重/肥胖未产妇。他们将是 随机（每组 75 人）：1) 睡眠更好或 2) 注意力控制（出生准备）。数据将于 16 点收集 20（基线）、28-30（治疗结束）和 34-36（治疗后）妊娠周 (GW) 使用有效和 可靠的仪器在自由生活的情况下监测睡眠，采用最先进的方法评估血糖 水平和胰岛素敏感性。我们的具体目标是： (1) 定义 BETTER 与 Birth-Prep 对生育的影响 葡萄糖耐量（空腹血糖 - 主要结果）和胰岛素敏感性，以及 (2) 确定疗效 与 Birth-Prep 相比，更好地改善参与者的睡眠持续时间、睡眠质量和时间，以及 (3) 确定 其他因素在多大程度上代表关键效应调节因素，包括经济困难、社会心理 干预的压力和种族歧视（探索性目标）。我们研究的长期目标是 1) 开发低成本、有效的方法来优化产妇新陈代谢和福祉 很容易用于医院或社区诊所的产前护理，2) 整合睡眠卫生 主流产前教育中改善低收入非洲母亲葡萄糖代谢的原则 美国妇女。这有助于改善母亲及其后代和下一代的健康状况。 该提案支持 NIMHD 改善少数族裔健康和消除健康差距的使命。