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: 10296816
• 负责人: Bilgay Izci Balserak
• 金额: $ 65.08万
• 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/10296816
• 关键词: Address; Adverse effects; Affect; African American; 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; 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; Research; Risk; Risk Factors; Role; Science; Sleep; Sleep disturbances; Social status; Social support; Stress; Telephone; Testing; Thinking; Time; Woman; Work; aged; attentional control; base; control trial; cost; cost effective; fasting glucose; fetal; fitbit; food security; glucose metabolism; glucose tolerance; glycemic control; health disparity; healthy lifestyle; improved; innovation; instrument; insulin sensitivity; maternal hyperglycemia; minority health; 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.

孕产妇高血糖包括妊娠糖尿病（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 子痫前期，原发性剖宫产，巨糖症，短期出生创伤以及增加的风险 从长远来看，母亲和后代的肥胖症，2型糖尿病和心血管疾病。国家医疗 即使对于短期后果，GDM的成本也很高，为每年18亿美元。超重/肥胖AAPW具有 任何种族的GDM，GDM复发和非糖尿病高血糖的风险最高。睡觉 差异也存在。 AAPW的睡眠时间较短，睡眠的中点（时机），睡眠连续性较差和 质量比白人妇女。我们和其他 时间与GDM风险增加有关。睡眠障碍，怀孕无处不在，可能代表 孕产妇高血糖的可修改风险因素。而认知/行为方法产生了强大的 一般人群中睡眠持续时间和质量的改善，我们是唯一一个测试A的影响的群体 非药物睡眠干预措施可改善AAPW中母体葡萄糖代谢。我们的初步工作 建议睡眠B.E.T.T.E.R.解决唤醒睡眠卫生原理（卧室，锻炼，紧张，紧张， 在床上，进食和节奏中的时间），针对24小时的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建立 我们以文化为目标和单独量身定制的更好干预措施的有效性来促进母亲 AAPW中的葡萄糖代谢。我们将注册150个超重/肥胖的无效AAPW，年龄18-40。他们会的 随机分别（每组75）至：1）睡眠更好或2）注意控制（出生prep）。数据将在16- 20（基线），28-30（治疗结束）和34-36（治疗后）妊娠周（GWS）使用有效和 可靠的仪器在自由生活条件下使用最先进的方法评估葡萄糖的仪器 水平和胰岛素敏感性。我们的具体目的是：（1）定义更好与出生prep的影响 葡萄糖耐受性（空腹葡萄糖主要结果）和胰岛素敏感性，（2）确定效率 更好的与出生预科 其他因素代表关键效果修饰符在内的程度，包括经济困难，社会心理 干预的压力和种族歧视（探索目的）。我们研究的长期目标是 1）开发低成本和有效的方法来优化材料代谢和福祉 从医院或社区诊所中轻松从事产前护理，以及2）整合睡眠卫生 主流产前教育的原则，以改善低收入非洲的母体葡萄糖代谢 美国妇女。这可以有助于母亲，后代和下一代的更好的健康成果。 该提案支持NIMHD改善少数族裔健康和消除健康差异的使命。