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.

孕妇高血糖包括妊娠期糖尿病（GDM）不成比例地影响5-11%