Research Project

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

African American population is projected to increase up to 18% by 2060 in the US and as the population increases, the deleterious effects of maternal hyperglycemia will also. Sleep disparities exist in African American pregnant women and can lead to disparities in maternal hyperglycemia and related maternal and fetal complications of pregnancy. This innovative study using individually tailored, culturally adapted intervention has the potential to advance science, reduce hyperglycemia, improve glucose metabolism, and improve maternal-fetal well-being by demonstrating the effectiveness of sleep BETTER intervention.

Principal Investigator: Izci-Balserak, Bilgay
Start Date: 2021-08-20
End Date: 2026-04-30
Funding Source: National Institute on Minority Health and Health Disparities

Abstract

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