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

University Of Illinois At Chicago, Chicago IL

Investigators

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 pre-eclampsia, 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 differences also exist. AAPW have shorter sleep, 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 (primary endpoint) and 34-36 (durability period) 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 test the hypotheses that: (1) BETTER will improve glucose tolerance (fasting glucose-primary outcome), insulin sensitivity from baseline to 28-30 GWs and glycemic control from baseline to 34-36 GWs; (2) BETTER will result in greater sleep duration, better sleep quality, and earlier sleep timing compared to the Birth-Prep intervention from baseline to 34-36 GWs. Our exploratory aim (3) is to determine the extent to which other factors represent key effect modifiers including economic hardships, psychosocial stress and unfair treatment for the intervention. The long-term goals of our research are 1) to develop a cost-effective sleep intervention that can be easily implemented 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 supports NIMHD’s mission of improving minority health and eliminating health differences.