African Americans, Disparities in Pregnancy Complications, Diversity, Exercise, Fitness Trackers, Overweight or Obesity, Pregnancy Complications, Pregnancy Related, Sleep Disparities, Sleep Disturbances, Sleep Hygiene, Stress, Psychological
Conditions
Keywords
Sleep, Pregnancy, Intervention, glucose metabolism,
Brief summary
The purpose of this randomized controlled trial is to establish the effectiveness of a culturally targeted and individually tailored behavioral intervention to promote maternal glucose metabolism in African American women.
Detailed description
This is a randomized controlled parallel-group trial with two arms. Potential subjects will be identified from the OB Clinics at UI health systems, the University of Illinois at Chicago. After baseline assessments, the subjects will be randomized to the attention control arm (Birth-Prep) or BETTER intervention.
Interventions
BEHAVIORALBetter
It is a nonpharmacologic sleep intervention to improve maternal glucose metabolism in African American Pregnant Women (AAPW). Sleep BETTER is composed of sleep hygiene practices and cognitive-behavioral principles.
BEHAVIORALBirth Prep
The intervention involves training about pregnancy-related issues, and follow up
Sponsors
University of Illinois at Chicago
National Institute on Minority Health and Health Disparities (NIMHD)
Office of Research on Women's Health (ORWH)
Office of Behavioral and Social Sciences Research (OBSSR)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* African American pregnant woman. * Women between 16 and 22 GWs. * Overweight or obese - pregravid Body Mass Index \>25.0 kg/m2. * Singleton gestation. * Established prenatal care at The University of Illinois Hospital \& Health Sciences. * System Obstetric (UIHHSS' OB) clinics. Able to understand, speak and write in English.
Exclusion criteria
* Multiple gestations. * Night-shift work. * Diagnosed sleep disorders. * Known fetal chromosomal or anatomical abnormalities. * Diagnosed mood disorders. * Gestational diabetes in early pregnancy. * Glycated Hemoglobin (HbA1c) ≥ 6.5%. * Hypoglycemic medications. * Stimulant medication or taking a sleeping aid. * Active drug abuse/excessive alcohol intake.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fasting Glucose at baseline | 16-22 Gestational Weeks (GWs) | A fasting blood sample for glucose will be collected |
| Fasting Glucose | 28-32 Gestational Weeks (GWs) | A fasting blood sample for glucose will be collected |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at baseline | 16-22 Gestational Weeks | Insulin Resistance |
| Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | 28-32 Gestational Weeks | Insulin Resistance |
| Glucose Area Under the Curve at baseline | 16-22 Gestational Weeks | Glucose tolerance |
| Glucose Area Under the Curve | 28-32 Gestational Weeks | Glucose tolerance |
| Sleep Quality - Self-reported of sleep quality at the baseline "before the intervention" | 16-22 Gestational Weeks | Self-reported sleep quality over the past month will be assessed by using Pittsburgh Sleep Quality Index (PSQI) Questionnaire. * It is a 19 self-rated questions, 4-point Likert-scale. Each score ranges from 0 - 3. * It is a self-report measure that assesses sleep quality and severity of specific sleep related complaints over the previous month. * Higher score=poorer sleep quality. |
| Sleep Quality - Self-reported of sleep quality | 28-32 Gestational Weeks | Self-reported sleep quality over the past month will be assessed by using Pittsburgh Sleep Quality Index (PSQI) Questionnaire. * It is a 19 self-rated questions, 4-point Likert-scale. Each score ranges from 0 - 3. * It is a self-report measure that assesses sleep quality and severity of specific sleep related complaints over the previous month. * Higher score=poorer sleep quality. |
| Sleep duration and sleep timing - Subjectively and Objectively Assessment at the baseline "before the intervention" | 16-22 Gestational Weeks | sleep duration will be assessed using a wearable device (Fitbit Charge 4) accompanied by a sleep diary. Sleep timing (midpoint) will be calculated as the halfway point between bedtime and rise time. |
| Sleep duration and sleep timing - Subjective and Objective Assessment | 28-32 Gestational Weeks | sleep duration will be assessed using a wearable device (Fitbit Charge 4) accompanied by a sleep diary. Sleep timing (midpoint) will be calculated as the halfway point between bedtime and rise time. |
| Medical Records Extraction Form | "post delivery, up to 3 months post intervention" | Maternal-fetal outcomes will be assesses by reviewing participants' medical records and report the incidence of: newborn's hypoglycemia, macrosomia, \& intensive care admission - preterm and cesarean deliveries, preeclampsia, gestational hypertension and any other important events. In addition, Apgar scores and birth weight will be reported. Pregnancy outcomes will be obtained from medical charts to understand if there are differences regarding these outcomes between the BETTER and control groups. |
Countries
United States
Contacts
CONTACTBilgay Izci Balserak, PhD
PRINCIPAL_INVESTIGATORBilgay Izci Balserak, PhD
University of Illinois at Chicago
Outcome results
None listed