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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
150
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.
The intervention involves training about pregnancy-related issues, and follow up
University of Illinois at Chicago
Chicago, Illinois, United States
RECRUITINGUniversity of Illinois at Chicago
Chicago, Illinois, United States
RECRUITINGFasting Glucose at baseline
A fasting blood sample for glucose will be collected
Time frame: 16-22 Gestational Weeks (GWs)
Fasting Glucose
A fasting blood sample for glucose will be collected
Time frame: 28-32 Gestational Weeks (GWs)
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at baseline
Insulin Resistance
Time frame: 16-22 Gestational Weeks
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Insulin Resistance
Time frame: 28-32 Gestational Weeks
Glucose Area Under the Curve at baseline
Glucose tolerance
Time frame: 16-22 Gestational Weeks
Glucose Area Under the Curve
Glucose tolerance
Time frame: 28-32 Gestational Weeks
Glucose Area Under the Curve
Glucose tolerance
Time frame: 34-36 Gestational Weeks
Sleep Quality - Self-reported of sleep quality at the baseline "before the intervention"
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.
Time frame: 16-22 Gestational Weeks
Sleep Quality - Self-reported of sleep quality
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.
Time frame: 28-32 Gestational Weeks
Sleep Quality - Self-reported of sleep quality
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.
Time frame: 34-36 Gestational Weeks
Sleep duration and sleep timing - Subjectively and Objectively Assessment at the baseline "before the intervention"
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.
Time frame: 16-22 Gestational Weeks
Sleep duration and sleep timing - Subjective and Objective Assessment
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.
Time frame: 28-32 Gestational Weeks
Sleep duration and sleep timing - Subjective and Objective Assessment
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.
Time frame: 34-36 Gestational Weeks
Medical Records Extraction Form
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.
Time frame: "post delivery, up to 3 months post intervention"
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