Better Lifestyle Counseling for African American Women During Pregnancy

Overview

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.

Full Title of Study: “A Randomized Control Trial to Improve Metabolic Outcomes in African American Pregnant Women”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: November 30, 2026

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

  • Behavioral: Better
    • 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.
  • Behavioral: Birth Prep
    • The intervention involves training about pregnancy-related issues, and follow up

Arms, Groups and Cohorts

  • Active Comparator: Intervention arm
    • Sleep hygiene practices and cognitive-behavioral principles
  • Placebo Comparator: Attention control
    • Training about pregnancy issues

Clinical Trial Outcome Measures

Primary Measures

  • Fasting Glucose at baseline
    • Time Frame: 16-20 Gestational Weeks (GWs)
    • A fasting blood sample for glucose will be collected
  • Fasting Glucose
    • Time Frame: 28-30 Gestational Weeks (GWs)
    • A fasting blood sample for glucose will be collected

Secondary Measures

  • Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at baseline
    • Time Frame: 16-20 Gestational Weeks
    • Insulin Resistance
  • Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
    • Time Frame: 28-30 Gestational Weeks
    • Insulin Resistance
  • Glucose Area Under the Curve at baseline
    • Time Frame: 16-20 Gestational Weeks
    • Glucose tolerance
  • Glucose Area Under the Curve
    • Time Frame: 28-30 Gestational Weeks
    • Glucose tolerance
  • Glucose Area Under the Curve
    • Time Frame: 34-36 Gestational Weeks
    • Glucose tolerance
  • Sleep Quality – Self-reported of sleep quality at the baseline “before the intervention”
    • Time Frame: 16-20 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
    • Time Frame: 28-30 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
    • Time Frame: 34-36 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”
    • Time Frame: 16-20 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
    • Time Frame: 28-30 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
    • Time Frame: 34-36 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
    • Time Frame: “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.

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Illinois at Chicago
  • Collaborator
    • National Institute on Minority Health and Health Disparities (NIMHD)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Bilgay Izci Balserak, Associate Professor – University of Illinois at Chicago
  • Overall Official(s)
    • Bilgay Izci Balserak, PhD, Principal Investigator, University of Illinois at Chicago
  • Overall Contact(s)
    • Bilgay Izci Balserak, PhD, 312-996-2718, bilgay@uic.edu

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