Better Lifestyle Counseling for African American Women During Pregnancy (BETTER)

A Randomized Control Trial to Improve Metabolic Outcomes in African American Pregnant Women

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.

Study Overview

• Status: Recruiting
• Conditions: Stress, Psychological; Pregnancy Complications; Pregnancy Related; Exercise; Overweight or Obesity; Fitness Trackers; Sleep Hygiene; Sleep Disturbances; African Americans; Diversity; Disparities in Pregnancy Complications; Sleep Disparities
• Intervention / Treatment: Behavioral: Better; Behavioral: Birth Prep

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bilgay Izci Balserak, PhD; Phone Number: 312-996-2718; Email: bilgay@uic.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • University of Illinois at Chicago
      • Contact: Bilgay Izci Balserak, PhD; Phone Number: 312-996-2718
    • Chicago, Illinois, United States, 606012
      • Recruiting
      • University of Illinois at Chicago
      • Contact: Bilgay Izci B Balserak, PhD; Phone Number: 312-996-2718; Email: bilgay@uic.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention arm; Sleep hygiene practices and cognitive-behavioral principles	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.; Other Names: Sleep BETTER
Placebo Comparator: Attention control; Training about pregnancy issues	Behavioral: Birth Prep; The intervention involves training about pregnancy-related issues, and follow up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting Glucose at baseline	A fasting blood sample for glucose will be collected	16-22 Gestational Weeks (GWs)
Fasting Glucose	A fasting blood sample for glucose will be collected	28-32 Gestational Weeks (GWs)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose Area Under the Curve	Glucose tolerance	34-36 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.	34-36 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.	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.	"post delivery, up to 3 months post intervention"
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at baseline	Insulin Resistance	16-22 Gestational Weeks
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)	Insulin Resistance	28-32 Gestational Weeks
Glucose Area Under the Curve at baseline	Glucose tolerance	16-22 Gestational Weeks
Glucose Area Under the Curve	Glucose tolerance	28-32 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.	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.	28-32 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.	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.	28-32 Gestational Weeks

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD); Office of Behavioral and Social Sciences Research (OBSSR); Office of Research on Women's Health (ORWH)
• Investigators: Principal Investigator: Bilgay Izci Balserak, PhD, University of Illinois at Chicago

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2022
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: January 15, 2022
• First Submitted That Met QC Criteria: January 31, 2022
• First Posted (Actual): February 10, 2022

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Sleep, Pregnancy, Intervention, glucose metabolism,
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Overnutrition; Nutrition Disorders; Body Weight; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Stress, Psychological; Dyssomnias; Parasomnias; Overweight; Pregnancy Complications
• Other Study ID Numbers: 2021-0918; R01MD015724 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No