Better Lifestyle Counseling for African American Women During Pregnancy

Pregnancy Related Clinical Trial

— BETTER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05234125
• Other study ID #: 2021-0918
• Secondary ID: R01MD015724
• Status: Recruiting
• Phase: N/A
• Start date: August 16, 2022
• Est. completion date: December 30, 2026

Study information

• Verified date: May 2024
• Source: University of Illinois at Chicago
• Contact: Bilgay Izci Balserak, PhD
• Phone: 312-996-2718
• Email: bilgay[@]uic.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 30, 2026
• Est. primary completion date: November 30, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• African Americans
• Exercise
• Fitness Trackers
• Overweight
• Overweight or Obesity
• Pregnancy Complications
• Pregnancy Related
• Sleep Disturbances
• Sleep Hygiene
• Stress, Psychological

Intervention

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

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (4)

Lead Sponsor	Collaborator
University of Illinois at Chicago	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)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting Glucose at baseline	A fasting blood sample for glucose will be collected	16-22 Gestational Weeks (GWs)
Primary	Fasting Glucose	A fasting blood sample for glucose will be collected	28-32 Gestational Weeks (GWs)
Secondary	Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at baseline	Insulin Resistance	16-22 Gestational Weeks
Secondary	Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)	Insulin Resistance	28-32 Gestational Weeks
Secondary	Glucose Area Under the Curve at baseline	Glucose tolerance	16-22 Gestational Weeks
Secondary	Glucose Area Under the Curve	Glucose tolerance	28-32 Gestational Weeks
Secondary	Glucose Area Under the Curve	Glucose tolerance	34-36 Gestational Weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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"