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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05234125
Other study ID # 2021-0918
Secondary ID R01MD015724
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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"
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