Better Lifestyle Counseling for African American Women During Pregnancy

Not Applicable

Recruiting

• Conditions: Disparities in Pregnancy Complications; Pregnancy Related; Sleep Disturbances; Sleep Hygiene; Pregnancy Complications; Stress, Psychological; Exercise; African Americans; Diversity; Fitness Trackers
• Interventions: Behavioral: Birth Prep; Behavioral: Better

• Registration Number: NCT05234125
• Lead Sponsor: University of Illinois at Chicago

Brief 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.

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 Timeline

• Study First Submitted: 2022-01-15
• Study First Submitted QC: 2022-01-31
• Study First Posted: 2022-02-10
• Study Start: 2022-08-16
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04
• Primary Completion: 2026-11-02
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Attention control	Birth Prep	Training about pregnancy issues
Intervention arm	Better	Sleep hygiene practices and cognitive-behavioral principles

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at baseline	16-22 Gestational Weeks	Insulin Resistance
Glucose Area Under the Curve at baseline	16-22 Gestational Weeks	Glucose tolerance
Sleep Quality - Self-reported of sleep quality at the baseline "before the intervention"	16-22 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	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.
Glucose Area Under the Curve	34-36 Gestational Weeks	Glucose tolerance
Sleep duration and sleep timing - Subjective and Objective Assessment	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	"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.
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)	28-32 Gestational Weeks	Insulin Resistance
Sleep duration and sleep timing - Subjectively and Objectively Assessment at the baseline "before the intervention"	16-22 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.

Trial Locations

Locations (1)

University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States