NCT05234125

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
12mo left

Started Aug 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Aug 2022Apr 2027

First Submitted

Initial submission to the registry

January 15, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

August 16, 2022

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

April 4, 2025

Status Verified

April 1, 2025

Enrollment Period

4.2 years

First QC Date

January 15, 2022

Last Update Submit

April 1, 2025

Conditions

Overweight or ObesityPregnancy RelatedSleep DisturbancesSleep HygienePregnancy ComplicationsDiversityStress, PsychologicalFitness TrackersExerciseAfrican AmericansDisparities in Pregnancy ComplicationsSleep Disparities

Keywords

Sleep, Pregnancy, Intervention, glucose metabolism,

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (12)

  • Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at baseline

    16-22 Gestational Weeks

  • Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

    28-32 Gestational Weeks

  • Glucose Area Under the Curve at baseline

    16-22 Gestational Weeks

  • Glucose Area Under the Curve

    28-32 Gestational Weeks

  • Glucose Area Under the Curve

    34-36 Gestational Weeks

  • +7 more secondary outcomes

Study Arms (2)

Intervention arm

ACTIVE COMPARATOR

Sleep hygiene practices and cognitive-behavioral principles

Behavioral: Better

Attention control

PLACEBO COMPARATOR

Training about pregnancy issues

Behavioral: Birth Prep

Interventions

BetterBEHAVIORAL

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.

Also known as: Sleep BETTER
Intervention arm
Birth PrepBEHAVIORAL

The intervention involves training about pregnancy-related issues, and follow up

Attention control

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Illinois at Chicago

Chicago, Illinois, 606012, United States

RECRUITING

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

RECRUITING

Related Publications (1)

  • Irsheed GA, Steffen A, Quinn L, Chen P, Maharana S, Burke L, Borbas L, Alameda G, Maganuru R, Balserak BI. Poor Sleep Environment and Increased Insulin Resistance in Black/African American Pregnant Women: A Cross-Sectional Study. J Racial Ethn Health Disparities. 2025 Nov 18. doi: 10.1007/s40615-025-02747-5. Online ahead of print.

    PMID: 41254328DERIVED

MeSH Terms

Conditions

OverweightObesityParasomniasSleep HygienePregnancy ComplicationsStress, PsychologicalMotor Activity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsSleep Wake DisordersNervous System DiseasesMental DisordersHealth BehaviorBehaviorFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesBehavioral Symptoms

Study Officials

  • Bilgay Izci Balserak, PhD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bilgay Izci Balserak, PhD

CONTACT

312-996-2718bilgay@uic.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 15, 2022

First Posted

February 10, 2022

Study Start

August 16, 2022

Primary Completion (Estimated)

November 2, 2026

Study Completion (Estimated)

April 30, 2027

Last Updated

April 4, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

US(2)