Better Lifestyle Counseling for African American Women During Pregnancy

NCT ID: NCT05234125

Last Updated: 2025-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-16

Study Completion Date

2027-04-30

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Intervention arm

Sleep hygiene practices and cognitive-behavioral principles

Group Type ACTIVE_COMPARATOR

Better

Intervention Type BEHAVIORAL

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.

Attention control

Training about pregnancy issues

Group Type PLACEBO_COMPARATOR

Birth Prep

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

Birth Prep

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Sleep BETTER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

Office of Research on Women's Health (ORWH)

NIH

Sponsor Role collaborator

Office of Behavioral and Social Sciences Research (OBSSR)

NIH

Sponsor Role collaborator

University of Illinois at Chicago

OTHER

Sponsor Role lead

Responsible Party

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Bilgay Izci Balserak

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bilgay Izci Balserak, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

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University of Illinois at Chicago

Chicago, Illinois, United States

Site Status RECRUITING

University of Illinois at Chicago

Chicago, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Bilgay Izci Balserak, PhD

Role: CONTACT

312-996-2718

Facility Contacts

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Bilgay Izci B Balserak, PhD

Role: primary

312-996-2718

Bilgay Izci Balserak, PhD

Role: primary

312-996-2718

Other Identifiers

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R01MD015724

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2021-0918

Identifier Type: -

Identifier Source: org_study_id

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