Status:
RECRUITING
Better Lifestyle Counseling for African American Women During Pregnancy
Lead Sponsor:
University of Illinois at Chicago
Collaborating Sponsors:
National Institute on Minority Health and Health Disparities (NIMHD)
Office of Research on Women's Health (ORWH)
Conditions:
Overweight or Obesity
Pregnancy Related
Eligibility:
FEMALE
18-40 years
Phase:
NA
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 A...
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 baselin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05234125
Start Date
August 16 2022
End Date
April 30 2027
Last Update
April 4 2025
Active Locations (2)
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1
University of Illinois at Chicago
Chicago, Illinois, United States, 606012
2
University of Illinois at Chicago
Chicago, Illinois, United States, 60612