NCT05234125NARecruiting
Better Lifestyle Counseling for African American Women During Pregnancy
University of Illinois at Chicago
Start Date
8/16/2022
Completion Date
12/30/2027
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.
Eligibility Criteria
Age Range: 18 years to 40 years
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.
Interventions
BEHAVIORAL
Better
BEHAVIORAL
Birth Prep
Conditions
Overweight or ObesityPregnancy RelatedSleep DisturbancesSleep HygienePregnancy ComplicationsDiversityStress, PsychologicalFitness TrackersExerciseAfrican AmericansDisparities in Pregnancy ComplicationsSleep Disparities
Locations
University of Illinois at Chicago
Chicago, Illinois 606012
United States
University of Illinois at Chicago
Chicago, Illinois 60612
United States