A Randomized Control Trial to Improve Metabolic Outcomes in African American Pregnant Women
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Overweight or Obesity
- Sponsor
- University of Illinois at Chicago
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Fasting Glucose
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Bilgay Izci Balserak
Associate Professor
University of Illinois at Chicago
Eligibility Criteria
Inclusion Criteria
- •African American pregnant woman.
- •Women between 16 and 22 GWs.
- •Overweight or obese - pregravid Body Mass Index \>25.0 kg/m
- •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.
Outcomes
Primary Outcomes
Fasting Glucose
Time Frame: 28-32 Gestational Weeks (GWs)
A fasting blood sample for glucose will be collected
Fasting Glucose at baseline
Time Frame: 16-22 Gestational Weeks (GWs)
A fasting blood sample for glucose will be collected
Secondary Outcomes
- Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at baseline(16-22 Gestational Weeks)
- Glucose Area Under the Curve at baseline(16-22 Gestational Weeks)
- Sleep Quality - Self-reported of sleep quality at the baseline "before the intervention"(16-22 Gestational Weeks)
- Sleep Quality - Self-reported of sleep quality(34-36 Gestational Weeks)
- Glucose Area Under the Curve(34-36 Gestational Weeks)
- Sleep duration and sleep timing - Subjective and Objective Assessment(34-36 Gestational Weeks)
- Medical Records Extraction Form("post delivery, up to 3 months post intervention")
- Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)(28-32 Gestational Weeks)
- Sleep duration and sleep timing - Subjectively and Objectively Assessment at the baseline "before the intervention"(16-22 Gestational Weeks)