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Lifestyle Counseling for Pregnancy (BETTER Trial)

N/A
Recruiting
Led By Bilgay Izci Balserak, PhD
Research Sponsored by University of Illinois at Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women between 16 and 22 gestational weeks
Overweight or obese with pregravid Body Mass Index >25.0 kg/m2
Must not have
Hypoglycemic medications
Known fetal chromosomal or anatomical abnormalities
Timeline
Screening 3 weeks
Treatment Varies
Follow Up "post delivery, up to 3 months post intervention"

Summary

This trial is testing a new way to help African American women keep their glucose levels under control.

Who is the study for?
This trial is for African American women who are between 16 and 22 weeks pregnant, overweight or obese, with a single baby. They must be receiving prenatal care at UIHHSS' OB clinics and speak English. It's not for those working night shifts, with sleep or mood disorders, early gestational diabetes, drug/alcohol issues, or taking certain medications.
What is being tested?
The study tests a behavioral intervention tailored to improve glucose metabolism in African American pregnant women. Participants will receive lifestyle counseling aimed at promoting better sleep and physical activity habits during pregnancy.
What are the potential side effects?
Since the intervention involves lifestyle counseling rather than medication, side effects may include discomfort from changes in routine but no medical side effects like you'd expect from drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am pregnant and between 16 and 22 weeks along.
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My BMI before pregnancy was over 25.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am taking medication to lower my blood sugar.
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My unborn baby has been diagnosed with genetic or physical abnormalities.
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I have been diagnosed with a sleep disorder.
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I am currently taking medication for sleep or stimulants.
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I have been diagnosed with a mood disorder.
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I was diagnosed with diabetes during the early part of my pregnancy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~"post delivery, up to 3 months post intervention"
This trial's timeline: 3 weeks for screening, Varies for treatment, and "post delivery, up to 3 months post intervention" for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Fasting Glucose
Fasting Glucose at baseline
Secondary study objectives
Glucose Area Under the Curve
Glucose Area Under the Curve at baseline
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
+6 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Intervention armActive Control1 Intervention
Sleep hygiene practices and cognitive-behavioral principles
Group II: Attention controlPlacebo Group1 Intervention
Training about pregnancy issues

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoLead Sponsor
639 Previous Clinical Trials
1,568,853 Total Patients Enrolled
1 Trials studying Pregnancy Complications
432 Patients Enrolled for Pregnancy Complications
National Institute on Minority Health and Health Disparities (NIMHD)NIH
434 Previous Clinical Trials
1,378,683 Total Patients Enrolled
2 Trials studying Pregnancy Complications
534 Patients Enrolled for Pregnancy Complications
Office of Research on Women's Health (ORWH)NIH
32 Previous Clinical Trials
35,961 Total Patients Enrolled
1 Trials studying Pregnancy Complications
10,038 Patients Enrolled for Pregnancy Complications

Media Library

Better Clinical Trial Eligibility Overview. Trial Name: NCT05234125 — N/A
Pregnancy Complications Research Study Groups: Intervention arm, Attention control
Pregnancy Complications Clinical Trial 2023: Better Highlights & Side Effects. Trial Name: NCT05234125 — N/A
Better 2023 Treatment Timeline for Medical Study. Trial Name: NCT05234125 — N/A
~71 spots leftby Nov 2026
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