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Better Lifestyle Counseling for African American Women During Pregnancy
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.
Conditions:
🦠 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
More conditions available...
🗓️ Study Start (Actual) 16 August 2022
🗓️ Primary Completion (Estimated) 30 November 2026
✅ Study Completion (Estimated) 30 December 2026
👥 Enrollment (Estimated) 150
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Chicago, Illinois, United States
📍 Chicago, Illinois, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 18 Years to 40 Years (ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 15 January 2022
  • First Submitted that Met QC Criteria 31 January 2022
  • First Posted 10 February 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 7 May 2024
  • Last Update Posted 9 May 2024
  • Last Verified May 2024
I'm interested ...!!