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NCT Number: NCT05234125

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.

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Key information

Conditions

Overweight or Obesity African Americans Behavior Behavioral Symptoms Body Weight Disparities in Pregnancy Complications Diversity Exercise Female Urogenital Diseases and Pregnancy Complications Fitness Trackers Health Behavior Mental Disorders Motor Activity Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Parasomnias Pathological Conditions, Signs and Symptoms Pregnancy Complications Pregnancy Related Signs and Symptoms Sleep Disparities Sleep Disturbances Sleep Hygiene Sleep Wake Disorders Stress, Psychological Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois at Chicago, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Better

Behavioral

It is a nonpharmacologic sleep intervention to improve maternal glucose metabolism in African American Pregnant Women (AAPW). Sleep BETTER is composed of sleep hygiene practices and cognitive-behavioral principles.

Other names: Sleep BETTER

Birth Prep

Behavioral

The intervention involves training about pregnancy-related issues, and follow up

Primary outcomes

  1. Fasting Glucose at baseline

    Time frame: 16-22 Gestational Weeks (GWs)

    A fasting blood sample for glucose will be collected

  2. Fasting Glucose

    Time frame: 28-32 Gestational Weeks (GWs)

    A fasting blood sample for glucose will be collected

Secondary outcomes

  1. Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at baseline

    Time frame: 16-22 Gestational Weeks

    Insulin Resistance

  2. Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

    Time frame: 28-32 Gestational Weeks

    Insulin Resistance

  3. Glucose Area Under the Curve at baseline

    Time frame: 16-22 Gestational Weeks

    Glucose tolerance

  4. Glucose Area Under the Curve

    Time frame: 28-32 Gestational Weeks

    Glucose tolerance

  5. Glucose Area Under the Curve

    Time frame: 34-36 Gestational Weeks

    Glucose tolerance

  6. Sleep Quality - Self-reported of sleep quality at the baseline "before the intervention"

    Time frame: 16-22 Gestational Weeks

    Self-reported sleep quality over the past month will be assessed by using Pittsburgh Sleep Quality Index (PSQI) Questionnaire.

    • It is a 19 self-rated questions, 4-point Likert-scale. Each score ranges from 0 - 3.
    • It is a self-report measure that assesses sleep quality and severity of specific sleep related complaints over the previous month.
    • Higher score=poorer sleep quality.

  7. Sleep Quality - Self-reported of sleep quality

    Time frame: 28-32 Gestational Weeks

    Self-reported sleep quality over the past month will be assessed by using Pittsburgh Sleep Quality Index (PSQI) Questionnaire.

    • It is a 19 self-rated questions, 4-point Likert-scale. Each score ranges from 0 - 3.
    • It is a self-report measure that assesses sleep quality and severity of specific sleep related complaints over the previous month.
    • Higher score=poorer sleep quality.

  8. Sleep Quality - Self-reported of sleep quality

    Time frame: 34-36 Gestational Weeks

    Self-reported sleep quality over the past month will be assessed by using Pittsburgh Sleep Quality Index (PSQI) Questionnaire.

    • It is a 19 self-rated questions, 4-point Likert-scale. Each score ranges from 0 - 3.
    • It is a self-report measure that assesses sleep quality and severity of specific sleep related complaints over the previous month.
    • Higher score=poorer sleep quality.

  9. Sleep duration and sleep timing - Subjectively and Objectively Assessment at the baseline "before the intervention"

    Time frame: 16-22 Gestational Weeks

    sleep duration will be assessed using a wearable device (Fitbit Charge 4) accompanied by a sleep diary.

    Sleep timing (midpoint) will be calculated as the halfway point between bedtime and rise time.

  10. Sleep duration and sleep timing - Subjective and Objective Assessment

    Time frame: 28-32 Gestational Weeks

    sleep duration will be assessed using a wearable device (Fitbit Charge 4) accompanied by a sleep diary.

    Sleep timing (midpoint) will be calculated as the halfway point between bedtime and rise time.

  11. Sleep duration and sleep timing - Subjective and Objective Assessment

    Time frame: 34-36 Gestational Weeks

    Sleep duration will be assessed using a wearable device (Fitbit Charge 4) accompanied by a sleep diary. Sleep timing (midpoint) will be calculated as the halfway point between bedtime and rise time.

  12. Medical Records Extraction Form

    Time frame: "post delivery, up to 3 months post intervention"

    Maternal-fetal outcomes will be assesses by reviewing participants' medical records and report the incidence of: newborn's hypoglycemia, macrosomia, & intensive care admission - preterm and cesarean deliveries, preeclampsia, gestational hypertension and any other important events.

    In addition, Apgar scores and birth weight will be reported.

    Pregnancy outcomes will be obtained from medical charts to understand if there are differences regarding these outcomes between the BETTER and control groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Bilgay Izci Balserak, PhD

CONTACT

[email protected]

312-996-2718

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)
  • Office of Behavioral and Social Sciences Research (OBSSR)
  • Office of Research on Women's Health (ORWH)

Registry information

Official study title

A Randomized Control Trial to Improve Metabolic Outcomes in African American Pregnant Women

Acronym: BETTER

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Feb 10, 2022
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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