Clinical trial NCT05234125: Better Lifestyle Counseling for African American Women During Pregnancy
Official title: A Randomized Control Trial to Improve Metabolic Outcomes in African American Pregnant Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Keywords: Sleep, Pregnancy, Intervention, glucose metabolism,
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
name: Office of Research on Women's Health (ORWH)
name: Office of Behavioral and Social Sciences Research (OBSSR)
First posted: 2022-02-10
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fasting Glucose at baseline
timeFrame: 16-22 Gestational Weeks (GWs)
measure: Fasting Glucose
timeFrame: 28-32 Gestational Weeks (GWs)
Secondary outcomes:
measure: Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at baseline
timeFrame: 16-22 Gestational Weeks
measure: Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
timeFrame: 28-32 Gestational Weeks
measure: Glucose Area Under the Curve at baseline
timeFrame: 16-22 Gestational Weeks
measure: Glucose Area Under the Curve
timeFrame: 28-32 Gestational Weeks
measure: Glucose Area Under the Curve
timeFrame: 34-36 Gestational Weeks
measure: Sleep Quality - Self-reported of sleep quality at the baseline "before the intervention"
timeFrame: 16-22 Gestational Weeks
measure: Sleep Quality - Self-reported of sleep quality
timeFrame: 28-32 Gestational Weeks
measure: Sleep Quality - Self-reported of sleep quality
timeFrame: 34-36 Gestational Weeks
measure: Sleep duration and sleep timing - Subjectively and Objectively Assessment at the baseline "before the intervention"
timeFrame: 16-22 Gestational Weeks
measure: Sleep duration and sleep timing - Subjective and Objective Assessment
timeFrame: 28-32 Gestational Weeks
measure: Sleep duration and sleep timing - Subjective and Objective Assessment
timeFrame: 34-36 Gestational Weeks
measure: Medical Records Extraction Form
timeFrame: "post delivery, up to 3 months post intervention"
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Bilgay Izci Balserak, PhD
role: PRINCIPAL_INVESTIGATOR
References: