Better Lifestyle Counseling for African American Women During Pregnancy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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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

Intervention / Treatment
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* Behavioral: Better
* Behavioral: Birth Prep


Participation Criteria
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Eligibility Criteria
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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
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention arm<br>Sleep hygiene practices and cognitive-behavioral principles | Behavioral: Better<br>* 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.<br>* Other names: Sleep BETTER;|
| Placebo Comparator: Attention control<br>Training about pregnancy issues | Behavioral: Birth Prep<br>* The intervention involves training about pregnancy-related issues, and follow up<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Glucose at baseline | A fasting blood sample for glucose will be collected | 16-20 Gestational Weeks (GWs) | 
| Fasting Glucose | A fasting blood sample for glucose will be collected | 28-30 Gestational Weeks (GWs) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at baseline | Insulin Resistance | 16-20 Gestational Weeks | 
| Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | Insulin Resistance | 28-30 Gestational Weeks | 
| Glucose Area Under the Curve at baseline | Glucose tolerance | 16-20 Gestational Weeks | 
| Glucose Area Under the Curve | Glucose tolerance | 28-30 Gestational Weeks | 
| Glucose Area Under the Curve | Glucose tolerance | 34-36 Gestational Weeks | 
| Sleep Quality - Self-reported of sleep quality at the baseline before the intervention | 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. | 16-20 Gestational Weeks | 
| Sleep Quality - Self-reported of sleep quality | 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. | 28-30 Gestational Weeks | 
| Sleep Quality - Self-reported of sleep quality | 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. | 34-36 Gestational Weeks | 
| Sleep duration and sleep timing - Subjectively and Objectively Assessment at the baseline before the intervention | 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. | 16-20 Gestational Weeks | 
| Sleep duration and sleep timing - Subjective and Objective Assessment | 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. | 28-30 Gestational Weeks | 
| Sleep duration and sleep timing - Subjective and Objective Assessment | 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. | 34-36 Gestational Weeks | 
| Medical Records Extraction Form | 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. | post delivery, up to 3 months post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep, Pregnancy, Intervention, glucose metabolism,