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| ID | Type | Description | Link |
|---|---|---|---|
| R01MD015724 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
| Office of Research on Women's Health (ORWH) | NIH |
| Office of Behavioral and Social Sciences Research (OBSSR) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Active Comparator | Sleep hygiene practices and cognitive-behavioral principles |
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| Attention control | Placebo Comparator | Training about pregnancy issues |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Glucose at baseline | A fasting blood sample for glucose will be collected | 16-22 Gestational Weeks (GWs) |
| Fasting Glucose | A fasting blood sample for glucose will be collected | 28-32 Gestational Weeks (GWs) |
| Measure | Description | Time Frame |
|---|---|---|
| Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at baseline | Insulin Resistance | 16-22 Gestational Weeks |
| Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | Insulin Resistance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bilgay Izci Balserak, PhD | Contact | 312-996-2718 | bilgay@uic.edu |
| Name | Affiliation | Role |
|---|---|---|
| Bilgay Izci Balserak, PhD | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Chicago | Recruiting | Chicago | Illinois | 606012 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41254328 | Derived | Irsheed GA, Steffen A, Quinn L, Chen P, Maharana S, Burke L, Borbas L, Alameda G, Maganuru R, Balserak BI. Poor Sleep Environment and Increased Insulin Resistance in Black/African American Pregnant Women: A Cross-Sectional Study. J Racial Ethn Health Disparities. 2025 Nov 18. doi: 10.1007/s40615-025-02747-5. Online ahead of print. |
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|
| Birth Prep | Behavioral | The intervention involves training about pregnancy-related issues, and follow up |
|
| 28-32 Gestational Weeks |
| Glucose Area Under the Curve at baseline | Glucose tolerance | 16-22 Gestational Weeks |
| Glucose Area Under the Curve | Glucose tolerance | 28-32 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.
| 16-22 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.
| 28-32 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.
| 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. | 16-22 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. | 28-32 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" |
| University of Illinois at Chicago | Recruiting | Chicago | Illinois | 60612 | United States |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D020447 | Parasomnias |
| D000070263 | Sleep Hygiene |
| D011248 | Pregnancy Complications |
| D013315 | Stress, Psychological |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001526 | Behavioral Symptoms |
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