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Better Lifestyle Counseling for African American Women During Pregnancy (BETTER)

Primary Purpose

Overweight or Obesity, Pregnancy Related, Sleep Disturbances

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Better
Birth Prep
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight or Obesity focused on measuring Sleep, Pregnancy, Intervention, glucose metabolism,

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • African American pregnant woman.
  • Women between 16 and 20 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 drugs abuse/excessive alcohol intake.

Sites / Locations

  • University of Illinois at ChicagoRecruiting
  • University of Illinois at ChicagoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intervention arm

Attention control

Arm Description

Sleep hygiene practices and cognitive-behavioral principles

Training about pregnancy issues

Outcomes

Primary Outcome Measures

Fasting Glucose at baseline
A fasting blood sample for glucose will be collected
Fasting Glucose
A fasting blood sample for glucose will be collected

Secondary Outcome Measures

Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at baseline
Insulin Resistance
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Insulin Resistance
Glucose Area Under the Curve at baseline
Glucose tolerance
Glucose Area Under the Curve
Glucose tolerance
Glucose Area Under the Curve
Glucose tolerance
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
January 15, 2022
Last Updated
March 17, 2023
Sponsor
University of Illinois at Chicago
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD), Office of Research on Women's Health (ORWH), Office of Behavioral and Social Sciences Research (OBSSR)
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1. Study Identification

Unique Protocol Identification Number
NCT05234125
Brief Title
Better Lifestyle Counseling for African American Women During Pregnancy
Acronym
BETTER
Official Title
A Randomized Control Trial to Improve Metabolic Outcomes in African American Pregnant Women
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 16, 2022 (Actual)
Primary Completion Date
November 30, 2026 (Anticipated)
Study Completion Date
December 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD), Office of Research on Women's Health (ORWH), Office of Behavioral and Social Sciences Research (OBSSR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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,

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Active Comparator
Arm Description
Sleep hygiene practices and cognitive-behavioral principles
Arm Title
Attention control
Arm Type
Placebo Comparator
Arm Description
Training about pregnancy issues
Intervention Type
Behavioral
Intervention Name(s)
Better
Other Intervention Name(s)
Sleep BETTER
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Birth Prep
Intervention Description
The intervention involves training about pregnancy-related issues, and follow up
Primary Outcome Measure Information:
Title
Fasting Glucose at baseline
Description
A fasting blood sample for glucose will be collected
Time Frame
16-20 Gestational Weeks (GWs)
Title
Fasting Glucose
Description
A fasting blood sample for glucose will be collected
Time Frame
28-30 Gestational Weeks (GWs)
Secondary Outcome Measure Information:
Title
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at baseline
Description
Insulin Resistance
Time Frame
16-20 Gestational Weeks
Title
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Description
Insulin Resistance
Time Frame
28-30 Gestational Weeks
Title
Glucose Area Under the Curve at baseline
Description
Glucose tolerance
Time Frame
16-20 Gestational Weeks
Title
Glucose Area Under the Curve
Description
Glucose tolerance
Time Frame
28-30 Gestational Weeks
Title
Glucose Area Under the Curve
Description
Glucose tolerance
Time Frame
34-36 Gestational Weeks
Title
Sleep Quality - Self-reported of sleep quality at the baseline "before the intervention"
Description
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.
Time Frame
16-20 Gestational Weeks
Title
Sleep Quality - Self-reported of sleep quality
Description
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.
Time Frame
28-30 Gestational Weeks
Title
Sleep Quality - Self-reported of sleep quality
Description
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.
Time Frame
34-36 Gestational Weeks
Title
Sleep duration and sleep timing - Subjectively and Objectively Assessment at the baseline "before the intervention"
Description
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.
Time Frame
16-20 Gestational Weeks
Title
Sleep duration and sleep timing - Subjective and Objective Assessment
Description
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.
Time Frame
28-30 Gestational Weeks
Title
Sleep duration and sleep timing - Subjective and Objective Assessment
Description
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.
Time Frame
34-36 Gestational Weeks
Title
Medical Records Extraction Form
Description
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.
Time Frame
"post delivery, up to 3 months post intervention"

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bilgay Izci Balserak, PhD
Phone
312-996-2718
Email
bilgay@uic.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bilgay Izci Balserak, PhD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
606012
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bilgay Izci B Balserak, PhD
Phone
312-996-2718
Email
bilgay@uic.edu
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bilgay Izci Balserak, PhD
Phone
312-996-2718

12. IPD Sharing Statement

Plan to Share IPD
No

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Better Lifestyle Counseling for African American Women During Pregnancy

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