Overweight or ObesityBETTERNCT05234125
Better Lifestyle Counseling for African American Women During Pregnancy
A study testing Better and Birth Prep in people with Overweight or Obesity and Pregnancy Related, run by University of Illinois Chicago at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Overweight or Obesity, Pregnancy Related, Sleep Disturbances
- What is being tested?
- Better and Birth Prep
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Aug 2022to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Multiple gestations.
- Night-shift work.
- Diagnosed sleep disorders.
- Known fetal chromosomal or anatomical abnormalities.
- Diagnosed mood disorders.
- Gestational diabetes in early pregnancy.
Show all 10Show fewer
- Glycated Hemoglobin (HbA1c) ≥ 6.5%.
- Hypoglycemic medications.
- Stimulant medication or taking a sleeping aid.
- Active drug abuse/excessive alcohol intake.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Illinois at Chicago
Chicago, Illinois, 606012
Bilgay Izci B Balserak, PhD, 13129962718, bilgay@uic.edu
- Recruiting
University of Illinois at Chicago
Chicago, Illinois, 60612
Bilgay Izci Balserak, PhD, 312-996-2718
About this study
Official title: A Randomized Control Trial to Improve Metabolic Outcomes in African American Pregnant Women
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.
Read the 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.
- Conditions
- Overweight or Obesity, Pregnancy Related, Sleep Disturbances, Sleep Hygiene, Pregnancy Complications, Diversity
- Being tested
- Better, Birth Prep
- Keywords
- Sleep, Pregnancy, Intervention, glucose metabolism,
- Medical subject headings
- Overweight, Obesity, Parasomnias, Sleep Hygiene, Pregnancy Complications, Stress, Psychological, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BetterBehavioural
Also called Sleep BETTER
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.
Birth PrepBehavioural
The intervention involves training about pregnancy-related issues, and follow up
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Active comparator | Sleep hygiene practices and cognitive-behavioral principles Receives: Behavioral: Better |
| Attention control | Placebo comparator | Training about pregnancy issues Receives: Behavioral: Birth Prep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting Glucose at baseline
A fasting blood sample for glucose will be collected
Measured: 16-22 Gestational Weeks (GWs)
Fasting Glucose
A fasting blood sample for glucose will be collected
Measured: 28-32 Gestational Weeks (GWs)
Secondary outcomes (12)
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at baseline
Insulin Resistance
Measured: 16-22 Gestational Weeks
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Insulin Resistance
Measured: 28-32 Gestational Weeks
Glucose Area Under the Curve at baseline
Glucose tolerance
Measured: 16-22 Gestational Weeks
Glucose Area Under the Curve
Glucose tolerance
Measured: 28-32 Gestational Weeks
Glucose Area Under the Curve
Glucose tolerance
Measured: 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.
Measured: 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.
- 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.
Measured: 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.
- 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: "post delivery, up to 3 months post intervention"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start16 Aug 2022
- Primary completion2 Sep 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight or ObesityStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- 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)
- Responsible party
- Principal investigator, Bilgay Izci Balserak, University of Illinois Chicago
- Investigators
- Bilgay Izci Balserak, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05234125
- Sponsor's protocol ID
- 2021-0918
- Other IDs
- R01MD015724
- Acronym
- BETTER
- Status last verified
- May 2026
- First submitted
- 15 Jan 2022
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41254328
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial to Improve Metabolic Outcomes in African American Pregnant Women
- ClinicalTrials.gov ID
- NCT05234125
- Acronym / sponsor ID
- BETTER / 2021-0918
- Conditions
- Overweight or Obesity, Pregnancy Related, Sleep Disturbances, Sleep Hygiene, Pregnancy Complications, Diversity
- Keywords
- Sleep, Pregnancy, Intervention, glucose metabolism,
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- 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)
- Study start
- 16 Aug 2022 (actual)
- Primary completion
- 2 Sep 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Active comparator | Behavioral: BetterSleep hygiene practices and cognitive-behavioral principles |
| Attention control | Placebo comparator | Behavioral: Birth PrepTraining about pregnancy issues |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- Multiple gestations.
- Night-shift work.
- Diagnosed sleep disorders.
- Known fetal chromosomal or anatomical abnormalities.
- Diagnosed mood disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BetterAlso: Sleep BETTERIt 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. | Behavioural | Intervention arm |
| Birth PrepThe intervention involves training about pregnancy-related issues, and follow up | Behavioural | Attention control |
Primary outcome
Fasting Glucose at baseline
Time frame: 16-22 Gestational Weeks (GWs)
A fasting blood sample for glucose will be collected
Fasting Glucose
Time frame: 28-32 Gestational Weeks (GWs)
A fasting blood sample for glucose will be collected
12 secondary outcomes
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at baseline
Time frame: 16-22 Gestational Weeks
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: 28-32 Gestational Weeks
Glucose Area Under the Curve at baseline
Time frame: 16-22 Gestational Weeks
Glucose Area Under the Curve
Time frame: 28-32 Gestational Weeks
Glucose Area Under the Curve
Time frame: 34-36 Gestational Weeks
Sleep Quality - Self-reported of sleep quality at the baseline "before the intervention"
Time frame: 16-22 Gestational Weeks
Sleep Quality - Self-reported of sleep quality
Time frame: 28-32 Gestational Weeks
Sleep Quality - Self-reported of sleep quality
Time frame: 34-36 Gestational Weeks
Sleep duration and sleep timing - Subjectively and Objectively Assessment at the baseline "before the intervention"
Time frame: 16-22 Gestational Weeks
Sleep duration and sleep timing - Subjective and Objective Assessment
Time frame: 28-32 Gestational Weeks
Sleep duration and sleep timing - Subjective and Objective Assessment
Time frame: 34-36 Gestational Weeks
Medical Records Extraction Form
Time frame: "post delivery, up to 3 months post intervention"
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Derived from this study: PubMed 41254328Irsheed 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bilgay Izci Balserak, PhD principal investigator
University of Illinois Chicago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Better and Birth Prep in people with Overweight or Obesity and Pregnancy Related, run by University of Illinois Chicago at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bilgay Izci Balserak, PhD (312-996-2718, bilgay@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting Glucose at baseline (time frame: 16-22 Gestational Weeks (GWs)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05234125, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.