An interventional study of Better and Birth Prep in Overweight or Obesity, Pregnancy Related and Sleep Disturbances, sponsored by University of Illinois at Chicago. Recruiting at 2 sites in United States. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-07-09.
Sponsored by University of Illinois at Chicago · Not applicable, Interventional, and Prevention
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 150 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →University of Illinois at Chicago is the lead sponsor of 506 studies on the registry; 120 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.
Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sleep hygiene practices and cognitive-behavioral principles
Behavioral: Better
Training about pregnancy issues
Behavioral: Birth Prep
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.
Also known as: Sleep BETTER
The intervention involves training about pregnancy-related issues, and follow up
Fasting Glucose at baseline
A fasting blood sample for glucose will be collected
Time frame: 16-22 Gestational Weeks (GWs)
Fasting Glucose
A fasting blood sample for glucose will be collected
Time frame: 28-32 Gestational Weeks (GWs)
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at baseline
Insulin Resistance
Time frame: 16-22 Gestational Weeks
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Insulin Resistance
Time frame: 28-32 Gestational Weeks
Glucose Area Under the Curve at baseline
Glucose tolerance
Time frame: 16-22 Gestational Weeks
Glucose Area Under the Curve
Glucose tolerance
Time frame: 28-32 Gestational Weeks
Glucose Area Under the Curve
Glucose tolerance
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: "post delivery, up to 3 months post intervention"
Plan to share: No
Started Aug 2022 (actual). Primary completion is estimated for Sep 2027, 60 months after the start.
Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 60 months is above that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
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