Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
416 participants
INTERVENTIONAL
2019-11-26
2025-12-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TLC Group Prenatal Care
TLC will start in the late first trimester or early second trimester and run for \~6-10 sessions. Groups of 2-10 consented women, with two or more GDM risk factors, will meet under the supervision of an obstetric provider (nurse practitioner or MD) and co-facilitator (health educator, nutritionist, or nurse) for two-hour sessions. A major focus of TLC will be education, and much of each visit will be spent on pregnancy, exercise/nutrition education, and behavioral health.
TLC Group Prenatal Care
TLC will start in the late first trimester or early second trimester and run for \~6-10 sessions. Groups of 2-10 consented women, with two or more GDM risk factors, will meet under the supervision of an obstetric provider (nurse practitioner or MD) and co-facilitator (health educator, nutritionist, or nurse) for two-hour sessions. A major focus of TLC will be education, and much of each visit will be spent on pregnancy, exercise/nutrition education, and behavioral health.
Traditional Prenatal Care
Subjects randomized to routine care will receive their prenatal care with their primary obstetric provider. Patients are seen for 10-15 minutes every four weeks until 28 weeks' gestation, every two weeks (or more by provider discretion) until 37 weeks and weekly until delivery. Visits focus on routine screening tests and prenatal care. Traditional care participants will receive a phone call once a month, until 28 weeks gestation, from a nurse practitioner to check-in on pregnancy goals, healthy eating, and exercise. Each subject's medical chart will be reviewed for demographics, antenatal management, maternal and neonatal outcomes.
No interventions assigned to this group
Interventions
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TLC Group Prenatal Care
TLC will start in the late first trimester or early second trimester and run for \~6-10 sessions. Groups of 2-10 consented women, with two or more GDM risk factors, will meet under the supervision of an obstetric provider (nurse practitioner or MD) and co-facilitator (health educator, nutritionist, or nurse) for two-hour sessions. A major focus of TLC will be education, and much of each visit will be spent on pregnancy, exercise/nutrition education, and behavioral health.
Eligibility Criteria
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Inclusion Criteria
* ≤16 weeks gestation
* Two or more of the following GDM risk factors:
* BMI ≥ 25
* Physical inactivity
* First degree relative with diabetes
* High risk race or ethnicity (African American, Latino, Native American, Asian American, Pacific Islander)
* Prior infant weighing ≥ 4,000 g
* Prior GDM
* Hypertension (140/90 mm Hg or receiving treatment)
* High-density lipoprotein cholesterol level \<35 mg/dL or triglycerides \> 250 mg/dL
* Polycystic ovarian syndrome
* A1c ≥ 5.7%
* Impaired glucose tolerance
* Impaired fasting glucose on previous testing
* History of cardiovascular disease
* Ability to attend group prenatal visits at specified days and times
* Willingness to be randomized
* Ability to give informed consent
Exclusion Criteria
* Positive glucose challenge test during early pregnancy
* Multiple gestation (require extra care)
* Major fetal anomaly (require extra care)
* Serious medical co-morbidity necessitating more care than can be safely provided in group setting, as deemed by medical provider (require extra care)
* Serious psychiatric illness, including schizophrenia, necessitating more care than can be safely provided in group setting, as deemed by medical provider (require extra care)
13 Years
FEMALE
No
Sponsors
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American Diabetes Association
OTHER
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Ebony B Carter, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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Washington University in St. Louis
St Louis, Missouri, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Countries
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Other Identifiers
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23-2333
Identifier Type: -
Identifier Source: org_study_id