Status:
ACTIVE_NOT_RECRUITING
Targeted Lifestyle Change Group Prenatal Care
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
American Diabetes Association
Conditions:
Pregnancy
Gestational Diabetes
Eligibility:
FEMALE
13+ years
Phase:
NA
Brief Summary
To conduct a randomized trial to determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal and neonatal outcomes in women at high risk for developing gestational diabetes...
Detailed Description
Long term, the investigator aims to test the central hypothesis that those in TLC will have better maternal and neonatal outcomes than those in TC. The objective is to conduct a randomized trial to de...
Eligibility Criteria
Inclusion
- English speaking
- ≤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
- Type 2 diabetes (eligible for Diabetes Group Care)
- 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)
Key Trial Info
Start Date :
November 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
416 Patients enrolled
Trial Details
Trial ID
NCT04090307
Start Date
November 26 2019
End Date
December 30 2025
Last Update
November 6 2025
Active Locations (2)
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1
Washington University in St. Louis
St Louis, Missouri, United States, 63110
2
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599