NCT04090307Completed
Targeted Lifestyle Change Group Prenatal Care
Targeted Lifestyle Change (TLC) Group Prenatal Care for Obese Women at High Risk for Gestational Diabetes: a Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 18 Feb 2026
Brief summary (registry, in English)
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 mellitus (GDM).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 305 (actual)
- First submitted
- 9 Aug 2019
- Start date
- 26 Nov 2019
- Primary completion date
- 20 Oct 2025
- Lead sponsor
- University of North Carolina, Chapel Hill
- Diseases
- Obesity
- NCT number
- NCT04090307
What you commit to
- Study type: Interventional
- Participants enrolled: 305
- From 26 Nov 2019 to the primary completion date, 20 Oct 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Type 2 diabetes (eligible for Diabetes Group 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)
Lab values
- Positive glucose challenge test during early pregnancy
Other
- 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)
Who the study is looking for
- 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
Age in the registry: 13 years to - · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of North Carolina at Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| Washington University in St. Louis Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.