Group prenatal care for women at high risk of gestational diabetes

Targeted Lifestyle Change (TLC) Group Prenatal Care for Obese Women at High Risk for Gestational Diabetes: a Randomized Controlled Trial

This study is testing if group prenatal care that focuses on lifestyle changes can help women at high risk for gestational diabetes have healthier pregnancies and babies compared to regular care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 416 (estimated)
• Ages: 13 Years and up
• Sex: Female
• Sponsor: University of North Carolina, Chapel Hill (Academic / other)
• Locations: 2 sites (Saint Louis, Missouri and 1 other locations)
• Trial ID: NCT04090307 on ClinicalTrials.gov

What this trial studies

This trial aims to evaluate the effectiveness of Targeted Lifestyle Change Group Prenatal Care (TLC) on improving maternal and neonatal outcomes for women at high risk of developing gestational diabetes mellitus (GDM). Participants will be randomly assigned to receive TLC or standard care, with a focus on assessing birthweight, neonatal body composition, and maternal health outcomes. The study will also explore psychosocial factors such as stress and depression among participants. The goal is to determine if group prenatal care can lead to better health outcomes compared to traditional care.

Who should consider this trial

Good fit: Ideal candidates are English-speaking women who are less than 16 weeks pregnant and have multiple risk factors for gestational diabetes.

Not a fit: Patients with type 2 diabetes or those experiencing multiple gestations or major fetal anomalies may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved health outcomes for mothers and their babies by effectively managing gestational diabetes risk.

How similar studies have performed: Other studies have shown promise in group prenatal care approaches, indicating potential for success in this novel application for gestational diabetes management.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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)

Where this trial is running

Saint Louis, Missouri and 1 other locations

• Washington University in St. Louis — Saint Louis, Missouri, United States (Suspended)
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)

Study contacts

• Principal investigator: Ebony B Carter, MD, MPH — University of North Carolina, Chapel Hill
• Study coordinator: Catalina Montiel, MPH

Conditions Pregnancy; Gestational Diabetes; Group Prenatal Care; Diabetes