Targeted Lifestyle Change Group Prenatal Care (TLC)

University of North Carolina (UNC)

Status: Active, not recruiting

Conditions: Gestational Diabetes; Pregnancy

Treatments: Behavioral: TLC Group Prenatal Care

Study type: Interventional

Funder types: Other

Identifiers

NCT04090307

23-2333

Details and patient eligibility

About

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).

Full 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 determine the effect of TLC group prenatal care on birthweight and neonatal body composition, maternal healthy lifestyle and diabetes-related outcomes, delivery and neonatal outcomes, and psychosocial stress and depression.

Enrollment: 416 estimated patients

Sex: Female

Ages: 13+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

416 participants in 2 patient groups

TLC Group Prenatal Care

Experimental group

Description:

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.

Treatment:

Behavioral: TLC Group Prenatal Care

Traditional Prenatal Care

No Intervention group

Description:

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.