Active Not Recruiting
NA
INTERVENTIONAL
NCT04090307
Targeted Lifestyle Change Group Prenatal Care
View on ClinicalTrials.gov
Updated Dec 15, 2025
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 mellitus (GDM).
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 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.
Interventions
Name:
TLC Group Prenatal Care
Type:
BEHAVIORAL
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.
Primary Outcomes
Measure:
Effects of TLC group prenatal care on birth weight
TimeFrame:
Delivery/within 1 week of delivery
Description:
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant weight in grams
Measure:
Effects of TLC group prenatal care on neonatal length
TimeFrame:
Delivery/within 1 week of delivery
Description:
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant length in cm
Measure:
Effects on TLC group prenatal care on neonatal head circumference
TimeFrame:
Delivery/within 1 week of delivery
Description:
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant head circumference in cm
Measure:
Effects of TLC group prenatal care on infant skinfold thickness
TimeFrame:
Delivery/within 1 week of delivery
Description:
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant skinfold thickness of ilium, thigh, triceps, and subscapular
Trial Information
NCT ID
NCT04090307
Status
Active Not Recruiting
Study Type
INTERVENTIONAL
Phases
NA
Sponsor
University of North Carolina, Chapel Hill
Last Updated
December 15, 2025