Targeted Lifestyle Change Group Prenatal Care

Last updated: November 4, 2025
Sponsor: University of North Carolina, Chapel Hill
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Pregnancy

Diabetes Prevention

Diabetes And Hypertension

Treatment

TLC Group Prenatal Care

Clinical Study ID

NCT04090307
23-2333
  • Ages > 13
  • Female

Study 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).

Eligibility Criteria

Inclusion

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, AsianAmerican, 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

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 ingroup setting, as deemed by medical provider (require extra care)

  • Serious psychiatric illness, including schizophrenia, necessitating more care thancan be safely provided in group setting, as deemed by medical provider (requireextra care)

Study Design

Total Participants: 416
Treatment Group(s): 1
Primary Treatment: TLC Group Prenatal Care
Phase:
Study Start date:
November 26, 2019
Estimated Completion Date:
December 30, 2025

Study 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.

Connect with a study center

  • Washington University in St. Louis

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University in St. Louis

    St Louis 4407066, Missouri 4398678 63110
    United States

    Site Not Available

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • University of North Carolina at Chapel Hill

    Chapel Hill 4460162, North Carolina 4482348 27599
    United States

    Site Not Available

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