Targeted Lifestyle Change Group Prenatal Care

Description

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).

Conditions

Pregnancy, Gestational Diabetes

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Study Overview

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Study Details

Study overview

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).

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

Targeted Lifestyle Change Group Prenatal Care

Condition
Pregnancy
Intervention / Treatment

-

Contacts and Locations

Saint Louis

Washington University in St. Louis, Saint Louis, Missouri, United States, 63110

Chapel Hill

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States, 27599

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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)

Ages Eligible for Study

13 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of North Carolina, Chapel Hill,

Ebony B Carter, MD, MPH, PRINCIPAL_INVESTIGATOR, University of North Carolina, Chapel Hill

Study Record Dates

2025-12