Targeted Lifestyle Change Group Prenatal Care

NCT04090307 | Completed

• 1 other identifier: 23-2333
• Study Type: interventional
• Target: 305
• Locations: 1 country
• Sites: 2

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).

Conditions

Gestational Diabetes; Pregnancy

Keywords

Group Prenatal Care; Diabetes

Outcome Measures

Primary Outcomes (4)

• Effects of TLC group prenatal care on birth weight

  Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant weight in grams

  Delivery/within 1 week of delivery

• Effects of TLC group prenatal care on neonatal length

  Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant length in cm

  Delivery/within 1 week of delivery

• Effects on TLC group prenatal care on neonatal head circumference

  Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant head circumference in cm

  Delivery/within 1 week of delivery

• Effects of TLC group prenatal care on infant skinfold thickness

  Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant skinfold thickness of ilium, thigh, triceps, and subscapular

  Delivery/within 1 week of delivery

Secondary Outcomes (33)

• Maternal diagnosis of gestational diabetes

  Up to the time of delivery

• Physical activity and eating behavior

  At enrollment, the last study visit/delivery, and 4-12 weeks postpartum

• Maternal gestational weight gain

  Initial visit through 4-12 weeks postpartum

• Maternal hypertensive disorders of pregnancy including gestational hypertension, chronic hypertension, preeclampsia, eclampsia, and HELLP

  Initial visit through 4-12 weeks postpartum

• Rates of appointment attendance

  Up to the time of delivery

Study Arms (2)

TLC Group Prenatal Care

EXPERIMENTAL

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.

Behavioral: TLC Group Prenatal Care

Traditional Prenatal Care

NO INTERVENTION

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.

Interventions

TLC Group Prenatal Care BEHAVIORAL

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.

TLC Group Prenatal Care

Eligibility Criteria

• Age: 13 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• American Diabetes Association: collaborator
• University of North Carolina, Chapel Hill: lead

Study Sites (2)

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ebony B Carter, MD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2019
• First Posted: September 16, 2019
• Study Start: November 26, 2019
• Primary Completion: October 20, 2025
• Study Completion: October 20, 2025
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

US (2)