← Back to Search

Lifestyle Changes for Gestational Diabetes (TLC Trial)

N/A

Recruiting

Led By Ebony B Carter, MD,MPH

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up delivery

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the effects of Targeted Lifestyle Change Group Prenatal Care (TLC) versus usual care on maternal and neonatal outcomes in women at high risk for developing gestational diabetes mellitus (GDM).

Who is the study for?

This trial is for English-speaking women under 16 weeks pregnant, at high risk for gestational diabetes due to factors like being overweight, inactive, having a family history of diabetes or certain ethnic backgrounds. They must be able to attend group prenatal visits and agree to random assignment in the study.

What is being tested?

The study is testing Targeted Lifestyle Change Group Prenatal Care (TLC) to see if it improves outcomes for mothers and babies at risk of gestational diabetes. Women will be randomly placed into groups where they receive this specialized care during pregnancy.

What are the potential side effects?

Since TLC involves lifestyle changes rather than medication, side effects are minimal but may include the discomforts typically associated with changes in diet and exercise routines.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ delivery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~delivery

This trial's timeline: 3 weeks for screening, Varies for treatment, and delivery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Effects of TLC group prenatal care on birth weight

Total Lung Capacity

Effects of TLC group prenatal care on neonatal length

+1 more

Secondary study objectives

Assessing prenatal care patient satisfaction for those in TLC compared to traditional prenatal care using a satisfaction survey.

Breastfeeding rates among those in TLC compared to traditional prenatal care.

Depression

+30 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TLC Group Prenatal CareExperimental Treatment1 Intervention

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.

Group II: Traditional Prenatal CareActive Control1 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.

Do I qualify?Apply below to find out