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Lifestyle Changes for Gestational Diabetes (TLC Trial)
N/A
Waitlist Available
Led By Ebony B Carter, MD,MPH
Research Sponsored by Washington University School of Medicine
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 enrollment through 4-12 weeks postpartum
Awards & highlights
TLC Trial 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.Check my eligibility
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.See study design
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.
TLC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ delivery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~delivery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Effects of TLC group prenatal care on birth weight
Total Lung Capacity
Effects of TLC group prenatal care on neonatal length
+1 moreSecondary outcome measures
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 moreTLC 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.
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Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,293 Total Patients Enrolled
Ebony B Carter, MD,MPHPrincipal InvestigatorWashington University School of Medicine
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have tested positive for high blood sugar during early pregnancy.I have type 2 diabetes.You have two or more of the following: high body mass index (BMI), physical inactivity, a close family member with diabetes, belong to a high-risk race or ethnicity, had a previous large baby, had gestational diabetes before, have high blood pressure, low levels of "good" cholesterol or high triglycerides, polycystic ovarian syndrome, high blood sugar levels, history of heart disease, can attend group prenatal visits on specific days and times, are willing to be randomly assigned to a group, and can provide informed consent.The baby has a serious health issue that needs special attention.
Research Study Groups:
This trial has the following groups:- Group 1: Traditional Prenatal Care
- Group 2: TLC Group Prenatal Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What results is this research hoping to achieve?
"The principal aim of this medical trial, which will be assessed within a week after birth is to analyze the impact of TLC group prenatal care on newborns' weight. Secondary objectives include examining maternal insulin sensitivity (fasting and 30 min insulin), infant APGAR score, and gestational weight gain in mothers."
Answered by AI
Are there any vacancies remaining in this experiment for participants?
"Unfortunately, the trial posted on clinicaltrials.gov is no longer enlisting patients at this time; last updated September 8th 2021. Nevertheless, there are 178 other medical trials actively recruiting participants as of now."
Answered by AI
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