Targeted Lifestyle Change Group Prenatal Care (TLC)

February 17, 2026 updated by: University of North Carolina, Chapel Hill

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
305

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University in St. Louis
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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, 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

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 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TLC Group Prenatal Care
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
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.
No Intervention: Traditional Prenatal Care
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Effects of TLC group prenatal care on birth weight
Time Frame: Delivery/within 1 week of delivery
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
Time Frame: Delivery/within 1 week of delivery
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
Time Frame: Delivery/within 1 week of delivery
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
Time Frame: Delivery/within 1 week of delivery
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maternal diagnosis of gestational diabetes
Time Frame: Up to the time of delivery
Assessing maternal diagnosis of gestational diabetes using 2-step method(1-hour glucose challenge test, 3-hour glucose tolerance test, need for medication)
Up to the time of delivery
Physical activity and eating behavior
Time Frame: At enrollment, the last study visit/delivery, and 4-12 weeks postpartum
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on physical activity and eating behavior survey
At enrollment, the last study visit/delivery, and 4-12 weeks postpartum
Maternal gestational weight gain
Time Frame: Initial visit through 4-12 weeks postpartum
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on 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
Time Frame: Initial visit through 4-12 weeks postpartum
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal hypertensive disorders of pregnancy
Initial visit through 4-12 weeks postpartum
Rates of appointment attendance
Time Frame: Up to the time of delivery
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on number of prenatal visits attended
Up to the time of delivery
Rates of maternal postpartum visit attendance for those in TLC compared to traditional prenatal care
Time Frame: 4-12 weeks postpartum
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on postpartum visit attendance
4-12 weeks postpartum
Rate of maternal contraception initiation for those in TLC compared to traditional prenatal care.
Time Frame: Delivery through 4-12 weeks postpartum
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal postpartum contraception initiation
Delivery through 4-12 weeks postpartum
Breastfeeding rates among those in TLC compared to traditional prenatal care.
Time Frame: Delivery through 4-12 weeks postpartum
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal breastfeeding
Delivery through 4-12 weeks postpartum
Postpartum weight retention
Time Frame: Up to 12 weeks postpartum
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal postpartum weight retention
Up to 12 weeks postpartum
Postpartum 2 hour glucose tolerance testing (if applicable)
Time Frame: 4-12 weeks Postpartum
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal glucose tolerance testing
4-12 weeks Postpartum
Insulin resistance
Time Frame: Through study completion, up to 12 weeks postpartum
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal insulin resistance (fasting and 30 min insulin).
Through study completion, up to 12 weeks postpartum
Insulin sensitivity
Time Frame: Through study completion, up to 12 weeks postpartum
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal insulin sensitivity (fasting and 30 min insulin).
Through study completion, up to 12 weeks postpartum
Assessing prenatal care patient satisfaction for those in TLC compared to traditional prenatal care using a satisfaction survey.
Time Frame: Delivery
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal prenatal care satisfaction
Delivery
Neonatal gestational age at delivery
Time Frame: Delivery
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant gestational age at delivery
Delivery
Induction of labor rates for those in TLC compared to traditional prenatal care
Time Frame: Delivery
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal induction of labor
Delivery
Mode of delivery for those in TLC compared to traditional prenatal care.
Time Frame: Delivery
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC)on maternal mode of delivery
Delivery
Neonatal shoulder dystocia rates for those in TLC compared to traditional prenatal care.
Time Frame: Delivery
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant shoulder dystocia
Delivery
Neonatal APGAR score
Time Frame: Delivery
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant APGAR score
Delivery
Neonatal cord blood analytes
Time Frame: Delivery
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant cord blood analytes, c-peptide.
Delivery
Neonatal cord blood analytes of pH for those in TLC compared to traditional prenatal care.
Time Frame: Delivery
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant cord blood analytes, pH.
Delivery
Neonatal cord blood analytes of base excess for those in TLC compared to traditional prenatal care.
Time Frame: Delivery
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant cord blood analytes, base excess.
Delivery
Neonatal NICU admission
Time Frame: Delivery
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant NICU admission
Delivery
Neonatal hypoglycemia
Time Frame: Delivery
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant hypoglycemia
Delivery
Neonatal hematocrit
Time Frame: Delivery
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant hematocrit
Delivery
Neonatal jaundice
Time Frame: Delivery
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant jaundice
Delivery
Neonatal respiratory distress syndrome
Time Frame: Delivery
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant respiratory distress syndrome
Delivery
Neonatal stillbirth
Time Frame: Delivery
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant stillbirth
Delivery
Depression
Time Frame: Enrollment through 4-12 weeks postpartum
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal depression using Edinburgh Postnatal Depression Scale
Enrollment through 4-12 weeks postpartum
Psychosocial stress
Time Frame: Enrollment through 4-12 weeks postpartum
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal stress using the perceived stress scale
Enrollment through 4-12 weeks postpartum
Determine the effect of TLC on psychosocial stress and depression using the pregnancy distress questionnaire
Time Frame: Enrollment through 4-12 weeks postpartum
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal distress
Enrollment through 4-12 weeks postpartum
Determine the effect of TLC on psychosocial stress and depression using the life events checklist
Time Frame: Enrollment through 4-12 weeks postpartum
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal life events
Enrollment through 4-12 weeks postpartum
Determine the effect of TLC on psychosocial stress and depression using the generalized anxiety disorder-7 test
Time Frame: Enrollment through 4-12 weeks postpartum
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal anxiety
Enrollment through 4-12 weeks postpartum
Determine the effect of TLC on psychosocial stress and depression using the Munich Chronotype Questionnaire (MCTQ)
Time Frame: Enrollment through 4-12 weeks postpartum
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal sleep hygiene.
Enrollment through 4-12 weeks postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of North Carolina, Chapel Hill

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
American Diabetes Association

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ebony B Carter, MD, MPH, University of North Carolina, Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 26, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 20, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 20, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 9, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 16, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23-2333

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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