Targeted Lifestyle Change Group Prenatal Care (TLC)

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: Enrolling by invitation
• Conditions: Pregnancy; Gestational Diabetes
• Intervention / Treatment: Behavioral: TLC Group Prenatal Care

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: Interventional
• Enrollment (Anticipated): 416
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

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

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal diagnosis of gestational diabetes	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	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	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	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	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	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.	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.	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal breastfeeding	Delivery through 4-12 weeks postpartum
Postpartum weight retention	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)	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal glucose tolerance testing	4-12 weeks Postpartum
Insulin resistance	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	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.	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal prenatal care satisfaction	Delivery
Neonatal gestational age at 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	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.	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.	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant shoulder dystocia	Delivery
Neonatal APGAR score	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant APGAR score	Delivery
Neonatal cord blood analytes	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.	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.	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant cord blood analytes, base excess.	Delivery
Neonatal NICU admission	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant NICU admission	Delivery
Neonatal hypoglycemia	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant hypoglycemia	Delivery
Neonatal hematocrit	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant hematocrit	Delivery
Neonatal jaundice	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant jaundice	Delivery
Neonatal respiratory distress syndrome	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant respiratory distress syndrome	Delivery
Neonatal stillbirth	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant stillbirth	Delivery
Depression	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	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	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	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	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)	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal sleep hygiene.	Enrollment through 4-12 weeks postpartum

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Ebony B Carter, MD,MPH, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2019
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: August 9, 2019
• First Submitted That Met QC Criteria: September 11, 2019
• First Posted (Actual): September 16, 2019

Study Record Updates

• Last Update Posted (Actual): January 31, 2023
• Last Update Submitted That Met QC Criteria: January 27, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Diabetes; Group Prenatal Care
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Pregnancy Complications; Diabetes, Gestational
• Other Study ID Numbers: 201901030

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No