Targeted Lifestyle Change Group Prenatal Care

University of North Carolina, Chapel Hill305 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

305

Conditions

Pregnancy Gestational Diabetes

Interventions

TLC Group Prenatal CareBEHAVIORAL

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.

Eligibility

Sex: FEMALEMin age: 13 Years

Medical Language ↔ Plain English

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)

Locations (2)

Washington University in St. Louis

St Louis, Missouri, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Delivery/within 1 week of delivery

Secondary Outcomes

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)

Time frame: 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

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

Maternal gestational weight gain

Data from ClinicalTrials.gov

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Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal gestational weight gain

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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).

Time frame: 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).

Time frame: 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

Time frame: Delivery

Neonatal gestational age at delivery

Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant gestational age at delivery

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Delivery

Neonatal APGAR score

Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant APGAR score

Time frame: Delivery

Neonatal cord blood analytes

Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant cord blood analytes, c-peptide.

Time frame: 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.

Time frame: 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.

Time frame: Delivery

Neonatal NICU admission

Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant NICU admission

Time frame: Delivery

Neonatal hypoglycemia

Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant hypoglycemia

Time frame: Delivery

Neonatal hematocrit

Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant hematocrit

Time frame: Delivery

Neonatal jaundice

Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant jaundice

Time frame: Delivery

Neonatal respiratory distress syndrome

Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant respiratory distress syndrome

Time frame: Delivery

Neonatal stillbirth

Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant stillbirth

Time frame: Delivery

Depression

Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal depression using Edinburgh Postnatal Depression Scale