Clinical trial NCT04090307: Targeted Lifestyle Change Group Prenatal Care
Official title: Targeted Lifestyle Change (TLC) Group Prenatal Care for Obese Women at High Risk for Gestational Diabetes: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy
Gestational Diabetes
Keywords: Group Prenatal Care
Diabetes
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: American Diabetes Association
First posted: 2019-09-16
Enrollment: 416
Sex: FEMALE
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Effects of TLC group prenatal care on birth weight
timeFrame: Delivery/within 1 week of delivery
measure: Effects of TLC group prenatal care on neonatal length
timeFrame: Delivery/within 1 week of delivery
measure: Effects on TLC group prenatal care on neonatal head circumference
timeFrame: Delivery/within 1 week of delivery
measure: Effects of TLC group prenatal care on infant skinfold thickness
timeFrame: Delivery/within 1 week of delivery
Secondary outcomes:
measure: Maternal diagnosis of gestational diabetes
timeFrame: Up to the time of delivery
measure: Physical activity and eating behavior
timeFrame: At enrollment, the last study visit/delivery, and 4-12 weeks postpartum
measure: Maternal gestational weight gain
timeFrame: Initial visit through 4-12 weeks postpartum
measure: Maternal hypertensive disorders of pregnancy including gestational hypertension, chronic hypertension, preeclampsia, eclampsia, and HELLP
timeFrame: Initial visit through 4-12 weeks postpartum
measure: Rates of appointment attendance
timeFrame: Up to the time of delivery
measure: Rates of maternal postpartum visit attendance for those in TLC compared to traditional prenatal care
timeFrame: 4-12 weeks postpartum
measure: Rate of maternal contraception initiation for those in TLC compared to traditional prenatal care.
timeFrame: Delivery through 4-12 weeks postpartum
measure: Breastfeeding rates among those in TLC compared to traditional prenatal care.
timeFrame: Delivery through 4-12 weeks postpartum
measure: Postpartum weight retention
timeFrame: Up to 12 weeks postpartum
measure: Postpartum 2 hour glucose tolerance testing (if applicable)
timeFrame: 4-12 weeks Postpartum
measure: Insulin resistance
timeFrame: Through study completion, up to 12 weeks postpartum
measure: Insulin sensitivity
timeFrame: Through study completion, up to 12 weeks postpartum
measure: Assessing prenatal care patient satisfaction for those in TLC compared to traditional prenatal care using a satisfaction survey.
timeFrame: Delivery
measure: Neonatal gestational age at delivery
timeFrame: Delivery
measure: Induction of labor rates for those in TLC compared to traditional prenatal care
timeFrame: Delivery
measure: Mode of delivery for those in TLC compared to traditional prenatal care.
timeFrame: Delivery
measure: Neonatal shoulder dystocia rates for those in TLC compared to traditional prenatal care.
timeFrame: Delivery
measure: Neonatal APGAR score
timeFrame: Delivery
measure: Neonatal cord blood analytes
timeFrame: Delivery
measure: Neonatal cord blood analytes of pH for those in TLC compared to traditional prenatal care.
timeFrame: Delivery
measure: Neonatal cord blood analytes of base excess for those in TLC compared to traditional prenatal care.
timeFrame: Delivery
measure: Neonatal NICU admission
timeFrame: Delivery
measure: Neonatal hypoglycemia
timeFrame: Delivery
measure: Neonatal hematocrit
timeFrame: Delivery
measure: Neonatal jaundice
timeFrame: Delivery
measure: Neonatal respiratory distress syndrome
timeFrame: Delivery
measure: Neonatal stillbirth
timeFrame: Delivery
measure: Depression
timeFrame: Enrollment through 4-12 weeks postpartum
measure: Psychosocial stress
timeFrame: Enrollment through 4-12 weeks postpartum
measure: Determine the effect of TLC on psychosocial stress and depression using the pregnancy distress questionnaire
timeFrame: Enrollment through 4-12 weeks postpartum
measure: Determine the effect of TLC on psychosocial stress and depression using the life events checklist
timeFrame: Enrollment through 4-12 weeks postpartum
measure: Determine the effect of TLC on psychosocial stress and depression using the generalized anxiety disorder-7 test
timeFrame: Enrollment through 4-12 weeks postpartum
measure: Determine the effect of TLC on psychosocial stress and depression using the Munich Chronotype Questionnaire (MCTQ)
timeFrame: Enrollment through 4-12 weeks postpartum
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Ebony B Carter, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: