Targeted Lifestyle Change Group Prenatal Care
- Conditions
- PregnancyGestational Diabetes
- Interventions
- Behavioral: TLC Group Prenatal Care
- Registration Number
- NCT04090307
- Lead Sponsor
- University of North Carolina, Chapel Hill
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 416
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TLC Group Prenatal Care 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.
- Primary Outcome Measures
Name Time Method Effects of TLC group prenatal care on birth weight Delivery/within 1 week of delivery Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant weight in grams
Effects of TLC group prenatal care on neonatal length Delivery/within 1 week of delivery Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant length in cm
Effects on TLC group prenatal care on neonatal head circumference Delivery/within 1 week of delivery Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant head circumference in cm
Effects of TLC group prenatal care on infant skinfold thickness 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
- Secondary Outcome Measures
Name Time Method Maternal diagnosis of gestational diabetes 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)
Physical activity and eating behavior 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
Maternal gestational weight gain Initial visit through 4-12 weeks postpartum Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal gestational weight gain
Maternal hypertensive disorders of pregnancy including gestational hypertension, chronic hypertension, preeclampsia, eclampsia, and HELLP Initial visit through 4-12 weeks postpartum Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal hypertensive disorders of pregnancy
Rates of appointment attendance Up to the time of delivery Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on number of prenatal visits attended
Rates of maternal postpartum visit attendance for those in TLC compared to traditional prenatal care 4-12 weeks postpartum Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on postpartum visit attendance
Rate of maternal contraception initiation for those in TLC compared to traditional prenatal care. Delivery through 4-12 weeks postpartum Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal postpartum contraception initiation
Breastfeeding rates among those in TLC compared to traditional prenatal care. Delivery through 4-12 weeks postpartum Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal breastfeeding
Postpartum weight retention Up to 12 weeks postpartum Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal postpartum weight retention
Postpartum 2 hour glucose tolerance testing (if applicable) 4-12 weeks Postpartum Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal glucose tolerance testing
Insulin resistance 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).
Insulin sensitivity 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).
Assessing prenatal care patient satisfaction for those in TLC compared to traditional prenatal care using a satisfaction survey. Delivery Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal prenatal care satisfaction
Neonatal gestational age at delivery Delivery Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant gestational age at delivery
Induction of labor rates for those in TLC compared to traditional prenatal care Delivery Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal induction of labor
Mode of delivery for those in TLC compared to traditional prenatal care. Delivery Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC)on maternal mode of delivery
Neonatal shoulder dystocia rates for those in TLC compared to traditional prenatal care. Delivery Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant shoulder dystocia
Neonatal APGAR score Delivery Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant APGAR score
Neonatal cord blood analytes Delivery Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant cord blood analytes, c-peptide.
Neonatal cord blood analytes of pH for those in TLC compared to traditional prenatal care. Delivery Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant cord blood analytes, pH.
Neonatal cord blood analytes of base excess for those in TLC compared to traditional prenatal care. Delivery Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant cord blood analytes, base excess.
Neonatal NICU admission Delivery Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant NICU admission
Neonatal hypoglycemia Delivery Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant hypoglycemia
Neonatal hematocrit Delivery Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant hematocrit
Neonatal jaundice Delivery Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant jaundice
Neonatal respiratory distress syndrome Delivery Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant respiratory distress syndrome
Neonatal stillbirth Delivery Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant stillbirth
Depression 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
Psychosocial stress 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
Determine the effect of TLC on psychosocial stress and depression using the pregnancy distress questionnaire Enrollment through 4-12 weeks postpartum Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal distress
Determine the effect of TLC on psychosocial stress and depression using the life events checklist Enrollment through 4-12 weeks postpartum Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal life events
Determine the effect of TLC on psychosocial stress and depression using the generalized anxiety disorder-7 test Enrollment through 4-12 weeks postpartum Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal anxiety
Determine the effect of TLC on psychosocial stress and depression using the Munich Chronotype Questionnaire (MCTQ) Enrollment through 4-12 weeks postpartum Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal sleep hygiene.
Trial Locations
- Locations (2)
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Washington University in St. Louis
🇺🇸Saint Louis, Missouri, United States