Gestational Diabetes, Pregnancy
Conditions
Keywords
Group Prenatal Care, Diabetes
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.
Interventions
BEHAVIORALTLC 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.
Sponsors
University of North Carolina, Chapel Hill
American Diabetes Association
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
13 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREbony B Carter, MD, MPH
University of North Carolina, Chapel Hill
Outcome results
None listed