The investigators primary objective is to conduct a randomized trial to determine the effect of diabetes group prenatal care on glycemic control and postpartum weight retention in women with type 2 diabetes and gestational diabetes.
Long term, the investigator aims to test the central hypothesis that group prenatal care, compared to traditional prenatal care, will improve, 1.) glycemic control and, 2.) postpartum weight retention in women with type 2 and gestational diabetes. The objective of this proposal is to conduct a randomized trial in two phases to determine the effect of Diabetes Group Care (GC) on glycemic control in pregnant women with T2DM and GDM (Antepartum Phase) and the impact on postpartum weight retention (Postpartum Phase).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
117
Enrolled subjects will be randomly assigned in a 2:1 ratio to group or traditional care.
Washington University in St. Louis
St Louis, Missouri, United States
University of Utah
Salt Lake City, Utah, United States
Effect of Diabetes Group Care on maternal glycemic control
Determine the effect of Diabetes Group care on maternal glycemic control by randomizing women to Diabetes group care or traditional care and compare 1) Mean fasting blood glucose, 2) Mean 1-hour post-prandial blood glucose, and 3) Hemoglobin A1c at delivery, 4-12 weeks postpartum, six months postpartum, one year postpartum
Time frame: Initial study visit (22-34 weeks) through one year postpartum
Effect of Diabetes Group Care on postpartum weight retention
Determine the impact of Diabetes Group care on postpartum weight retention in pounds based on postpartum weight retention at one year. Average weight retention will be compared at 4-12 weeks, six months postpartum, and one year postpartum.
Time frame: Pre-pregnancy weight (up to 6 months prior to initial visit) through one year postpartum
Completion of self-care activities
Determine the effect of Diabetes Group care on maternal diabetes self-care activities by using the Diabetes Self-care Activities Scale (a measure of the number of days during the prior week in which the subject followed diet, exercise, blood sugar testing, and medication adherence recommendations)
Time frame: 37-39 weeks gestation
Effect of Diabetes Group Care on number of blood glucose values
Determine the effect of Diabetes Group care by measuring the percentage of recommended blood glucose values entered on logs since initial study visit
Time frame: Initial study visit (22-34 weeks) through 39 weeks gestation
Maternal Antepartum Compliance
Determine the effect of Diabetes Group Care on maternal antepartum compliance by assessing the number of prenatal appointments attended
Time frame: Initial study visit (22-34weeks) through 4-12 weeks postpartum
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Maternal Antepartum Physical Activity/Eating Behavior
Determine the effect of Diabetes Group Care on maternal antepartum physical activity/eating behavior using a physical activity/eating behavior questionnaire
Time frame: Initial study visit (22-34weeks) through one year postpartum
Maternal Antepartum Weight Gain
Determine the effect of Diabetes Group Care on maternal antepartum weight gain in pounds
Time frame: Initial study visit (22-34weeks) through delivery
Maternal Intrapartum Mode of Delivery
Determine the effect of Diabetes Group Care on maternal intrapartum mode of delivery by assessing whether infant was delivered spontaneously, using vacuum, forceps, or cesarean.
Time frame: Delivery through 4-12 weeks postpartum
Maternal Intrapartum Hypertensive Disease of Pregnancy
Determine the effect of Diabetes Group Care on maternal intrapartum hypertensive disorders of pregnancy by assessing whether they develop gestational hypertension, preeclampsia, or eclampsia.
Time frame: Delivery through 4-12 weeks postpartum
Maternal Postpartum Readmission
Determine the effect of Diabetes Group Care on maternal postpartum readmission by assessing number of maternal hospital readmissions within 6 weeks postpartum.
Time frame: 4-12 weeks postpartum
Maternal Postpartum Visit Attendance
Determine the effect of Diabetes Group Care on maternal postpartum visit attendance by assessing whether she attends a postpartum visit between 4-12 weeks postpartum.
Time frame: 4-12 weeks postpartum
Maternal Postpartum Glucose Testing
Determine the effect of Diabetes Group Care on maternal postpartum glucose testing
Time frame: 4-12 weeks postpartum
Maternal Postpartum Breastfeeding
Determine the effect of Diabetes Group Care on maternal postpartum breastfeeding using a breastfeeding scale questionnaire
Time frame: 4-12 weeks postpartum, six months postpartum, one year postpartum
Maternal Postpartum Contraception
Determine the effect of Diabetes Group Care on maternal postpartum contraception choices by assessing use of short acting reversible contraception, long acting reversible, and sterilization.
Time frame: 4-12 weeks postpartum, six months postpartum, one year postpartum
Neonatal Birthweight
Determine the effect of Diabetes Group Care on neonatal birth weight in grams
Time frame: delivery admission
Neonatal Gestational Age
Determine the effect of Diabetes Group Care on neonatal gestational age at delivery
Time frame: delivery admission
Neonatal APGAR Scores
Determine the effect of Diabetes Group Care on neonatal APGAR score
Time frame: delivery admission
Neonatal Adiposity and body composition
Determine the effect of Diabetes Group Care on neonatal adiposity and body composition by air displacement plethysmography within 1 week of delivery. Skin fold thickness of triceps, subscapular, ilium, and thigh at delivery, six weeks, six months, one year postpartum.
Time frame: delivery admission through one year postpartum
Neonatal body measurements-Weight
Determine the effect of Diabetes Group Care on neonatal weight in grams
Time frame: delivery through one year postpartum
Neonatal body measurements-Length
Determine the effect of Diabetes Group Care on neonatal length in centimeters
Time frame: delivery through one year postpartum
Neonatal body measurements-Head Circumference
Determine the effect of Diabetes Group Care on neonatal head circumference in centimeters
Time frame: delivery through one year postpartum
Neonatal NICU Admission
Determine the effect of Diabetes Group Care on neonatal NICU admission
Time frame: delivery admission
Neonatal Hypoglycemia
Determine the effect of Diabetes Group Care on neonatal hypoglycemia
Time frame: delivery admission
Neonatal Outcomes
Determine the effect of Diabetes Group Care on neonatal hematocrit
Time frame: delivery admission
Neonatal Jaundice
Determine the effect of Diabetes Group Care on neonatal jaundice
Time frame: delivery admission
Neonatal Stillbirth Rates
Determine the effect of Diabetes Group Care on neonatal stillbirth rates
Time frame: delivery admission
Psychosocial Stress
Determine the effect of Diabetes Group Care on psychosocial stress by comparing Cohen's Perceived Stress at study entry visit, last study visit (37-39 weeks) and 4-12 weeks postpartum, six months postpartum, one year postpartum.
Time frame: Initial study visit (22-34weeks) through one year postpartum
Psychosocial Stress
Determine the effect of Diabetes Group Care on psychosocial stress by comparing life events checklist at study entry visit and six months postpartum
Time frame: Initial study visit (22-34weeks) and six months postpartum
Psychosocial Distress
Determine the effects of Diabetes Group Care on psychosocial stress by comparing Pregnancy Distress questionnaire at study entry, last study visit (37-39 weeks), and 4-12 weeks postpartum
Time frame: Initial study visit (22-34 weeks) through 4-12 weeks postpartum
Psychosocial Anxiety
Determine the effects of Diabetes Group Care on psychosocial stress by comparing GAD-7 at study entry, last study visit (37-39weeks) and 4-12 weeks postpartum, six months postpartum, one year postpartum.
Time frame: Initial study visit (22-34weeks) through one year postpartum
Psychosocial Depression
Determine the effects of Diabetes Group Care on depression by comparing the Edinburgh Postnatal Depression Scale at study entry, last study visit (37-39 weeks) and 4-12 weeks postpartum, six months postpartum, one year postpartum
Time frame: Initial study visit (22-34weeks) through 1 year postpartum
Psychosocial Stress and Depression
Determine the effects of Diabetes Group Care on stress and depression by measuring alcohol or drug use in first year postpartum
Time frame: Delivery through postpartum