Group Versus Traditional Prenatal Care for Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Group Versus Traditional Prenatal Care for Diabetes: A Randomized Controlled Trial

Conditions
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Pregnancy, Gestational Diabetes, Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Group prenatal care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English speaking Type 2 diabetes OR gestational diabetes diagnosed by 2-step method(1) OR likely pre-existing Type 2 diabetes with one of the following during pregnancy and </= 34 weeks: 1 hour glucose challenge test >/= 185mg/dL OR A1c >/= 6.5% OR Fasting plasma glucose > 126mg/dL (2) Ability to attend group prenatal visit at specified days and times Willingness to be randomized at 22 weeks 0 days-34 weeks 0 days OR initial visit between 24 weeks 0 days-34 weeks 0 days Ability to give informed consent Exclusion Criteria: Prior participation in diabetes group care Type 1 Diabetes Multiple gestation Major fetal anomaly Serious medical co-morbidity necessitating more care than can be safely provided in group setting, as deemed by medical provider. Serious psychiatric illness including schizophrenia necessitating more care than can safely be provided in group setting, as deemed by medical provider.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Routine Prenatal Care<br>Subjects randomized to routine care will receive their care in the usual diabetic clinic attended by residents and faculty. They will receive consultation with the diabetes educator at diagnosis and as needed. Patients are seen every 2 weeks (or more by provider discretion) until 37 weeks and weekly until delivery. Visits are 10-15 minutes and focus on routine screening tests and review of blood sugar logs/medication titration. | |
| Experimental: Group prenatal care<br>Group visits will be held every 2 weeks in a continuous cycle through a six session curriculum. Women will have weekly visits beginning at 37 weeks with traditional prenatal visits on the weeks when the group does not meet. Groups of 2-12 women will meet for two hour visits and much of that time will be spent on pregnancy, behavioral health, diabetes and nutrition education. Groups will be co-facilitated by a health educator and an obstetric provider. Women may be instructed to have additional visits in the traditional clinic at the discretion of the obstetric provider. | Behavioral: Group prenatal care<br>* Enrolled subjects will be randomly assigned in a 2:1 ratio to group or traditional care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | Pre-pregnancy weight (up to 6 months prior to initial visit) through one year postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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 | 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 | Initial study visit (22-34weeks) through 4-12 weeks postpartum | 
| 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 | 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 | 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. | 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. | 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. | 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. | 4-12 weeks postpartum | 
| Maternal Postpartum Glucose Testing | Determine the effect of Diabetes Group Care on maternal postpartum glucose testing | 4-12 weeks postpartum | 
| Maternal Postpartum Breastfeeding | Determine the effect of Diabetes Group Care on maternal postpartum breastfeeding using a breastfeeding scale questionnaire | 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. | 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 | delivery admission | 
| Neonatal Gestational Age | Determine the effect of Diabetes Group Care on neonatal gestational age at delivery | delivery admission | 
| Neonatal APGAR Scores | Determine the effect of Diabetes Group Care on neonatal APGAR score | 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. | delivery admission through one year postpartum | 
| Neonatal body measurements-Weight | Determine the effect of Diabetes Group Care on neonatal weight in grams | delivery through one year postpartum | 
| Neonatal body measurements-Length | Determine the effect of Diabetes Group Care on neonatal length in centimeters | delivery through one year postpartum | 
| Neonatal body measurements-Head Circumference | Determine the effect of Diabetes Group Care on neonatal head circumference in centimeters | delivery through one year postpartum | 
| Neonatal NICU Admission | Determine the effect of Diabetes Group Care on neonatal NICU admission | delivery admission | 
| Neonatal Hypoglycemia | Determine the effect of Diabetes Group Care on neonatal hypoglycemia | delivery admission | 
| Neonatal Outcomes | Determine the effect of Diabetes Group Care on neonatal hematocrit | delivery admission | 
| Neonatal Jaundice | Determine the effect of Diabetes Group Care on neonatal jaundice | delivery admission | 
| Neonatal Stillbirth Rates | Determine the effect of Diabetes Group Care on neonatal stillbirth rates | 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. | 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 | 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 | 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. | 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 | 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 | Delivery through postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Group prenatal care, Diabetes