Back to resultsGroup Versus Traditional Prenatal Care for Diabetes
Primary Purpose
Pregnancy, Gestational Diabetes, Type 2 Diabetes
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group prenatal care
Sponsored by
About this trial
This is an interventional treatment trial for Pregnancy focused on measuring Group prenatal care, Diabetes
Eligibility Criteria
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.
Sites / Locations
- Washington University in St. Louis
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Routine Prenatal Care
Group prenatal care
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
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)
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
Maternal Antepartum Compliance
Determine the effect of Diabetes Group Care on maternal antepartum compliance by assessing the number of prenatal appointments attended
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
Maternal Antepartum Weight Gain
Determine the effect of Diabetes Group Care on maternal antepartum weight gain in pounds
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.
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.
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.
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.
Maternal Postpartum Glucose Testing
Determine the effect of Diabetes Group Care on maternal postpartum glucose testing
Maternal Postpartum Breastfeeding
Determine the effect of Diabetes Group Care on maternal postpartum breastfeeding using a breastfeeding scale questionnaire
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.
Neonatal Birthweight
Determine the effect of Diabetes Group Care on neonatal birth weight in grams
Neonatal Gestational Age
Determine the effect of Diabetes Group Care on neonatal gestational age at delivery
Neonatal APGAR Scores
Determine the effect of Diabetes Group Care on neonatal APGAR score
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.
Neonatal body measurements-Weight
Determine the effect of Diabetes Group Care on neonatal weight in grams
Neonatal body measurements-Length
Determine the effect of Diabetes Group Care on neonatal length in centimeters
Neonatal body measurements-Head Circumference
Determine the effect of Diabetes Group Care on neonatal head circumference in centimeters
Neonatal NICU Admission
Determine the effect of Diabetes Group Care on neonatal NICU admission
Neonatal Hypoglycemia
Determine the effect of Diabetes Group Care on neonatal hypoglycemia
Neonatal Outcomes
Determine the effect of Diabetes Group Care on neonatal hematocrit
Neonatal Jaundice
Determine the effect of Diabetes Group Care on neonatal jaundice
Neonatal Stillbirth Rates
Determine the effect of Diabetes Group Care on neonatal stillbirth rates
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.
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
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
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.
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
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
Full Information
NCT ID
NCT03301792
First Posted
September 15, 2017
Last Updated
July 20, 2022
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03301792
Brief Title
Group Versus Traditional Prenatal Care for Diabetes
Official Title
Group Versus Traditional Prenatal Care for Diabetes: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 14, 2017 (Actual)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Gestational Diabetes, Type 2 Diabetes
Keywords
Group prenatal care, Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
117 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Routine Prenatal Care
Arm Type
No Intervention
Arm Description
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.
Arm Title
Group prenatal care
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Group prenatal care
Intervention Description
Enrolled subjects will be randomly assigned in a 2:1 ratio to group or traditional care.
Primary Outcome Measure Information:
Title
Effect of Diabetes Group Care on maternal glycemic control
Description
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
Title
Effect of Diabetes Group Care on postpartum weight retention
Description
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
Secondary Outcome Measure Information:
Title
Completion of self-care activities
Description
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
Title
Effect of Diabetes Group Care on number of blood glucose values
Description
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
Title
Maternal Antepartum Compliance
Description
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
Title
Maternal Antepartum Physical Activity/Eating Behavior
Description
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
Title
Maternal Antepartum Weight Gain
Description
Determine the effect of Diabetes Group Care on maternal antepartum weight gain in pounds
Time Frame
Initial study visit (22-34weeks) through delivery
Title
Maternal Intrapartum Mode of Delivery
Description
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
Title
Maternal Intrapartum Hypertensive Disease of Pregnancy
Description
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
Title
Maternal Postpartum Readmission
Description
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
Title
Maternal Postpartum Visit Attendance
Description
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
Title
Maternal Postpartum Glucose Testing
Description
Determine the effect of Diabetes Group Care on maternal postpartum glucose testing
Time Frame
4-12 weeks postpartum
Title
Maternal Postpartum Breastfeeding
Description
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
Title
Maternal Postpartum Contraception
Description
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
Title
Neonatal Birthweight
Description
Determine the effect of Diabetes Group Care on neonatal birth weight in grams
Time Frame
delivery admission
Title
Neonatal Gestational Age
Description
Determine the effect of Diabetes Group Care on neonatal gestational age at delivery
Time Frame
delivery admission
Title
Neonatal APGAR Scores
Description
Determine the effect of Diabetes Group Care on neonatal APGAR score
Time Frame
delivery admission
Title
Neonatal Adiposity and body composition
Description
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
Title
Neonatal body measurements-Weight
Description
Determine the effect of Diabetes Group Care on neonatal weight in grams
Time Frame
delivery through one year postpartum
Title
Neonatal body measurements-Length
Description
Determine the effect of Diabetes Group Care on neonatal length in centimeters
Time Frame
delivery through one year postpartum
Title
Neonatal body measurements-Head Circumference
Description
Determine the effect of Diabetes Group Care on neonatal head circumference in centimeters
Time Frame
delivery through one year postpartum
Title
Neonatal NICU Admission
Description
Determine the effect of Diabetes Group Care on neonatal NICU admission
Time Frame
delivery admission
Title
Neonatal Hypoglycemia
Description
Determine the effect of Diabetes Group Care on neonatal hypoglycemia
Time Frame
delivery admission
Title
Neonatal Outcomes
Description
Determine the effect of Diabetes Group Care on neonatal hematocrit
Time Frame
delivery admission
Title
Neonatal Jaundice
Description
Determine the effect of Diabetes Group Care on neonatal jaundice
Time Frame
delivery admission
Title
Neonatal Stillbirth Rates
Description
Determine the effect of Diabetes Group Care on neonatal stillbirth rates
Time Frame
delivery admission
Title
Psychosocial Stress
Description
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
Title
Psychosocial Stress
Description
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
Title
Psychosocial Distress
Description
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
Title
Psychosocial Anxiety
Description
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
Title
Psychosocial Depression
Description
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
Title
Psychosocial Stress and Depression
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ebony B. Carter, MD, MPH
Organizational Affiliation
Assistant Professor, Washington University in St. Louis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Group Versus Traditional Prenatal Care for Diabetes
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