Group Versus Traditional Prenatal Care for Diabetes

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pregnancy; Type 2 Diabetes; Gestational Diabetes
• Intervention / Treatment: Behavioral: Group prenatal care

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).

• Study Type: Interventional
• Enrollment (Estimated): 117
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University in St. Louis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. English speaking

2. 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. 1 hour glucose challenge test >/= 185mg/dL OR
   2. A1c >/= 6.5% OR
   3. Fasting plasma glucose > 126mg/dL (2)
3. Ability to attend group prenatal visit at specified days and times
4. 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
5. Ability to give informed consent

Exclusion Criteria:

1. Prior participation in diabetes group care
2. Type 1 Diabetes
3. Multiple gestation
4. Major fetal anomaly
5. Serious medical co-morbidity necessitating more care than can be safely provided in group setting, as deemed by medical provider.
6. Serious psychiatric illness including schizophrenia necessitating more care than can safely be provided in group setting, as deemed by medical provider.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Routine Prenatal Care; 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; 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; Enrolled subjects will be randomly assigned in a 2:1 ratio to group or traditional care.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Megan Lawlor, MD, Assistant Professor, Washington University in St. Louis

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2017
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: September 15, 2017
• First Submitted That Met QC Criteria: October 3, 2017
• First Posted (Actual): October 4, 2017

Study Record Updates

• Last Update Posted (Estimated): December 6, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Diabetes; Group prenatal care
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: 201707118; 201906068 (1001)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No