Group Versus Traditional Prenatal Care for Diabetes

Not Applicable

Active, not recruiting

• Conditions: Gestational Diabetes; Type 2 Diabetes; Pregnancy
• Interventions: Behavioral: Group prenatal care

• Registration Number: NCT03301792
• Lead Sponsor: Washington University School of Medicine

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).

Study Timeline

• Study Start: 2017-09-14
• Study First Submitted: 2017-09-15
• Study First Submitted QC: 2017-10-03
• Study First Posted: 2017-10-04
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-04
• Last Update Posted: 2023-12-06
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 117

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group prenatal care	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.

Primary Outcome Measures

Name	Time	Method
Effect of Diabetes Group Care on maternal glycemic control	Initial study visit (22-34 weeks) through one year postpartum	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	Pre-pregnancy weight (up to 6 months prior to initial visit) through one year postpartum	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

Name	Time	Method
Effect of Diabetes Group Care on number of blood glucose values	Initial study visit (22-34 weeks) through 39 weeks gestation	Determine the effect of Diabetes Group care by measuring the percentage of recommended blood glucose values entered on logs since initial study visit
Psychosocial Anxiety	Initial study visit (22-34weeks) through one year postpartum	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	Initial study visit (22-34weeks) through 1 year postpartum	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
Maternal Intrapartum Hypertensive Disease of Pregnancy	Delivery through 4-12 weeks postpartum	Determine the effect of Diabetes Group Care on maternal intrapartum hypertensive disorders of pregnancy by assessing whether they develop gestational hypertension, preeclampsia, or eclampsia.
Neonatal body measurements-Weight	delivery through one year postpartum	Determine the effect of Diabetes Group Care on neonatal weight in grams
Neonatal NICU Admission	delivery admission	Determine the effect of Diabetes Group Care on neonatal NICU admission
Psychosocial Distress	Initial study visit (22-34 weeks) through 4-12 weeks postpartum	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
Maternal Postpartum Readmission	4-12 weeks postpartum	Determine the effect of Diabetes Group Care on maternal postpartum readmission by assessing number of maternal hospital readmissions within 6 weeks postpartum.
Maternal Postpartum Breastfeeding	4-12 weeks postpartum, six months postpartum, one year postpartum	Determine the effect of Diabetes Group Care on maternal postpartum breastfeeding using a breastfeeding scale questionnaire
Neonatal Birthweight	delivery admission	Determine the effect of Diabetes Group Care on neonatal birth weight in grams
Neonatal APGAR Scores	delivery admission	Determine the effect of Diabetes Group Care on neonatal APGAR score
Neonatal Adiposity and body composition	delivery admission through one year postpartum	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 Hypoglycemia	delivery admission	Determine the effect of Diabetes Group Care on neonatal hypoglycemia
Neonatal Outcomes	delivery admission	Determine the effect of Diabetes Group Care on neonatal hematocrit
Neonatal Jaundice	delivery admission	Determine the effect of Diabetes Group Care on neonatal jaundice
Psychosocial Stress and Depression	Delivery through postpartum	Determine the effects of Diabetes Group Care on stress and depression by measuring alcohol or drug use in first year postpartum
Maternal Intrapartum Mode of Delivery	Delivery through 4-12 weeks postpartum	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 Postpartum Visit Attendance	4-12 weeks postpartum	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 Contraception	4-12 weeks postpartum, six months postpartum, one year postpartum	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 body measurements-Length	delivery through one year postpartum	Determine the effect of Diabetes Group Care on neonatal length in centimeters
Completion of self-care activities	37-39 weeks gestation	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)
Maternal Antepartum Compliance	Initial study visit (22-34weeks) through 4-12 weeks postpartum	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	Initial study visit (22-34weeks) through one year postpartum	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	Initial study visit (22-34weeks) through delivery	Determine the effect of Diabetes Group Care on maternal antepartum weight gain in pounds
Maternal Postpartum Glucose Testing	4-12 weeks postpartum	Determine the effect of Diabetes Group Care on maternal postpartum glucose testing
Neonatal Gestational Age	delivery admission	Determine the effect of Diabetes Group Care on neonatal gestational age at delivery
Neonatal body measurements-Head Circumference	delivery through one year postpartum	Determine the effect of Diabetes Group Care on neonatal head circumference in centimeters
Psychosocial Stress	Initial study visit (22-34weeks) and six months postpartum	Determine the effect of Diabetes Group Care on psychosocial stress by comparing life events checklist at study entry visit and six months postpartum
Neonatal Stillbirth Rates	delivery admission	Determine the effect of Diabetes Group Care on neonatal stillbirth rates

Trial Locations

Locations (1)

Washington University in St. Louis; 🇺🇸 Saint Louis, Missouri, United States