Group Versus Traditional Prenatal Care for Diabetes

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03301792
• Other study ID #: 201707118; 201906068 (1001)
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 14, 2017
• Est. completion date: August 31, 2025

Study information

• Verified date: December 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 117
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes
• Pregnancy
• Type 2 Diabetes

Intervention

Behavioral:
• Group prenatal care
Enrolled subjects will be randomly assigned in a 2:1 ratio to group or traditional care.

Locations

Country	Name	City	State
United States	Washington University in St. Louis	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Maternal Postpartum Glucose Testing	Determine the effect of Diabetes Group Care on maternal postpartum glucose testing	4-12 weeks postpartum
Secondary	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
Secondary	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
Secondary	Neonatal Birthweight	Determine the effect of Diabetes Group Care on neonatal birth weight in grams	delivery admission
Secondary	Neonatal Gestational Age	Determine the effect of Diabetes Group Care on neonatal gestational age at delivery	delivery admission
Secondary	Neonatal APGAR Scores	Determine the effect of Diabetes Group Care on neonatal APGAR score	delivery admission
Secondary	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
Secondary	Neonatal body measurements-Weight	Determine the effect of Diabetes Group Care on neonatal weight in grams	delivery through one year postpartum
Secondary	Neonatal body measurements-Length	Determine the effect of Diabetes Group Care on neonatal length in centimeters	delivery through one year postpartum
Secondary	Neonatal body measurements-Head Circumference	Determine the effect of Diabetes Group Care on neonatal head circumference in centimeters	delivery through one year postpartum
Secondary	Neonatal NICU Admission	Determine the effect of Diabetes Group Care on neonatal NICU admission	delivery admission
Secondary	Neonatal Hypoglycemia	Determine the effect of Diabetes Group Care on neonatal hypoglycemia	delivery admission
Secondary	Neonatal Outcomes	Determine the effect of Diabetes Group Care on neonatal hematocrit	delivery admission
Secondary	Neonatal Jaundice	Determine the effect of Diabetes Group Care on neonatal jaundice	delivery admission
Secondary	Neonatal Stillbirth Rates	Determine the effect of Diabetes Group Care on neonatal stillbirth rates	delivery admission
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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