Group Versus Traditional Prenatal Care for Diabetes

NCT03301792 | Active Not Recruiting

• 1 other identifier: 202209158
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 2

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.

Conditions

Pregnancy; Gestational Diabetes; Type 2 Diabetes

Keywords

Group prenatal care; Diabetes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (30)

• Completion of self-care activities

  37-39 weeks gestation

• Effect of Diabetes Group Care on number of blood glucose values

  Initial study visit (22-34 weeks) through 39 weeks gestation

• Maternal Antepartum Compliance

  Initial study visit (22-34weeks) through 4-12 weeks postpartum

• Maternal Antepartum Physical Activity/Eating Behavior

  Initial study visit (22-34weeks) through one year postpartum

• Maternal Antepartum Weight Gain

  Initial study visit (22-34weeks) through delivery

Study Arms (2)

Routine Prenatal Care

NO INTERVENTION

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 prenatal care

EXPERIMENTAL

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

Interventions

Group prenatal care BEHAVIORAL

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

Group prenatal care

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (2)

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational; Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Megan Lawlor, MD

  Assistant Professor, Washington University in St. Louis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2017
• First Posted: October 4, 2017
• Study Start: September 14, 2017
• Primary Completion: November 17, 2025
• Study Completion: May 1, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

US (2)