PregnancyNCT03301792
Group Versus Traditional Prenatal Care for Diabetes
A study testing Group prenatal care in people with Pregnancy and Gestational Diabetes, run by Washington University School of Medicine at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pregnancy, Gestational Diabetes, Type 2 Diabetes
- What is being tested?
- Group prenatal care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Sep 2017to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Utah
Salt Lake City, Utah, 84132
Washington University in St. Louis
St Louis, Missouri, 63110
About this study
Official title: 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.
Read the 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).
- Conditions
- Pregnancy, Gestational Diabetes, Type 2 Diabetes
- Being tested
- Group prenatal care
- Keywords
- Group prenatal care, Diabetes
- Medical subject headings
- Diabetes, Gestational, Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group prenatal careBehavioural
Enrolled subjects will be randomly assigned in a 2:1 ratio to group or traditional care.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Group prenatal care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Pre-pregnancy weight (up to 6 months prior to initial visit) through one year postpartum
Secondary outcomes (30)
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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4-12 weeks postpartum
Maternal Postpartum Glucose Testing
Determine the effect of Diabetes Group Care on maternal postpartum glucose testing
Measured: 4-12 weeks postpartum
Maternal Postpartum Breastfeeding
Determine the effect of Diabetes Group Care on maternal postpartum breastfeeding using a breastfeeding scale questionnaire
Measured: 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.
Measured: 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
Measured: delivery admission
Neonatal Gestational Age
Determine the effect of Diabetes Group Care on neonatal gestational age at delivery
Measured: delivery admission
Neonatal APGAR Scores
Determine the effect of Diabetes Group Care on neonatal APGAR score
Measured: 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.
Measured: delivery admission through one year postpartum
Neonatal body measurements-Weight
Determine the effect of Diabetes Group Care on neonatal weight in grams
Measured: delivery through one year postpartum
Neonatal body measurements-Length
Determine the effect of Diabetes Group Care on neonatal length in centimeters
Measured: delivery through one year postpartum
Neonatal body measurements-Head Circumference
Determine the effect of Diabetes Group Care on neonatal head circumference in centimeters
Measured: delivery through one year postpartum
Neonatal NICU Admission
Determine the effect of Diabetes Group Care on neonatal NICU admission
Measured: delivery admission
Neonatal Hypoglycemia
Determine the effect of Diabetes Group Care on neonatal hypoglycemia
Measured: delivery admission
Neonatal Outcomes
Determine the effect of Diabetes Group Care on neonatal hematocrit
Measured: delivery admission
Neonatal Jaundice
Determine the effect of Diabetes Group Care on neonatal jaundice
Measured: delivery admission
Neonatal Stillbirth Rates
Determine the effect of Diabetes Group Care on neonatal stillbirth rates
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: Delivery through postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start14 Sep 2017
- Primary completion17 Nov 2025
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sydney Thayer, MD, Principal investigator, WashU Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03301792
- Sponsor's protocol ID
- 202209158
- Status last verified
- Aug 2026
- First submitted
- 15 Sep 2017
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Versus Traditional Prenatal Care for Diabetes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03301792
- Acronym / sponsor ID
- 202209158
- Conditions
- Pregnancy, Gestational Diabetes, Type 2 Diabetes
- Keywords
- Group prenatal care, Diabetes
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 117 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 14 Sep 2017 (actual)
- Primary completion
- 17 Nov 2025 (actual)
- Study completion
- Sep 2026 (estimated)
- First posted
- 4 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Group prenatal careGroup 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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:
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group prenatal careEnrolled subjects will be randomly assigned in a 2:1 ratio to group or traditional care. | Behavioural | Group prenatal care |
Primary outcome
Effect of Diabetes Group Care on maternal glycemic control
Time frame: 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
Time frame: 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.
30 secondary outcomes
Completion of self-care activities
Time frame: 37-39 weeks gestation
Effect of Diabetes Group Care on number of blood glucose values
Time frame: Initial study visit (22-34 weeks) through 39 weeks gestation
Maternal Antepartum Compliance
Time frame: Initial study visit (22-34weeks) through 4-12 weeks postpartum
Maternal Antepartum Physical Activity/Eating Behavior
Time frame: Initial study visit (22-34weeks) through one year postpartum
Maternal Antepartum Weight Gain
Time frame: Initial study visit (22-34weeks) through delivery
Maternal Intrapartum Mode of Delivery
Time frame: Delivery through 4-12 weeks postpartum
Maternal Intrapartum Hypertensive Disease of Pregnancy
Time frame: Delivery through 4-12 weeks postpartum
Maternal Postpartum Readmission
Time frame: 4-12 weeks postpartum
Maternal Postpartum Visit Attendance
Time frame: 4-12 weeks postpartum
Maternal Postpartum Glucose Testing
Time frame: 4-12 weeks postpartum
Maternal Postpartum Breastfeeding
Time frame: 4-12 weeks postpartum, six months postpartum, one year postpartum
Maternal Postpartum Contraception
Time frame: 4-12 weeks postpartum, six months postpartum, one year postpartum
Neonatal Birthweight
Time frame: delivery admission
Neonatal Gestational Age
Time frame: delivery admission
Neonatal APGAR Scores
Time frame: delivery admission
Neonatal Adiposity and body composition
Time frame: delivery admission through one year postpartum
Neonatal body measurements-Weight
Time frame: delivery through one year postpartum
Neonatal body measurements-Length
Time frame: delivery through one year postpartum
Neonatal body measurements-Head Circumference
Time frame: delivery through one year postpartum
Neonatal NICU Admission
Time frame: delivery admission
Neonatal Hypoglycemia
Time frame: delivery admission
Neonatal Outcomes
Time frame: delivery admission
Neonatal Jaundice
Time frame: delivery admission
Neonatal Stillbirth Rates
Time frame: delivery admission
Psychosocial Stress
Time frame: Initial study visit (22-34weeks) through one year postpartum
Psychosocial Stress
Time frame: Initial study visit (22-34weeks) and six months postpartum
Psychosocial Distress
Time frame: Initial study visit (22-34 weeks) through 4-12 weeks postpartum
Psychosocial Anxiety
Time frame: Initial study visit (22-34weeks) through one year postpartum
Psychosocial Depression
Time frame: Initial study visit (22-34weeks) through 1 year postpartum
Psychosocial Stress and Depression
Time frame: Delivery through postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sydney Thayer, MD principal investigator
WashU Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group prenatal care in people with Pregnancy and Gestational Diabetes, run by Washington University School of Medicine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Diabetes Group Care on maternal glycemic control (time frame: Initial study visit (22-34 weeks) through one year postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.