ClinicalTrials.gg
RecruitingNCT07176793Updated Sep 14, 2026

Pregnancy and Postpartum Breastfeeding Support for Patients With Gestational Diabetes

An observational study in Gestational Diabetes Mellitus (GDM), Diabetes Type 2 and Breastfeeding Continuation, sponsored by University of California, Davis. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by University of California, Davis · Observational

From the registry’s dates

  • Started Mar 2026; still recruiting 7 months later.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
10
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 251 studies in Diabetes, Gestational with a site in United States — 53 open to participants now, 65 under way, 2 of them phase 3. Diabetes, Gestational · United States.

Planned enrollment
50th of 57
10 · median 72
Started
2026
with 10 others
Observational
57 of 251
10 open now
Primary completion
2026-12
later than 27 of 64 live
Registered
239th of 251
by date

Among the 251 studies in Diabetes, Gestational with a site in United States, this one is the 50th largest by planned enrollment of the 57 observational ones, is one of 11 that started in 2026, is one of 57 observational ones, reaches primary completion later than 27 of the 64 other live ones, and was the 239th registered.

By phase

251 studies; the count open now beside each. This study's row is marked.

No phase154 · 32 open
Observationalthis study57 · 10 open
Phase 111 · 5 open
Phase 411 · 3 open
Phase 37 · 1 open
Phase 26 · 1 open
Phase 1/23 · 0 open
Phase 2/32 · 1 open

By the year they started

First in 2000; this study’s year is marked. 11 started in 2026.

Size and results

Median enrollment 80 across the 194 interventional studies, 72 across the 57 observational. Of the 154 that completed or were terminated, 35 (23%) have results posted.

Was this useful?
Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 251 studies in Diabetes, Gestational with a site in United States, or all of them as a file.
02

Study summary

The investigators will use implementation methods to develop better breastfeeding support for patients with gestational diabetes as a way to prevent type 2 diabetes.

Read the detailed description

Gestational diabetes (GDM) is common and happens in about 8 of every 100 births. GDM can cause health problems right away and later in life. People who have GDM are 10 times more likely to get diabetes later on. Breastfeeding can help prevent diabetes. If a mother breastfeeds for 12 months or more, their chance of getting type 2 diabetes goes down by 30%. For people with GDM, not breastfeeding makes it more than twice as likely they'll get type 2 diabetes compared to those who do breastfeed. Infants also benefit-being breastfed lowers their chances of getting type 1 or type 2 diabetes later in life.

There are many barriers that people with GDM experience when breastfeeding. Compared to postpartum patients without GDM, those with GDM are 38% more likely to stop breastfeeding early. Right after birth, patients with GDM are 3.5 times less likely to be breastfeeding only (no formula) when they leave the hospital.

There are ways to help people with GDM breastfeed more, like meeting with a lactation consultant, getting help over the phone, and learning about healthy eating and exercise. But these programs aren't used much outside the hospital. Clinicians need better plans to support breastfeeding for mothers with GDM.

This study will use implementation mapping and the consolidated framework for implementation research to co-design a plan that helps mothers with GDM keep breastfeeding. The study will take place at UC Davis Health in Sacramento, California over a 1-year period.

03

Conditions studied

  • Gestational Diabetes Mellitus (GDM)
  • Diabetes Type 2
  • Breastfeeding Continuation
  • Breastfeeding Support

Keywords

  • Gestational Diabetes
  • Preventing Diabetes Type 2 after GDM
  • Breastfeeding
  • Focus Groups
  • Implementation mapping
  • Breastfeeding support strategy
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients with Gestational Diabetes Mellitus

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • ≥18 years old and able to communicate in English
  • Fits into one of the following:

    1. patients with GDM who are recently pregnant and/or postpartum;
    2. health care providers (nurses, physicians, lactation consultants, etc.) who would implement the strategy
    3. executive leadership

Exclusion criteria

Exclusion Criteria:

  • Subjects not meeting the inclusion criteria will be considered ineligible for participation
05

Study design

Observational model
Other
Time perspective
Other
Enrollment
10 participants (estimated)
Patient registry
No

Groups and cohorts

  • Panel of key informants

    The informant panel will include pregnant or postpartum individuals with a diagnosis of GDM. Staff at the UC Davis Health Campus including health care providers and staff who would be involved in implementing the breastfeeding support strategy and department leadership. All participants will be ≥18 years old and able to communicate in English

    Other: Implementation mapping to develop a multilevel health system strategy for prevention of type 2 diabetes through targeted breastfeeding support for patients with gestational diabetes

Interventions

  • OtherImplementation mapping to develop a multilevel health system strategy for prevention of type 2 diabetes through targeted breastfeeding support for patients with gestational diabetes

    Conduct implementation mapping to develop a multilevel health system breastfeeding support strategy for patients with GDM at UC Davis Health in Sacramento, California, a large academic medical center. The study design for this mapping process will include five steps in this 1-year proposal: (1) conduct a needs and assets assessment and identify implementers; (2) identify implementation outcomes and determinants; (3) choose mechanisms of change and design implementation strategies; (4) produce implementation protocols and materials; and prepare for the final step, (5) evaluate implementation outcomes, by selecting outcome measures for a future trial . This disciplined and systematic approach to intervention development will directly inform my future directions: a mixed methods feasibility trial to pilot the implementation strategy developed here, followed by a full-scale randomized trial to test the strategy's effectiveness in reducing diabetes risk.

    Also known as: Consolidated Framework for Implementation Research

06

What researchers measure

Primary outcomes

  1. Design novel implementation strategies for future mixed method trial

    Implementation mapping data will systematically inform the design of a multilevel implementation strategy to be tested in a future pilot trial. Following guidance for rigorous early-phase studies that avoid the futility of premature, underpowered trials, this design focuses on a patient-centered, informant-engaged approach within a systematic framework; with future plans to test the implementation strategy in a feasibility trial that generates proof-of-concept evidence on a primary prevention strategy for diabetes by supporting breastfeeding for patients with GDM.

    Time frame: September 2026

07

Study locations

1 of 1 sites recruiting
  • UC Davis Medical Center
    Sacramento, California 95817, United States
    Recruiting
    • Elva Horath, MD · Contact
    • Adrienne Hoyt-Austin, DO · Contact
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2026 (actual). Primary completion is estimated for Dec 2026, 9 months after the start.

Of 142 non-industry observational studies under Diabetes, Gestational, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 70. This study's planned 9 months is below that.

Counting every sponsor, half of 144 studies reached it within 43 months; a quarter within 19 and three quarters within 73.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 9, 2025
First posted
Sep 16, 2025
StartActual
Mar 23, 2026
Primary completionEst.
Dec 30, 2026
CompletionEst.
Dec 30, 2026
Last update
Sep 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07176793
Responsible party
Sponsor
First posted
Sep 16, 2025
Start date
Mar 23, 2026
Primary completion
Dec 30, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Sep 14, 2026

Study contacts

Adrienne Hoyt-Austin, DO, MAS, IBCLC
Contact
aehoyt@health.ucdavis.edu
916-734-4580
Elva T Horath, MD
Contact
ethorath@health.ucdavis.edu
510-910-4443
Adrienne Hoyt-Austin, DO, MAS, IBCLC
principal investigator · UC Davis Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion