NCT07176793 · University of California, Davis
Pregnancy and Postpartum Breastfeeding Support for Patients With Gestational Diabetes
What this study is about
The investigators will use implementation methods to develop better breastfeeding support for patients with gestational diabetes as a way to prevent type 2 diabetes.
View original scientific description
The investigators will use implementation methods to develop better breastfeeding support for patients with gestational diabetes as a way to prevent type 2 diabetes.
Interventions
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
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.
Primary outcome measures
Design novel implementation strategies for future mixed method trial
Time frame: September 2026
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- ≥18 years old and able to communicate in English
- Fits into one of the following:
- patients with GDM who are recently pregnant and/or postpartum;
- health care providers (nurses, physicians, lactation consultants, etc.) who would implement the strategy
- executive leadership
Exclusion criteria
- Subjects not meeting the inclusion criteria will be considered ineligible for participation
Where
- Sacramento, California
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 7, 2026 · Source of record for eligibility and locations