Pregnancy and Postpartum Breastfeeding Support for Patients With Gestational Diabetes

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of California, Davis

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

≥18 years old and able to communicate in English

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

Disqualifiers

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

Trial population

Patients with Gestational Diabetes Mellitus

Trial design

Design model

Other

Time perspective

Other

Treatments tested in this trial

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

    Other intervention

    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.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Panel of key informants1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Davis

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator