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 volunteersQualifiers
≥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
Other
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 interventionConduct 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
Trial outcomes
Primary outcomes
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.
Sponsors and contacts
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University of California, Davis
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator