UC Davis Medical Center
Sacramento, California, 95817, United States
Location status: Recruiting
Location contact
Adrienne Hoyt-Austin, DO
CONTACT
Elva Horath, MD
CONTACT
NCT Number: NCT07176793
The investigators will use implementation methods to develop better breastfeeding support for patients with gestational diabetes as a way to prevent type 2 diabetes.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Sacramento, California, 95817, United States
Location status: Recruiting
Adrienne Hoyt-Austin, DO
CONTACT
Elva Horath, MD
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Consolidated Framework for Implementation Research
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.
Contact information is provided by the study sponsor or research team.
Adrienne Hoyt-Austin, DO, MAS, IBCLC
CONTACT
Elva T Horath, MD
CONTACT
University of California, Davis
Other
Preventing Type 2 Diabetes Following Gestational Diabetes: Implementation Mapping for a Multilevel Breastfeeding Support Strategy
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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