Pregnancy and Postpartum Breastfeeding Support for Patients With Gestational Diabetes

NCT07176793 | Not Yet Recruiting

• 3 other identifiers: 233628215P30DK092924-15RNG211604-12
• Study Type: observational
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Keywords

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

Outcome Measures

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.

  September 2026

Study Arms (1)

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

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

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

Panel of key informants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Gestational Diabetes Mellitus

You may qualify if:

• ≥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

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• University of California, Davis: lead

MeSH Terms

Conditions

Diabetes, Gestational; Diabetes Mellitus, Type 2; Breast Feeding

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Feeding Behavior; Behavior

Study Officials

• Adrienne Hoyt-Austin, DO, MAS, IBCLC

  UC Davis Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adrienne Hoyt-Austin, DO, MAS, IBCLC

CONTACT

916-734-4580; aehoyt@health.ucdavis.edu

Elva T Horath, MD

CONTACT

510-910-4443; ethorath@health.ucdavis.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 16, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01