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Recruiting NCT07176793

Pregnancy and Postpartum Breastfeeding Support for Patients With Gestational Diabetes

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Implementation mapping to develop a multilevel health system strategy for prevention of type 2 diabetes through targeted breastfeeding support for patients with gestational diabetes.
Who it may be relevant to
Registry conditions: Gestational Diabetes Mellitus (GDM), Diabetes Type 2, Breastfeeding Continuation, Breastfeeding Support. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Preventing Type 2 Diabetes Following Gestational Diabetes: Implementation Mapping for a Multilevel Breastfeeding Support Strategy

Overview

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

Detailed description

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.

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 im

Primary outcome measures

  • Design novel implementation strategies for future mixed method trial [Time frame: September 2026]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

United States · 1 center
  • UC Davis Medical Center — Sacramento

Identifiers

NCT: NCT07176793 · 2336282 · 5P30DK092924-15 · RNG211604-12

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗