NCT05343494

Maternal Health Diabetes Prevention Study

Maternal Health Diabetes Prevention Project Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Tulane University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The aim of this project is to use the Exploration, Preparation, Implementation, Sustainment (EPIS) framework to collect pilot data on the implementation of a Diabetes Prevention Program-like intervention in the Women, Infants, and Children (WIC) program.

Detailed description

In this study, investigators will pilot a 2-month Diabetes Prevention Program-like program (delivered by WIC staff) to 20 women with recent gestational diabetes (6 weeks to 12 months postpartum) who receive WIC services. The goal of this pilot is to evaluate the feasibility, acceptability, appropriateness, fidelity of implementing this intervention in the setting of WIC clinics and feasibility of conducting a larger-scale study.

Conditions

• Gestational Diabetes
• PreDiabetes
• Hyperglycemia
• Glucose Intolerance During Pregnancy

Interventions

Type	Name	Description
BEHAVIORAL	Lifestyle Intervention	The intervention has been modified from a subset of sessions from the National DPP Prevent T2 Curriculum (an adapted DPP for community settings that improves cardiometabolic outcomes and is implemented nationwide). The intervention will consist of 8 weekly sessions. The first session will be one-on-one and subsequent sessions will be in small groups. Sessions 1, 2, and 6 will be in-person and other sessions will be held by Zoom.

Timeline

• Start date: 2022-04-04
• Primary completion: 2022-10-05
• Completion: 2022-10-05
• First posted: 2022-04-25
• Last updated: 2022-11-30

Locations

1 site across 1 country: United States