Maternal Health Diabetes Prevention Study

Not Applicable

Completed

• Conditions: Glucose Intolerance During Pregnancy; Hyperglycemia; PreDiabetes; Gestational Diabetes
• Interventions: Behavioral: Lifestyle Intervention

• Registration Number: NCT05343494
• Lead Sponsor: Tulane University

Brief 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.

Study Timeline

• Status Verified: 2022-04
• Study Start: 2022-04-04
• Study First Submitted: 2022-04-04
• Study First Submitted QC: 2022-04-19
• Study First Posted: 2022-04-25
• Primary Completion: 2022-10-05
• Study Completion: 2022-10-05
• Last Update Submitted: 2022-11-29
• Last Update Posted: 2022-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• Age ≥18 years
• 6 weeks to 12 months postpartum
• Medical record documented diagnosis of GDM during most recent pregnancy
• Access to a device that can access the internet
• English speaking

Exclusion Criteria

• Pregnant or planning to become pregnant in the next two months
• Planning to move out of the area in the next two months
• Self-report of diagnosed diabetes
• Use of glucose-lowering medications
• Plasma glucose >200 mg/dL and classic symptoms of hyperglycemia (thirst, polyuria, weight loss, blurry vision) or HbA1c >6.5% (based on screening visit blood draw)
• Unable or unwilling to provide informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lifestyle Intervention	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.

Primary Outcome Measures

Name	Time	Method
Fidelity - sessions attended	8-week intervention	Number of sessions attended throughout the 8 week intervention

Secondary Outcome Measures

Name	Time	Method
Fidelity - sessions held	8-week intervention	Number of sessions held throughout the 8 week intervention
Fidelity - session content	8-week intervention	Assessment of whether key concepts were covered during sessions
Intervention feasibility	2-month data collection visit	Feasibility questionnaire delivered to participants and staff delivering the intervention
Intervention appropriateness	2-month data collection visit	Appropriateness questionnaire delivered to participants and staff delivering the intervention
Intervention acceptability	2-month data collection visit	Acceptability questionnaire delivered to participants and staff delivering the intervention

Trial Locations

Locations (1)

Tulane Office of Health Research; 🇺🇸 New Orleans, Louisiana, United States