Maternal Health Diabetes Prevention Study

Tulane University

Status: Completed

Conditions: Gestational Diabetes; Hyperglycemia; Glucose Intolerance During Pregnancy; PreDiabetes

Treatments: Behavioral: Lifestyle Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05343494

2021-1234

OT2HL158287 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Lifestyle Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Lifestyle Intervention