Maternal Health Diabetes Prevention Study

Tulane University20 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Gestational Diabetes PreDiabetes Hyperglycemia Glucose Intolerance During Pregnancy

Interventions

Lifestyle InterventionBEHAVIORAL

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.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Tulane Office of Health Research

New Orleans, Louisiana, United States

Outcomes

Primary Outcomes

Fidelity - sessions attended

Number of sessions attended throughout the 8 week intervention

Time frame: 8-week intervention

Secondary Outcomes

Fidelity - sessions held

Number of sessions held throughout the 8 week intervention

Time frame: 8-week intervention

Fidelity - session content

Assessment of whether key concepts were covered during sessions

Time frame: 8-week intervention

Intervention feasibility

Feasibility questionnaire delivered to participants and staff delivering the intervention

Time frame: 2-month data collection visit

Intervention appropriateness

Appropriateness questionnaire delivered to participants and staff delivering the intervention

Time frame: 2-month data collection visit

Intervention acceptability

Acceptability questionnaire delivered to participants and staff delivering the intervention

Time frame: 2-month data collection visit

Data from ClinicalTrials.gov

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