Maternal Health Diabetes Prevention Project Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gestational Diabetes
- Sponsor
- Tulane University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Fidelity - sessions attended
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Fidelity - sessions attended
Time Frame: 8-week intervention
Number of sessions attended throughout the 8 week intervention
Secondary Outcomes
- Fidelity - sessions held(8-week intervention)
- Fidelity - session content(8-week intervention)
- Intervention feasibility(2-month data collection visit)
- Intervention appropriateness(2-month data collection visit)
- Intervention acceptability(2-month data collection visit)