Maternal Health Diabetes Prevention Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Maternal Health Diabetes Prevention Project Pilot Study

Conditions
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Gestational Diabetes, PreDiabetes, Hyperglycemia, Glucose Intolerance During Pregnancy

Intervention / Treatment
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* Behavioral: Lifestyle Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle Intervention<br>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. | Behavioral: Lifestyle Intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fidelity - sessions attended | Number of sessions attended throughout the 8 week intervention | 8-week intervention | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Prevention Program, Behavioral Intervention, Diet, Physical Activity, Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)