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Recruiting NCT06180811

Evaluating the Effectiveness of a Food is Medicine Community Health Worker Program for Pregnant Women

Trial Parameters

Condition Pre-Eclampsia
Sponsor Christiana Care Health Services
Study Type INTERVENTIONAL
Phase N/A
Enrollment 250
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2024-01-02
Completion 2025-11
Interventions
Women's Health Delaware Food FarmacyUsual Standard of Care

Brief Summary

The purpose of this study is to conduct a pilot randomized controlled trial of a food is medicine community health worker intervention called the Women's Health Delaware Food Farmacy compared to the usual standard of care among pregnant ChristianaCare patients at risk for adverse clinical outcomes. The pilot study has three specific aims: Aim 1: To assess the feasibility of the Women's Health Delaware Food Farmacy and refine the program as needed Aim 2: To determine the prevalence of and change in social needs Aim 3: To evaluate the effectiveness of the Women's Health Delaware Food Farmacy on maternal and child health, healthcare utilization, and clinical event outcomes as well as patient-reported outcomes compared to the usual standard of care

Eligibility Criteria

Inclusion Criteria: * ChristianaCare Women's Health patient * 18 years or older * 4 to 14 weeks pregnant * Singleton pregnancy * Medicaid * BMI of 30 or higher * Reside in New Castle County Exclusion Criteria: * Current diagnosis of type 1 or type 2 diabetes * Multiple pregnancy * Currently enrolled in another Community Health Worker program * Not able to store and prepare meals * Diagnosed with severe medical comorbidities that might interfere with their ability to participate in the intervention, such as severe psychiatric illness or imminent hospitalization * Not able to understand and communicate effectively in English or Spanish

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