Status:
RECRUITING
Evaluating the Effectiveness of a Food is Medicine Community Health Worker Program for Pregnant Women
Lead Sponsor:
Christiana Care Health Services
Collaborating Sponsors:
University of Delaware
Conditions:
Pre-Eclampsia
Obesity
Eligibility:
FEMALE
18+ years
Phase:
NA
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 u...
Detailed Description
This study is a pilot randomized controlled trial where eligible pregnant ChristianaCare patients will be identified weekly through an automated list, and patients who consent will be randomized to 1 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06180811
Start Date
January 2 2024
End Date
November 1 2025
Last Update
May 6 2024
Active Locations (1)
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1
ChristianaCare Christiana Hospital
Newark, Delaware, United States, 19718