Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT06180811

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

Led by Christiana Care Health Services · Updated on 2024-05-06

250

Participants Needed

1

Research Sites

95 weeks

Total Duration

On this page

Sponsors

C

Christiana Care Health Services

Lead Sponsor

U

University of Delaware

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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 participation, such as severe psychiatric illness or imminent hospitalization
  • Not able to understand and communicate effectively in English or Spanish

AI-Screening

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Trial Site Locations

Total: 1 location

1

ChristianaCare Christiana Hospital

Newark, Delaware, United States, 19718

Actively Recruiting

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Research Team

K

Kathleen McCallops, PhD

CONTACT

M

Michelle Axe, MS, CHES

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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