RecruitingNot ApplicableNCT06180811

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

Evaluating the Effectiveness of a Food is Medicine Community Health Worker Program for Pregnant Women: Addressing Social Needs and Improving Health Outcomes


Sponsor

Christiana Care Health Services

Enrollment

250 participants

Start Date

Jan 2, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria7

  • ChristianaCare Women's Health patient
  • years or older
  • to 14 weeks pregnant
  • Singleton pregnancy
  • Medicaid
  • BMI of 30 or higher
  • Reside in New Castle County

Exclusion Criteria6

  • 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

Interventions

OTHERWomen's Health Delaware Food Farmacy

Participants will receive medically tailored groceries (10 meals per person in the household per week from enrollment to 4 weeks after delivery) high in micronutrients that are delivered to their homes weekly. They will also interact weekly with their assigned Community Health Worker to address social needs and patient-centered goals.

OTHERUsual Standard of Care

Participants will receive the usual standard of care.


Locations(1)

ChristianaCare Christiana Hospital

Newark, Delaware, United States

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NCT06180811


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