MedTrace Logo

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

NCT06180811 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2024-05-06

No results posted yet for this study

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

Conditions

  • Pre-Eclampsia
  • Obesity
  • Gestational Diabetes
  • Gestational Hypertension

Interventions

OTHER

Women'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.

OTHER

Usual Standard of Care

Participants will receive the usual standard of care.

Sponsors & Collaborators

  • University of Delaware

    collaborator OTHER

  • Christiana Care Health Services

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-02
Primary Completion
2025-11-30
Completion
2025-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06180811 on ClinicalTrials.gov