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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Delaware
ChristianaCare Christiana Hospital
RECRUITING
Newark
Contact Information
Primary
Kathleen McCallops, PhD
kathleen.mccallops@christianacare.org
3024286590
Backup
Michelle Axe, MS, CHES
michelle.axe@christianacare.org
3024286590
Time Frame
Start Date: 2024-01-02
Estimated Completion Date: 2025-11
Participants
Target number of participants: 250
Treatments
Experimental: 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.
Active_comparator: Usual Standard of Care
Participants will receive the usual standard of care.
Sponsors
Leads: Christiana Care Health Services
Collaborators: University of Delaware

This content was sourced from clinicaltrials.gov