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

Obesity Pre-Eclampsia Gestational Diabetes Gestational Hypertension

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

Plain Language Summary

Simplified for easier understanding

This study tests a "Food is Medicine" program that uses community health workers to support pregnant women in getting healthy food. The program provides food resources, nutrition education, and community support to reduce pregnancy complications related to diet and weight, like gestational diabetes or pre-eclampsia. **You may be eligible if...** - You are a patient at ChristianaCare Women's Health - You are 18 years or older and 4 to 14 weeks pregnant with one baby - You are on Medicaid and live in New Castle County - Your BMI is 30 or higher at the start of pregnancy **You may NOT be eligible if...** - You already have Type 1 or Type 2 diabetes - You are carrying more than one baby (twins, triplets, etc.) - You are currently enrolled in another nutrition program - You do not reside in New Castle County Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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.