Food assistance program for pregnant women at risk of health issues
Evaluating the Effectiveness of a Food is Medicine Community Health Worker Program for Pregnant Women: Addressing Social Needs and Improving Health Outcomes
NA · Christiana Care Health Services · NCT06180811
This study is testing a food assistance program that provides healthy groceries and support to pregnant women at risk for health issues to see if it helps improve their and their babies' health.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Christiana Care Health Services (other) |
| Locations | 1 site (Newark, Delaware) |
| Trial ID | NCT06180811 on ClinicalTrials.gov |
What this trial studies
This pilot randomized controlled trial evaluates the Women's Health Delaware Food Farmacy program, which provides medically tailored groceries and support to pregnant women at ChristianaCare who are at risk for adverse clinical outcomes. Participants will be randomly assigned to either receive the Food Farmacy intervention or continue with the usual standard of care. The program includes weekly deliveries of nutritious food, culinary training, and support from Community Health Workers to address social needs. The study aims to assess the feasibility of the program, changes in social needs, and its effectiveness on maternal and child health outcomes.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18 or older, with a BMI of 30 or higher, enrolled in Medicaid, and residing in New Castle County.
Not a fit: Patients with type 1 or type 2 diabetes, multiple pregnancies, or severe medical comorbidities may not benefit from this program.
Why it matters
Potential benefit: If successful, this program could improve maternal and child health outcomes for pregnant women facing food insecurity and related health risks.
How similar studies have performed: Other studies have shown promising results with food is medicine approaches, indicating potential for success in this novel intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Newark, Delaware
- ChristianaCare Christiana Hospital — Newark, Delaware, United States (RECRUITING)
Study contacts
- Study coordinator: Kathleen McCallops, PhD
- Email: kathleen.mccallops@christianacare.org
- Phone: 3024286590
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pre-Eclampsia, Obesity, Gestational Diabetes, Gestational Hypertension, Food is Medicine, Community Health Worker, Social Needs, Medically Tailored Groceries