This study is a pilot randomized controlled trial where eligible pregnant ChristianaCare
patients will be identified weekly through an automated list, and patients who consent will
be randomized to 1 of 2 arms (Women's Health Delaware Food Farmacy vs. usual standard of
care). Participants randomized to the Women's Health Delaware Food Farmacy program arm will
receive medically tailored groceries that are high in micronutrients critical for a healthy
pregnancy. The food provided will be the equivalent of 10 meals per person in the household
per week and will be delivered to participants weekly from enrollment to 4 weeks after giving
birth. Participants will receive culinary equipment and training, recipes, and educational
nutrition videos and will interact weekly with their assigned Community Health Worker to
address social needs and patient-centered goals. Participants randomized to the usual
standard of care arm will continue to receive their standard of care management.
All participants will complete a questionnaire with patient-reported outcomes (i.e., food
insecurity, dietary intake, health-related quality of life, and cost-related medication
underuse) at baseline and postpartum and a patient experience survey postpartum related to
their experiences receiving prenatal care and giving birth at ChristianaCare. In addition,
maternal and child health, healthcare utilization, and clinical event outcomes will be
documented for all participants via electronic health records and assessed retrospectively.
Quantitative indicators related to feasibility (i.e., acceptability, demand, and
implementation) will be collected such as program satisfaction, program enrollment and
retention, meals provided to participants and their household, food consumption, and
interactions with assigned Community Health Worker.
Aim 1: To assess the feasibility of the Women's Health Delaware Food Farmacy and refine the
program as needed
H1. Primary outcomes. The investigators hypothesize that the Women's Health Delaware Food
Farmacy will: (a) prove acceptable to participants, as measured by program satisfaction; (b)
meet demand, as measured by project recruitment and retention, number of meals provided to
participants and their household, and number of people providing food for; and (c) prove
implementable, as measured by food consumption, number of Community Health Worker
interactions, number of educational videos watched, number of recipes reviewed, and number of
meal preparation sessions.
Aim 2: To determine the prevalence of and change in social needs
H2. Primary outcome. Social needs will be identified by administering the ChristianaCare
Social Determinants of Health Screener and resource referrals will be sent on participants'
behalf to support their social needs, both of which are the usual standard of care. The
investigators hypothesize that social needs will be identified through the ChristianaCare
Social Determinants of Health Screener, and that compared to baseline, participants at
postpartum will experience reductions in their social needs. The investigators also
hypothesize there will be some participants whose social needs will not be resolved due to a
lack of community resources.
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
H3a. Primary outcomes. Maternal and child health outcomes: The investigators hypothesize that
compared to usual standard of care, the Women's Health Delaware Food Farmacy group will
demonstrate improvements in maternal and child health outcomes (e.g., preeclampsia and small
for gestational age) from baseline to postpartum.
H3b. Primary outcomes. Maternal and child healthcare utilization outcomes: The investigators
hypothesize that compared to usual standard of care, the Women's Health Delaware Food Farmacy
group will demonstrate reductions in maternal and child healthcare utilization outcomes
(e.g., neonatal intensive care unit [NICU] admission and maternal length of stay) from
baseline to postpartum.
H3c. Primary outcomes. Maternal and child clinical event outcomes: The investigators
hypothesize that compared to usual standard of care, the Women's Health Delaware Food Farmacy
group will demonstrate reductions in maternal and child clinical event outcomes (e.g.,
cesarean delivery and fetal death) from baseline to postpartum.
H3d. Secondary outcomes. Patient-reported outcomes: The investigators hypothesize that
compared to usual standard of care, the Women's Health Delaware Food Farmacy group will
demonstrate improvements in patient-reported outcomes (i.e., food insecurity, dietary intake,
health-related quality of life, and cost-related medication underuse) from baseline to
postpartum.