An interventional study of Women's Health Delaware Food Farmacy and Usual Standard of Care in Pre-Eclampsia, Obesity and Gestational Diabetes, sponsored by Christiana Care Health Services. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-06.
Sponsored by Christiana Care Health Services · Not applicable, Interventional, and Treatment
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
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.
916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.
This study's planned enrollment of 250 is above the median of 110 across 480 interventional studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →Christiana Care Health Services is the lead sponsor of 94 studies on the registry; 6 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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: Women's Health Delaware Food Farmacy
Participants will receive the usual standard of care.
Other: Usual Standard of Care
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.
Participants will receive the usual standard of care.
Social Determinants of Health
Measured with ChristianaCare Social Determinants of Health Screener; Number of socials needs range from 0-11, higher scores indicate greater number of social needs
Time frame: Changes from baseline to 2-6 weeks after delivery
Gestational Weight Gain
Observed gestational weight gained
Time frame: Changes from baseline to 2-6 weeks after delivery
Body Mass Index
Observed body mass index changes
Time frame: Changes from baseline to 2-6 weeks after delivery
Gestational Diabetes
Occurrence of gestational diabetes
Time frame: From baseline to delivery
Gestational Hypertension
Occurrence of gestational hypertension
Time frame: From baseline to delivery
Systolic and Diastolic Blood Pressure
Observed systolic and diastolic blood pressure
Time frame: Changes from baseline to 2-6 weeks after delivery
Preeclampsia
Occurrence of preeclampsia and week diagnosed during pregnancy
Time frame: From baseline to 2-6 weeks after delivery
Hydramnios
Occurrence of hydramnios
Time frame: From baseline to delivery
Gestational Age
Baby's gestational age at birth
Time frame: At delivery
Small for Gestational Age
Birth weight less than 10th percentile based on gestational age
Time frame: At delivery
Preterm Birth
Preterm birth less than 37 weeks
Time frame: At delivery
Fetal Macrosomia
Birth weight greater than 90th percentile based on gestational age
Time frame: At delivery
Cesarean Delivery
Occurrence of cesarean delivery including those planned and unplanned
Time frame: At delivery
Fetal Death
Occurrence of fetal death
Time frame: From baseline to delivery
NICU Admission
Occurrence of NICU admission for any reason
Time frame: Within 48 hours after delivery
NICU Length of Stay
Number of days baby was admitted to NICU
Time frame: From NICU admission date to NICU discharge date, assessed up to 90 days
Maternal Length of Stay
Number of days hospitalized following delivery
Time frame: From delivery date to hospital discharge date, assessed up to 90 days
Postpartum Admission
Number of postpartum hospital admissions for any reason
Time frame: From delivery discharge to 90 days after
Postpartum Admission Length of Stay
Number of days hospitalized
Time frame: From postpartum admission date to hospital discharge date, assessed up to 90 days
Hospital Admission
Number of hospital admissions for any reason
Time frame: From baseline up to delivery
Hospital Admission Length of Stay
Number of days hospitalized
Time frame: From admission date to hospital discharge date, assessed up to 90 days
Emergency Room Visit
Number of emergency room visits for any reason
Time frame: From baseline to 90 days after delivery
Food Insecurity
Measured with United States Department of Agriculture Household Food Security Survey Module 6-Item Short Form, 30-day; Scores range from 0-6, higher scores indicate lower food security
Time frame: Changes from baseline to 2-6 weeks after delivery
Dietary Intake
Measured with Dietary Screener Questionnaire (DSQ-10) and six items from Dietary Screener Questionnaire (DSQ-26); Scores will be calculated using the National Cancer Institute's scoring algorithms
Time frame: Changes from baseline to 2-6 weeks after delivery
Health-Related Quality of Life
Measured with Centers for Disease Control and Prevention's Health-Related Quality of Life (HRQOL-4) scale; Number of healthy days range from 0-30, higher scores indicate greater number of healthy days
Time frame: Changes from baseline to 2-6 weeks after delivery
Cost-Related Medication Underuse
Measured with Cost-Related Medication Underuse; Scores range from 0-4, scores greater than 0 indicate cost-related medication underuse
Time frame: Changes from baseline to 2-6 weeks after delivery
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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