Evaluating the Effectiveness of a Food is Medicine Community Health Worker Program for Pregnant Women

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Pre-Eclampsia, Obesity, Gestational Diabetes, Gestational Hypertension

Intervention / Treatment
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* Other: Women's Health Delaware Food Farmacy
* Other: Usual Standard of Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Women's Health Delaware Food Farmacy<br>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<br>* 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.<br>|
| Active Comparator: Usual Standard of Care<br>Participants will receive the usual standard of care. | Other: Usual Standard of Care<br>* Participants will receive the usual standard of care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Changes from baseline to 2-6 weeks after delivery | 
| Gestational Weight Gain | Observed gestational weight gained | Changes from baseline to 2-6 weeks after delivery | 
| Body Mass Index | Observed body mass index changes | Changes from baseline to 2-6 weeks after delivery | 
| Gestational Diabetes | Occurrence of gestational diabetes | From baseline to delivery | 
| Gestational Hypertension | Occurrence of gestational hypertension | From baseline to delivery | 
| Systolic and Diastolic Blood Pressure | Observed systolic and diastolic blood pressure | Changes from baseline to 2-6 weeks after delivery | 
| Preeclampsia | Occurrence of preeclampsia and week diagnosed during pregnancy | From baseline to 2-6 weeks after delivery | 
| Hydramnios | Occurrence of hydramnios | From baseline to delivery | 
| Gestational Age | Baby's gestational age at birth | At delivery | 
| Small for Gestational Age | Birth weight less than 10th percentile based on gestational age | At delivery | 
| Preterm Birth | Preterm birth less than 37 weeks | At delivery | 
| Fetal Macrosomia | Birth weight greater than 90th percentile based on gestational age | At delivery | 
| Cesarean Delivery | Occurrence of cesarean delivery including those planned and unplanned | At delivery | 
| Fetal Death | Occurrence of fetal death | From baseline to delivery | 
| NICU Admission | Occurrence of NICU admission for any reason | Within 48 hours after delivery | 
| NICU Length of Stay | Number of days baby was admitted to NICU | From NICU admission date to NICU discharge date, assessed up to 90 days | 
| Maternal Length of Stay | Number of days hospitalized following delivery | From delivery date to hospital discharge date, assessed up to 90 days | 
| Postpartum Admission | Number of postpartum hospital admissions for any reason | From delivery discharge to 90 days after | 
| Postpartum Admission Length of Stay | Number of days hospitalized | From postpartum admission date to hospital discharge date, assessed up to 90 days | 
| Hospital Admission | Number of hospital admissions for any reason | From baseline up to delivery | 
| Hospital Admission Length of Stay | Number of days hospitalized | From admission date to hospital discharge date, assessed up to 90 days | 
| Emergency Room Visit | Number of emergency room visits for any reason | From baseline to 90 days after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | Changes from baseline to 2-6 weeks after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Food is Medicine, Community Health Worker, Social Needs, Medically Tailored Groceries, Randomized Controlled Trial, Maternal and Child Health