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

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

Study Overview

• Status: Recruiting
• Conditions: Obesity; Pre-Eclampsia; Gestational Diabetes; Gestational Hypertension
• Intervention / Treatment: Other: Women's Health Delaware Food Farmacy; Other: Usual Standard of Care

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kathleen McCallops, PhD; Phone Number: 3024286590; Email: kathleen.mccallops@christianacare.org
• Study Contact Backup: Name: Michelle Axe, MS, CHES; Phone Number: 3024286590; Email: michelle.axe@christianacare.org

Study Locations

• United States
  • Delaware
    • Newark, Delaware, United States, 19718
      • Recruiting
      • ChristianaCare Christiana Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Women'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.	Other: Women'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.
Active Comparator: Usual Standard of Care; Participants will receive the usual standard of care.	Other: Usual Standard of Care; Participants will receive the usual standard of care.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Christiana Care Health Services
• Collaborators: University of Delaware

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: December 6, 2023
• First Submitted That Met QC Criteria: December 19, 2023
• First Posted (Actual): December 26, 2023

Study Record Updates

• Last Update Posted (Actual): January 8, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Community Health Worker; Maternal and Child Health; Social Needs; Food is Medicine; Medically Tailored Groceries
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Pregnancy Complications; Hypertension; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Eclampsia; Pre-Eclampsia; Diabetes, Gestational; Hypertension, Pregnancy-Induced
• Other Study ID Numbers: 605512; 90XP0484 (Other Grant/Funding Number: Administration for Children and Families)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No