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

NCT ID: NCT06180811

Last Updated: 2024-05-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-02
• Study Completion Date: 2025-11-30

Brief Summary

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

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.

Conditions

Pre-Eclampsia; Obesity; Gestational Diabetes; Gestational Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Women's Health Delaware Food Farmacy

Intervention Type: OTHER

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.

Usual Standard of Care

Participants will receive the usual standard of care.

Group Type: ACTIVE_COMPARATOR

Usual Standard of Care

Intervention Type: OTHER

Participants will receive the usual standard of care.

Interventions

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.

Intervention Type: OTHER

Usual Standard of Care

Participants will receive the usual standard of care.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Delaware

OTHER

Sponsor Role: collaborator

Christiana Care Health Services

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ChristianaCare Christiana Hospital

Newark, Delaware, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kathleen McCallops, PhD

Role: CONTACT

kathleen.mccallops@christianacare.org

3024286590

Michelle Axe, MS, CHES

Role: CONTACT

michelle.axe@christianacare.org

3024286590

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

90XP0484

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

605512

Identifier Type: -

Identifier Source: org_study_id