Clinical trial NCT06180811: Evaluating the Effectiveness of a Food is Medicine Community Health Worker Program for Pregnant Women
Official title: Evaluating the Effectiveness of a Food is Medicine Community Health Worker Program for Pregnant Women: Addressing Social Needs and Improving Health Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pre-Eclampsia
Obesity
Gestational Diabetes
Gestational Hypertension
Keywords: Food is Medicine
Community Health Worker
Social Needs
Medically Tailored Groceries
Randomized Controlled Trial
Maternal and Child Health
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
Collaborators: name: University of Delaware
First posted: 2023-12-26
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Social Determinants of Health
timeFrame: Changes from baseline to 2-6 weeks after delivery
measure: Gestational Weight Gain
timeFrame: Changes from baseline to 2-6 weeks after delivery
measure: Body Mass Index
timeFrame: Changes from baseline to 2-6 weeks after delivery
measure: Gestational Diabetes
timeFrame: From baseline to delivery
measure: Gestational Hypertension
timeFrame: From baseline to delivery
measure: Systolic and Diastolic Blood Pressure
timeFrame: Changes from baseline to 2-6 weeks after delivery
measure: Preeclampsia
timeFrame: From baseline to 2-6 weeks after delivery
measure: Hydramnios
timeFrame: From baseline to delivery
measure: Gestational Age
timeFrame: At delivery
measure: Small for Gestational Age
timeFrame: At delivery
measure: Preterm Birth
timeFrame: At delivery
measure: Fetal Macrosomia
timeFrame: At delivery
measure: Cesarean Delivery
timeFrame: At delivery
measure: Fetal Death
timeFrame: From baseline to delivery
measure: NICU Admission
timeFrame: Within 48 hours after delivery
measure: NICU Length of Stay
timeFrame: From NICU admission date to NICU discharge date, assessed up to 90 days
measure: Maternal Length of Stay
timeFrame: From delivery date to hospital discharge date, assessed up to 90 days
measure: Postpartum Admission
timeFrame: From delivery discharge to 90 days after
measure: Postpartum Admission Length of Stay
timeFrame: From postpartum admission date to hospital discharge date, assessed up to 90 days
measure: Hospital Admission
timeFrame: From baseline up to delivery
measure: Hospital Admission Length of Stay
timeFrame: From admission date to hospital discharge date, assessed up to 90 days
measure: Emergency Room Visit
timeFrame: From baseline to 90 days after delivery
Secondary outcomes:
measure: Food Insecurity
timeFrame: Changes from baseline to 2-6 weeks after delivery
measure: Dietary Intake
timeFrame: Changes from baseline to 2-6 weeks after delivery
measure: Health-Related Quality of Life
timeFrame: Changes from baseline to 2-6 weeks after delivery
measure: Cost-Related Medication Underuse
timeFrame: Changes from baseline to 2-6 weeks after delivery
Other outcomes:
Locations:
city: Newark
country: United States
facility: ChristianaCare Christiana Hospital
state: Delaware
Study officials:
References: