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

NCT06180811 | Recruiting

• 2 other identifiers: 60551290XP0484
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (22)

• 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 Outcomes (4)

• Food Insecurity

  Changes from baseline to 2-6 weeks after delivery

• Dietary Intake

  Changes from baseline to 2-6 weeks after delivery

• Health-Related Quality of Life

  Changes from baseline to 2-6 weeks after delivery

• Cost-Related Medication Underuse

  Changes from baseline to 2-6 weeks after delivery

Study Arms (2)

Women's Health Delaware Food Farmacy

EXPERIMENTAL

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

Usual Standard of Care

ACTIVE COMPARATOR

Participants will receive the usual standard of care.

Other: Usual Standard of Care

Interventions

Women's Health Delaware Food Farmacy 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.

Women's Health Delaware Food Farmacy

Usual Standard of Care OTHER

Participants will receive the usual standard of care.

Usual Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ChristianaCare Women's Health patient
• years or older
• to 14 weeks pregnant
• Singleton pregnancy
• Medicaid
• BMI of 30 or higher
• Reside in New Castle County

You may not qualify if:

• 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

Sponsors & Collaborators

• Christiana Care Health Services: lead
• University of Delaware: collaborator

Study Sites (1)

ChristianaCare Christiana Hospital

Newark, Delaware, 19718, United States

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia; Obesity; Diabetes, Gestational; Hypertension, Pregnancy-Induced

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Kathleen McCallops, PhD

CONTACT

3024286590; kathleen.mccallops@christianacare.org

Michelle Axe, MS, CHES

CONTACT

3024286590; michelle.axe@christianacare.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: December 26, 2023
• Study Start: January 2, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)