Recruiting

Community Health Worker

Sponsor:

Christiana Care Health Services

Code:

NCT06180811

Conditions

Pre-Eclampsia

Obesity

Gestational Diabetes

Gestational Hypertension

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Women's Health Delaware Food Farmacy

Usual Standard of Care

Study Details

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

Study ID

NCT06180811

Start date

Jan 2, 2024

Status verified date

May, 2024

Completion date

Nov, 2025

Anticipated

Primary completion date

Nov, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

active comparator: Usual Standard of Care

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.

Usual Standard of Care

Participants will receive the usual standard of care.

Primary outcome measure

  • Social Determinants of Health [ Time Frame: Changes from baseline to 2-6 weeks after delivery ]
  • Gestational Weight Gain [ Time Frame: Changes from baseline to 2-6 weeks after delivery ]
  • Body Mass Index [ Time Frame: Changes from baseline to 2-6 weeks after delivery ]
  • Gestational Diabetes [ Time Frame: From baseline to delivery ]
  • Gestational Hypertension [ Time Frame: From baseline to delivery ]
  • Systolic and Diastolic Blood Pressure [ Time Frame: Changes from baseline to 2-6 weeks after delivery ]
  • Preeclampsia [ Time Frame: From baseline to 2-6 weeks after delivery ]
  • Hydramnios [ Time Frame: From baseline to delivery ]
  • Gestational Age [ Time Frame: At delivery ]
  • Small for Gestational Age [ Time Frame: At delivery ]
  • Preterm Birth [ Time Frame: At delivery ]
  • Fetal Macrosomia [ Time Frame: At delivery ]
  • Cesarean Delivery [ Time Frame: At delivery ]
  • Fetal Death [ Time Frame: From baseline to delivery ]
  • NICU Admission [ Time Frame: Within 48 hours after delivery ]
  • NICU Length of Stay [ Time Frame: From NICU admission date to NICU discharge date, assessed up to 90 days ]
  • Maternal Length of Stay [ Time Frame: From delivery date to hospital discharge date, assessed up to 90 days ]
  • Postpartum Admission [ Time Frame: From delivery discharge to 90 days after ]
  • Postpartum Admission Length of Stay [ Time Frame: From postpartum admission date to hospital discharge date, assessed up to 90 days ]
  • Hospital Admission [ Time Frame: From baseline up to delivery ]
  • Hospital Admission Length of Stay [ Time Frame: From admission date to hospital discharge date, assessed up to 90 days ]
  • Emergency Room Visit [ Time Frame: From baseline to 90 days after delivery ]

Central Contacts and Locations

Central contacts

Kathleen McCallops, PhD

3024286590kathleen.mccallops@christianacare.org

Michelle Axe, MS, CHES

3024286590michelle.axe@christianacare.org

Locations

ChristianaCare Christiana Hospital

Recruiting

Newark, Delaware, United States, 19718

More Information

Sponsor

Christiana Care Health Services

Last update posted

May 6, 2024

Last verified

May, 2024

Keywords

  • Food is Medicine
  • Community Health Worker
  • Social Needs
  • Medically Tailored Groceries
  • Randomized Controlled Trial
  • Maternal and Child Health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Christiana Care Health Services on 2024-05-06.