RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Evaluating the Effectiveness of a Food is Medicine Community Health Worker Program for Pregnant Women: Addressing Social Needs and Improving Health Outcomes

Quick Facts

Study Start:2024-01-02
Study Completion:2025-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06180811

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ChristianaCare Women's Health patient
  2. * 18 years or older
  3. * 4 to 14 weeks pregnant
  4. * Singleton pregnancy
  5. * Medicaid
  6. * BMI of 30 or higher
  7. * Reside in New Castle County
  1. * Current diagnosis of type 1 or type 2 diabetes
  2. * Multiple pregnancy
  3. * Currently enrolled in another Community Health Worker program
  4. * Not able to store and prepare meals
  5. * Diagnosed with severe medical comorbidities that might interfere with their ability to participate in the intervention, such as severe psychiatric illness or imminent hospitalization
  6. * Not able to understand and communicate effectively in English or Spanish

Contacts and Locations

Study Contact

Kathleen McCallops, PhD
CONTACT
3024286590
kathleen.mccallops@christianacare.org
Michelle Axe, MS, CHES
CONTACT
3024286590
michelle.axe@christianacare.org

Study Locations (Sites)

ChristianaCare Christiana Hospital
Newark, Delaware, 19718
United States

Collaborators and Investigators

Sponsor: Christiana Care Health Services

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-02
Study Completion Date2025-11

Study Record Updates

Study Start Date2024-01-02
Study Completion Date2025-11

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Pre-Eclampsia
  • Obesity
  • Gestational Diabetes
  • Gestational Hypertension