Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06180811
Other study ID # 605512
Secondary ID 90XP0484
Status Recruiting
Phase N/A
First received
Last updated
Start date January 2, 2024
Est. completion date November 2025

Study information

Verified date May 2024
Source Christiana Care Health Services
Contact Kathleen McCallops, PhD
Phone 3024286590
Email kathleen.mccallops@christianacare.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 250
Est. completion date November 2025
Est. primary completion date November 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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


Intervention

Other:
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.

Locations

Country Name City State
United States ChristianaCare Christiana Hospital Newark Delaware

Sponsors (2)

Lead Sponsor Collaborator
Christiana Care Health Services University of Delaware

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Gestational Weight Gain Observed gestational weight gained Changes from baseline to 2-6 weeks after delivery
Primary Body Mass Index Observed body mass index changes Changes from baseline to 2-6 weeks after delivery
Primary Gestational Diabetes Occurrence of gestational diabetes From baseline to delivery
Primary Gestational Hypertension Occurrence of gestational hypertension From baseline to delivery
Primary Systolic and Diastolic Blood Pressure Observed systolic and diastolic blood pressure Changes from baseline to 2-6 weeks after delivery
Primary Preeclampsia Occurrence of preeclampsia and week diagnosed during pregnancy From baseline to 2-6 weeks after delivery
Primary Hydramnios Occurrence of hydramnios From baseline to delivery
Primary Gestational Age Baby's gestational age at birth At delivery
Primary Small for Gestational Age Birth weight less than 10th percentile based on gestational age At delivery
Primary Preterm Birth Preterm birth less than 37 weeks At delivery
Primary Fetal Macrosomia Birth weight greater than 90th percentile based on gestational age At delivery
Primary Cesarean Delivery Occurrence of cesarean delivery including those planned and unplanned At delivery
Primary Fetal Death Occurrence of fetal death From baseline to delivery
Primary NICU Admission Occurrence of NICU admission for any reason Within 48 hours after delivery
Primary 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
Primary Maternal Length of Stay Number of days hospitalized following delivery From delivery date to hospital discharge date, assessed up to 90 days
Primary Postpartum Admission Number of postpartum hospital admissions for any reason From delivery discharge to 90 days after
Primary Postpartum Admission Length of Stay Number of days hospitalized From postpartum admission date to hospital discharge date, assessed up to 90 days
Primary Hospital Admission Number of hospital admissions for any reason From baseline up to delivery
Primary Hospital Admission Length of Stay Number of days hospitalized From admission date to hospital discharge date, assessed up to 90 days
Primary Emergency Room Visit Number of emergency room visits for any reason From baseline to 90 days after delivery
Secondary Food Insecurity Measured with United States Department of Agriculture Household Food Security Survey Module 6-Item Short Form, 30-day; Scores range from 0-6, higher scores indicate lower food security Changes from baseline to 2-6 weeks after delivery
Secondary Dietary Intake Measured with Dietary Screener Questionnaire (DSQ-10) and six items from Dietary Screener Questionnaire (DSQ-26); Scores will be calculated using the National Cancer Institute's scoring algorithms Changes from baseline to 2-6 weeks after delivery
Secondary Health-Related Quality of Life Measured with Centers for Disease Control and Prevention's Health-Related Quality of Life (HRQOL-4) scale; Number of healthy days range from 0-30, higher scores indicate greater number of healthy days Changes from baseline to 2-6 weeks after delivery
Secondary Cost-Related Medication Underuse Measured with Cost-Related Medication Underuse; Scores range from 0-4, scores greater than 0 indicate cost-related medication underuse Changes from baseline to 2-6 weeks after delivery
See also
  Status Clinical Trial Phase
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2