Nurturing Outreach for Understanding and Reducing Inpatient Security of Health

NCT07010289 | Recruiting

• 1 other identifier: IRB00131272
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Food insecurity is the lack of consistent access to the food needed for a healthy life. Food insecurity among families whose child has been hospitalized is a critical problem affecting a large, vulnerable population. The purpose of this study is to identity the most effective ways to help those families with food insecurity.

Conditions

Food Insecurity

Keywords

vulnerable populations; hospitalized children; health inequity

Outcome Measures

Primary Outcomes (5)

• Number of Caregivers Asked to Take Part in Study

  Number of caregivers of pediatric inpatients asked to take part in the study.

  Month 4

• Number of Caregivers Consented

  Number of caregivers of pediatric inpatients who consented to take part in the study.

  Month 4

• Number of Meals Delivered

  Number of meals delivered to participants in the Meal Delivery arm.

  Month 4

• Number of Gift Cards Delivered

  Number of gift cards delivered to participants in the Grocery Gift Card arm.

  Month 4

• Number of Post-Intervention Surveys Completed

  Number of caregivers who completed the post-intervention satisfaction surveys upon study completion.

  Month 4

Other Outcomes (2)

• Rate of Readmission

  Month 4

• Rate of Primary Care Follow Up

  Month 4

Study Arms (6)

Prepared Meals

EXPERIMENTAL

Weekly home meal delivery for four weeks.

Other: Prepared Meals

Grocery Gift Cards

EXPERIMENTAL

Weekly grocery store gift cards for four weeks.

Other: Grocery Gift Cards

Standard of Care

ACTIVE COMPARATOR

Provision of printed and electronic food access resources.

Other: Standard of Care

Prepared Meals - Hematology/Oncology Cohort

EXPERIMENTAL

Weekly home meal delivery for four weeks.

Other: Prepared Meals

Grocery Gift Cards - Hematology/Oncology Cohort

EXPERIMENTAL

Weekly grocery store gift cards for four weeks.

Other: Grocery Gift Cards

Standard of Care - Hematology/Oncology Cohort

ACTIVE COMPARATOR

Provision of printed and electronic food access resources.

Other: Standard of Care

Interventions

Standard of Care OTHER

Participants will receive the current standard for care for families endorsing inpatient food insecurity during a hospitalization, which include provision of printed and electronic food access resources. Currently, all families with positive food insecurity screening are met by a community health worker in the hospital who reviews current food access status with families (including enrollment in federal nutrition programs) and provides them with printed and electronic resources of nearby food pantries and other food access resources available to them at time of discharge from the hospital.

Standard of Care; Standard of Care - Hematology/Oncology Cohort

Prepared Meals OTHER

Participants will receive the intervention of weekly home meal delivery, consecutively for 4 weeks, delivered to their home. The meals will be provided by Providence Community Kitchen, which is a program of Second Harvest Food Bank of Northwest NC. During the 4 weeks of meal provisions, participants will receive 7 family style frozen dinners delivered to the participant's home weekly. Meals are frozen, have minimal preparation time, and can be heated by oven.

Prepared Meals; Prepared Meals - Hematology/Oncology Cohort

Grocery Gift Cards OTHER

Participants will receive weekly grocery store gift cards, consecutively for 4 weeks. During the 4 weeks of gift card provisions, participants will receive (1) $40.00 grocery store gift card weekly, mailed to participants' home address by study staff.

Grocery Gift Cards; Grocery Gift Cards - Hematology/Oncology Cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• caregiver and legal guardian of a pediatric patient hospitalized in the acute care units of Brenner Children's Hospital, who have screened positive for food insecurity during the hospitalization.
• lives in the same household as the pediatric patient hospitalized
• lives in Forsyth County, North Carolina
• has a freezer and oven in the household
• does not have family members with food allergies in the household
• willing to accept weekly meal deliveries at home address
• speaks English or Spanish

You may not qualify if:

• subjects who do not have the capacity to give legally effective consent
• planning to leave Forsyth County, North Carolina within 6 months of enrollment date

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Brenner Children's Hospital

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Interventions

Fast Foods; Standard of Care

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Leila DeWitt, DO, MA

  Brenner Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leila DeWitt, DO, MA

CONTACT

336.713.3552; Leila.dewitt@advocatehealth.org

Selina Quinones

CONTACT

336.713.1502; selina.quinones@advocatehealth.org

Study Design

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

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 8, 2025
• Study Start: July 7, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will become available immediately after publication with no end date.
• Access Criteria: Data will be shared with anyone who wishes to access the data for any purpose. Proposals should be directed to study PI. Data requestors will need to sign a data access agreement.

Locations

US (1)