Nurturing Outreach for Understanding and Reducing Inpatient Security of Health

NCT ID: NCT07010289

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-07
• Study Completion Date: 2026-12-31

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.

Detailed Description

To address food insecurity among families who child has been hospitalized, study objectives are 1) to demonstrate the feasibility and acceptability of providing family meals and grocery store gift cards to address food insecurity among children discharged from the hospital, and 2) evaluate the potential impact of the interventions on household food insecurity, 30-day readmission rates, and primary care follow up. To accomplish these objectives, this pilot feasibility trial will be conducted at Atrium Health Levine Children's-Brenner Children's Hospital, an academic medical center that serves communities with high rates of food insecurity, in collaboration with our long-term partner Second Harvest Food Bank of Northwest North Carolina. The will recruit families whose child was admitted to the hospital and screened positive for food insecurity. All families will be enrolled for a total of 4 weeks to evaluate the difference in food insecurity, family health measures, and hospital-based quality metrics (including readmission rates and primary care follow up).

Conditions

Food Insecurity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Prepared Meals

Weekly home meal delivery for four weeks.

Group Type: EXPERIMENTAL

Prepared Meals

Intervention Type: 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.

Grocery Gift Cards

Weekly grocery store gift cards for four weeks.

Group Type: EXPERIMENTAL

Grocery Gift Cards

Intervention Type: 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.

Standard of Care

Provision of printed and electronic food access resources.

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: 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.

Interventions

Prepared Meals

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.

Intervention Type: OTHER

Grocery Gift Cards

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.

Intervention Type: OTHER

Standard of Care

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leila DeWitt, DO, MA

Role: PRINCIPAL_INVESTIGATOR

Brenner Children's Hospital

Locations

Brenner Children's Hospital

Winston-Salem, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Leila DeWitt, DO, MA

Role: CONTACT

Leila.dewitt@advocatehealth.org

336.713.3552

Selina Quinones

Role: CONTACT

squinone@wakehealth.edu

336.713.1502

Facility Contacts

Leila DeWitt, DO, MA

Role: primary

Leila.dewitt@advocatehealth.org

336-713-3552

Other Identifiers

IRB00131272

Identifier Type: -

Identifier Source: org_study_id