Recruiting

Food Insecurity

Sponsor:

Wake Forest University Health Sciences

Code:

NCT07010289

Conditions

Food Insecurity

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Prepared Meals

Grocery Gift Cards

Standard of Care

Study Details

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

Study ID

NCT07010289

Start date

Jul 7, 2025

Status verified date

Apr, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Prepared Meals

Weekly home meal delivery for four weeks.

experimental: Grocery Gift Cards

Weekly grocery store gift cards for four weeks.

active comparator: Standard of Care

Provision of printed and electronic food access resources.

experimental: Prepared Meals - Hematology/Oncology Cohort

Weekly home meal delivery for four weeks.

experimental: Grocery Gift Cards - Hematology/Oncology Cohort

Weekly grocery store gift cards for four weeks.

active comparator: Standard of Care - Hematology/Oncology Cohort

Provision of printed and electronic food access resources.

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.

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.

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.

Primary outcome measure

  • Number of Caregivers Asked to Take Part in Study [ Time Frame: Month 4 ]
  • Number of Caregivers Consented [ Time Frame: Month 4 ]
  • Number of Meals Delivered [ Time Frame: Month 4 ]
  • Number of Gift Cards Delivered [ Time Frame: Month 4 ]
  • Number of Post-Intervention Surveys Completed [ Time Frame: Month 4 ]

Central Contacts and Locations

Central contacts

Leila DeWitt, DO, MA

336.713.3552Leila.dewitt@advocatehealth.org

Selina Quinones

336.713.1502selina.quinones@advocatehealth.org

Locations

Brenner Children's Hospital

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Leila DeWitt, DO, MA

336-713-3552Leila.dewitt@advocatehealth.org

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Apr 24, 2026

Last verified

Apr, 2026

Keywords

  • vulnerable populations
  • hospitalized children
  • health inequity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-04-24.