Food InsecurityNOURISHNCT07010289
Nurturing Outreach for Understanding and Reducing Inpatient Security of Health
A study testing Prepared Meals and Grocery Gift Cards in people with Food Insecurity, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Food Insecurity
- What is being tested?
- Prepared Meals and Grocery Gift Cards
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brenner Children's Hospital
Winston-Salem, North Carolina, 27157
Leila DeWitt, DO, MA, 336-713-3552, Leila.dewitt@advocatehealth.org
About this study
Official title: NOURISH: Nurturing Outreach for Understanding and Reducing Inpatient Security of Health
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.
Read the 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
- Being tested
- Prepared Meals, Grocery Gift Cards, Standard of Care
- Keywords
- vulnerable populations, hospitalized children, health inequity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prepared MealsOther
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 CardsOther
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Prepared Meals | Experimental | Weekly home meal delivery for four weeks. Receives: Other: Prepared Meals |
| Grocery Gift Cards | Experimental | Weekly grocery store gift cards for four weeks. Receives: Other: Grocery Gift Cards |
| Standard of Care | Active comparator | Provision of printed and electronic food access resources. Receives: Other: Standard of Care |
| Prepared Meals - Hematology/Oncology Cohort | Experimental | Weekly home meal delivery for four weeks. Receives: Other: Prepared Meals |
| Grocery Gift Cards - Hematology/Oncology Cohort | Experimental | Weekly grocery store gift cards for four weeks. Receives: Other: Grocery Gift Cards |
| Standard of Care - Hematology/Oncology Cohort | Active comparator | Provision of printed and electronic food access resources. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Caregivers Asked to Take Part in Study
Number of caregivers of pediatric inpatients asked to take part in the study.
Measured: Month 4
Number of Caregivers Consented
Number of caregivers of pediatric inpatients who consented to take part in the study.
Measured: Month 4
Number of Meals Delivered
Number of meals delivered to participants in the Meal Delivery arm.
Measured: Month 4
Number of Gift Cards Delivered
Number of gift cards delivered to participants in the Grocery Gift Card arm.
Measured: Month 4
Number of Post-Intervention Surveys Completed
Number of caregivers who completed the post-intervention satisfaction surveys upon study completion.
Measured: Month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start7 Jul 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food InsecurityStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leila DeWitt, DO, MA, Principal investigator, Brenner Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07010289
- Sponsor's protocol ID
- IRB00131272
- Acronym
- NOURISH
- Status last verified
- Apr 2026
- First submitted
- 30 May 2025
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan to share individual participant data that underlie the results reported after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NOURISH: Nurturing Outreach for Understanding and Reducing Inpatient Security of Health
- ClinicalTrials.gov ID
- NCT07010289
- Acronym / sponsor ID
- NOURISH / IRB00131272
- Conditions
- Food Insecurity
- Keywords
- vulnerable populations, hospitalized children, health inequity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Prepared Meals | Experimental | Other: Prepared MealsWeekly home meal delivery for four weeks. |
| Grocery Gift Cards | Experimental | Other: Grocery Gift CardsWeekly grocery store gift cards for four weeks. |
| Standard of Care | Active comparator | Other: Standard of CareProvision of printed and electronic food access resources. |
| Prepared Meals - Hematology/Oncology Cohort | Experimental | Other: Prepared MealsWeekly home meal delivery for four weeks. |
| Grocery Gift Cards - Hematology/Oncology Cohort | Experimental | Other: Grocery Gift CardsWeekly grocery store gift cards for four weeks. |
| Standard of Care - Hematology/Oncology Cohort | Active comparator | Other: Standard of CareProvision of printed and electronic food access resources. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prepared MealsParticipants 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. | Other | Prepared Meals, Prepared Meals - Hematology/Oncology Cohort |
| Grocery Gift CardsParticipants 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. | Other | Grocery Gift Cards, Grocery Gift Cards - Hematology/Oncology Cohort |
| Standard of CareParticipants 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. | Other | Standard of Care, Standard of Care - Hematology/Oncology Cohort |
Primary outcome
Number of Caregivers Asked to Take Part in Study
Time frame: Month 4
Number of caregivers of pediatric inpatients asked to take part in the study.
Number of Caregivers Consented
Time frame: Month 4
Number of caregivers of pediatric inpatients who consented to take part in the study.
Number of Meals Delivered
Time frame: Month 4
Number of meals delivered to participants in the Meal Delivery arm.
Number of Gift Cards Delivered
Time frame: Month 4
Number of gift cards delivered to participants in the Grocery Gift Card arm.
Number of Post-Intervention Surveys Completed
Time frame: Month 4
Number of caregivers who completed the post-intervention satisfaction surveys upon study completion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: Yes. Plan to share individual participant data that underlie the results reported after deidentification (text, tables, figures, and appendices).
Related trials for Food Insecurity
Recruiting
Developing a Support Application for Food Pantries (SAFPAS) to Improve Client Access to Healthy Foods & Enhance Emergency Preparedness
Improving Healthy Food Access in Food Insecurity Populations in Normal and Emergency Situations
Recruiting
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
Diabetes Mellitus, Type 2, Nutrition Poor
Not yet recruiting
Community Health Worker Nutrition Self-Management Support for Cardio-Kidney-Metabolic Health
Hypertension (HTN), CKD - Chronic Kidney Disease
Not yet recruitingObservational study
Addressing Food Insecurity in Pregnancy
Food Insecurity, Pregnancy
Active, not recruiting
Pilot of Continuous Glucose Monitor-Augmented Food Is Medicine
Nutrition, Type 2 Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Leila DeWitt, DO, MA principal investigator
Brenner Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prepared Meals and Grocery Gift Cards in people with Food Insecurity, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leila DeWitt, DO, MA (336.713.3552, Leila.dewitt@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Caregivers Asked to Take Part in Study (time frame: Month 4). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.