Food InsecurityCRx-HNCT04171999
CommunityRx-Hunger
A study testing Community Rx-Hunger (CRx-H) in people with Food Insecurity, run by University of Chicago at 1 site in United States.
Trial summary
CommunityRx-Hunger (CRx-H) is a hospital-based intervention that addresses food insecurity and other health-related social needs such as transportation, housing, utilities, and safety. Study team members are recruiting caregivers at the time of their child's hospital admission at a large urban children's hospital. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Food Insecurity
- What is being tested?
- Community Rx-Hunger (CRx-H)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 660 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2020to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Native English or Spanish speaker
- Living in 1 of 27 zip codes in the study's target region
- Self-identify as a primary caregiver of a child <18 years old hospitalized in a large urban children's hospital
- Ability to send and receive text messages
- Access to a mobile phone and agrees to receive text messages from the study
Who cannot join
- Previous participation in a CRx research study.
- Caregivers of newborns in the hospital
- Patient hospital stay is less than 24 hours
- Patient hospital stay is 30 days or more
- Patient has an eating disorder as indicated in the EMR
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CommunityRx-Hunger: A Hospital-based Intervention for Primary Caregivers of Children Admitted to the Hospital
CommunityRx-Hunger (CRx-H) is a hospital-based intervention that addresses food insecurity and other health-related social needs such as transportation, housing, utilities, and safety. Study team members are recruiting caregivers at the time of their child's hospital admission at a large urban children's hospital. For Aim 1, the primary outcome is self-efficacy among food insecure caregivers compared to those who receive the usual standard of care. For Aim 2, the primary outcome is satisfaction with care compared between food secure and food insecure caregivers.
Read the detailed description
CommunityRx-Hunger (CRx-H) is a double-blinded randomized controlled trial aimed at increasing self-efficacy among caregivers with food insecurity in the household. CRx-H is recruiting primary caregivers of hospitalized children at a large urban children's hospital at the time of admission. Aim 1: Researchers are studying whether the intervention will increase self-efficacy among food insecure caregivers compared to those who receive the usual standard of care. Aim 2: Researchers will enroll and randomize caregivers with and without food insecurity to the intervention to compare satisfaction with care.
Eligible, self-identified caregivers will complete a baseline survey during the child's hospital stay, followed by phone surveys at 7, 30, 90, 180 days, and 12 months. Caregivers randomized to the intervention will receive a tailored list of resources to address food insecurity and other health-related social needs, plus a brief educational component delivered by a trained member of our research team. Cases will receive a "booster" dose of the resource list prior to discharge. After discharge, cases will receive proactive text messages about those same community resources.
All caregivers (regardless of research arm) will receive a series of text messages related to the study such as reminders to schedule the phone survey with a member of the research team.
- Conditions
- Food Insecurity
- Being tested
- Community Rx-Hunger (CRx-H)
- Keywords
- Food Insecurity, Caregivers, Clinical Trial, Hunger, Self-Efficacy, Health-Related Social Needs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Rx-Hunger (CRx-H)Other
The CRx-H Intervention provides "dosages" of health content that offer assistance for food insecurity and other health-related social needs. A caregiver randomized to the intervention will receive a hard-copy print-out of their tailored list of resources to address food insecurity. A member of our research team will deliver this list and provide a brief educational component which includes: a brief, structured script about the common problem of food insecurity in households with children and co-occuring HRSNs, review of the resource list which includes nearby, vetted resources to address these needs and coaching on how to activate resources on the list. Prior to discharge, the caregiver will receive a duplicate copy of the list of resources. After discharge, the caregiver will receive text messages at a frequency based on the Critical Time Intervention (CTI) Model, from baseline to 3 months post discharge, in order to receive ongoing support by a research team member.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care + Intervention (Case) | Experimental | Cases will receive the CommunityRx Intervention. Receives: Other: Community Rx-Hunger (CRx-H) |
| Usual Care (Control) | No intervention | Controls will receive the usual standard care, which consists of information about hospital food resources and access to Feed1st hospital food pantries prior to discharge. |
What is being measured
The primary outcome is the main question the study is designed to answer.
(Aim 1) Caregiver Self-efficacy at 12 Months Among Food Insecure Caregivers
Self-efficacy is measured by Bandura's Self-Efficacy Scale which asks, "How confident are you in your ability to find resources in your community that help you manage your health?" Responses will be assessed on a 5-point Likert scale ranging from "not at all confident" to "completely confident."
Measured: 12 months
(Aim 2) Caregiver Satisfaction With Hospital Discharge
Satisfaction with hospital discharge is measured by the Hospital Consumer Assessment of Healthcare Providers Survey (HCAHPS); "Child HCAHPS" which includes 8 items (range 0-100 with higher values representing higher satisfaction). Response options are "Yes, definitely," "Yes, somewhat" and "No." The items ask about the child and the hospital related to their recent stay.
Measured: 7 days post discharge from the hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start6 Jan 2020
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Food InsecurityStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 660 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Stacy T Lindau, MD, MPP, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171999
- Sponsor's protocol ID
- IRB20-0324
- Other IDs
- 1R01MD012630-01A1
- Acronym
- CRx-H
- Status last verified
- Nov 2023
- First submitted
- 19 Nov 2019
- Last updated
- 28 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abramsohn EM, Mendoza TA, Bartlett AH, Glasser NJ, Grana M, Jerome J, Miller DC, Murphy J, O'Malley C, Waxman E, Tessler Lindau S. Caregivers' Views of a Pediatric Inpatient Intervention to Address Health-Related Social Risks. Hosp Pediatr. 2025 Jan 1;15(1):46-56. doi: 10.1542/hpeds.2024-008025.
PubMed 39719355Asay S, Abramsohn EM, Winslow V, Jagai JS, Waxman E, Makelarski JA, Lindau ST. Food Insecurity and Community-Based Food Resources Among Caregivers of Hospitalized Children. Hosp Pediatr. 2024 Jul 1;14(7):520-531. doi: 10.1542/hpeds.2023-007597.
PubMed 38881356Cacioppo AM, Winslow V, Abramsohn EM, Jagai JS, Makelarski JA, Waxman E, Wroblewski K, Tessler Lindau S. Food Insecurity and Experiences of Discrimination Among Caregivers of Hospitalized Children. Pediatrics. 2023 Dec 1;152(6):e2023061750. doi: 10.1542/peds.2023-061750.
PubMed 37986582Lindau ST, Makelarski JA, Winslow VA, Abramsohn EM, Anand V, Burnet DL, Fuller CM, Grana M, Miller DC, Ren ES, Waxman E, Wroblewski KE. Low-Intensity Social Care and Child Acute Health Care Utilization: A Randomized Clinical Trial. JAMA Pediatr. 2025 Jun 1;179(6):610-620. doi: 10.1001/jamapediatrics.2025.0484.
PubMed 40293738Glasser NJ, Lindau ST, Wroblewski K, Abramsohn EM, Burnet DL, Fuller CM, Miller DC, O'Malley CA, Shiu E, Waxman E, Makelarski JA; CommunityRx-Hunger Collaborators. Effect of a Social Care Intervention on Health Care Experiences of Caregivers of Hospitalized Children: A Randomized Clinical Trial. JAMA Pediatr. 2023 Dec 1;177(12):1266-1275. doi: 10.1001/jamapediatrics.2023.4596.
PubMed 37902777Abramsohn EM, De Ornelas M, Borson S, Frazier CRM, Fuller CM, Grana M, Huang ES, Jagai JS, Makelarski JA, Miller D, Schulman-Green D, Shiu E, Thompson K, Winslow V, Wroblewski K, Lindau ST. CommunityRx, a social care assistance intervention for family and friend caregivers delivered at the point of care: two concurrent blinded randomized controlled trials. Trials. 2023 Oct 21;24(1):681. doi: 10.1186/s13063-023-07697-z.
PubMed 37864258Abramsohn EM, De Ornelas M, Borson S, Frazier CR, Fuller CM, Grana M, Huang ES, Jagai JS, Makelarski JA, Miller D, Schulman-Green D, Shiu E, Thompson K, Winslow V, Wroblewski K, Lindau ST. Two concurrent randomized controlled trials of CommunityRx, a social care intervention for family and friend caregivers delivered at the point of care. Res Sq [Preprint]. 2023 Mar 1:rs.3.rs-2464681. doi: 10.21203/rs.3.rs-2464681/v1.
PubMed 36909590
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CommunityRx-Hunger: A Hospital-based Intervention for Primary Caregivers of Children Admitted to the Hospital
- ClinicalTrials.gov ID
- NCT04171999
- Acronym / sponsor ID
- CRx-H / IRB20-0324
- Conditions
- Food Insecurity
- Keywords
- Food Insecurity, Caregivers, Clinical Trial, Hunger, Self-Efficacy, Health-Related Social Needs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 660 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 21 Nov 2019 (actual)
- Results
- Posted 27 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CommunityRx-Hunger (CRx-H) is a hospital-based intervention that addresses food insecurity and other health-related social needs such as transportation, housing, utilities, and safety. Study team members are recruiting caregivers at the time of their child's hospital admission at a large urban children's hospital. For Aim 1, the primary outcome is self-efficacy among food insecure caregivers compared to those who receive the usual standard of care. For Aim 2, the primary outcome is satisfaction with care compared between food secure and food insecure caregivers.
Detailed description
CommunityRx-Hunger (CRx-H) is a double-blinded randomized controlled trial aimed at increasing self-efficacy among caregivers with food insecurity in the household. CRx-H is recruiting primary caregivers of hospitalized children at a large urban children's hospital at the time of admission. Aim 1: Researchers are studying whether the intervention will increase self-efficacy among food insecure caregivers compared to those who receive the usual standard of care. Aim 2: Researchers will enroll and randomize caregivers with and without food insecurity to the intervention to compare satisfaction with care.
Eligible, self-identified caregivers will complete a baseline survey during the child's hospital stay, followed by phone surveys at 7, 30, 90, 180 days, and 12 months. Caregivers randomized to the intervention will receive a tailored list of resources to address food insecurity and other health-related social needs, plus a brief educational component delivered by a trained member of our research team. Cases will receive a "booster" dose of the resource list prior to discharge. After discharge, cases will receive proactive text messages about those same community resources.
All caregivers (regardless of research arm) will receive a series of text messages related to the study such as reminders to schedule the phone survey with a member of the research team.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care + Intervention (Case) | Experimental | Other: Community Rx-Hunger (CRx-H)Cases will receive the CommunityRx Intervention. |
| Usual Care (Control) | No intervention | –Controls will receive the usual standard care, which consists of information about hospital food resources and access to Feed1st hospital food pantries prior to discharge. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Native English or Spanish speaker
- Living in 1 of 27 zip codes in the study's target region
- Self-identify as a primary caregiver of a child <18 years old hospitalized in a large urban children's hospital
- Ability to send and receive text messages
- Access to a mobile phone and agrees to receive text messages from the study
Key exclusion criteria (5 listed)
- Previous participation in a CRx research study.
- Caregivers of newborns in the hospital
- Patient hospital stay is less than 24 hours
- Patient hospital stay is 30 days or more
- Patient has an eating disorder as indicated in the EMR
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 |
|---|---|---|
| Community Rx-Hunger (CRx-H)The CRx-H Intervention provides "dosages" of health content that offer assistance for food insecurity and other health-related social needs. A caregiver randomized to the intervention will receive a hard-copy print-out of their tailored list of resources to address food insecurity. A member of our research team will deliver this list and provide a brief educational component which includes: a brief, structured script about the common problem of food insecurity in households with children and co-occuring HRSNs, review of the resource list which includes nearby, vetted resources to address these needs and coaching on how to activate resources on the list. Prior to discharge, the caregiver will receive a duplicate copy of the list of resources. After discharge, the caregiver will receive text messages at a frequency based on the Critical Time Intervention (CTI) Model, from baseline to 3 months post discharge, in order to receive ongoing support by a research team member. | Other | Usual Care + Intervention (Case) |
Primary outcome
(Aim 1) Caregiver Self-efficacy at 12 Months Among Food Insecure Caregivers
Time frame: 12 months
Self-efficacy is measured by Bandura's Self-Efficacy Scale which asks, "How confident are you in your ability to find resources in your community that help you manage your health?" Responses will be assessed on a 5-point Likert scale ranging from "not at all confident" to "completely confident."
(Aim 2) Caregiver Satisfaction With Hospital Discharge
Time frame: 7 days post discharge from the hospital
Satisfaction with hospital discharge is measured by the Hospital Consumer Assessment of Healthcare Providers Survey (HCAHPS); "Child HCAHPS" which includes 8 items (range 0-100 with higher values representing higher satisfaction). Response options are "Yes, definitely," "Yes, somewhat" and "No." The items ask about the child and the hospital related to their recent stay.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 39719355Abramsohn EM, Mendoza TA, Bartlett AH, Glasser NJ, Grana M, Jerome J, Miller DC, Murphy J, O'Malley C, Waxman E, Tessler Lindau S. Caregivers' Views of a Pediatric Inpatient Intervention to Address Health-Related Social Risks. Hosp Pediatr. 2025 Jan 1;15(1):46-56. doi: 10.1542/hpeds.2024-008025.
- Results publication: PubMed 38881356Asay S, Abramsohn EM, Winslow V, Jagai JS, Waxman E, Makelarski JA, Lindau ST. Food Insecurity and Community-Based Food Resources Among Caregivers of Hospitalized Children. Hosp Pediatr. 2024 Jul 1;14(7):520-531. doi: 10.1542/hpeds.2023-007597.
- Results publication: PubMed 37986582Cacioppo AM, Winslow V, Abramsohn EM, Jagai JS, Makelarski JA, Waxman E, Wroblewski K, Tessler Lindau S. Food Insecurity and Experiences of Discrimination Among Caregivers of Hospitalized Children. Pediatrics. 2023 Dec 1;152(6):e2023061750. doi: 10.1542/peds.2023-061750.
- Derived from this study: PubMed 40293738Lindau ST, Makelarski JA, Winslow VA, Abramsohn EM, Anand V, Burnet DL, Fuller CM, Grana M, Miller DC, Ren ES, Waxman E, Wroblewski KE. Low-Intensity Social Care and Child Acute Health Care Utilization: A Randomized Clinical Trial. JAMA Pediatr. 2025 Jun 1;179(6):610-620. doi: 10.1001/jamapediatrics.2025.0484.
- Derived from this study: PubMed 37902777Glasser NJ, Lindau ST, Wroblewski K, Abramsohn EM, Burnet DL, Fuller CM, Miller DC, O'Malley CA, Shiu E, Waxman E, Makelarski JA; CommunityRx-Hunger Collaborators. Effect of a Social Care Intervention on Health Care Experiences of Caregivers of Hospitalized Children: A Randomized Clinical Trial. JAMA Pediatr. 2023 Dec 1;177(12):1266-1275. doi: 10.1001/jamapediatrics.2023.4596.
- Derived from this study: PubMed 37864258Abramsohn EM, De Ornelas M, Borson S, Frazier CRM, Fuller CM, Grana M, Huang ES, Jagai JS, Makelarski JA, Miller D, Schulman-Green D, Shiu E, Thompson K, Winslow V, Wroblewski K, Lindau ST. CommunityRx, a social care assistance intervention for family and friend caregivers delivered at the point of care: two concurrent blinded randomized controlled trials. Trials. 2023 Oct 21;24(1):681. doi: 10.1186/s13063-023-07697-z.
- Derived from this study: PubMed 36909590Abramsohn EM, De Ornelas M, Borson S, Frazier CR, Fuller CM, Grana M, Huang ES, Jagai JS, Makelarski JA, Miller D, Schulman-Green D, Shiu E, Thompson K, Winslow V, Wroblewski K, Lindau ST. Two concurrent randomized controlled trials of CommunityRx, a social care intervention for family and friend caregivers delivered at the point of care. Res Sq [Preprint]. 2023 Mar 1:rs.3.rs-2464681. doi: 10.21203/rs.3.rs-2464681/v1.
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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. This study is not recruiting at the moment.
Stacy T Lindau, MD, MPP principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Rx-Hunger (CRx-H) in people with Food Insecurity, run by University of Chicago 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 28 Jul 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?
Yes. Results are posted in the registry (first posted 27 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(Aim 1) Caregiver Self-efficacy at 12 Months Among Food Insecure Caregivers (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04171999, which also lists 7 linked publications.
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 28 Jul 2026.