CClinicalTrials.gg
CompletedNCT06919445NO MORE FIUpdated Jan 13, 2026

Novel Mobile Resource for Food Insecurity

An interventional study of 'Text Connect' text messages in Food Insecurity, sponsored by Vanderbilt University Medical Center. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-01-13.

Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
608
Allocation
Randomized
Sex
All
01

Study summary

The goal of this clinical trial is to learn if a novel text-message-based intervention is a more effective method for providing food resource information to families of recently hospitalized children who are experiencing food insecurity compared to the current standard practice of a paper handout delivered at the time of hospital discharge. The hypotheses the investigators seek to prove are:

  1. That the Text Connect intervention will have greater reach and engagement and be more effective in facilitating connection to food resources than receiving a paper handout alone.
  2. That the Text Connect intervention will improve household food security to a greater degree than a paper handout alone.
Read the detailed description

The mHealth intervention, Text Connect, leverages universal FI screening embedded in the routine clinical care of hospitalized children and offers an innovative approach to providing food resource information that addresses previously identified challenges. The anonymous nature of the text message may empower families with concerns related to sharing their need to pursue resources. Leveraging an already existing online social resource database that is frequently updated and searchable by ZIP Code in many different languages ensures that community program information is accurate, relevant, and tailored to the user's needs. Automated delivery to a personal device addresses the barrier of not receiving referral information and enables patients and families to utilize the information when most convenient for them. Importantly, it is also a promising approach to disseminating this information to all individuals with FI. While development of an app or link in an online portal is a possible electronic information dissemination approach, there are known challenges in accessing such tools that would limit use by many in the population that most frequently experiences FI.

By leveraging an electronic health record vendor's (Epic) native screening questions to identify eligible families and an external social resource database to provide tailored resources, this approach is scalable to other care settings, other domains of needs, and other institutions. Most importantly, successful implementation of this intervention holds the potential to improve family food security and child health outcomes.

The investigator's pilot study testing the feasibility, usability, and acceptability of this proposed approach to resource provision demonstrated that the intervention reaches the majority of the intended population, over half of recipients engage with the content, has excellent usability, and is acceptable to families. Thus, the overarching goal of this proposal is to rigorously test this approach to resource information delivery through a randomized controlled trial to inform health-system approaches to providing social resource information in response to screening. The specific aims are:

Aim 1: In a randomized controlled trial, the investigators will test the reach, engagement, and effectiveness of resource connection of the mHealth intervention, Text Connect, as compared to usual care, a paper resource handout, among families with FI. The investigators hypothesize that the mHealth intervention Text Connect will have greater reach and engagement and be more effective in facilitating connection to food resources than receiving a paper handout alone.

Aim 2: Assess the impact of the Text Connect intervention on household food and nutrition security status, perceived stigma, and trust in the healthcare team compared to usual care. The investigators hypothesize that the Text Connect intervention will improve household food security to a greater degree than a paper handout alone.

02

Conditions studied

  • Food Insecurity

Keywords

  • mHealth
  • Pediatric
  • Food Insecurity
03

In context

Lead sponsor

Vanderbilt University Medical Center is the lead sponsor of 824 studies on the registry; 164 are open to participants now.

Of its 122 completed or terminated interventional studies of FDA-regulated products, 91 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Must be a caregiver of a child admitted to the hospital
  • Must have a positive screening for Food Insecurity documented in the Electronic Health Record as conducted as part of the child's routine clinical care

Exclusion criteria

Exclusion Criteria:

  • Primary language other than English or Spanish
  • Repeat admission during the study period
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
608 participants (actual)

Study arms

  • No intervention
    Usual Food Resources Control

    Caregivers included in the usual care group receive a paper food resource handout as part of their discharge paperwork. This paper is given to the family and reviewed by the nurse completing their discharge. Families may also meet with a resource navigator during admission if they indicate a desire to talk with someone about food resources during their hospitalization. Finally, all caregivers with FI identified during screening are eligible to receive a food box or frozen meal at the time of discharge from the hospital.

  • Experimental
    Usual Food Resources PLUS Text Connect Intervention

    Caregivers included in the intervention arm receive a 'Text Connect' message with food resource information one day and four days after discharge in addition to the usual care information received by the control group

    Other: 'Text Connect' text messages

Interventions

  • Other'Text Connect' text messages

    The Text Connect message includes 1) a link to a FindHelp (an online social resource database available in over 100 languages) search tailored to the recipient's home ZIP code 2) information regarding applying for the Supplemental Nutrition Assistance Program (SNAP), and information regarding applying for the Special Supplemental Program for Women, Infants, and Children (WIC). All text message content was initially developed in consultation with caregivers of children with FI identified during an admission through a Community Engagement studio and was approved by the institution's Effective Health Communication Core. The investigators have adapted the content based on feedback from participants in the pilot study.

06

What researchers measure

Primary outcomes

  1. Resource Connection (Effectiveness)

    Effectiveness is measured as the proportion of caregivers who report (Yes/No) getting a new food resource since getting home from their child's hospitalization.

    Time frame: Days 5, 12, and 30

  2. Caregiver-reported Engagement with information

    Measured among control and intervention groups as the proportion of caregivers who report reading (Yes/No) or using the content of the discharge resource handout (control) or text message (intervention) to search for a new resource

    Time frame: Days 5, 12, and 30

  3. System-collected Engagement with information

    Measured among the intervention group as the proportion of caregivers who click on the embedded FindHelp search link

    Time frame: Days 1 and 4

  4. Caregiver-reported Reach

    Reach will be measured among intervention and control groups as the proportion of caregivers who report receiving the text message (intervention) or paper handout (control)

    Time frame: 5, 12, & 30

  5. System-collected Reach

    Will be measured among among the intervention cohort as the proportion of caregivers who have successful delivery of at least one Text Connect intervention message as recorded by Twilio report of text message delivery

    Time frame: Day 1 and 4

Secondary outcomes

  1. Food Security

    Food Security is measured by the 18 item USDA Food Security Survey. The items ask about households ability to afford enough food. Raw scores range from 0-18, which are then classified into categories including very low food security (8-18), low food security (3-7), marginal food security (1-2) and high food security (0)

    Time frame: Day 30

  2. Nutrition Security

    Nutrition Security is measured by 4-item Center for Nutrition and Health Impact Nutrition Security Scale. The items ask about caregivers ability to access nutritious foods. Answer choices include 'Never, Rarely, Sometimes, Often, Always, and Don't Know'. Scores range from 0-4, where higher scores indicate higher nutrition

    Time frame: Day 30

  3. Resilience

    Resilience is measured by Center for Nutrition and Health Impact Adaptive Capacity 2-item Screener. The items ask about caregivers ability to find assistance in the face of financial challenges. Answer choices include a 6-point Likert Scale from Strongly Agree to Strongly Disagree, with responses of Slightly Disagree, Disagree, or Strongly Disagree to either question indicating a positive screen for needing additional support to navigate financial challenges.

    Time frame: Day 30

  4. Stigma

    Stigma is measured by a modified version of the Discrimination in Medical Settings scale asking about the child's recent hospitalization. The items ask about negative experiences in the health care setting. Each question is rated on a 5-point Likert scale (1-never, 2-rarely, 3-sometimes, 4-most of the time, 5-always). Scores range from 5-35 with higher scores indicating more experiences of discrimination.

    Time frame: Day 30

  5. Trust in Health Care System

    Trust in health care team is measured by 5-point Likert scale, where higher score indicates higher level of trust.

    Time frame: Day 30

07

Study locations

1 site
  • Monroe Carell Jr Children's Hospital at Vanderbilt
    Nashville, Tennessee 37232, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06919445
Lead sponsor
Vanderbilt University Medical Center
Responsible party
Cristin Fritz (Assistant Professor of Pediatrics, Vanderbilt University Medical Center) — Principal investigator
First posted
Apr 9, 2025
Start date
Mar 3, 2025
Primary completion
Jan 9, 2026
Completion
Jan 9, 2026
Last update
Jan 13, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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