Food InsecurityNO MORE FINCT06919445
Novel Mobile Resource for Food Insecurity
A study testing 'Text Connect' text messages in people with Food Insecurity, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Food Insecurity
- What is being tested?
- 'Text Connect' text messages
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 608 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2025to 9 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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
Who cannot join
- Primary language other than English or Spanish
- Repeat admission during the study period
Trial locations and contacts
1 site in 1 country.
United States1 site
Monroe Carell Jr Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
About this study
Official title: Novel Mobile Resource for Food Insecurity Randomized Controlled Trial
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:
- 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.
- 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.
- Conditions
- Food Insecurity
- Being tested
- 'Text Connect' text messages
- Keywords
- mHealth, Pediatric, Food Insecurity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
'Text Connect' text messagesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Food Resources Control | No intervention | 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. |
| Usual Food Resources PLUS Text Connect Intervention | Experimental | 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 Receives: Other: 'Text Connect' text messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Days 5, 12, and 30
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
Measured: Days 5, 12, and 30
System-collected Engagement with information
Measured among the intervention group as the proportion of caregivers who click on the embedded FindHelp search link
Measured: Days 1 and 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)
Measured: 5, 12, & 30
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
Measured: Day 1 and 4
Secondary outcomes (5)
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)
Measured: Day 30
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
Measured: Day 30
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.
Measured: Day 30
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.
Measured: Day 30
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.
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start3 Mar 2025
- Primary completion9 Jan 2026
- Study completion9 Jan 2026
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 Vanderbilt University Medical CenterThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 608 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristin Fritz, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06919445
- Sponsor's protocol ID
- 241490
- Acronym
- NO MORE FI
- Status last verified
- Jan 2026
- First submitted
- 21 Mar 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Mobile Resource for Food Insecurity Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06919445
- Acronym / sponsor ID
- NO MORE FI / 241490
- Conditions
- Food Insecurity
- Keywords
- mHealth, Pediatric, Food Insecurity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 608 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 9 Jan 2026 (actual)
- Study completion
- 9 Jan 2026 (actual)
- First posted
- 9 Apr 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.
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:
- 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.
- That the Text Connect intervention will improve household food security to a greater degree than a paper handout alone.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Food Resources Control | No intervention | –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. |
| Usual Food Resources PLUS Text Connect Intervention | Experimental | Other: 'Text Connect' text messagesCaregivers 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Primary language other than English or Spanish
- Repeat admission during the study period
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 |
|---|---|---|
| 'Text Connect' text messagesThe 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. | Other | Usual Food Resources PLUS Text Connect Intervention |
Primary outcome
Resource Connection (Effectiveness)
Time frame: Days 5, 12, and 30
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.
Caregiver-reported Engagement with information
Time frame: Days 5, 12, and 30
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
System-collected Engagement with information
Time frame: Days 1 and 4
Measured among the intervention group as the proportion of caregivers who click on the embedded FindHelp search link
Caregiver-reported Reach
Time frame: 5, 12, & 30
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)
System-collected Reach
Time frame: Day 1 and 4
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
5 secondary outcomes
Food Security
Time frame: Day 30
Nutrition Security
Time frame: Day 30
Resilience
Time frame: Day 30
Stigma
Time frame: Day 30
Trust in Health Care System
Time frame: Day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 'Text Connect' text messages in people with Food Insecurity, run by Vanderbilt University Medical Center 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 2 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: finished, as of the sponsor's last update on 13 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Resource Connection (Effectiveness) (time frame: Days 5, 12, and 30). 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 13 Jan 2026.