Novel Mobile Resource for Food Insecurity

NCT06919445 | Completed

• 1 other identifier: 241490
• Study Type: interventional
• Target: 608
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.That the Text Connect intervention will improve household food security to a greater degree than a paper handout alone.

Conditions

Food Insecurity

Keywords

mHealth; Pediatric; Food Insecurity

Outcome Measures

Primary Outcomes (5)

• 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.

  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

  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

  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)

  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

  Day 1 and 4

Secondary Outcomes (5)

• Food Security

  Day 30

• Nutrition Security

  Day 30

• Resilience

  Day 30

• Stigma

  Day 30

• Trust in Health Care System

  Day 30

Study Arms (2)

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

Other: 'Text Connect' text messages

Interventions

'Text Connect' text messages OTHER

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.

Usual Food Resources PLUS Text Connect Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Monroe Carell Jr Children's Hospital at Vanderbilt

Nashville, Tennessee, 37232, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: April 9, 2025
• Study Start: March 3, 2025
• Primary Completion: January 9, 2026
• Study Completion: January 9, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)