Novel Mobile Resource for Food Insecurity

NCT ID: NCT06919445

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 608 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-03
• Study Completion Date: 2026-01-09

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. 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

'Text Connect' text messages

Intervention Type: 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.

Interventions

'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.

Intervention Type: OTHER

Eligibility Criteria

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

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Cristin Fritz

Assistant Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Monroe Carell Jr Children's Hospital at Vanderbilt

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

241490

Identifier Type: -

Identifier Source: org_study_id