Clinical trial NCT06919445: Novel Mobile Resource for Food Insecurity
Official title: Novel Mobile Resource for Food Insecurity Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Food Insecurity
Keywords: mHealth
Pediatric
Food Insecurity
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Resource Connection (Effectiveness)
timeFrame: Days 5, 12, and 30
measure: Caregiver-reported Engagement with information
timeFrame: Days 5, 12, and 30
measure: System-collected Engagement with information
timeFrame: Days 1 and 4
measure: Caregiver-reported Reach
timeFrame: 5, 12, & 30
measure: System-collected Reach
timeFrame: Day 1 and 4
Secondary outcomes:
measure: Food Security
timeFrame: Day 30
measure: Nutrition Security
timeFrame: Day 30
measure: Resilience
timeFrame: Day 30
measure: Stigma
timeFrame: Day 30
measure: Trust in Health Care System
timeFrame: Day 30
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Monroe Carell Jr Children's Hospital at Vanderbilt
state: Tennessee
Study officials:
References: