Clinical trial NCT03284372: Safer Food Allergy Management for Adolescents
Official title: Safer Food Allergy Management for Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Allergy
Adherence, Medication
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Philadelphia
First posted: 2017-09-15
Enrollment: 138
Sex: ALL
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Among the 15 million people with food allergies in the U.S., adolescents experience the highest risk of adverse events. Yet, there are few evidence-based strategies to improve food allergy management in adolescents. In a cohort multiple randomized controlled trial, this study will include two experiments to test the effectiveness of text message reminders and incentives to encourage epinephrine-carrying.

Detailed description: Among the 15 million people with food allergies in the United States, adolescents experience the highest risk of adverse events, including death from anaphylaxis. Visits to one pediatric emergency department for anaphylaxis doubled between 2001 and 2006, suggesting a rapidly escalating public health burden. Despite this critical concern, there are few evidence-based strategies to improve food allergy management in adolescents, who must sustain three core prevention strategies: diligent avoidance of allergenic foods, consistent carrying of potentially life-saving epinephrine auto-injectors, and prompt administration of epinephrine in the event of anaphylaxis.

The objective of this study is to develop and test interventions to encourage safer food allergy management among adolescents. The primary outcome is consistency of epinephrine-carrying, measured using cell phone photographs at randomly-timed check-ins. This study will be among the first to longitudinally track normative food allergy management practices and one of the first to test behavior change strategies.

In a cohort multiple randomized controlled trial (n=130), the study will include two experiments to test the effectiveness of text message reminders and incentives, using various incentive designs that have proven effective in prior behavioral economics interventions to encourage weight loss and smoking cessation. Aim 1. Test the impact of a text-message reminder system on consistency of epinephrine carrying. Aim 2. Test the impact of modest incentives on consistency of epinephrine carrying. Based on promising preliminary data, the central hypothesis is that, compared to controls, adolescents who receive text message reminders plus modest financial incentives will more consistently carry their epinephrine.

Eligibility criteria: Inclusion Criteria:

* Food allergy diagnosis by a physician and recorded in the medical chart
* Prior prescription of epinephrine auto-injector to treat anaphylaxis
* Access to a cell phone capable of sending and receiving text messages and photographs (our team will provide cell phones to participants willing to participate, but who do not own a cellphone)
* Fluent in English
* Between ages 15-19 at baseline

Exclusion Criteria:

* Unable to obtain permission (consent) of a parent to participate in the study
* Will not or cannot give assent
* Currently participating in another clinical trial with related aims

Primary outcomes:
measure: Proportion of check-ins at which participant is carrying epinephrine auto-injector
timeFrame: 10 randomly timed check-ins during the 10-week intervention period
Secondary outcomes:
measure: Characterize adolescents' normative food allergy management practices
timeFrame: Year-long cohort study
measure: Characterize adolescents' normative food allergy management practices
timeFrame: Year-long cohort study
measure: Develop a set of text message reminders to promote safer food allergy management among adolescents
timeFrame: 2-year project period
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Carolyn C Cannuscio, ScD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Philadelphia
name: Jonathan Spergel, MD
role: PRINCIPAL_INVESTIGATOR
References: