NCT03284372

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 15, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

January 18, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

March 25, 2021

Status Verified

March 1, 2021

Enrollment Period

2 years

First QC Date

September 7, 2017

Last Update Submit

March 22, 2021

Conditions

Food AllergyAdherence, Medication

Outcome Measures

Primary Outcomes (1)

  • Proportion of check-ins at which participant is carrying epinephrine auto-injector

    Proportion of check-ins at which participant is carrying epinephrine auto-injector, measured using cell phone photographs

    10 randomly timed check-ins during the 10-week intervention period

Secondary Outcomes (3)

  • Characterize adolescents' normative food allergy management practices

    Year-long cohort study

  • Characterize adolescents' normative food allergy management practices

    Year-long cohort study

  • Develop a set of text message reminders to promote safer food allergy management among adolescents

    2-year project period

Study Arms (5)

Intervention 1

EXPERIMENTAL

Text Message Only

Behavioral: Text Message Only

Intervention 2, Incentive

EXPERIMENTAL

Text message + Incentive

Behavioral: Text message + Incentive 1

Cohort

NO INTERVENTION

For the cohort multiple randomized controlled trial (cmRCT), investigators will recruit 130 participants (the base cohort) ages 15-19. The base cohort allows investigators to measure normative food allergy self-management practices, while also serving as a control for experiments in Interventions 1 and 2.

Control

NO INTERVENTION

The baseline cohort serves as the control group in this cmRCT. Participants will not receive text message reminders (during Intervention 1) or incentives (during Intervention 2). However, they will participate in all data collection points, including text message check-ins to assess epinephrine-carrying. Participants in the base cohort will receive usual care.

Adolescent Allergy Advisors

NO INTERVENTION

We will pilot the text messages to be used in Interventions 1 and 2 through interviews and cognitive testing among 20 Adolescent Allergy Advisors, who will critique message content, framing, and language. These advisors will not be part of the cohort multiple randomized controlled trial.

Interventions

Text Message OnlyBEHAVIORAL

The intervention group (n=25, randomly selected from the base cohort) will receive informational and socially supportive text messages during a 10-week intervention. Investigators will deploy the intervention using the Way to Health platform, which automates outgoing messages and feedback. Many of the messages will be sent to all Intervention 1 participants, to assure consistency of the intervention. A subset will be tailored to address participants' specific allergies. At 10 unannounced check-ins, we will send text messages asking participants in the intervention and control groups if they are carrying their epinephrine.

Intervention 1
Text message + Incentive 1BEHAVIORAL

Among base cohort members not exposed to the text message only intervention (#1), we will randomly select a new intervention group (n=50) to receive text message reminders plus Incentive 1. At each of 10 unannounced check-ins, if unsuccessful in documenting epinephrine-carrying, participants will lose part of their incentive. The remainder of the Cohort (control) will receive text reminders.

Intervention 2, Incentive

Eligibility Criteria

Age15 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Dupuis R, Spergel JM, Brown-Whitehorn TF, Troxel AB, Kenney EL, Block JP, Feuerstein-Simon R, Marti XL, Mollen CJ, Meisel ZF, Volpp KG, Gortmaker SL, Cannuscio CC. Incidence of food allergic reactions among adolescents engaged in food allergy management. Ann Allergy Asthma Immunol. 2025 Jun;134(6):719-723.e2. doi: 10.1016/j.anai.2025.02.023. Epub 2025 Mar 9.

    PMID: 40068800DERIVED

MeSH Terms

Conditions

Food HypersensitivityMedication Adherence

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateHypersensitivityImmune System DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Carolyn C Cannuscio, ScD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

  • Jonathan Spergel, MD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2017

First Posted

September 15, 2017

Study Start

January 18, 2018

Primary Completion

January 18, 2020

Study Completion

July 31, 2020

Last Updated

March 25, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)