<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03284372</url>
  </required_header>
  <id_info>
    <org_study_id>827073</org_study_id>
    <nct_id>NCT03284372</nct_id>
  </id_info>
  <brief_title>Safer Food Allergy Management for Adolescents</brief_title>
  <official_title>Safer Food Allergy Management for Adolescents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Children's Hospital of Philadelphia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pennsylvania</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Among the 15 million people with food allergies in the U.S., adolescents experience the&#xD;
      highest risk of adverse events. Yet, there are few evidence-based strategies to improve food&#xD;
      allergy management in adolescents. In a cohort multiple randomized controlled trial, this&#xD;
      study will include two experiments to test the effectiveness of text message reminders and&#xD;
      incentives to encourage epinephrine-carrying.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Among the 15 million people with food allergies in the United States, adolescents experience&#xD;
      the highest risk of adverse events, including death from anaphylaxis. Visits to one pediatric&#xD;
      emergency department for anaphylaxis doubled between 2001 and 2006, suggesting a rapidly&#xD;
      escalating public health burden. Despite this critical concern, there are few evidence-based&#xD;
      strategies to improve food allergy management in adolescents, who must sustain three core&#xD;
      prevention strategies: diligent avoidance of allergenic foods, consistent carrying of&#xD;
      potentially life-saving epinephrine auto-injectors, and prompt administration of epinephrine&#xD;
      in the event of anaphylaxis.&#xD;
&#xD;
      The objective of this study is to develop and test interventions to encourage safer food&#xD;
      allergy management among adolescents. The primary outcome is consistency of&#xD;
      epinephrine-carrying, measured using cell phone photographs at randomly-timed check-ins. This&#xD;
      study will be among the first to longitudinally track normative food allergy management&#xD;
      practices and one of the first to test behavior change strategies.&#xD;
&#xD;
      In a cohort multiple randomized controlled trial (n=130), the study will include two&#xD;
      experiments to test the effectiveness of text message reminders and incentives, using various&#xD;
      incentive designs that have proven effective in prior behavioral economics interventions to&#xD;
      encourage weight loss and smoking cessation. Aim 1. Test the impact of a text-message&#xD;
      reminder system on consistency of epinephrine carrying. Aim 2. Test the impact of modest&#xD;
      incentives on consistency of epinephrine carrying. Based on promising preliminary data, the&#xD;
      central hypothesis is that, compared to controls, adolescents who receive text message&#xD;
      reminders plus modest financial incentives will more consistently carry their epinephrine.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 18, 2018</start_date>
  <completion_date type="Actual">July 31, 2020</completion_date>
  <primary_completion_date type="Actual">January 18, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of check-ins at which participant is carrying epinephrine auto-injector</measure>
    <time_frame>10 randomly timed check-ins during the 10-week intervention period</time_frame>
    <description>Proportion of check-ins at which participant is carrying epinephrine auto-injector, measured using cell phone photographs</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Characterize adolescents' normative food allergy management practices</measure>
    <time_frame>Year-long cohort study</time_frame>
    <description>Characterize adolescents' normative food allergy management practices, measured comparing baseline and follow-up surveys that assess social challenges, out-of-home eating, allergen avoidance, and response to adverse events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characterize adolescents' normative food allergy management practices</measure>
    <time_frame>Year-long cohort study</time_frame>
    <description>Characterize adolescents' normative food allergy management practices, measured using periodic text-message questions that assess social challenges, out-of-home eating, allergen avoidance, and response to adverse events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Develop a set of text message reminders to promote safer food allergy management among adolescents</measure>
    <time_frame>2-year project period</time_frame>
    <description>Develop a set of text message reminders to promote safer food allergy management among adolescents by cognitively testing text message content</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">138</enrollment>
  <condition>Food Allergy</condition>
  <condition>Adherence, Medication</condition>
  <arm_group>
    <arm_group_label>Intervention 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Text Message Only</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention 2, Incentive</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Text message + Incentive</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adolescent Allergy Advisors</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Text Message Only</intervention_name>
    <description>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.</description>
    <arm_group_label>Intervention 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Text message + Incentive 1</intervention_name>
    <description>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.</description>
    <arm_group_label>Intervention 2, Incentive</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Food allergy diagnosis by a physician and recorded in the medical chart&#xD;
&#xD;
          -  Prior prescription of epinephrine auto-injector to treat anaphylaxis&#xD;
&#xD;
          -  Access to a cell phone capable of sending and receiving text messages and photographs&#xD;
             (our team will provide cell phones to participants willing to participate, but who do&#xD;
             not own a cellphone)&#xD;
&#xD;
          -  Fluent in English&#xD;
&#xD;
          -  Between ages 15-19 at baseline&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to obtain permission (consent) of a parent to participate in the study&#xD;
&#xD;
          -  Will not or cannot give assent&#xD;
&#xD;
          -  Currently participating in another clinical trial with related aims&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carolyn C Cannuscio, ScD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jonathan Spergel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital of Philadelphia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>March 22, 2021</last_update_submitted>
  <last_update_submitted_qc>March 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</mesh_term>
    <mesh_term>Food Hypersensitivity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03284372
org study id: 827073
nct id: NCT03284372
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Proportion of check-ins at which participant is carrying epinephrine auto-injector
time frame: 10 randomly timed check-ins during the 10-week intervention period
description: Proportion of check-ins at which participant is carrying epinephrine auto-injector, measured using cell phone photographs
measure: Characterize adolescents' normative food allergy management practices
time frame: Year-long cohort study
description: Characterize adolescents' normative food allergy management practices, measured comparing baseline and follow-up surveys that assess social challenges, out-of-home eating, allergen avoidance, and response to adverse events.
measure: Characterize adolescents' normative food allergy management practices
time frame: Year-long cohort study
description: Characterize adolescents' normative food allergy management practices, measured using periodic text-message questions that assess social challenges, out-of-home eating, allergen avoidance, and response to adverse events.
measure: Develop a set of text message reminders to promote safer food allergy management among adolescents
time frame: 2-year project period
description: Develop a set of text message reminders to promote safer food allergy management among adolescents by cognitively testing text message content
arm group label: Intervention 1
arm group type: Experimental
description: Text Message Only
arm group label: Intervention 2, Incentive
arm group type: Experimental
description: Text message + Incentive
arm group label: Cohort
arm group type: No Intervention
description: 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.
arm group label: Control
arm group type: No Intervention
description: 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.
arm group label: Adolescent Allergy Advisors
arm group type: No Intervention
description: 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.
intervention type: Behavioral
intervention name: Text Message Only
description: 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.
arm group label: Intervention 1
intervention type: Behavioral
intervention name: Text message + Incentive 1
description: 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.
arm group label: Intervention 2, Incentive
criteria: 
gender: All
minimum age: 15 Years
maximum age: 19 Years
healthy volunteers: No
last name: Carolyn C Cannuscio, ScD
role: Principal Investigator
affiliation: University of Pennsylvania
last name: Jonathan Spergel, MD
role: Principal Investigator
affiliation: Children's Hospital of Philadelphia
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hypersensitivity
mesh term: Food Hypersensitivity
sharing ipd: No