<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/NCT03762135</url>
  </required_header>
  <id_info>
    <org_study_id>HUM0000143430</org_study_id>
    <secondary_id>2R42MD008840-02</secondary_id>
    <nct_id>NCT03762135</nct_id>
  </id_info>
  <brief_title>Location Initiated Individualized Texts for Adolescent Health (LIITAH)</brief_title>
  <official_title>Location Initiated Individualized Texts for Adolescent Health (LIITAH)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Minority Health and Health Disparities (NIMHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to test whether the mobile application (app.) helps adolescents&#xD;
      make healthy food choices, decreasing calories purchased from restaurants, fewer number of&#xD;
      visits to restaurants, and if it has an impact on their body mass index (BMI). Eligible&#xD;
      adolescents will be enrolled in the study along with a parent for approximately 6 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 4, 2021</start_date>
  <completion_date type="Actual">November 21, 2022</completion_date>
  <primary_completion_date type="Actual">November 21, 2022</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visits to restaurants</measure>
    <time_frame>over 6 months</time_frame>
    <description>number of visits will be obtained from the app.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Calories purchased from restaurants</measure>
    <time_frame>over 6 months</time_frame>
    <description>number of calories purchased by the adolescent and for the adolescent will be assessed using annotated photos, and nutritional data from the restaurant menus.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in body mass index (BMI)</measure>
    <time_frame>baseline, 6 months</time_frame>
    <description>height and weight will be obtained</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">79</enrollment>
  <condition>Overweight</condition>
  <condition>Obese</condition>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Full version of the LIITah App.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be given the LIITAH app. which consists of 1) enhanced location identification (ELI), 2) self reported nutrients by annotated photos (SNAP), 3) delivery of individually and culturally tailored point of purchase (POP) prompts along with tailored messages sent at other times of the day, 4) use of app. in connection with parents, 5) goal setting, 6) a point system</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Partial App. (ELI and SNAP only)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will be given only the ELI and SNAP components. It will detect their presence in a restaurant and allow users to document their purchases by submitting annotated photos, but it will not deliver any POP prompts encouraging them to make healthy choices, or messages at other times of the day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Full version of the LIITah App.</intervention_name>
    <description>Participants will download the LIITAH app. For the first 2 weeks the app. will only record presence in a restaurant and ask users to submit photos of their food. in week 3 all of the program features will be activated.</description>
    <arm_group_label>Full version of the LIITah App.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Partial App. (ELI and SNAP only)</intervention_name>
    <description>Participants will download the LIITAH app. It will detect their presence in a restaurant and users will submit annotated photos of their purchases</description>
    <arm_group_label>Partial App. (ELI and SNAP only)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  eat restaurant food at least 3 times a week and have a parent who agrees to&#xD;
             participate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susan J Woolford, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>January 31, 2023</last_update_submitted>
  <last_update_submitted_qc>January 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Susan J Woolford, MD, MPH</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 6, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/35/NCT03762135/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03762135
org study id: HUM0000143430
secondary id: 2R42MD008840-02
nct id: NCT03762135
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
The goal of this study is to test whether the mobile application (app.) helps adolescents
      make healthy food choices, decreasing calories purchased from restaurants, fewer number of
      visits to restaurants, and if it has an impact on their body mass index (BMI). Eligible
      adolescents will be enrolled in the study along with a parent for approximately 6 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Visits to restaurants
time frame: over 6 months
description: number of visits will be obtained from the app.
measure: Calories purchased from restaurants
time frame: over 6 months
description: number of calories purchased by the adolescent and for the adolescent will be assessed using annotated photos, and nutritional data from the restaurant menus.
measure: Change in body mass index (BMI)
time frame: baseline, 6 months
description: height and weight will be obtained
arm group label: Full version of the LIITah App.
arm group type: Experimental
description: Participants will be given the LIITAH app. which consists of 1) enhanced location identification (ELI), 2) self reported nutrients by annotated photos (SNAP), 3) delivery of individually and culturally tailored point of purchase (POP) prompts along with tailored messages sent at other times of the day, 4) use of app. in connection with parents, 5) goal setting, 6) a point system
arm group label: Partial App. (ELI and SNAP only)
arm group type: Active Comparator
description: Participants will be given only the ELI and SNAP components. It will detect their presence in a restaurant and allow users to document their purchases by submitting annotated photos, but it will not deliver any POP prompts encouraging them to make healthy choices, or messages at other times of the day.
intervention type: Other
intervention name: Full version of the LIITah App.
description: Participants will download the LIITAH app. For the first 2 weeks the app. will only record presence in a restaurant and ask users to submit photos of their food. in week 3 all of the program features will be activated.
arm group label: Full version of the LIITah App.
intervention type: Other
intervention name: Partial App. (ELI and SNAP only)
description: Participants will download the LIITAH app. It will detect their presence in a restaurant and users will submit annotated photos of their purchases
arm group label: Partial App. (ELI and SNAP only)
criteria: 
gender: All
minimum age: 13 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Susan J Woolford, MD
role: Principal Investigator
affiliation: University of Michigan
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Susan J Woolford, MD, MPH
investigator title: Assistant Professor
mesh term: Overweight
sharing ipd: No
provided document: 