<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/NCT04492592</url>
  </required_header>
  <id_info>
    <org_study_id>17182</org_study_id>
    <nct_id>NCT04492592</nct_id>
  </id_info>
  <brief_title>JUS Media? Programme: A Food-Focused Media Literacy Intervention for Americanized Adolescents and Mothers Globally</brief_title>
  <official_title>The J(Amaican and) U(Nited) S(Tates) Media? Programme: A Food-Focused Media Literacy Intervention for Americanized Adolescents and Mothers Globally</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Illinois at Urbana-Champaign</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The University of The West Indies</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Illinois at Urbana-Champaign</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The J(amaican and) U(nited) S(tates) Media? Programme is a culturally-tailored food-focused&#xD;
      media literacy preventive intervention designed to promote healthier eating habits among&#xD;
      remotely acculturating early adolescents and their mothers in Jamaica (i.e., they have&#xD;
      internalized American culture) and are exposed to U.S. food advertising. The JUS Media?&#xD;
      Programme consists of a 2-session face:face weekend workshop for adolescent-mother pairs&#xD;
      supplemented by 8 weeks of SMS/text messages to reinforce workshop themes. Adolescents and&#xD;
      their mothers learn critical thinking skills to combat the unhealthy food messages they&#xD;
      encounter in food advertising, particularly advertising on U.S. cable TV. The efficacy of the&#xD;
      JUS Media? Programme was evaluated with a small experimental study utilizing a randomized&#xD;
      controlled trial design among adolescents and mothers in Jamaica.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Western diet is common in the United States and has a lot of salt, sugar, and fat. Modern&#xD;
      globalization has shifted eating habits in many countries toward this unhealthy Western diet.&#xD;
      For example, U.S. cable TV in other countries promotes this Western diet through&#xD;
      advertisements for junk foods and sugary drinks. This is a major concern because experimental&#xD;
      research studies show that seeing food advertising while watching TV leads to eating more&#xD;
      food afterwards. Research studies also show that people who watch a lot of TV tend to think&#xD;
      that junk food is not that harmful.&#xD;
&#xD;
      Researchers now believe that some people living outside the U.S. are drawn to the U.S.&#xD;
      culture and lifestyle and can become &quot;Americanized&quot; through a process called remote&#xD;
      acculturation. These Americanized people in other countries such as Jamaica are mostly&#xD;
      teenagers, but sometimes also adults. Americanized people outside the United States are even&#xD;
      more likely to adopt the unhealthy Western diet even though they have never lived in the&#xD;
      United States. In research the investigators did before getting this grant, they showed that&#xD;
      Americanized youth and mothers in Jamaica watched more hours of U.S. cable daily and also ate&#xD;
      more unhealthy food. This led them to develop a new healthy eating education program for&#xD;
      Americanized families in Jamaica that highlighted the role of U.S. media - the &quot;J(amaican)&#xD;
      U(nited) S(tates) Media? Programme&quot;. The JUS Media? Programme teaches young people and&#xD;
      mothers to question the health messages in food advertising on U.S. cable TV so that they can&#xD;
      be smarter and healthier consumers. For example, the JUS Media? Programme covers the&#xD;
      recommended food guidelines in Jamaica and teaches adolescents and their mothers the&#xD;
      principles of media literacy, such as to think about &quot;who is the source of this message?&quot;&#xD;
      &quot;what do they want you to do?&quot; and &quot;what information is missing?&quot;. Finally, the JUS Media?&#xD;
      Programme teaches participants to use these media literacy principles to challenge unhealthy&#xD;
      food advertisements by creating smart, funny parody versions called subvertisements.&#xD;
&#xD;
      In this project,the investigators evaluated how well the JUS Media? Programme worked for 7th&#xD;
      graders and their mothers in Jamaica. About 30 adolescents and their mothers got a 2-session&#xD;
      workshop, another 30 families got the workshop and text messages, and another 30 families did&#xD;
      not get any part of the program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2017</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</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>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Participants were not told what arm of the intervention they were in (i.e., they were not told if they were receiving the intervention or not).</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in Dietary Intake Using a 24-Hour Recall Method</measure>
    <time_frame>4 measurement points: baseline, 4 weeks, 6 weeks, 17-20 weeks (study ended at this final timepoint).</time_frame>
    <description>24-Hour Recall. Each participant reported detailed information on all foods and beverages consumed in the previous 24 hours via structured interviews with open-ended responses over the phone, and reported dietary intake was coded into coded for the presence (1) or absence (0) of fruits, raw vegetables, cooked vegetables, fats/oils, and sugary foods/beverages (aligning with the major national food groups of the population studied).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CHANGE IN STAGE OF CHANGE TOWARDS HEALTHY EATING</measure>
    <time_frame>4 measurement points: baseline, 4 weeks, 6 weeks, 17-20 weeks (study ended at this final timepoint).</time_frame>
    <description>A stages of change measure of healthy eating (Wright et al., 2015) was adapted to measure participants' adherence to 5 additional food-based dietary guidelines of the Jamaica Ministry of Health. Participants reported their adherence to each dietary guideline using a 1-6 likert type scale ranging from 1 &quot;precontemplation stage (No, and I do not intend to [insert wording from guideline]...in the next 6 months&quot; to 6 &quot;total abstinence (I do not consume...[insert wording from guideline).&quot; Higher scores on this scale represent being closer to one's healthy eating goal.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>CHANGE IN FOOD-FOCUSED MEDIA LITERACY</measure>
    <time_frame>4 measurement points: baseline, 4 weeks, 6 weeks, 17-20 weeks (study ended at this final timepoint).</time_frame>
    <description>Food-focused media literacy was measured with a 14-item scale (Powell &amp; Gross, 2018). Participants responded on a 4-point likert type scale ranging from 1 (strongly disagree) to 4 (strongly agree). Higher scores on this scale represent higher food-focused media literacy.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">184</enrollment>
  <condition>Nutrition Poor</condition>
  <arm_group>
    <arm_group_label>Workshop Only</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 session weekend face:face workshop for adolescent-mother pairs</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Workshop + SMS/Texting</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 session weekend face:face workshop for adolescent-mother pairs followed by 8 weeks of supplementary text messages (NOTE: there was no 'SMS/texting-only' arm of this study)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention provided.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Workshop</intervention_name>
    <description>Workshop</description>
    <arm_group_label>Workshop + SMS/Texting</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SMS/Texting</intervention_name>
    <description>SMS/Texting</description>
    <arm_group_label>Workshop + SMS/Texting</arm_group_label>
    <arm_group_label>Workshop Only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        • 7th grader enrolled in the participating schools and present at school on the days of&#xD;
        recruitment.&#xD;
&#xD;
        Exclusion criteria for each adolescent or mother seeking to enroll:&#xD;
&#xD;
          -  mother/student was not born in Jamaica&#xD;
&#xD;
          -  mother/student is not a Jamaican citizen&#xD;
&#xD;
          -  mother/student is a citizen (including dual citizen) of the United States&#xD;
&#xD;
          -  mother/student has not lived in Jamaica for the past 15 years (mother) or 8 years&#xD;
             (student)&#xD;
&#xD;
          -  mother and student do not live together&#xD;
&#xD;
          -  mother has been primary guardian for &lt;5 years&#xD;
&#xD;
          -  study screening scores show no U.S. TV usage or no affinity for the U.S. culture, and&#xD;
             very low junk food consumption&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>August 15, 2019</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>July 29, 2020</last_update_submitted>
  <last_update_submitted_qc>July 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Minnesota</investigator_affiliation>
    <investigator_full_name>Gail Marcia Ferguson</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</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/NCT04492592
org study id: 17182
nct id: NCT04492592
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The J(amaican and) U(nited) S(tates) Media? Programme is a culturally-tailored food-focused
      media literacy preventive intervention designed to promote healthier eating habits among
      remotely acculturating early adolescents and their mothers in Jamaica (i.e., they have
      internalized American culture) and are exposed to U.S. food advertising. The JUS Media?
      Programme consists of a 2-session face:face weekend workshop for adolescent-mother pairs
      supplemented by 8 weeks of SMS/text messages to reinforce workshop themes. Adolescents and
      their mothers learn critical thinking skills to combat the unhealthy food messages they
      encounter in food advertising, particularly advertising on U.S. cable TV. The efficacy of the
      JUS Media? Programme was evaluated with a small experimental study utilizing a randomized
      controlled trial design among adolescents and mothers in Jamaica.
The Western diet is common in the United States and has a lot of salt, sugar, and fat. Modern
      globalization has shifted eating habits in many countries toward this unhealthy Western diet.
      For example, U.S. cable TV in other countries promotes this Western diet through
      advertisements for junk foods and sugary drinks. This is a major concern because experimental
      research studies show that seeing food advertising while watching TV leads to eating more
      food afterwards. Research studies also show that people who watch a lot of TV tend to think
      that junk food is not that harmful.

      Researchers now believe that some people living outside the U.S. are drawn to the U.S.
      culture and lifestyle and can become "Americanized" through a process called remote
      acculturation. These Americanized people in other countries such as Jamaica are mostly
      teenagers, but sometimes also adults. Americanized people outside the United States are even
      more likely to adopt the unhealthy Western diet even though they have never lived in the
      United States. In research the investigators did before getting this grant, they showed that
      Americanized youth and mothers in Jamaica watched more hours of U.S. cable daily and also ate
      more unhealthy food. This led them to develop a new healthy eating education program for
      Americanized families in Jamaica that highlighted the role of U.S. media - the "J(amaican)
      U(nited) S(tates) Media? Programme". The JUS Media? Programme teaches young people and
      mothers to question the health messages in food advertising on U.S. cable TV so that they can
      be smarter and healthier consumers. For example, the JUS Media? Programme covers the
      recommended food guidelines in Jamaica and teaches adolescents and their mothers the
      principles of media literacy, such as to think about "who is the source of this message?"
      "what do they want you to do?" and "what information is missing?". Finally, the JUS Media?
      Programme teaches participants to use these media literacy principles to challenge unhealthy
      food advertisements by creating smart, funny parody versions called subvertisements.

      In this project,the investigators evaluated how well the JUS Media? Programme worked for 7th
      graders and their mothers in Jamaica. About 30 adolescents and their mothers got a 2-session
      workshop, another 30 families got the workshop and text messages, and another 30 families did
      not get any part of the program.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: Single (Participant)
masking description: Participants were not told what arm of the intervention they were in (i.e., they were not told if they were receiving the intervention or not).
measure: Changes in Dietary Intake Using a 24-Hour Recall Method
time frame: 4 measurement points: baseline, 4 weeks, 6 weeks, 17-20 weeks (study ended at this final timepoint).
description: 24-Hour Recall. Each participant reported detailed information on all foods and beverages consumed in the previous 24 hours via structured interviews with open-ended responses over the phone, and reported dietary intake was coded into coded for the presence (1) or absence (0) of fruits, raw vegetables, cooked vegetables, fats/oils, and sugary foods/beverages (aligning with the major national food groups of the population studied).
measure: CHANGE IN STAGE OF CHANGE TOWARDS HEALTHY EATING
time frame: 4 measurement points: baseline, 4 weeks, 6 weeks, 17-20 weeks (study ended at this final timepoint).
description: A stages of change measure of healthy eating (Wright et al., 2015) was adapted to measure participants' adherence to 5 additional food-based dietary guidelines of the Jamaica Ministry of Health. Participants reported their adherence to each dietary guideline using a 1-6 likert type scale ranging from 1 "precontemplation stage (No, and I do not intend to [insert wording from guideline]...in the next 6 months" to 6 "total abstinence (I do not consume...[insert wording from guideline)." Higher scores on this scale represent being closer to one's healthy eating goal.
measure: CHANGE IN FOOD-FOCUSED MEDIA LITERACY
time frame: 4 measurement points: baseline, 4 weeks, 6 weeks, 17-20 weeks (study ended at this final timepoint).
description: Food-focused media literacy was measured with a 14-item scale (Powell & Gross, 2018). Participants responded on a 4-point likert type scale ranging from 1 (strongly disagree) to 4 (strongly agree). Higher scores on this scale represent higher food-focused media literacy.
arm group label: Workshop Only
arm group type: Experimental
description: 2 session weekend face:face workshop for adolescent-mother pairs
arm group label: Workshop + SMS/Texting
arm group type: Experimental
description: 2 session weekend face:face workshop for adolescent-mother pairs followed by 8 weeks of supplementary text messages (NOTE: there was no 'SMS/texting-only' arm of this study)
arm group label: Control
arm group type: No Intervention
description: No intervention provided.
intervention type: Behavioral
intervention name: Workshop
description: Workshop
arm group label: Workshop + SMS/Texting
intervention type: Behavioral
intervention name: SMS/Texting
description: SMS/Texting
arm group label: Workshop + SMS/Texting
arm group label: Workshop Only
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: University of Minnesota
investigator full name: Gail Marcia Ferguson
investigator title: Associate Professor
mesh term: Malnutrition
sharing ipd: No