xml: <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/NCT06009575</url>
    </required_header>
    <id_info>
      <org_study_id>US</org_study_id>
      <nct_id>NCT06009575</nct_id>
    </id_info>
    <brief_title>Local Culture-Based Nutrition Education Intervention on Iron Supplement Tablets (IST) Consumption Compliance in Female Adolescents at Ogan Komering Ilir Regency: A Quasi-Experimental Protocol Study</brief_title>
    <official_title>Local Culture-Based Nutrition Education Intervention on Iron Supplement Tablets (IST) Consumption Compliance in Female Adolescents at Ogan Komering Ilir Regency: A Quasi-Experimental Protocol Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universitas Sriwijaya</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Indonesia University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Universitas Sriwijaya</source>
    <oversight_info>
      <has_dmc>Yes</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>
        The goal of this clinical trial is to test the impact of a local culture-based nutritional&#xD;
        education intervention on IST consumption compliance among female adolescents in the Ogan&#xD;
        Komering Ilir Regency. The main questions it aims to answer are:&#xD;
  &#xD;
        a To identify information for the development of a local culture-based nutrition education&#xD;
        model and to build a ready-to-implement local culture-based nutrition education model.&#xD;
  &#xD;
        b. To evaluate the implementation of the Anemia Prevention and Control Program among female&#xD;
        adolescents in Ogan Komering Ilir Regency.&#xD;
  &#xD;
        c. To test the impact of the local culture-based nutrition education model on the improvement&#xD;
        of knowledge, attitude, and IST consumption compliance among female adolescents.&#xD;
  &#xD;
        Participants will received IST and local culture-based nutrition education. Researchers will&#xD;
        compare control group received IST as the Ministry of Health's program for the prevention of&#xD;
        anemia with a subsidy for providing IST&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">July 1, 2021</start_date>
    <completion_date type="Actual">January 31, 2022</completion_date>
    <primary_completion_date type="Actual">January 31, 2022</primary_completion_date>
    <phase>Phase 3</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>Prevention</primary_purpose>
      <masking>Triple (Participant, Care Provider, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Educational Intervention</measure>
      <time_frame>12 Weeks</time_frame>
      <description>The local culture to be used was based on the results of a qualitative study conducted prior to the intervention, where Kelakar Betok is the local culture preferred by female adolescents, used as a means of nutrition education. Subsequently, the social media used in nutrition education publicity is Instagram. Nutrition education is provided in the form of educational videos based on local culture broadcasted through the Instagram account @remaja.bebasanemia.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Iron Supplement Tablet (IST) Administration</measure>
      <time_frame>16 Weeks</time_frame>
      <description>The IST used as an intervention consists of IST containing 60 mg FeSO4 and 400 mcg of folic acid, which is a government program. The program policy for administering IST to female adolescents is carried out once a week in the year, which was given in a blanket approach. This supplementation was carried out at educational institutions. The schools that receive iron tablets are Junior High Schools and Senior High Schools</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">126</enrollment>
    <condition>Anemia</condition>
    <condition>Iron Deficiency Anemia</condition>
    <arm_group>
      <arm_group_label>intervention group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Iron Supplement Tablets</intervention_name>
      <description>The intervention group received IST and local culture-based nutrition education</description>
      <arm_group_label>control group</arm_group_label>
      <arm_group_label>intervention group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  public schools have received the IST program from the government, and the distance&#xD;
               between schools is at least 10 kilometers&#xD;
  &#xD;
            -  students enrolled in grade 11, age range 15-17 years, menstruating, owning a&#xD;
               smartphone, having an Instagram account, and obtaining parental approval to&#xD;
               participate in this study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  schools that are currently the object of another study and are difficult to reach&#xD;
               (remote areas)&#xD;
  &#xD;
            -  students who have a BMI value≤ -3 SD and do not watch complete educational videos for&#xD;
               the sample in the intervention group&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>11 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Anita Rahmiwati</name>
        <address>
          <city>Palembang</city>
          <state>South Sumatera</state>
          <zip>30139</zip>
          <country>Indonesia</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Indonesia</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 19, 2023</last_update_submitted>
    <last_update_submitted_qc>August 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Universitas Sriwijaya</investigator_affiliation>
      <investigator_full_name>Anita Rahmiwati</investigator_full_name>
      <investigator_title>Dr</investigator_title>
    </responsible_party>
    <keyword>anemia</keyword>
    <keyword>Iron Supplement Tablets</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Anemia</mesh_term>
      <mesh_term>Anemia, Iron-Deficiency</mesh_term>
      <mesh_term>Iron Deficiencies</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>Study Protocol Statistical Analysis Plan (SAP)</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06009575
  org study id: US
  nct id: NCT06009575
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to test the impact of a local culture-based nutritional
        education intervention on IST consumption compliance among female adolescents in the Ogan
        Komering Ilir Regency. The main questions it aims to answer are:
  
        a To identify information for the development of a local culture-based nutrition education
        model and to build a ready-to-implement local culture-based nutrition education model.
  
        b. To evaluate the implementation of the Anemia Prevention and Control Program among female
        adolescents in Ogan Komering Ilir Regency.
  
        c. To test the impact of the local culture-based nutrition education model on the improvement
        of knowledge, attitude, and IST consumption compliance among female adolescents.
  
        Participants will received IST and local culture-based nutrition education. Researchers will
        compare control group received IST as the Ministry of Health's program for the prevention of
        anemia with a subsidy for providing IST
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Triple (Participant, Care Provider, Investigator)
  measure: Educational Intervention
  time frame: 12 Weeks
  description: The local culture to be used was based on the results of a qualitative study conducted prior to the intervention, where Kelakar Betok is the local culture preferred by female adolescents, used as a means of nutrition education. Subsequently, the social media used in nutrition education publicity is Instagram. Nutrition education is provided in the form of educational videos based on local culture broadcasted through the Instagram account @remaja.bebasanemia.
  measure: Iron Supplement Tablet (IST) Administration
  time frame: 16 Weeks
  description: The IST used as an intervention consists of IST containing 60 mg FeSO4 and 400 mcg of folic acid, which is a government program. The program policy for administering IST to female adolescents is carried out once a week in the year, which was given in a blanket approach. This supplementation was carried out at educational institutions. The schools that receive iron tablets are Junior High Schools and Senior High Schools
  arm group label: intervention group
  arm group type: Experimental
  arm group label: control group
  arm group type: Active Comparator
  intervention type: Dietary Supplement
  intervention name: Iron Supplement Tablets
  description: The intervention group received IST and local culture-based nutrition education
  arm group label: control group
  arm group label: intervention group
  criteria: 
  gender: Female
  minimum age: 11 Years
  maximum age: 18 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Indonesia
  responsible party type: Principal Investigator
  investigator affiliation: Universitas Sriwijaya
  investigator full name: Anita Rahmiwati
  investigator title: Dr
  mesh term: Anemia
  mesh term: Anemia, Iron-Deficiency
  mesh term: Iron Deficiencies
  sharing ipd: Undecided
  ipd description: Study Protocol Statistical Analysis Plan (SAP)