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/NCT06038071</url>
    </required_header>
    <id_info>
      <org_study_id>MODAM-fMUAC</org_study_id>
      <nct_id>NCT06038071</nct_id>
    </id_info>
    <brief_title>Family Mid-Upper Arm Circumference (MUAC) Follow-up After Recovery From Acute Malnutrition (MODAM-fMUAC)</brief_title>
    <acronym>MODAM-fMUAC</acronym>
    <official_title>Efficacy and Safety of Family Mid-upper Arm Circumference (MUAC) After Recovery From Severe and Moderate Acute Malnutrition</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Action Against Hunger USA</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Washington</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Ethiopian Public Health Institute</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Action Against Hunger USA</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>
        Protocols for the community-based management of acute malnutrition (CMAM) have not changed&#xD;
        significantly for more than 20 years, with relatively complex treatment protocols and&#xD;
        persistent supply chain challenges that have limited overall program coverage, leaving&#xD;
        millions of malnourished children without care annually. The overarching goal of this&#xD;
        research project is to simultaneously test two novel simplified approaches in CMAM with&#xD;
        potential to improve program coverage. The simplified approach includes two parallel clinical&#xD;
        trials for SAM and MAM treatment. For the Family MUAC follow-up study, children who recover&#xD;
        from these two parallel clinical trials will be enrolled in trial to test the effectiveness&#xD;
        of MUAC screening at home by the child's caregivers as a self-referral strategy, compared to&#xD;
        a scheduled health facility-led strategy and the standard of care of community-based&#xD;
        follow-up visits.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 25, 2023</start_date>
    <completion_date type="Anticipated">September 25, 2026</completion_date>
    <primary_completion_date type="Anticipated">September 25, 2026</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>Diagnostic</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>number of episodes of relapse to acute malnutrition identified</measure>
      <time_frame>6 months</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>weight-for-height Z-score (WHZ) at time relapse to acute malnutrition identified</measure>
      <time_frame>6 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>mid-upper arm circumference (MUAC) at time relapse to acute malnutrition identified</measure>
      <time_frame>6 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>number of episodes of relapse to edematous malnutrition / kwashiorkor identified</measure>
      <time_frame>6 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>recovery rates following treatment of relapse to acute malnutrition</measure>
      <time_frame>6 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>mortality</measure>
      <time_frame>6 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>hospitalization</measure>
      <time_frame>6 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>loss to follow-up</measure>
      <time_frame>6 months</time_frame>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">3600</enrollment>
    <condition>Severe Acute Malnutrition</condition>
    <condition>Moderate Acute Malnutrition</condition>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>nutrition, IYCF, and WASH education at discharge, followed by regular community-based screenings led by health extension workers, with one final visit scheduled at 6 months after discharge</description>
    </arm_group>
    <arm_group>
      <arm_group_label>scheduled followup</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>standard of care plus scheduled follow-up visits at 1 month, 3 months, 6 months after discharge</description>
    </arm_group>
    <arm_group>
      <arm_group_label>family MUAC</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>standard of care plus Family MUAC training for the primary caregiver present at the time of recovery, with one final visit scheduled at 6 months after discharge</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>nutrition, IYCF, WASH education</intervention_name>
      <description>nutrition, IYCF, WASH education</description>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_label>family MUAC</arm_group_label>
      <arm_group_label>scheduled followup</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>scheduled anthropometric screening</intervention_name>
      <description>anthropometric screening by health care workers at 1, 3, and 6 months</description>
      <arm_group_label>scheduled followup</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>family MUAC</intervention_name>
      <description>family MUAC training for the primary caregiver present at the time of recovery</description>
      <arm_group_label>family MUAC</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  children 6-59 months of old who recovered from SAM or MAM following treatment in&#xD;
               either the MODAM-SAM or MODAM-MAM trials&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  caregiver not planning on remaining in the local area for the subsequent 6 months&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Months</minimum_age>
      <maximum_age>59 Months</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Heather C Stobaugh</last_name>
      <role>Principal Investigator</role>
      <affiliation>Action Against Hunger USA</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Indi Trehan, MD MPH DTM&amp;H</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Washington</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Yosef B Asefaw, MSc</last_name>
      <role>Principal Investigator</role>
      <affiliation>Ethiopian Public Health Institute</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Indi Trehan</last_name>
      <phone>+12067696068</phone>
      <email>itrehan@uw.edu</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Action Against Hunger USA</investigator_affiliation>
      <investigator_full_name>Heather Stobaugh</investigator_full_name>
      <investigator_title>Senior Research and Learning Specialist</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Malnutrition</mesh_term>
      <mesh_term>Severe Acute Malnutrition</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
    </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/NCT06038071
  org study id: MODAM-fMUAC
  nct id: NCT06038071
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Protocols for the community-based management of acute malnutrition (CMAM) have not changed
        significantly for more than 20 years, with relatively complex treatment protocols and
        persistent supply chain challenges that have limited overall program coverage, leaving
        millions of malnourished children without care annually. The overarching goal of this
        research project is to simultaneously test two novel simplified approaches in CMAM with
        potential to improve program coverage. The simplified approach includes two parallel clinical
        trials for SAM and MAM treatment. For the Family MUAC follow-up study, children who recover
        from these two parallel clinical trials will be enrolled in trial to test the effectiveness
        of MUAC screening at home by the child's caregivers as a self-referral strategy, compared to
        a scheduled health facility-led strategy and the standard of care of community-based
        follow-up visits.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Diagnostic
  masking: Double (Investigator, Outcomes Assessor)
  measure: number of episodes of relapse to acute malnutrition identified
  time frame: 6 months
  measure: weight-for-height Z-score (WHZ) at time relapse to acute malnutrition identified
  time frame: 6 months
  measure: mid-upper arm circumference (MUAC) at time relapse to acute malnutrition identified
  time frame: 6 months
  measure: number of episodes of relapse to edematous malnutrition / kwashiorkor identified
  time frame: 6 months
  measure: recovery rates following treatment of relapse to acute malnutrition
  time frame: 6 months
  measure: mortality
  time frame: 6 months
  measure: hospitalization
  time frame: 6 months
  measure: loss to follow-up
  time frame: 6 months
  arm group label: Control Group
  arm group type: Active Comparator
  description: nutrition, IYCF, and WASH education at discharge, followed by regular community-based screenings led by health extension workers, with one final visit scheduled at 6 months after discharge
  arm group label: scheduled followup
  arm group type: Active Comparator
  description: standard of care plus scheduled follow-up visits at 1 month, 3 months, 6 months after discharge
  arm group label: family MUAC
  arm group type: Experimental
  description: standard of care plus Family MUAC training for the primary caregiver present at the time of recovery, with one final visit scheduled at 6 months after discharge
  intervention type: Other
  intervention name: nutrition, IYCF, WASH education
  description: nutrition, IYCF, WASH education
  arm group label: Control Group
  arm group label: family MUAC
  arm group label: scheduled followup
  intervention type: Other
  intervention name: scheduled anthropometric screening
  description: anthropometric screening by health care workers at 1, 3, and 6 months
  arm group label: scheduled followup
  intervention type: Other
  intervention name: family MUAC
  description: family MUAC training for the primary caregiver present at the time of recovery
  arm group label: family MUAC
  criteria: 
  gender: All
  minimum age: 6 Months
  maximum age: 59 Months
  healthy volunteers: No
  last name: Heather C Stobaugh
  role: Principal Investigator
  affiliation: Action Against Hunger USA
  last name: Indi Trehan, MD MPH DTM&H
  role: Principal Investigator
  affiliation: University of Washington
  last name: Yosef B Asefaw, MSc
  role: Principal Investigator
  affiliation: Ethiopian Public Health Institute
  last name: Indi Trehan
  phone: +12067696068
  email: itrehan@uw.edu
  responsible party type: Principal Investigator
  investigator affiliation: Action Against Hunger USA
  investigator full name: Heather Stobaugh
  investigator title: Senior Research and Learning Specialist
  mesh term: Malnutrition
  mesh term: Severe Acute Malnutrition
  sharing ipd: Yes