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Family Mid-Upper Arm Circumference (MUAC) Follow-up After Recovery From Acute Malnutrition (MODAM-fMUAC) (MODAM-fMUAC)

Primary Purpose

Severe Acute Malnutrition, Moderate Acute Malnutrition

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
nutrition, IYCF, WASH education
scheduled anthropometric screening
family MUAC
Sponsored by
Action Against Hunger USA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Severe Acute Malnutrition

Eligibility Criteria

6 Months - 59 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: children 6-59 months of old who recovered from SAM or MAM following treatment in either the MODAM-SAM or MODAM-MAM trials Exclusion Criteria: caregiver not planning on remaining in the local area for the subsequent 6 months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Experimental

    Arm Label

    Control Group

    scheduled followup

    family MUAC

    Arm 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

    standard of care plus scheduled follow-up visits at 1 month, 3 months, 6 months after discharge

    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

    Outcomes

    Primary Outcome Measures

    number of episodes of relapse to acute malnutrition identified

    Secondary Outcome Measures

    weight-for-height Z-score (WHZ) at time relapse to acute malnutrition identified
    mid-upper arm circumference (MUAC) at time relapse to acute malnutrition identified
    number of episodes of relapse to edematous malnutrition / kwashiorkor identified
    recovery rates following treatment of relapse to acute malnutrition
    mortality
    hospitalization
    loss to follow-up

    Full Information

    First Posted
    September 8, 2023
    Last Updated
    September 14, 2023
    Sponsor
    Action Against Hunger USA
    Collaborators
    University of Washington, Ethiopian Public Health Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06038071
    Brief Title
    Family Mid-Upper Arm Circumference (MUAC) Follow-up After Recovery From Acute Malnutrition (MODAM-fMUAC)
    Acronym
    MODAM-fMUAC
    Official Title
    Efficacy and Safety of Family Mid-upper Arm Circumference (MUAC) After Recovery From Severe and Moderate Acute Malnutrition
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 25, 2023 (Anticipated)
    Primary Completion Date
    September 25, 2026 (Anticipated)
    Study Completion Date
    September 25, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Action Against Hunger USA
    Collaborators
    University of Washington, Ethiopian Public Health Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Severe Acute Malnutrition, Moderate Acute Malnutrition

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    3600 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Group
    Arm Type
    Active Comparator
    Arm 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 Title
    scheduled followup
    Arm Type
    Active Comparator
    Arm Description
    standard of care plus scheduled follow-up visits at 1 month, 3 months, 6 months after discharge
    Arm Title
    family MUAC
    Arm Type
    Experimental
    Arm 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(s)
    nutrition, IYCF, WASH education
    Intervention Description
    nutrition, IYCF, WASH education
    Intervention Type
    Other
    Intervention Name(s)
    scheduled anthropometric screening
    Intervention Description
    anthropometric screening by health care workers at 1, 3, and 6 months
    Intervention Type
    Other
    Intervention Name(s)
    family MUAC
    Intervention Description
    family MUAC training for the primary caregiver present at the time of recovery
    Primary Outcome Measure Information:
    Title
    number of episodes of relapse to acute malnutrition identified
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    weight-for-height Z-score (WHZ) at time relapse to acute malnutrition identified
    Time Frame
    6 months
    Title
    mid-upper arm circumference (MUAC) at time relapse to acute malnutrition identified
    Time Frame
    6 months
    Title
    number of episodes of relapse to edematous malnutrition / kwashiorkor identified
    Time Frame
    6 months
    Title
    recovery rates following treatment of relapse to acute malnutrition
    Time Frame
    6 months
    Title
    mortality
    Time Frame
    6 months
    Title
    hospitalization
    Time Frame
    6 months
    Title
    loss to follow-up
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Maximum Age & Unit of Time
    59 Months
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: children 6-59 months of old who recovered from SAM or MAM following treatment in either the MODAM-SAM or MODAM-MAM trials Exclusion Criteria: caregiver not planning on remaining in the local area for the subsequent 6 months
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Indi Trehan
    Phone
    +12067696068
    Email
    itrehan@uw.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Heather C Stobaugh
    Organizational Affiliation
    Action Against Hunger USA
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Indi Trehan, MD MPH DTM&H
    Organizational Affiliation
    University of Washington
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Yosef B Asefaw, MSc
    Organizational Affiliation
    Ethiopian Public Health Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

    Family Mid-Upper Arm Circumference (MUAC) Follow-up After Recovery From Acute Malnutrition (MODAM-fMUAC)

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