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NCT Number: NCT06038071

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

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.

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Key information

Conditions

Severe Acute Malnutrition Malnutrition Moderate Acute Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

6 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sekota, Amhara, Ethiopia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nutrition, IYCF, WASH education

Other

nutrition, IYCF, WASH education

scheduled anthropometric screening

Other

anthropometric screening by health care workers at 1, 3, and 6 months

family MUAC

Other

family MUAC training for the primary caregiver present at the time of recovery

Primary outcomes

  1. number of episodes of relapse to acute malnutrition identified

    Time frame: 6 months

Secondary outcomes

  1. weight-for-height Z-score (WHZ) at time relapse to acute malnutrition identified

    Time frame: 6 months

  2. mid-upper arm circumference (MUAC) at time relapse to acute malnutrition identified

    Time frame: 6 months

  3. number of episodes of relapse to edematous malnutrition / kwashiorkor identified

    Time frame: 6 months

  4. recovery rates following treatment of relapse to acute malnutrition

    Time frame: 6 months

  5. mortality

    Time frame: 6 months

  6. hospitalization

    Time frame: 6 months

  7. loss to follow-up

    Time frame: 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Indi Trehan

CONTACT

[email protected]

+12067696068

Sponsors and collaborators

Lead sponsor

Action Against Hunger USA

Other

Collaborators

  • Ethiopian Public Health Institute
  • University of Washington

Registry information

Official study title

Efficacy and Safety of Family Mid-upper Arm Circumference (MUAC) After Recovery From Severe and Moderate Acute Malnutrition

Acronym: MODAM-fMUAC

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 14, 2023
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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