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

NCT06038071 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3600

Last updated 2024-07-16

No results posted yet for this study

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.

Conditions

  • Severe Acute Malnutrition
  • Moderate Acute Malnutrition

Interventions

OTHER

nutrition, IYCF, WASH education

nutrition, IYCF, WASH education

OTHER

scheduled anthropometric screening

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

OTHER

family MUAC

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

Sponsors & Collaborators

  • University of Washington

    collaborator OTHER
  • Ethiopian Public Health Institute

    collaborator OTHER_GOV
  • Action Against Hunger USA

    lead OTHER

Principal Investigators

  • Heather C Stobaugh · Action Against Hunger USA

  • Indi Trehan, MD MPH DTM&H · University of Washington

  • Yosef B Asefaw, MSc · Ethiopian Public Health Institute

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-25
Primary Completion
2026-09-25
Completion
2026-09-25

Countries

  • Ethiopia

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06038071 on ClinicalTrials.gov