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

NCT06038071 | Recruiting DMC

• 1 other identifier: MODAM-fMUAC
• Study Type: interventional
• Target: 3,600
• Locations: 1 country
• Sites: 3

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.

Conditions

Severe Acute Malnutrition; Moderate Acute Malnutrition

Outcome Measures

Primary Outcomes (1)

• number of episodes of relapse to acute malnutrition identified

  6 months

Secondary Outcomes (7)

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

  6 months

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

  6 months

• number of episodes of relapse to edematous malnutrition / kwashiorkor identified

  6 months

• recovery rates following treatment of relapse to acute malnutrition

  6 months

• mortality

  6 months

Study Arms (3)

Control Group

ACTIVE COMPARATOR

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

Other: nutrition, IYCF, WASH education

scheduled followup

ACTIVE COMPARATOR

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

Other: nutrition, IYCF, WASH education; Other: scheduled anthropometric screening

family MUAC

EXPERIMENTAL

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

Other: nutrition, IYCF, WASH education; Other: family MUAC

Interventions

nutrition, IYCF, WASH education OTHER

nutrition, IYCF, WASH education

Control Group; family MUAC; scheduled followup

scheduled anthropometric screening OTHER

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

scheduled followup

family MUAC OTHER

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

family MUAC

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children 6-59 months of old who recovered from SAM or MAM following treatment in either the MODAM-SAM or MODAM-MAM trials

You may not qualify if:

• caregiver not planning on remaining in the local area for the subsequent 6 months

Sponsors & Collaborators

• Action Against Hunger USA: lead
• University of Washington: collaborator
• Ethiopian Public Health Institute: collaborator

Study Sites (3)

Sekota

Sekota, Amhara, Ethiopia

NOT YET RECRUITING

Teltele

Teltelē, Oromiya, Ethiopia

RECRUITING

Gode

Gode, Somali, Ethiopia

RECRUITING

Related Publications (1)

• Trehan I, Beyene Y, Darsene H, Adams BS, Wrabel M, Gizaw G, Legese LA, Cichon B, Chitekwe S, Shellemew MW, Tessema M, Stobaugh HC. The Modified Dosages for Acute Malnutrition (MODAM) study: protocol for three integrated randomized controlled trials of novel approaches for the management of childhood wasting in Ethiopia. BMC Nutr. 2025 Apr 8;11(1):71. doi: 10.1186/s40795-025-01054-w.

  PMID: 40200326 DERIVED

MeSH Terms

Conditions

Severe Acute Malnutrition

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Officials

• Heather C Stobaugh

  Action Against Hunger USA

  PRINCIPAL INVESTIGATOR

• Indi Trehan, MD MPH DTM&H

  University of Washington

  PRINCIPAL INVESTIGATOR

• Yosef B Asefaw, MSc

  Ethiopian Public Health Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Indi Trehan

CONTACT

+12067696068; itrehan@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research and Learning Specialist

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 14, 2023
• Study Start: September 25, 2023
• Primary Completion (Estimated): September 25, 2026
• Study Completion (Estimated): September 25, 2026
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share

Locations

ET (3)