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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Moderate Acute Malnutrition; Severe Acute Malnutrition
• Intervention / Treatment: Other: nutrition, IYCF, WASH education; Other: scheduled anthropometric screening; Other: family MUAC

• Study Type: Interventional
• Enrollment (Estimated): 3600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Indi Trehan; Phone Number: +12067696068; Email: itrehan@uw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group; 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; nutrition, IYCF, WASH education
Active Comparator: scheduled followup; standard of care plus scheduled follow-up visits at 1 month, 3 months, 6 months after discharge	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
Experimental: family MUAC; 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; nutrition, IYCF, WASH education; Other: family MUAC; family MUAC training for the primary caregiver present at the time of recovery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
number of episodes of relapse to acute malnutrition identified	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
mortality	6 months
hospitalization	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
loss to follow-up	6 months
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

Collaborators and Investigators

• Sponsor: Action Against Hunger USA
• Collaborators: University of Washington; Ethiopian Public Health Institute
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Estimated): September 25, 2023
• Primary Completion (Estimated): September 25, 2026
• Study Completion (Estimated): September 25, 2026

Study Registration Dates

• First Submitted: September 8, 2023
• First Submitted That Met QC Criteria: September 8, 2023
• First Posted (Actual): September 14, 2023

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 14, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Severe Acute Malnutrition
• Other Study ID Numbers: MODAM-fMUAC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No