Clinical trial NCT06038071: Family Mid-Upper Arm Circumference (MUAC) Follow-up After Recovery From Acute Malnutrition (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
Overall status: RECRUITING
Phase: NA
Conditions: Severe Acute Malnutrition
Moderate Acute Malnutrition
Lead sponsor: Action Against Hunger USA
Sponsor class: OTHER
Collaborators: name: University of Washington
name: Ethiopian Public Health Institute
First posted: 2023-09-14
Enrollment: 3600
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: number of episodes of relapse to acute malnutrition identified
timeFrame: 6 months
Secondary outcomes:
measure: weight-for-height Z-score (WHZ) at time relapse to acute malnutrition identified
timeFrame: 6 months
measure: mid-upper arm circumference (MUAC) at time relapse to acute malnutrition identified
timeFrame: 6 months
measure: number of episodes of relapse to edematous malnutrition / kwashiorkor identified
timeFrame: 6 months
measure: recovery rates following treatment of relapse to acute malnutrition
timeFrame: 6 months
measure: mortality
timeFrame: 6 months
measure: hospitalization
timeFrame: 6 months
measure: loss to follow-up
timeFrame: 6 months
Other outcomes:
Locations:
city: Sekota
country: Ethiopia
facility: Sekota
state: Amhara
city: Teltele
country: Ethiopia
facility: Teltele
state: Oromia
city: Gode
country: Ethiopia
facility: Gode
state: Somali Region
Study officials:
affiliation: Action Against Hunger USA
name: Heather C Stobaugh
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Indi Trehan, MD MPH DTM&H
role: PRINCIPAL_INVESTIGATOR
affiliation: Ethiopian Public Health Institute
name: Yosef B Asefaw, MSc
role: PRINCIPAL_INVESTIGATOR
References: