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

Not Applicable

Recruiting

• Conditions: Moderate Acute Malnutrition; Severe Acute Malnutrition
• Interventions: Other: nutrition, IYCF, WASH education; Other: scheduled anthropometric screening; Other: family MUAC

• Registration Number: NCT06038071
• Lead Sponsor: Action Against Hunger USA

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-08
• Study First Submitted QC: 2023-09-08
• Study First Posted: 2023-09-14
• Study Start: 2023-09-25
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-16
• Primary Completion: 2026-09-25
• Study Completion: 2026-09-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3600

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	nutrition, IYCF, WASH education	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
scheduled followup	scheduled anthropometric screening	standard of care plus scheduled follow-up visits at 1 month, 3 months, 6 months after discharge
scheduled followup	nutrition, IYCF, WASH education	standard of care plus scheduled follow-up visits at 1 month, 3 months, 6 months after discharge
family MUAC	nutrition, IYCF, WASH education	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
family MUAC	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

Primary Outcome Measures

Name	Time	Method
number of episodes of relapse to acute malnutrition identified	6 months

Secondary Outcome Measures

Name	Time	Method
mid-upper arm circumference (MUAC) at time relapse to acute malnutrition identified	6 months
recovery rates following treatment of relapse to acute malnutrition	6 months
hospitalization	6 months
number of episodes of relapse to edematous malnutrition / kwashiorkor identified	6 months
loss to follow-up	6 months
weight-for-height Z-score (WHZ) at time relapse to acute malnutrition identified	6 months
mortality	6 months

Trial Locations

Locations (3)

Sekota; 🇪🇹 Sekota, Amhara, Ethiopia

Gode; 🇪🇹 Gode, Somali Region, Ethiopia

Teltele; 🇪🇹 Teltele, Oromia, Ethiopia