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

Study Overview
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Brief Summary
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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.

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

Conditions
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Severe Acute Malnutrition, Moderate Acute Malnutrition

Intervention / Treatment
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* Other: nutrition, IYCF, WASH education
* Other: scheduled anthropometric screening
* Other: family MUAC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 59 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>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<br>* nutrition, IYCF, WASH education<br>|
| Active Comparator: scheduled followup<br>standard of care plus scheduled follow-up visits at 1 month, 3 months, 6 months after discharge | Other: nutrition, IYCF, WASH education<br>* nutrition, IYCF, WASH education<br>Other: scheduled anthropometric screening<br>* anthropometric screening by health care workers at 1, 3, and 6 months<br>|
| Experimental: family MUAC<br>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<br>* nutrition, IYCF, WASH education<br>Other: family MUAC<br>* family MUAC training for the primary caregiver present at the time of recovery<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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