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| Name | Class |
|---|---|
| University of Washington | OTHER |
| Ethiopian Public Health Institute | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| scheduled followup | Active Comparator | standard of care plus scheduled follow-up visits at 1 month, 3 months, 6 months after discharge |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nutrition, IYCF, WASH education | Other | nutrition, IYCF, WASH education |
|
| Measure | Description | Time Frame |
|---|---|---|
| number of episodes of relapse to acute malnutrition identified | 6 months |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Indi Trehan | Contact | +12067696068 | itrehan@uw.edu |
| Name | Affiliation | Role |
|---|---|---|
| Heather C Stobaugh | Action Against Hunger USA | Principal Investigator |
| Indi Trehan, MD MPH DTM&H | University of Washington | Principal Investigator |
| Yosef B Asefaw, MSc |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sekota | Not yet recruiting | Sekota | Amhara | Ethiopia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40200326 | Derived | 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. |
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| scheduled anthropometric screening | Other | anthropometric screening by health care workers at 1, 3, and 6 months |
|
| family MUAC | Other | family MUAC training for the primary caregiver present at the time of recovery |
|
| 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 |
| Ethiopian Public Health Institute |
| Principal Investigator |
| Teltele | Recruiting | Teltelē | Oromiya | Ethiopia |
|
| Gode | Recruiting | Gode | Somali | Ethiopia |
|
| ID | Term |
|---|---|
| D000067011 | Severe Acute Malnutrition |
| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D009752 | Nutritional Status |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D006304 | Health Status |
| D003710 | Demography |
| D011154 | Population Characteristics |
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