Severe Acute Malnutrition, Moderate Acute Malnutrition
Conditions
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.
Interventions
OTHERnutrition, IYCF, WASH education
nutrition, IYCF, WASH education
OTHERscheduled anthropometric screening
anthropometric screening by health care workers at 1, 3, and 6 months
OTHERfamily MUAC
family MUAC training for the primary caregiver present at the time of recovery
Sponsors
University of Washington
Ethiopian Public Health Institute
Action Against Hunger USA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 59 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of episodes of relapse to acute malnutrition identified | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| weight-for-height Z-score (WHZ) at time relapse to acute malnutrition identified | 6 months |
| hospitalization | 6 months |
| loss to follow-up | 6 months |
| mortality | 6 months |
Countries
Ethiopia
Contacts
Primary ContactIndi Trehan
Outcome results
None listed