Family Mid-Upper Arm Circumference (MUAC) Follow-up After Recovery From Acute Malnutrition (MODAM-fMUAC)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-59
SponsorAction Against Hunger USA
About this trial
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
This trial does not accept healthy volunteersQualifiers
children 6-59 months of old who recovered from SAM or MAM following treatment in either the MODAM-SAM or MODAM-MAM trials
Disqualifiers
caregiver not planning on remaining in the local area for the subsequent 6 months
Trial design
Design model
Parallel
Treatments tested in this trial
nutrition, IYCF, WASH education
Other interventionnutrition, IYCF, WASH education
scheduled anthropometric screening
Other interventionanthropometric screening by health care workers at 1, 3, and 6 months
family MUAC
Other interventionfamily MUAC training for the primary caregiver present at the time of recovery
Treatment groups
3,600 Participants
are divided into 3 treatment groupsGroup A: Control GroupActive comparator 1 intervention
Group B: scheduled followupActive comparator 2 interventions
Group C: family MUACExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
number of episodes of relapse to acute malnutrition identified
Time frame
6 monthsSecondary outcomes
1
weight-for-height Z-score (WHZ) at time relapse to acute malnutrition identified
Time frame
6 months2
mid-upper arm circumference (MUAC) at time relapse to acute malnutrition identified
Time frame
6 months3
number of episodes of relapse to edematous malnutrition / kwashiorkor identified
Time frame
6 months4
recovery rates following treatment of relapse to acute malnutrition
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Action Against Hunger USA
Lead sponsor
University of Washington
Collaborator
Ethiopian Public Health Institute
Collaborator
Source ClinicalTrials.gov