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

Action Against Hunger USA

Status: Enrolling

Conditions: Severe Acute Malnutrition; Moderate Acute Malnutrition

Treatments: Other: family MUAC; Other: nutrition, IYCF, WASH education; Other: scheduled anthropometric screening

Study type: Interventional

Funder types: Other

Identifiers

NCT06038071

MODAM-fMUAC

Details and patient eligibility

About

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.

Enrollment: 3,600 estimated patients

Sex: All

Ages: 6 to 59 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

3,600 participants in 3 patient groups

Control Group

Active Comparator group

Description:

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

Treatment:

Other: nutrition, IYCF, WASH education

scheduled followup

Active Comparator group

Description:

standard of care plus scheduled follow-up visits at 1 month, 3 months, 6 months after discharge

Treatment:

Other: scheduled anthropometric screening

Other: nutrition, IYCF, WASH education

family MUAC

Experimental group

Description:

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

Treatment:

Other: nutrition, IYCF, WASH education

Other: family MUAC