Impact of timing of RUTF dose reduction and visit frequency on acute malnutrition treatment effectiveness in Mali: A 2x2 Factorial Cluster-Randomized Controlled Trial

ABSTRACT Background Severe acute malnutrition (SAM) among children under 5 years of age is generally treated in outpatient settings providing caregivers with weekly ready-to-use therapeutic food (RUTF) rations to be administered at home. Recent updates to global treatment guidelines suggest that RUTF dose can be reduced once children progress to moderate stage (MAM). No evidence exists on the optimal timing of the dosage reduction or on ideal visit frequency. Objectives We aimed to test the impact of 1) immediate RUTF dose reduction (1a) versus including a 2-week transition (1b) among children admitted with SAM and 2) fortnightly (2a) versus weekly (2b) visit frequency during MAM phase among children admitted with SAM and MAM. Methods and findings This prospective cluster-randomized controlled non-inferiority trial followed a 2 x 2 factorial design and divided 39 health areas (clusters) of Nara, Mali, into 4 groups implementing: A) 1a+2a B) 1a+2b, C) 1b+2a, and D) 1b+2b. Simplified, combined treatment was used providing 2 daily RUTF sachets to children admitted as SAM (mid-upper arm-circumference=MUAC