Reduced Dosage and/or Visitation Protocol for the Treatment of Acute Malnutrition in Kenya

N/ANot Yet RecruitingNCT07420062

International Food Policy Research Institute2,274 enrolled

Overview

Severe acute malnutrition (SAM) places children at significant risk of mortality. Outpatient treatment programs are effective but there is a need to increase treatment coverage and reduce costs of treatment. Reducing the dosage of therapeutic food products and/or reducing visitation required by caregivers may be beneficial but evidence is limited on the treatment outcomes and costs of these approaches. This study will compare two dosage options (full vs reduced dosages) of the World Health Organization protocol for the treatment of SAM and high-risk moderate acute malnutrition (HR-MAM) to each other and to the Kenya national protocol (which involves reducing dosage, changing treatment product, and reducing visitation schedule during the course of the treatment once the SAM child reaches the criteria for moderate acute malnutrition before recovery), in terms of treatment performance and cost. We will conduct a cluster-randomized controlled trial including 45 facilities in Samburu, West Pokot, and Wajir sub-counties. Children 6-59 months old being admitted into outpatient treatment programs for SAM or HR-MAM will be enrolled. Outcomes will be recovery, default, death, transfer, and non-response rates; treatment adherence; mean amount of therapeutic products needed for recovery; mean length of stay; and anthropometry at discharge. We will conduct a costing study in which we will estimate the costs per child admitted into treatment and cost per treated child recovered. We will estimate the non-inferiority of each of the two WHO protocol dosage options (full vs reduced) compared to the Kenya national protocol, and of the two WHO protocol options compared to each other (full vs reduced). Enrollment will begin in early 2026, and continue for 10 months. We will also conduct an observational sub-study documenting outcomes on children with MAM but who are not considered high risk in a sub-set of study facilities. Evidence generated from the study will identify the optimal treatment strategy for better treatment performance and lower cost, providing policymakers in Kenya and across the globe with high-quality evidence to inform policy change.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Interventions

WHO-reducedOTHER

Children will receive the full, weight-based dosage of RUTF (150-185 kcal/kg/day) until the resolution of severe wasting, followed by a shift to reduced dosage (100-130 kcal/kg/day) until recovery. Treatment visits will be weekly until recovery.

WHO-fullOTHER

Children will receive the continuous full, weight-based dosage of 150-185 kcal/kg/day until recovery. Visits will be weekly until recovery.

Kenya-IMAMOTHER

Children will receive the Kenya Integrated Management of Acute Malnutrition protocol for treatment. In this protocol, children will receive the weight-based dosing RUTF during treatment while they meet the SAM criteria (150-185 kcal/kg/day) and then 1 sachet RUSF for SAM children meeting the MAM criteria on the recovery period. Visits will be weekly during the SAM phase, and bi-weekly during the MAM phase.

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 59 Months

Medical Language ↔ Plain English

Inclusion Criteria: * 6-59.9 months of age at admission into treatment * Child admitted to the national treatment program according to the following criteria: * For SAM: WHZ \<-3 or MUAC \<115 mm or presence of bilateral oedema, absence of clinical complications, pass the appetite test * For high-risk MAM: -3 ≥ WHZ \<-2 or 115mm ≥ MUAC \<125 mm, and one or more of the following factors: MUAC of 115-119 mm, weight-for-age z-score (WAZ) \< -3, age \< 24 months, failing to recover from MAM after receiving other interventions (e.g. counselling, nutrient dense diet), relapse, history of SAM, co-morbidity (medical problems needing mid- or long-term follow-up care, and with a significant association with nutritional status, such as HIV, tuberculosis, or a physical or mental disability) * Accompanied by caregiver or legal guardian * Caregiver or legal guardian consents to participate Exclusion Criteria: * SAM requiring hospitalization (presence of clinical complications, failure to pass the appetite test, or presence of bilateral pitting edema) * Enrolled in MAM or SAM treatment program before implementation of the treatment protocols to which the facilities were randomized * Presence of physical abnormalities that make measurement of anthropometry impossible * Caregiver has intention to move out of the study area within the next 3 months

Outcomes

Primary Outcomes

Anthropometric recovery

The number of discharges considered cured (WHZ ≥ -2 and MUAC ≥ 125 mm and absence of bilateral edema for two consecutive visits, within 12 weeks of enrollment in the program) divided by the total number of discharges recorded.

Time frame: Within 12 weeks of enrollment in the treatment program

Secondary Outcomes

Non-response

the number of children who failed to meet recovery criteria after 4 months in the program, divided by the total number of children admitted into treatment

Time frame: Within 12 weeks of enrollment in the treatment program

Transfer

the number of children transferred to inpatient care or outpatient therapeutic care during the course of treatment, divided by the total number of children admitted into treatment

Time frame: within 12 weeks of enrollment into the treatment program

Default rate

the number of children who were absent from three consecutive weekly visits during treatment, divided by the total number of children admitted into treatment

Time frame: Within 12 weeks of enrollment into the treatment program

Relapse

admission for a new episode of either MAM or SAM within 2 months of recovery from a previous episode.

Time frame: Within 2 months of recovery from a previous episode

Weight gain velocity

grams per kilogram of body weight per day gained during treatment

Time frame: Between enrollment into the treatment program and discharge (which is up to 12 weeks after enrollment into the treatment program)

Length of stay

number of days spent on treatment (days between admission and discharge) among children who reached anthropometric recovery

Time frame: between enrollment into the program and discharge (within 12 weeks of enrollment into the program)

Treatment adherence

the number of children enrolled for treatment who attended all study visits (i.e., who did not miss any visits) divided by the number of children admitted into treatment, among children who reached anthropometric recovery

Time frame: within 12 weeks of enrollment into the treatment program

Weight at discharge

Weight at the time of discharge from treatment

Time frame: At discharge (within 12 weeks of enrollment into the treatment program

Length/height at discharge

Length/height at the time of discharge from treatment

Time frame: At discharge (within 12 weeks of enrollment into the treatment program)

Weight-for-length/height-zscore at discharge

Weight-for-length/height-zscore at the time of discharge from treatment

Time frame: At discharge (within 12 weeks of enrollment into the treatment program)

Middle upper arm circumference at discharge

Middle upper arm circumference at the time of discharge from treatment

Time frame: At discharge (within 12 weeks of enrollment into the treatment program)

Length/height-for-age z-score at discharge

Length/height-for-age z-score at the time of discharge from treatment

Time frame: At discharge (within 12 weeks of enrollment into the treatment program)

Change in length/height at discharge

Change in length/height between enrollment and the time of discharge from treatment