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

Research to Improve the Screening for Wasting and the Identification and Treatment of Wasted Children (R-SWITCH): Reduced Dosage and/or Visitation Protocol for the Treatment of Severe Acute Malnutrition in Kenya

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 Overview

• Status: Not yet recruiting
• Conditions: Wasting; Acute Malnutrition in Childhood; Acute Malnutrition, Severe; Acute Malnutrition, Moderate
• Intervention / Treatment: Other: WHO-reduced; Other: WHO-full; Other: Kenya-IMAM

• Study Type: Interventional
• Enrollment (Estimated): 2274
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rebecca Brander, PhD; Phone Number: 202-862-5600; Email: r.brander@cgiar.org
• Study Contact Backup: Name: Sophie Ochola, PhD; Phone Number: +254721449803; Email: ocholasa55@gmail.com

Study Locations

• Kenya
  • West Pokot County
    • Kitale, West Pokot County, Kenya
      • West Pokot, Wajir, and Samburu counties
      • Contact: Rebecca Brander; Phone Number: 202-862-5600; Email: r.brander@cgiar.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WHO-reduced; 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.	Other: WHO-reduced; 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.
Experimental: WHO-full; Children will receive the continuous full, weight-based dosage of 150-185 kcal/kg/day until recovery. Visits will be weekly until recovery.	Other: WHO-full; Children will receive the continuous full, weight-based dosage of 150-185 kcal/kg/day until recovery. Visits will be weekly until recovery.
Active Comparator: Kenya-IMAM; 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.	Other: Kenya-IMAM; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within 12 weeks of enrollment in the treatment program

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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.	Within 2 months of recovery from a previous episode
Weight gain velocity	grams per kilogram of body weight per day gained during treatment	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	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	within 12 weeks of enrollment into the treatment program
Weight at discharge	Weight at the time of discharge from treatment	At discharge (within 12 weeks of enrollment into the treatment program
Length/height at discharge	Length/height at the time of discharge from treatment	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	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	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	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	Between enrollment into the program and at discharge, which is up to 12 weeks within enrollment into the program
Weight-for-age z-score at discharge	Weight-for-age z-score at the time of discharge from treatment	At discharge (within 12 weeks of enrollment into the treatment program)
Change in weight at discharge	Change in weight between enrollment into the program and at discharge, which is up to 12 weeks within enrollment into the program	Between enrollment into the program and at discharge, which is up to 12 weeks within enrollment into the program
Change in weight-for-length/height z-score at discharge	Change in weight-for-length/height-zscore between enrollment into the program and at discharge, which is up to 12 weeks within enrollment into the program	Between enrollment into the program and at discharge, which is up to 12 weeks within enrollment into the program
Change in middle upper arm circumference at discharge	Change in middle upper arm circumference between enrollment into the program and at discharge, which is up to 12 weeks within enrollment into the program	Between enrollment into the program and at discharge, which is up to 12 weeks within enrollment into the program
Change in length/height-for-age z-score at discharge	Change in length/height-for-age z-score between enrollment into the program and at discharge, which is up to 12 weeks within enrollment into the program	Between enrollment into the program and at discharge, which is up to 12 weeks within enrollment into the program
Change in weight-for-age z-score at discharge	Change in weight-for-age z-score between enrollment into the program and at discharge, which is up to 12 weeks within enrollment into the program	Between enrollment into the program and at discharge, which is up to 12 weeks within enrollment into the program

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of product needed for recovery	number of sachets of RUTF or RUSF provided to children during the course of treatment among children who reached anthropometric recovery	between enrollment into treatment and discharge (within 12 weeks of enrollment into the treatment program)
Mortality	the number of children who died during the treatment course, divided by the total number of children admitted into treatment	between enrollment into treatment and discharge (within 12 weeks of enrollment into the treatment program)

Collaborators and Investigators

• Sponsor: International Food Policy Research Institute
• Collaborators: Kenyatta University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: February 3, 2026
• First Submitted That Met QC Criteria: February 12, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Neoplasms; Body Weight; Immune System Diseases; Body Weight Changes; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Malnutrition; Weight Loss; Thinness; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Hemic and Lymphatic Diseases; Severe Acute Malnutrition; Lymphoma, Follicular; Cachexia
• Other Study ID Numbers: 2025-RSWITCH-TX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

All data will be fully anonymized and de-identified. No names, GPS coordinates, dates of birth or other identifying data will be stored in the databases.

At the time of publication of scientific articles presenting primary results, the fully anonymized databases will become a public good and will be made available to the scientific community, government, and partners.

• IPD Sharing Time Frame: At the time of publication of scientific articles presenting primary results.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No