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
1 other identifier
interventional
2,274
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2026
CompletedFirst Posted
Study publicly available on registry
February 19, 2026
CompletedStudy Start
First participant enrolled
March 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
February 19, 2026
February 1, 2026
1 year
February 3, 2026
February 12, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (19)
Non-response
Within 12 weeks of enrollment in the treatment program
Transfer
within 12 weeks of enrollment into the treatment program
Default rate
Within 12 weeks of enrollment into the treatment program
Relapse
Within 2 months of recovery from a previous episode
Weight gain velocity
Between enrollment into the treatment program and discharge (which is up to 12 weeks after enrollment into the treatment program)
- +14 more secondary outcomes
Other Outcomes (2)
Amount of product needed for recovery
between enrollment into treatment and discharge (within 12 weeks of enrollment into the treatment program)
Mortality
between enrollment into treatment and discharge (within 12 weeks of enrollment into the treatment program)
Study Arms (3)
WHO-reduced
EXPERIMENTALChildren 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-full
EXPERIMENTALChildren will receive the continuous full, weight-based dosage of 150-185 kcal/kg/day until recovery. Visits will be weekly until recovery.
Kenya-IMAM
ACTIVE COMPARATORChildren 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.
Interventions
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.
Children will receive the continuous full, weight-based dosage of 150-185 kcal/kg/day until recovery. Visits will be weekly until recovery.
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- International Food Policy Research Institutelead
- Kenyatta Universitycollaborator
Study Sites (1)
West Pokot, Wajir, and Samburu counties
Kitale, West Pokot County, Kenya
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2026
First Posted
February 19, 2026
Study Start
March 1, 2026
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
May 1, 2027
Last Updated
February 19, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- At the time of publication of scientific articles presenting primary results.
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.