Acute Malnutrition in ChildhoodRSWITCHNCT07420062
Reduced Dosage and/or Visitation Protocol for the Treatment of Acute Malnutrition in Kenya
A study testing WHO-reduced, WHO-full and Kenya-IMAM in people with Acute Malnutrition in Childhood and Acute Malnutrition, Severe, run by International Food Policy Research Institute at 1 site in Kenya.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Acute Malnutrition in Childhood, Acute Malnutrition, Severe, Acute Malnutrition, Moderate
- What is being tested?
- WHO-reduced, WHO-full and Kenya-IMAM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,274 participants
- Where
- 1 siteKenya
- Study dates
- 1 Mar 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kenya1 site
West Pokot, Wajir, and Samburu counties
Kitale, West Pokot County
Rebecca Brander, 202-862-5600, r.brander@cgiar.org
About this study
Official title: 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.
- Conditions
- Acute Malnutrition in Childhood, Acute Malnutrition, Severe, Acute Malnutrition, Moderate, Wasting
- Being tested
- WHO-reduced, WHO-full, Kenya-IMAM
- Medical subject headings
- Severe Acute Malnutrition, Lymphoma, Follicular, Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| WHO-reduced | Experimental | 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. Receives: Other: WHO-reduced |
| WHO-full | Experimental | Children will receive the continuous full, weight-based dosage of 150-185 kcal/kg/day until recovery. Visits will be weekly until recovery. Receives: Other: WHO-full |
| Kenya-IMAM | Active comparator | 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. Receives: Other: Kenya-IMAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 12 weeks of enrollment in the treatment program
Secondary outcomes (19)
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
Measured: 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
Measured: 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
Measured: 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.
Measured: Within 2 months of recovery from a previous episode
Weight gain velocity
grams per kilogram of body weight per day gained during treatment
Measured: 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
Measured: 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
Measured: within 12 weeks of enrollment into the treatment program
Weight at discharge
Weight at the time of discharge from treatment
Measured: At discharge (within 12 weeks of enrollment into the treatment program
Length/height at discharge
Length/height at the time of discharge from treatment
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Between enrollment into the program and at discharge, which is up to 12 weeks within enrollment into the program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Malnutrition in ChildhoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Facility-based, cluster randomized controlled trial. The unit of randomization (cluster) is the health facilities.
- Masking
- None (open label)
- Enrolment
- 2,274 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Food Policy Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Kenyatta University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07420062
- Sponsor's protocol ID
- 2025-RSWITCH-TX
- Acronym
- RSWITCH
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07420062
- Acronym / sponsor ID
- RSWITCH / 2025-RSWITCH-TX
- Conditions
- Acute Malnutrition in Childhood, Acute Malnutrition, Severe, Acute Malnutrition, Moderate, Wasting
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,274 participants (estimated)
- Lead sponsor
- International Food Policy Research InstituteUniversity, hospital or other
- Collaborators
- Kenyatta University
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Facility-based, cluster randomized controlled trial. The unit of randomization (cluster) is the health facilities.
| Arm | Type | Receives |
|---|---|---|
| WHO-reduced | Experimental | Other: WHO-reducedChildren 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 | Experimental | Other: WHO-fullChildren 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 comparator | Other: Kenya-IMAMChildren 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. |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 6-59.9 months of age at admission into treatment
- Child admitted to the national treatment program according to the following criteria:
- Accompanied by caregiver or legal guardian
- Caregiver or legal guardian consents to participate
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WHO-reducedChildren 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 |
| WHO-fullChildren 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 |
| Kenya-IMAMChildren 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 |
Primary outcome
Anthropometric recovery
Time frame: Within 12 weeks of enrollment in the treatment program
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.
19 secondary outcomes
Non-response
Time frame: Within 12 weeks of enrollment in the treatment program
Transfer
Time frame: within 12 weeks of enrollment into the treatment program
Default rate
Time frame: Within 12 weeks of enrollment into the treatment program
Relapse
Time frame: Within 2 months of recovery from a previous episode
Weight gain velocity
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
Time frame: between enrollment into the program and discharge (within 12 weeks of enrollment into the program)
Treatment adherence
Time frame: within 12 weeks of enrollment into the treatment program
Weight at discharge
Time frame: At discharge (within 12 weeks of enrollment into the treatment program
Length/height at discharge
Time frame: At discharge (within 12 weeks of enrollment into the treatment program)
Weight-for-length/height-zscore at discharge
Time frame: At discharge (within 12 weeks of enrollment into the treatment program)
Middle upper arm circumference at discharge
Time frame: At discharge (within 12 weeks of enrollment into the treatment program)
Length/height-for-age z-score at discharge
Time frame: At discharge (within 12 weeks of enrollment into the treatment program)
Change in length/height at discharge
Time frame: 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
Time frame: At discharge (within 12 weeks of enrollment into the treatment program)
Change in weight at discharge
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Between enrollment into the program and at discharge, which is up to 12 weeks within enrollment into the program
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WHO-reduced, WHO-full and Kenya-IMAM in people with Acute Malnutrition in Childhood and Acute Malnutrition, Severe, run by International Food Policy Research Institute at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca Brander, PhD (202-862-5600, r.brander@cgiar.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anthropometric recovery (time frame: Within 12 weeks of enrollment in the treatment program). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.