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NCT Number: NCT07420062

Reduced Dosage and/or Visitation Protocol for the Treatment of 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.

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Key information

Conditions

Acute Malnutrition in Childhood Acute Malnutrition, Moderate Acute Malnutrition, Severe Body Weight Body Weight Changes Cachexia Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Malnutrition Neoplasms Neoplasms by Histologic Type Nutrition Disorders Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Severe Acute Malnutrition Signs and Symptoms Thinness Wasting Weight Loss

Age range

6 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WHO-reduced

Other

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-full

Other

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

Kenya-IMAM

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Non-response

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

    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

  2. Transfer

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

    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

  3. Default rate

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

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

  4. Relapse

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

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

  5. 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)

    grams per kilogram of body weight per day gained during treatment

  6. Length of stay

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

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

  7. Treatment adherence

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

    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

  8. Weight at discharge

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

    Weight at the time of discharge from treatment

  9. Length/height at discharge

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

    Length/height at the time of discharge from treatment

  10. Weight-for-length/height-zscore at discharge

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

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

  11. Middle upper arm circumference at discharge

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

    Middle upper arm circumference at the time of discharge from treatment

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

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

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

  13. 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

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

  14. Weight-for-age z-score at discharge

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

    Weight-for-age z-score at the time of discharge from treatment

  15. 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 between enrollment into the program and at discharge, which is up to 12 weeks within enrollment into the program

  16. 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 weight-for-length/height-zscore between enrollment into the program and at discharge, which is up to 12 weeks within enrollment into the program

  17. 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 middle upper arm circumference between enrollment into the program and at discharge, which is up to 12 weeks within enrollment into the program

  18. 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 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

  19. 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

    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

Other outcomes

  1. Amount of product needed for recovery

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

    number of sachets of RUTF or RUSF provided to children during the course of treatment among children who reached anthropometric recovery

  2. Mortality

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

    the number of children who died during the treatment course, divided by the total number of children admitted into treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Rebecca Brander, PhD

CONTACT

[email protected]

202-862-5600

Sophie Ochola, PhD

CONTACT

[email protected]

+254721449803

Sponsors and collaborators

Lead sponsor

International Food Policy Research Institute

Other

Collaborators

  • Kenyatta University

Registry information

Official study 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

Acronym: RSWITCH

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 19, 2026
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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