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Acute Malnutrition, SevereR-SWITCHNCT06441305

Expanding Coverage of Severe Acute Malnutrition (SAM) Treatment in Kenya

A study testing SWITCH intervention package in people with Acute Malnutrition, Severe and Malnutrition, Child, run by International Food Policy Research Institute at 1 site in Kenya.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Child wasting is a type of malnutrition which occurs when a child becomes too thin. This medical condition increases the risk of becoming sick or dying. A child with severe wasting needs to be seen in a medical consultation to check on health status and to receive some medicine and a medical food supplement for daily… Read more about this study

Who is it for?
Ages 6 months to 5 yearsHealthy volunteers can take part
What is being tested?
SWITCH intervention package
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,600 participants
Where
1 siteKenya
Study dates
3 Jun 2024to 30 Jul 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 months to 5 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Household in a village of the study area covered by a CHP (although the child may or may not be registered by a CHP) AND
  • Child is 6-59.9 months of age AND
  • Caregiver consents to be part of the study AND
  • any of the following:
  • WHZ < -3 (relative to WHO 2006 reference) OR
  • MUAC <115 mm OR
  • Presence of bilateral edema OR
  • receiving treatment as follow-up for an initial SAM condition on the way to full recovery

Who cannot join

  • Congenital malformation that makes anthropometric measurements impossible.
  • Length is below 54 cm or height is above 120cm.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Elodie Becquey, PhD contact

778487085 ext. +221

e.becquey@cgiar.org

Kenya1 site, 1 recruiting
  • Turkana South and Turkana East and Aroo

    Lodwar

    Elodie Becquey, 00221778487085, e.becquey@cgiar.org

    Recruiting

Other trials in Kenya

About this study

Official title: Assessing the Impact, Implementation and Cost of Empowering Community Health Promoters to Improve Wasting Treatment Coverage in Turkana County Through Family-led MUAC Scale-up, Weight-for-age Screening, and Defaulters' Follow-up

Child wasting is a type of malnutrition which occurs when a child becomes too thin. This medical condition increases the risk of becoming sick or dying. A child with severe wasting needs to be seen in a medical consultation to check on health status and to receive some medicine and a medical food supplement for daily consumption until cured. Yet, only a small proportion of children suffering from severe wasting are presently receiving appropriate treatment.

In Kenya, there is an opportunity to build on the existing network of community health promoters (CHPs) to increase the number of children with wasting who are identified and treated. In intervention areas, CHPs will be equipped with smartphones and an application which provides guidance on household members to visit and simple actions to take, related to health. CHPs will distribute color-coded mid-upper arm circumference tapes to households with young children and train caregivers on how to use it. After training, CHPs will send Short Message Services (SMS) to remind caregivers to regularly measure the arm circumference of the child. In addition, CHPs will receive a scale to measure the weight of children every month. Finally, wasted children registered in the treatment program who fail to attend a planned consultation will be flagged to their CHP through the phone application, and CHPs will conduct a specific home visit to investigate and help solve potential issues.

Read more

The study will assess whether this community intervention (called SWITCH) allows to identify and treat more children suffering from severe wasting. Before the start of the intervention, the proportion of wasted children receiving treatment in 40 community units in Turkana South, Turkana East and Aroo will be assessed. After this survey, a computer will randomly select 20 community units where the intervention will be scaled up. The survey will be repeated after 2 years to assess if the proportion of severely wasted children receiving treatment is higher in the area where the intervention was scaled up compared to the area where it was not scaled up.

In addition, after 1 year of implementation, the study will assess how the intervention was scaled up, what are the main challenges, and what are the overall perceptions on the intervention in the community among those who receive it and those who deliver it. Finally, costs of the various components of the intervention will be measured for all actors involved, including for caregivers.

Read the detailed description

Despite the burden and impact of child wasting on morbidity and mortality, only a small proportion of severely wasted children are presently receiving treatment. In Kenya, there is an opportunity to strengthen the screening for wasting and the identification and treatment of wasted children (SWITCH) through community health promoters (CHPs) who, per policy, are trained, equipped, incentivized and supervised by community health agents (CHAs).

An intervention package will be implemented including: 1) Digitization to support CHPs, 2) Family-led Mid-Upper Arm Circumference (MUAC) enhanced by digitization, with a two-way messaging platform between CHP and caregivers, and reminders for timely training at 6 months of age, 3) Equipment of CHPs with a baby-mother scale for measurement of weight-for-age to detect likely wasting, and 4) Real-time follow-up in the community (facilitated by digitization) of defaulters and non-respondent children enrolled for wasting treatment.

A randomized controlled trial will be used to assess the impact of the SWITCH intervention on severe wasting treatment coverage in Turkana. Twenty randomly selected community units of 40 will receive the intervention. An exhaustive screening campaign conducted at baseline and endline (after 2 years) in the 40 community units will identify children with severe wasting (MUAC < 115 mm or Weight-for-Height Z-score < -3 or bilateral pitting oedema) or recovering from severe wasting (defined by receipt and consumption of Ready-to-Use Therapeutic Food), who will be enrolled in a survey assessing treatment coverage, program exposure and other pathways to impact, and confounders.

In addition, the study will assess the reach, adoption by CHPs, and implementation challenges of the SWITCH package through additional qualitative (interviews and observations) and quantitative data collection at all levels of program delivery (beneficiaries, CHPs, CHAs, program implementers); and the unit cost of the SWITCH package per beneficiary (and cost-effectiveness if the package is effective) through an activity-based costing-ingredients approach.

Being tested
SWITCH intervention package
Keywords
Outpatient Therapeutic Feeding Program, Treatment, Screening, Wasting, Severe acute malnutrition
Medical subject headings
Severe Acute Malnutrition, Child Nutrition Disorders, Cachexia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SWITCH intervention packageBehavioural

    • Addition of digital monitoring \& supervision by CHA
    • Digitized registration of households by CHPs every 6 months
    • Digital reminders to CHP to conduct home visit if a child has never been visited in 3 mo.
    • Digital reminder for timely training to family MUAC of all family members through home visit by CHP when child turns 6 months of age.
    • Platform for 2-ways messaging: biweekly SMS reminders to caregivers through the CHP's app; feedback by caregiver
    • Community level screening based on weight and weight-for-age (WAZ) led by CHP every other month (aligned with Community Action Days),
    • Digital calculation of WAZ.
    • CHP and Growth Monitoring and Promotion refer to health facility if WAZ<-3 to check on WHZ eligibility
    • At the end of every wasting treatment consultation, compilation of the list of defaulters and non-respondents, for immediate transmission by CHA to relevant CHP through digital task of an instruction for immediate follow-up.
Study groups in NCT06441305
Study groupRoleWhat they receive
Standard of CareNo intervention* Register-based household registration (census) by CHP every 12 months * Some family MUAC of variable and unknown coverage/frequency, national guidance developed. * Some passive screening using weight-for-height z-score at Health Facility and during outreach during Malezi bora (child health week every 6 months). * Monthly compilation by CHA (supervisors) of the list of defaulters and non-respondents for transmission to relevant community health promoter (CHP) during monthly in-person meeting.
SWITCH intervention packageExperimental* Addition of digital monitoring \& supervision by CHA * Digitized registration of households by CHPs every 6 months * Digital reminders to CHP to conduct home visit if a child has never been visited in 3 mo. * Digital reminder for timely training to family MUAC of all family members through home visit by CHP when child turns 6 months of age. * Platform for 2-ways messaging: biweekly SMS reminders to caregivers through the CHP's app; feedback by caregiver * Community level screening based on weight and weight-for-age (WAZ) led by CHP every other month (aligned with Community Action Days), * Digital calculation of WAZ. * CHP and Growth Monitoring and Promotion refer to health facility if WAZ<-3 to check on WHZ eligibility * At the end of every wasting treatment consultation, compilation of the list of defaulters and non-respondents, for immediate transmission by CHA to relevant CHP through digital task of an instruction for immediate follow-up.
Receives: Behavioral: SWITCH intervention package

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Period prevalence of severe wasting (SAM) treatment coverage in children 6-59 months of age

    defined as the proportion of children suffering from SAM or recovering from SAM who currently receive treatment.

    • SAM defined by weight-for-height Z-score (WHZ) <-3 (relative to World Health Organization (WHO) 2006 reference) or MUAC <115 mm or by the presence of bilateral edema.

    Children recovering from SAM through treatment will be considered to receive treatment for an initial SAM condition if they both attended an IMAM consultation in the previous 15 days (as reported by caregiver OR by a consultation card) AND either:

    • consumed RUTF at least once in the previous 3 days (as reported by the caregiver AND confirmed by observation of >= 1 full or 2 empty RUTF sachets) OR
    • consumed RUSF at least once in the previous 3 days (as reported by the caregiver AND confirmed by observation by the enumerator of >= 1 full or 2 empty RUSF sachets) AND child was previously enrolled for SAM treatment immediately prior to MAM treatment (as confirmed by treatment card OR reported by the mother

    Measured: After 24 months of program implementation

Secondary outcomes (22)
  1. Point prevalence of SAM outpatient therapeutic program (OTP) treatment coverage in children 6-59 months of age

    Defined as the proportion of children with SAM at the time of the survey that are under treatment (see definition under primary outcome)

    Measured: After 24 months of program implementation

  2. Screening coverage of SAM

    Defined as the proportion of children aged 6-59 months suffering from SAM ((currently or on their way to recovery from SAM through treatment for an initial SAM condition) ) screened for wasting over the last 30 days (as reported by the caregiver)

    Measured: After 24 months of program implementation

  3. Prevalence of SAM

    Defined as the proportion of children aged 6-59 months with SAM (defined as WHZ <-3 (relative to World Health Organization (WHO) 2006 reference) or a MUAC < 115 mm or the presence of bilateral pitting edema). Also calculated on the restricted population of children aged 6-59 months suffering or recovering from SAM (same definition as for primary outcome)

    Measured: After 24 months of program implementation

  4. Prevalence of very low WHZ

    Defined as the proportion of children aged 6-59 months with WHZ <-3 (relative to World Health Organization (WHO) 2006 reference).

    Measured: After 24 months of program implementation

  5. Prevalence of very low MUAC

    Defined as the proportion of children aged 6-59 months with MUAC<115 mm

    Measured: After 24 months of program implementation

  6. Prevalence of moderate acute malnutrition (MAM)

    Defined as the proportion of children aged 6-59 months with MAM (defined as -3<= WHZ <-2 (relative to World Health Organization (WHO) 2006 reference) or 115<= MUAC < 125 mm). Also calculated on the restricted population of children aged 6-59 months suffering or recovering from SAM (same definition as for primary outcome)

    Measured: After 24 months of program implementation

  7. Prevalence of wasting

    Defined as the proportion of children aged 6-59 months with wasting (defined as WHZ <-2 (relative to World Health Organization (WHO) 2006 reference) or a MUAC < 125 mm or the presence of bilateral pitting edema). Also calculated on the restricted population of children aged 6-59 months suffering or recovering from SAM (same definition as for primary outcome)

    Measured: After 24 months of program implementation

  8. Prevalence of stunting

    Defined as the proportion of children aged 6-59 months suffering from SAM or recovering from SAM with stunting (defined as height-for-age Z-scores (HAZ) <-2 or a MUAC < 125 mm or the presence of bilateral pitting edema). To calculate HAZ scores the 2006 WHO growth reference will be used

    Measured: After 24 months of program implementation

  9. Prevalence of underweight and severe underweight

    Defined as the proportion of children aged 6-59 months suffering from SAM or recovering from SAM with underweight (defined as weight-for-age Z-scores (WAZ) <-2 ) and severe underweight (defined as WAZ <-3 ). To calculate WAZ scores the 2006 WHO growth reference will be used

    Measured: After 24 months of program implementation

  10. Mean height-for-age Z-score (HAZ)

    In 6-59 months old children suffering from SAM or recovering from SAM. Scores will be calculated relative to World Health Organization (WHO) 2006 reference, with a higher score meaning a better outcome

    Measured: After 24 months of program implementation

  11. Mean weight-for-height Z-score (WHZ)

    In 6-59 months old children.To calculate WHZ scores the 2006 WHO growth reference will be used

    Measured: After 24 months of program implementation

  12. Mean weight-for-age Z-score (WAZ)

    In 6-59 months old children suffering from SAM or recovering from SAM. To calculate WAZ scores the 2006 WHO growth reference will be used

    Measured: After 24 months of program implementation

  13. Mean mid-upper arm circumference (MUAC)

    In 6-59 months old children.

    Measured: After 24 months of program implementation

  14. Caregiver's knowledge score

    The score will be calculated by adding one point for each right answer to a series of questions related to infant and child feeding, child health and hygiene, the condition of severe acute malnutrition, outpatient therapeutic programs, screening of wasting. Questions were specifically developed for the study based on program activities and asked to caregiver of children aged 6-59 months suffering from SAM or recovering from SAM

    Measured: After 24 months of program implementation

  15. Prevalence of appropriate immunization

    Proportion of children aged 6-18 months with SAM or enrolled in SAM OTP who received all recommended immunizations

    Measured: After 24 months of program implementation

  16. Coverage of the integrated management of acute malnutrition (IMAM) platform

    proportion of children aged 6-59 months suffering from SAM or recovering from SAM who attended an IMAM consultation in the previous 15 days (as reported by the caregiver or by an IMAM treatment card)

    Measured: After 24 months of program implementation

  17. Coverage of the community unit platform

    proportion of children aged 6-59 months suffering from SAM or recovering from SAM in contact with a CHP in the 2 months preceding the survey for community care-related matter (as reported by the caregiver)

    Measured: After 24 months of program implementation

  18. Coverage of family MUAC

    proportion of children aged 6-59 months suffering from SAM or recovering from SAM screened in the month preceding the survey by a family member using a MUAC tape (as reported by the caregiver)

    Measured: After 24 months of program implementation

  19. Coverage of family MUAC training

    proportion of children aged 6-59 months suffering from SAM or recovering from SAM for which at least one family member was trained to use MUAC tape (as reported by the caregiver)

    Measured: After 24 months of program implementation

  20. Coverage of MUAC tapes

    proportion of children aged 6-59 months suffering from SAM or recovering from SAM for which at least one family member owns a MUAC tape (as reported by the caregiver AND confirmed by observation)

    Measured: After 24 months of program implementation

  21. Coverage of WAZ screening

    proportion of children aged 6-59 months suffering from SAM or recovering from SAM weighed in the 2 months preceding the survey by a CHP or a health staff using a scale (as reported by the caregiver)

    Measured: After 24 months of program implementation

  22. Period prevalence of wasting treatment coverage in children 6-59 months of age

    Defined as the proportion of children suffering or recovering from wasting who currently receive treatment.

    • Wasting defined by weight-for-height Z-score (WHZ) <-2 (relative to World Health Organization (WHO) 2006 reference) or MUAC <125 mm or by the presence of bilateral edema.

    Children recovering from wasting will be considered to receive treatment if they both attended an IMAM consultation in the previous 15 days (as reported by caregiver OR by a consultation card) AND either:

    consumed RUTF at least once in the previous 3 days (as reported by the caregiver AND confirmed by observation of >= 1 full or 2 empty RUTF sachets) OR consumed RUSF at least once in the previous 3 days (as reported by the caregiver AND confirmed by observation by the enumerator of >= 1 full or 2 empty RUSF sachets) AND child does not suffer from SAM (as defined above)

    Measured: After 24 months of program implementation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2024
  2. Study start3 Jun 2024
  3. Primary completion30 Jul 2026 (estimated)
  4. Study completion30 Jul 2027 (estimated)

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Cluster randomized controlled trial. Unit/cluster of assignment is community unit catchment area. Parallel Assignment: baseline-endline design
Masking
None (open label)
Enrolment
1,600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06441305
Sponsor's protocol ID
RSWITCH-Kenya
Acronym
R-SWITCH
Status last verified
Jul 2026
First submitted
6 May 2024
Last updated
15 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All data will be carefully anonymized and de-identified so that the privacy of participants and research subjects is fully protected. Databases will be anonymized using identification codes. 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 (quantitative data) will become a public good and will be made available to the scientific community, government, and partners.

Questions about this trial

What is this clinical trial studying?

A study testing SWITCH intervention package in people with Acute Malnutrition, Severe and Malnutrition, Child, 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 8 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 15 Jul 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 Elodie Becquey, PhD (778487085 ext. +221, e.becquey@cgiar.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Period prevalence of severe wasting (SAM) treatment coverage in children 6-59 months of age (time frame: After 24 months of program implementation). 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 15 Jul 2026.

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