NCT06441305

Brief 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 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,600

participants targeted

Target at P75+ for not_applicable

Timeline
15mo left

Started Jun 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress61%
Jun 2024Jul 2027

First Submitted

Initial submission to the registry

May 6, 2024

Completed
28 days until next milestone

Study Start

First participant enrolled

June 3, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 4, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2027

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

2.2 years

First QC Date

May 6, 2024

Last Update Submit

March 25, 2026

Conditions

Keywords

Outpatient Therapeutic Feeding ProgramTreatmentScreeningWastingSevere acute malnutrition

Outcome Measures

Primary Outcomes (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

    After 24 months of program implementation

Secondary Outcomes (22)

  • Point prevalence of SAM outpatient therapeutic program (OTP) treatment coverage in children 6-59 months of age

    After 24 months of program implementation

  • Screening coverage of SAM

    After 24 months of program implementation

  • Prevalence of SAM

    After 24 months of program implementation

  • Prevalence of very low WHZ

    After 24 months of program implementation

  • Prevalence of very low MUAC

    After 24 months of program implementation

  • +17 more secondary outcomes

Study Arms (2)

Standard of Care

NO 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 package

EXPERIMENTAL

* 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.

Behavioral: SWITCH intervention package

Interventions

* 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.

SWITCH intervention package

Eligibility Criteria

Age6 Months - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turkana South and Turkana East and Aroo

Lodwar, Kenya

RECRUITING

MeSH Terms

Conditions

Severe Acute MalnutritionChild Nutrition DisordersCachexia

Condition Hierarchy (Ancestors)

MalnutritionNutrition DisordersNutritional and Metabolic DiseasesWeight LossBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsThinness

Study Officials

  • Elodie Becquey, PhD

    International Food Policy Research Institute

    PRINCIPAL INVESTIGATOR
  • Sophie Ochola, PhD

    Kenyatta University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elodie Becquey, PhD

CONTACT

Sophie Ochola, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Evaluator teams will be blinded from intervention allocation
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Cluster randomized controlled trial. Unit/cluster of assignment is community unit catchment area. Parallel Assignment: baseline-endline design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2024

First Posted

June 4, 2024

Study Start

June 3, 2024

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

July 30, 2027

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
At the time of publication of scientific articles presenting primary results.

Locations