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Acute Malnutrition, SevereR-SWITCHNCT06380504

Increasing the Coverage of Severe Acute Malnutrition (SAM) Treatment in Ethiopia

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

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

The R-SWITCH intervention aims to address the low coverage of treatment for severe wasting (SAM) by leveraging existing community groups to deliver an integrated package focused on prevention, screening, referral, and treatment of SAM. Read more about this study

Who is it for?
Ages 6 months to 5 yearsHealthy volunteers can take part
What is being tested?
R-SWITCH integrated intervention package
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,080 participants
Where
1 siteEthiopia
Study dates
2 May 2024to 30 Jun 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

  • Child 6-59 months of age
  • Suffering from SAM (defined as MUAC < 115mm or presence of bilateral pitting edema or Weight-for-Length Z-score <-3) OR currently enrolled in SAM OTP

Who cannot join

  • Anthropometric malformation or being handicapped which hampers anthropometric measurements.

Trial locations and contacts

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

Lieven Huybregts, PhD contact

202 862-6481 ext. +1

l.huybregts@cgiar.org

Alemayehu Haddis, PhD contact

alemayehuh@etpha.org

Ethiopia1 site, 1 recruiting
  • Kersa and Jeldessa woredas

    Jimma

    Lieven Huybregts, PhD

    Tefera Belachew, PhD

    Recruiting

Other trials in Ethiopia

About this study

Official title: Effect of Leveraging Community-level Structures to Strengthen Prevention, Screening and Treatment of Severe Acute Malnutrition in Ethiopia

The R-SWITCH intervention aims to address the low coverage of treatment for severe wasting (SAM) by leveraging existing community groups to deliver an integrated package focused on prevention, screening, referral, and treatment of SAM. It includes behavior change communication on child nutrition and health, active screening, improved passive screening at health posts, and follow-up of referred cases and those enrolled in outpatient treatment programs (OTP). The primary objectives of the R-SWITCH studies are to assess the intervention's impact on OTP coverage, identify implementation barriers and facilitators, and evaluate its cost-efficiency and cost-effectiveness.

Read the detailed description

Despite the high mortality risk of severe wasting (also referred to as severe acute malnutrition or SAM), only a small proportion of children with severe wasting are currently identified and admitted to available outpatient treatment programs (OTP). In 2020, an estimated 4.9 million children with severe wasting received treatment, approximately a third of the total burden. Outside of humanitarian settings, this proportion is even lower (estimated to be around 15%). These figures highlight the urgent need to increase treatment coverage to meet the Sustainable Development Goals (SDG), which aim to reduce the prevalence of child wasting to less than 5% by 2025 and less than 3% by 2030. The continuum of care for SAM, from case identification, referral to treatment, and post-treatment follow-up, is hampered by several barriers including caregiver lack of awareness on the risks and treatment services of SAM, stigma related to SAM, poor accessibility to treatment, frequent stockouts of treatment inputs, and the overall workload faced by first-line health workers.

The R-SWITCH intervention will leverage existing community groups to deliver an integrated package aimed at preventing SAM through behavior change communication (BCC) on child nutrition and health, increasing wasting screening coverage through active screening, family-led MUAC and improved passive screening health posts, increasing treatment coverage through follow-up of earlier referred cases, cases enrolled in OTP, and children who completed OTP and recovered.

The primary objectives of the R-SWITCH studies are:

  • To assess the impact of the R-SWITCH intervention on SAM OTP coverage
  • To identify implementation barriers and facilitators
  • To assess the cost-efficiency and cost-effectiveness of the intervention package and services
Being tested
R-SWITCH integrated 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.

  • R-SWITCH integrated intervention packageBehavioural

    1. Monthly group meetings of Alliance for Development (AFD) community groups) and their members (caregivers of children 0-59 months of age):
    • Introduction and refresher of Family-led MUAC
    • Active screening of wasting by AFD
    • Group SBCC on Infant and Young Child Feeding (IYCF), health and Water, Sanitation and Hygiene (WaSH) with a focus on SAM
    • Promotion of health services such as GMP
    1. Introduction of weight-for-age Z-score <-3 as screening criterion for passive screening by health extension workers at any contact with children (e.g. during GMP)
    2. Promotion of Family-led MUAC screening and SAM awareness to fathers during male agricultural/pastoralist extension activities and by community and religious leaders (creating social support)
    3. Follow-up and counselling during home visits by AFD leaders of i) earlier referred cases of SAM, ii) cases enrolled in SAM OTP, iii) and recovered SAM cases discharged from OTP
    4. Strengthening communication between HEW and AFDs
Study groups in NCT06380504
Study groupRoleWhat they receive
Standard of CareNo intervention* Usual screening of wasting by health extension workers (HEW) using MUAC * Previous introduction of Family-led MUAC (not maintained) * Behavior Change Communication (BCC) offered by Health extension worker (low intensity) * Treatment of SAM at health post or health center * Follow-up of SAM OTP defaults through home visits by HEW (very low intensity)
R-SWITCH integrated intervention packageExperimental1. Monthly group meetings of AFD community groups 2. Introduction of weight-for-age Z-score <-3 as an additional screening criterion 3. Promotion of Family-led MUAC screening and SAM awareness to fathers, community and religious leaders 4. Follow-up and counselling during home visits by AFD leaders 5. Strengthening communication between HEW and AFDs
Receives: Behavioral: R-SWITCH integrated intervention package

What is being measured

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

  1. Period prevalence of SAM OTP treatment coverage in children 6-59 months of age

    Defined as the proportion of children with Severe Acute Malnutrition (SAM) or enrolled in the SAM Outpatient Therapeutic program (OTP) that are "under treatment".

    • SAM is defined as a Mid-Upper Arm Circumference <115mm or a weight-for-height Z-score <-3 (relative to the World Health Organization (WHO) 2006 growth standards) or presence of bilateral pitting edema.
    • "Under treatment" is defined as:
    • the caregiver acknowledging the child is enrolled in a SAM OTP AND
    • the child was fed ready-to-use therapeutic food (RUTF) over the last three days AND
    • the caregiver can either show at least one full RUTF sachet OR more than one empty RUTF sachet.

    Measured: After 24 months of program implementation

Secondary outcomes (33)
  1. Point prevalence of SAM 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. Period prevalence of SAM OTP treatment coverage in the subgroup of treatment eligible children 6-59 months of age

    Defined as the proportion of children with Severe Acute Malnutrition (SAM) or Severe underweight (weight-for-age Z-score <-3) or enrolled in the SAM Outpatient Therapeutic program (OTP) that are "under treatment".

    • SAM is defined as a Mid-Upper Arm Circumference <115mm or a weight-for-height Z-score <-3 (relative to the WHO 2006 growth standards) or presence of bilateral pitting edema.
    • "Under treatment" is defined as:
    • the caregiver acknowledging the child is enrolled in a SAM OTP AND
    • the child was fed ready-to-use therapeutic food (RUTF) over the last three days AND
    • the caregiver can either show at least one full RUTF sachet OR more than one empty RUTF sachet.

    Measured: After 24 months of program implementation

  3. Screening coverage of SAM

    Defined as the proportion of children aged 6-59 months with SAM screened for wasting over the last 30 days (as reported by the caregiver)

    Measured: After 24 months of program implementation

  4. Screening coverage of severe underweight

    Defined as the proportion of children aged 6-59 months with severe underweight (weight-for-age Z-score <-3 relative to WHO 2006 growth standard) screened over the last 30 days (as reported by the caregiver)

    Measured: After 24 months of program implementation

  5. Platform specific screening coverage of SAM

    Defined as the proportion of children aged 6-59 months with SAM screened for wasting over the last 30 days (as reported by the caregiver):

    • by Family-led MUAC ( screening by family members using a MUAC tape)
    • during growth monitor promotion (GMP) consultations
    • during Integrated management of childhood illness consultations

    Measured: After 24 months of program implementation

  6. Growth Monitoring Promotion (GMP) consultation attendance

    Defined as the proportion of children aged 6-59 months with SAM that attended GMP over the last 30 days (as reported by the caregiver).

    Measured: After 24 months of program implementation

  7. AFD group meeting attendance

    Defined as the proportion of of children aged 6-59 months with SAM that attended the monthly AFD group contact over the last 30 days (as reported by the caregiver).

    Measured: After 24 months of program implementation

  8. AFD home visit coverage

    Defined as the proportion of children aged 6-59 months with SAM and children enrolled in SAM OTP that received a home visit by an AFD leader/member over the last 30 days (as reported by the caregiver).

    Measured: After 24 months of program implementation

  9. Prevalence of SAM

    Defined as the proportion of children aged 6-59 months with SAM (defined as WHZ <-3 or a MUAC < 115 mm or the presence of bilateral pitting edema). To calculate WHZ scores the 2006 WHO growth reference will be used

    Measured: After 24 months of program implementation

  10. Prevalence of wasting

    Defined as the proportion of children aged 6-59 months with wasting (defined as WHZ <-2 or a MUAC < 125 mm or the presence of bilateral pitting edema). To calculate WHZ scores the 2006 WHO growth reference will be used

    Measured: After 24 months of program implementation

  11. Prevalence of stunting

    Defined as the proportion of children aged 6-59 months 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

  12. Prevalence of underweight and severe underweight

    Defined as the proportion of children aged 6-59 months 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

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

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

    Measured: After 24 months of program implementation

  14. 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

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

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

    Measured: After 24 months of program implementation

  16. Mean mid-upper arm circumference (MUAC)

    In 6-59 months old children.

    Measured: After 24 months of program implementation

  17. Caregiver's knowledge related to breastfeeding, complementary feeding,child health and hygiene, the condition of severe acute malnutrition, outpatient therapeutic programs, screening of wasting

    Presented as a total standardized score and by knowledge domain

    Measured: After 24 months of program implementation

  18. Vaccination coverage

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

    Measured: After 24 months of program implementation

  19. Introduction of (semi) solid and soft complementary foods

    The proportion of children 6-8 months of age who consumed (semi) solid and soft complementary foods during the previous day

    Measured: After 24 months of program implementation

  20. Minimum dietary diversity in infants and young children (6-23 mo)

    The proportion of study children aged 6-23 months who consumed at least 5 of the 8 food groups (including breast milk) during the previous day

    Measured: After 24 months of program implementation

  21. Nr of food groups consumed by infants and young children (6-59 mo)

    The mean number of food groups consumed during the previous day by study children aged 6-59

    Measured: After 24 months of program implementation

  22. Minimum meal frequency in infants and young children

    Defined as the proportion of study children who had eaten during the previous day: 2 meals for breastfed children 6-8 months, 3 meals for breastfed children 9-23 months, or 4 meals for non-breastfed children 6-23 monthsMinimum meal frequency for children, defined as the proportion of children who had eaten the day before the survey: 2 meals for breastfed children 6-8 months, 3 meals for breastfed children 9-23 months, or 4 meals for non-breastfed children 6-23 months.

    Measured: After 24 months of program implementation

  23. Minimum acceptable diet in infants and young children

    Defined as the proportion of study children aged 6-23 months with both minimal dietary diversity and minimal meal frequency during the previous day

    Measured: After 24 months of program implementation

  24. Continuous breastfeeding 12-23 months

    Defined as the proportion of children aged 12-23 months breastfed during the previous day

    Measured: After 24 months of program implementation

  25. Egg and/or flesh food consumption

    Proportion of children 6-23 months of age who consumed egg and/or flesh food during the previous day

    Measured: After 24 months of program implementation

  26. Sweet beverage consumption

    Proportion of children 6-23 months of age who consumed a sweet beverage during the previous day

    Measured: After 24 months of program implementation

  27. Zero vegetable or fruit consumption consumption

    Proportion of children 6-23 months of age who did not consume any vegetables or fruits during the previous day

    Measured: After 24 months of program implementation

  28. Minimum milk feeding frequency for non-breastfed children

    Proportion of non-breastfed children 6-23 months of age who consumed at least two milk feeds during the previous day

    Measured: After 24 months of program implementation

  29. Weight-for-length Z-score and MUAC at Severe Acute Malnutrition (SAM) Outpatient Therapeutic Feeding program (OTP)

    Weight-for-length Z-score (relative to the 2006 WHO reference) and MUAC(mm)

    Measured: 24 months from baseline until endline of the study

  30. SAM OTP adherence

    Defined as the proportion of cases enrolled to SAM OTP who received timely treatment from dedicated services (health center or health post) until anthropometric recovery

    Measured: 24 months from baseline until endline of the study

  31. Weight gain rate during SAM OTP

    Defined as the weight gain during SAM OTP divided by the length of treatment and divided by the child's weight

    Measured: 24 months from baseline until endline of the study

  32. SAM OTP outcomes (drop-out, death, transfer, non-response rates)

    Among cases admitted to SAM OTP

    Measured: 24 months from baseline until endline of the study

  33. SAM OTP duration

    Defined as the number of days spent in SAM OTP (from admission to discharge)

    Measured: 24 months from baseline until endline of the study

Timeline

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

  1. First posted24 Apr 2024
  2. Study start2 May 2024
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Jun 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 health post catchment area. Parallel Assignment: baseline-endline design
Masking
None (open label)
Enrolment
1,080 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06380504
Sponsor's protocol ID
RSWITCH-Ethiopia
Acronym
R-SWITCH
Status last verified
Sep 2026
First submitted
18 Apr 2024
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Biru B, Huybregts L, Tamiru D, Areb M, Haddis A, Fall T, Toure M, Belachew T. Barriers and Factors Associated With Treatment Coverage of Severe Acute Malnutrition Among Children 6-59 Months in Agrarian and Pastoralist Areas of Ethiopia. Matern Child Nutr. 2026 Jul;22(3):e70219. doi: 10.1111/mcn.70219.

    PubMed 42381597

Questions about this trial

What is this clinical trial studying?

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

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 2 inclusion and 1 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 24 Sep 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 Ethiopia. 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 Lieven Huybregts, PhD (202 862-6481 ext. +1, l.huybregts@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 SAM OTP 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?

On the ClinicalTrials.gov record for NCT06380504, which also lists 1 linked publication.

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 24 Sep 2026.

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