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

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.

Study Overview

• Status: Recruiting
• Conditions: Wasting; Malnutrition, Child; Acute Malnutrition, Severe
• Intervention / Treatment: Behavioral: R-SWITCH integrated intervention package

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

• Study Type: Interventional
• Enrollment (Estimated): 1080
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lieven Huybregts, PhD; Phone Number: +1 202 862-6481; Email: l.huybregts@cgiar.org
• Study Contact Backup: Name: Alemayehu Haddis, PhD; Email: alemayehuh@etpha.org

Study Locations

• Ethiopia
  • Jimma, Ethiopia
    • Recruiting
    • Kersa and Jeldessa woredas
    • Principal Investigator: Lieven Huybregts, PhD
    • Principal Investigator: Tefera Belachew, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

- Anthropometric malformation or being handicapped which hampers anthropometric measurements.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care; 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)
Experimental: R-SWITCH integrated intervention package; Monthly group meetings of AFD community groups; Introduction of weight-for-age Z-score <-3 as an additional screening criterion; Promotion of Family-led MUAC screening and SAM awareness to fathers, community and religious leaders; Follow-up and counselling during home visits by AFD leaders; Strengthening communication between HEW and AFDs	Behavioral: R-SWITCH integrated intervention package; 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 MUACActive screening of wasting by AFDGroup SBCC on Infant and Young Child Feeding (IYCF), health and Water, Sanitation and Hygiene (WaSH) with a focus on SAMPromotion of health services such as GMP; 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); 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); 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; Strengthening communication between HEW and AFDs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 ANDthe child was fed ready-to-use therapeutic food (RUTF) over the last three days ANDthe caregiver can either show at least one full RUTF sachet OR more than one empty RUTF sachet.	After 24 months of program implementation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	After 24 months of program implementation
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 ANDthe child was fed ready-to-use therapeutic food (RUTF) over the last three days ANDthe caregiver can either show at least one full RUTF sachet OR more than one empty RUTF sachet.	After 24 months of program implementation
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)	After 24 months of program implementation
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)	After 24 months of program implementation
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	After 24 months of program implementation
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).	After 24 months of program implementation
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).	After 24 months of program implementation
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).	After 24 months of program implementation
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	After 24 months of program implementation
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	After 24 months of program implementation
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	After 24 months of program implementation
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	After 24 months of program implementation
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	After 24 months of program implementation
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	After 24 months of program implementation
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	After 24 months of program implementation
Mean mid-upper arm circumference (MUAC)	In 6-59 months old children.	After 24 months of program implementation
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	After 24 months of program implementation
Vaccination coverage	Proportion of children aged 6-18 months with SAM or enrolled in SAM OTP who received all age-recommended immunizations	After 24 months of program implementation
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	After 24 months of program implementation
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	After 24 months of program implementation
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	After 24 months of program implementation
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.	After 24 months of program implementation
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	After 24 months of program implementation
Continuous breastfeeding 12-23 months	Defined as the proportion of children aged 12-23 months breastfed during the previous day	After 24 months of program implementation
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	After 24 months of program implementation
Sweet beverage consumption	Proportion of children 6-23 months of age who consumed a sweet beverage during the previous day	After 24 months of program implementation
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	After 24 months of program implementation
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	After 24 months of program implementation
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)	24 months from baseline until endline of the study
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	24 months from baseline until endline of the study
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	24 months from baseline until endline of the study
SAM OTP outcomes (drop-out, death, transfer, non-response rates)	Among cases admitted to SAM OTP	24 months from baseline until endline of the study
SAM OTP duration	Defined as the number of days spent in SAM OTP (from admission to discharge)	24 months from baseline until endline of the study

Collaborators and Investigators

• Sponsor: International Food Policy Research Institute
• Collaborators: UNICEF; Ethiopian Public Health Association
• Investigators: Principal Investigator: Lieven Huybregts, PhD, International Food Policy Research Institute; Principal Investigator: Tefera Belachew, PhD, Ethiopian Public Health Association

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: April 18, 2024
• First Submitted That Met QC Criteria: April 23, 2024
• First Posted (Actual): April 24, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Treatment; Screening; Severe acute malnutrition; Wasting; Outpatient Therapeutic Feeding Program
• Additional Relevant MeSH Terms: Nutrition Disorders; Body Weight; Body Weight Changes; Malnutrition; Weight Loss; Thinness; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Severe Acute Malnutrition; Child Nutrition Disorders; Cachexia
• Other Study ID Numbers: RSWITCH-Ethiopia

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No