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

Not Applicable

Recruiting

• Conditions: Acute Malnutrition, Severe; Malnutrition, Child; Wasting
• Interventions: Behavioral: R-SWITCH integrated intervention package

• Registration Number: NCT06380504
• Lead Sponsor: International Food Policy Research Institute

Brief 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. 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.

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 Timeline

• Study First Submitted: 2024-04-18
• Study First Submitted QC: 2024-04-23
• Study First Posted: 2024-04-24
• Study Start: 2024-05-02
• Status Verified: 2024-10
• Last Update Submitted: 2024-11-02
• Last Update Posted: 2024-11-05
• Primary Completion: 2026-09-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1080

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

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Exclusion Criteria

• Anthropometric malformation or being handicapped which hampers anthropometric measurements.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
R-SWITCH integrated intervention package	R-SWITCH integrated intervention package	1. 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

Primary Outcome Measures

Name	Time	Method
Period prevalence of SAM OTP treatment coverage in children 6-59 months of age	After 24 months of program implementation	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.

Secondary Outcome Measures

Name	Time	Method
AFD group meeting attendance	After 24 months of program implementation	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).
Growth Monitoring Promotion (GMP) consultation attendance	After 24 months of program implementation	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).
Egg and/or flesh food consumption	After 24 months of program implementation	Proportion of children 6-23 months of age who consumed egg and/or flesh food during the previous day
Sweet beverage consumption	After 24 months of program implementation	Proportion of children 6-23 months of age who consumed a sweet beverage during the previous day
Platform specific screening coverage of SAM	After 24 months of program implementation	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
Mean weight-for-height Z-score (WHZ)	After 24 months of program implementation	In 6-59 months old children.To calculate WHZ scores the 2006 WHO growth reference will be used
Minimum dietary diversity in infants and young children (6-23 mo)	After 24 months of program implementation	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
Minimum milk feeding frequency for non-breastfed children	After 24 months of program implementation	Proportion of non-breastfed children 6-23 months of age who consumed at least two milk feeds during the previous day
Point prevalence of SAM OTP treatment coverage in children 6-59 months of age	After 24 months of program implementation	Defined as the proportion of children with SAM at the time of the survey that are under treatment (see definition under primary outcome
Screening coverage of severe underweight	After 24 months of program implementation	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)
Prevalence of underweight and severe underweight	After 24 months of program implementation	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
Mean mid-upper arm circumference (MUAC)	After 24 months of program implementation	In 6-59 months old children.
Minimum meal frequency in infants and young children	After 24 months of program implementation	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.
Period prevalence of SAM OTP treatment coverage in the subgroup of treatment eligible children 6-59 months of age	After 24 months of program implementation	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.
Screening coverage of SAM	After 24 months of program implementation	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)
Prevalence of SAM	After 24 months of program implementation	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
Mean height-for-age Z-score (HAZ)	After 24 months of program implementation	In 6-59 months old children. To calculate HAZ scores the 2006 WHO growth reference will be used
Mean weight-for-age Z-score (WAZ)	After 24 months of program implementation	In 6-59 months old children.To calculate WAZ scores the 2006 WHO growth reference will be used
Introduction of (semi) solid and soft complementary foods	After 24 months of program implementation	The proportion of children 6-8 months of age who consumed (semi) solid and soft complementary foods during the previous day
Continuous breastfeeding 12-23 months	After 24 months of program implementation	Defined as the proportion of children aged 12-23 months breastfed during the previous day
AFD home visit coverage	After 24 months of program implementation	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).
Prevalence of wasting	After 24 months of program implementation	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
Prevalence of stunting	After 24 months of program implementation	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
Caregiver's knowledge related to breastfeeding, complementary feeding,child health and hygiene, the condition of severe acute malnutrition, outpatient therapeutic programs, screening of wasting	After 24 months of program implementation	Presented as a total standardized score and by knowledge domain
Vaccination coverage	After 24 months of program implementation	Proportion of children aged 6-18 months with SAM or enrolled in SAM OTP who received all age-recommended immunizations
Nr of food groups consumed by infants and young children (6-59 mo)	After 24 months of program implementation	The mean number of food groups consumed during the previous day by study children aged 6-59
Weight-for-length Z-score and MUAC at Severe Acute Malnutrition (SAM) Outpatient Therapeutic Feeding program (OTP)	24 months from baseline until endline of the study	Weight-for-length Z-score (relative to the 2006 WHO reference) and MUAC(mm)
SAM OTP adherence	24 months from baseline until endline of the study	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
Minimum acceptable diet in infants and young children	After 24 months of program implementation	Defined as the proportion of study children aged 6-23 months with both minimal dietary diversity and minimal meal frequency during the previous day
Zero vegetable or fruit consumption consumption	After 24 months of program implementation	Proportion of children 6-23 months of age who did not consume any vegetables or fruits during the previous day
Weight gain rate during SAM OTP	24 months from baseline until endline of the study	Defined as the weight gain during SAM OTP divided by the length of treatment and divided by the child's weight
SAM OTP outcomes (drop-out, death, transfer, non-response rates)	24 months from baseline until endline of the study	Among cases admitted to SAM OTP
SAM OTP duration	24 months from baseline until endline of the study	Defined as the number of days spent in SAM OTP (from admission to discharge)

Trial Locations

Locations (1)

Kersa and Jeldessa woredas; 🇪🇹 Jimma, Ethiopia