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

NCT06380504 | Recruiting

• 1 other identifier: RSWITCH-Ethiopia
• Study Type: interventional
• Target: 1,080
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Malnutrition, Severe; Malnutrition, Child; Wasting

Keywords

Outpatient Therapeutic Feeding Program; Treatment; Screening; Wasting; Severe acute malnutrition

Outcome Measures

Primary Outcomes (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.

  After 24 months of program implementation

Secondary Outcomes (33)

• Point prevalence of SAM OTP treatment coverage in children 6-59 months of age

  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

  After 24 months of program implementation

• Screening coverage of SAM

  After 24 months of program implementation

• Screening coverage of severe underweight

  After 24 months of program implementation

• Platform specific screening coverage of SAM

  After 24 months of program implementation

Study Arms (2)

Standard of Care

NO 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 package

EXPERIMENTAL

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

Behavioral: R-SWITCH integrated intervention package

Interventions

R-SWITCH integrated intervention package BEHAVIORAL

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 2. 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) 3. 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) 4. 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 5. Strengthening communication between HEW and AFDs

R-SWITCH integrated intervention package

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• \- Anthropometric malformation or being handicapped which hampers anthropometric measurements.

Sponsors & Collaborators

• International Food Policy Research Institute: lead
• UNICEF: collaborator
• Ethiopian Public Health Association: collaborator

Study Sites (1)

Kersa and Jeldessa woredas

Jimma, Ethiopia

RECRUITING

MeSH Terms

Conditions

Severe Acute Malnutrition; Child Nutrition Disorders; Cachexia

Condition Hierarchy (Ancestors)

Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Study Officials

• Lieven Huybregts, PhD

  International Food Policy Research Institute

  PRINCIPAL INVESTIGATOR

• Tefera Belachew, PhD

  Ethiopian Public Health Association

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lieven Huybregts, PhD

CONTACT

202 862-6481; l.huybregts@cgiar.org

Alemayehu Haddis, PhD

CONTACT

alemayehuh@etpha.org

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
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster randomized controlled trial. Unit/cluster of assignment is health post catchment area. Parallel Assignment: baseline-endline design

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 24, 2024
• Study Start: May 2, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

ET (1)