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Augmenter la couverture du traitement de la malnutrition aiguë sévère (MAS) en Éthiopie (R-SWITCH)

21 septembre 2026 mis à jour par: International Food Policy Research Institute

Effet de l'exploitation des structures au niveau communautaire pour renforcer la prévention, le dépistage et le traitement de la malnutrition aiguë sévère en Éthiopie

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.

Aperçu de l'étude

Description détaillée

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

Type d'étude

Interventionnel

Inscription (Estimé)

1080

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

      • Jimma, Ethiopie
        • Recrutement
        • Kersa and Jeldessa woredas
        • Chercheur principal:
          • Lieven Huybregts, PhD
        • Chercheur principal:
          • Tefera Belachew, PhD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

6 mois à 5 ans (Enfant)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Recherche sur les services de santé
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Aucune 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)
Expérimental: 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
  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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Period prevalence of SAM OTP treatment coverage in children 6-59 months of age
Délai: 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.
After 24 months of program implementation

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Point prevalence of SAM OTP treatment coverage in children 6-59 months of age
Délai: 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

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
Délai: 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.
After 24 months of program implementation
Screening coverage of SAM
Délai: 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)

After 24 months of program implementation
Screening coverage of severe underweight
Délai: 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)

After 24 months of program implementation
Platform specific screening coverage of SAM
Délai: 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
After 24 months of program implementation
Growth Monitoring Promotion (GMP) consultation attendance
Délai: 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).

After 24 months of program implementation
AFD group meeting attendance
Délai: 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).

After 24 months of program implementation
AFD home visit coverage
Délai: 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).

After 24 months of program implementation
Prevalence of SAM
Délai: 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

After 24 months of program implementation
Prevalence of wasting
Délai: 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

After 24 months of program implementation
Prevalence of stunting
Délai: 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

After 24 months of program implementation
Prevalence of underweight and severe underweight
Délai: 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

After 24 months of program implementation
Mean height-for-age Z-score (HAZ)
Délai: After 24 months of program implementation

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)
Délai: After 24 months of program implementation

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)
Délai: After 24 months of program implementation

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)
Délai: After 24 months of program implementation

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
Délai: After 24 months of program implementation

Presented as a total standardized score and by knowledge domain

After 24 months of program implementation
Vaccination coverage
Délai: 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

After 24 months of program implementation
Introduction of (semi) solid and soft complementary foods
Délai: 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

After 24 months of program implementation
Minimum dietary diversity in infants and young children (6-23 mo)
Délai: 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

After 24 months of program implementation
Nr of food groups consumed by infants and young children (6-59 mo)
Délai: After 24 months of program implementation

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
Délai: 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.

After 24 months of program implementation
Minimum acceptable diet in infants and young children
Délai: 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

After 24 months of program implementation
Continuous breastfeeding 12-23 months
Délai: After 24 months of program implementation

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
Délai: 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

After 24 months of program implementation
Sweet beverage consumption
Délai: After 24 months of program implementation

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
Délai: 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

After 24 months of program implementation
Minimum milk feeding frequency for non-breastfed children
Délai: 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

After 24 months of program implementation
Weight-for-length Z-score and MUAC at Severe Acute Malnutrition (SAM) Outpatient Therapeutic Feeding program (OTP)
Délai: 24 months from baseline until endline of the study

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
Délai: 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

24 months from baseline until endline of the study
Weight gain rate during SAM OTP
Délai: 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

24 months from baseline until endline of the study
SAM OTP outcomes (drop-out, death, transfer, non-response rates)
Délai: 24 months from baseline until endline of the study

Among cases admitted to SAM OTP

24 months from baseline until endline of the study
SAM OTP duration
Délai: 24 months from baseline until endline of the study

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

24 months from baseline until endline of the study

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Lieven Huybregts, PhD, International Food Policy Research Institute
  • Chercheur principal: Tefera Belachew, PhD, Ethiopian Public Health Association

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

2 mai 2024

Achèvement primaire (Estimé)

30 septembre 2026

Achèvement de l'étude (Estimé)

30 juin 2027

Dates d'inscription aux études

Première soumission

18 avril 2024

Première soumission répondant aux critères de contrôle qualité

23 avril 2024

Première publication (Réel)

24 avril 2024

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

24 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

21 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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