- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT06380504
Augmenter la couverture du traitement de la malnutrition aiguë sévère (MAS) en Éthiopie (R-SWITCH)
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
Statut
Les conditions
Intervention / Traitement
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
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Lieven Huybregts, PhD
- Numéro de téléphone: +1 202 862-6481
- E-mail: l.huybregts@cgiar.org
Sauvegarde des contacts de l'étude
- Nom: Alemayehu Haddis, PhD
- E-mail: alemayehuh@etpha.org
Lieux d'étude
-
-
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Jimma, Ethiopie
- Recrutement
- Kersa and Jeldessa woredas
-
Chercheur principal:
- Lieven Huybregts, PhD
-
Chercheur principal:
- Tefera Belachew, PhD
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
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
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
|
|
|
Expérimental: R-SWITCH integrated intervention package
|
|
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".
|
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".
|
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):
|
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
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
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- RSWITCH-Ethiopia
Informations sur les médicaments et les dispositifs, documents d'étude
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