Increasing the Coverage of Severe Acute Malnutrition (SAM) Treatment in Ethiopia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-5
SponsorInternational Food Policy Research Institute
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
R-SWITCH integrated intervention package
Behavioral1. 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
Treatment groups
1,080 Participants
are divided into 2 treatment groupsGroup A: Standard of CareNo intervention 0 interventions
Group B: R-SWITCH integrated intervention packageExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
After 24 months of program implementationSecondary outcomes
1
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
Time frame
After 24 months of program implementation2
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 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.
Time frame
After 24 months of program implementation3
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)
Time frame
After 24 months of program implementation4
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)
Time frame
After 24 months of program implementationSponsors and contacts
Click on the lead sponsor to view all of their trials.
International Food Policy Research Institute
Lead sponsor
Ethiopian Public Health Association
Collaborator
UNICEF
Collaborator
Source ClinicalTrials.gov