Malnutrition, Child Clinical Trial
— R-SWITCHOfficial title:
Effect of Leveraging Community-level Structures to Strengthen Prevention, Screening and Treatment of Severe Acute Malnutrition in Ethiopia
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.
Status | Not yet recruiting |
Enrollment | 1080 |
Est. completion date | June 30, 2027 |
Est. primary completion date | June 30, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Months to 5 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
International Food Policy Research Institute | Ethiopian Public Health Association, UNICEF |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | After 24 months of program implementation | |
Secondary | 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. |
After 24 months of program implementation | |
Secondary | 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) | After 24 months of program implementation | |
Secondary | 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) | After 24 months of program implementation | |
Secondary | Platform specific 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):
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 | |
Secondary | Growth Monitoring Promotion (GMP) consultation attendance | 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 | |
Secondary | AFD group meeting attendance | 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 | |
Secondary | AFD home visit coverage | 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 | |
Secondary | Prevalence of SAM | 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 | |
Secondary | Prevalence of wasting | 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 | |
Secondary | Prevalence of stunting | 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 | |
Secondary | Prevalence of underweight and severe underweight | 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 | |
Secondary | Mean height-for-age Z-score (HAZ) | In 6-59 months old children. To calculate HAZ scores the 2006 WHO growth reference will be used | After 24 months of program implementation | |
Secondary | Mean weight-for-height Z-score (WHZ) | In 6-59 months old children.To calculate WHZ scores the 2006 WHO growth reference will be used | After 24 months of program implementation | |
Secondary | Mean weight-for-age Z-score (WAZ) | In 6-59 months old children.To calculate WAZ scores the 2006 WHO growth reference will be used | After 24 months of program implementation | |
Secondary | Mean mid-upper arm circumference (MUAC) | In 6-59 months old children. | After 24 months of program implementation | |
Secondary | Caregiver's knowledge related to breastfeeding, complementary feeding,child health and hygiene, the condition of severe acute malnutrition, outpatient therapeutic programs, screening of wasting | Presented as a total standardized score and by knowledge domain | After 24 months of program implementation | |
Secondary | Vaccination coverage | 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 | |
Secondary | Introduction of (semi) solid and soft complementary foods | 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 | |
Secondary | Minimum dietary diversity in infants and young children (6-23 mo) | 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 | |
Secondary | Nr of food groups consumed by infants and young children (6-59 mo) | The mean number of food groups consumed during the previous day by study children aged 6-59 | After 24 months of program implementation | |
Secondary | Minimum meal frequency in infants and young children | 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 | |
Secondary | Minimum acceptable diet in infants and young children | 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 | |
Secondary | Continuous breastfeeding 12-23 months | Defined as the proportion of children aged 12-23 months breastfed during the previous day | After 24 months of program implementation | |
Secondary | Egg and/or flesh food consumption | 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 | |
Secondary | Sweet beverage consumption | Proportion of children 6-23 months of age who consumed a sweet beverage during the previous day | After 24 months of program implementation | |
Secondary | Zero vegetable or fruit consumption consumption | 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 | |
Secondary | Minimum milk feeding frequency for non-breastfed children | 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 | |
Secondary | Weight-for-length Z-score and MUAC at Severe Acute Malnutrition (SAM) Outpatient Therapeutic Feeding program (OTP) | Weight-for-length Z-score (relative to the 2006 WHO reference) and MUAC(mm) | 24 months from baseline until endline of the study | |
Secondary | SAM OTP adherence | 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 | |
Secondary | Weight gain rate during SAM OTP | 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 | |
Secondary | SAM OTP outcomes (drop-out, death, transfer, non-response rates) | Among cases admitted to SAM OTP | 24 months from baseline until endline of the study | |
Secondary | SAM OTP duration | Defined as the number of days spent in SAM OTP (from admission to discharge) | 24 months from baseline until endline of the study |
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