Kersa and Jeldessa woredas
Jimma, Ethiopia
Location status: Recruiting
Location contact
Lieven Huybregts, PhD
PRINCIPAL_INVESTIGATOR
Tefera Belachew, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06380504
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.
Interested in participating?
Request Info6 month–5 year
All sexes
Interventional
Not applicable
Jimma, Ethiopia
Location status: Recruiting
Lieven Huybregts, PhD
PRINCIPAL_INVESTIGATOR
Tefera Belachew, PhD
PRINCIPAL_INVESTIGATOR
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:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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".
Time frame: 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
Time frame: 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".
Time frame: 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)
Time frame: 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)
Time frame: 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):
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: After 24 months of program implementation
In 6-59 months old children. To calculate HAZ scores the 2006 WHO growth reference will be used
Time frame: After 24 months of program implementation
In 6-59 months old children.To calculate WHZ scores the 2006 WHO growth reference will be used
Time frame: After 24 months of program implementation
In 6-59 months old children.To calculate WAZ scores the 2006 WHO growth reference will be used
Time frame: After 24 months of program implementation
In 6-59 months old children.
Time frame: After 24 months of program implementation
Presented as a total standardized score and by knowledge domain
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: After 24 months of program implementation
The mean number of food groups consumed during the previous day by study children aged 6-59
Time frame: 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.
Time frame: 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
Time frame: After 24 months of program implementation
Defined as the proportion of children aged 12-23 months breastfed during the previous day
Time frame: 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
Time frame: After 24 months of program implementation
Proportion of children 6-23 months of age who consumed a sweet beverage during the previous day
Time frame: 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
Time frame: 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
Time frame: 24 months from baseline until endline of the study
Weight-for-length Z-score (relative to the 2006 WHO reference) and MUAC(mm)
Time frame: 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
Time frame: 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
Time frame: 24 months from baseline until endline of the study
Among cases admitted to SAM OTP
Time frame: 24 months from baseline until endline of the study
Defined as the number of days spent in SAM OTP (from admission to discharge)
Contact information is provided by the study sponsor or research team.
International Food Policy Research Institute
Other
Effect of Leveraging Community-level Structures to Strengthen Prevention, Screening and Treatment of Severe Acute Malnutrition in Ethiopia
Acronym: R-SWITCH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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