Increasing the Coverage of Severe Acute Malnutrition (SAM) Treatment in Ethiopia

Malnutrition, Child Clinical Trial

— R-SWITCH  

Official title:

Effect of Leveraging Community-level Structures to Strengthen Prevention, Screening and Treatment of Severe Acute Malnutrition in Ethiopia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06380504
• Other study ID #: RSWITCH-Ethiopia
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 29, 2024
• Est. completion date: June 30, 2027

Study information

• Verified date: April 2024
• Source: International Food Policy Research Institute
• Contact: Lieven Huybregts, PhD
• Phone: 202 862-6481
• Email: l.huybregts[@]cgiar.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Cachexia
• Child Nutrition Disorders
• Malnutrition
• Malnutrition, Child
• Severe Acute Malnutrition
• Wasting

Intervention

Behavioral:
• R-SWITCH integrated intervention package
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 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) 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) 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 Strengthening communication between HEW and AFDs

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
International Food Policy Research Institute	Ethiopian Public Health Association, UNICEF

Outcome

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