Malnutrition, Child, Nutrition, Prevention
Conditions
Keywords
Small Quantity Lipid-based Nutrient Supplement, Child nutrition, Malnutrition prevention
Brief summary
Small Quantity Lipid-based Nutrient Supplements (SQ-LNS), are fortified, lipid-based nutritional supplements that were specifically designed for children 6-24 months to prevent malnutrition. Recent research has shown reductions in mortality, severe wasting, severe stunting, iron deficiency anemia, and developmental delays. SQ-LNS is currently available in individual daily dose packets of 20g. Healthy children age 6-24 months receive 1 packet per day (1dp), and are typically given a 1- or 2- month supply at a time (30-60 packets). Recently, Nutriset Développement has developed a new packaging design for SQ-LNS that reduces the cost by over 15% overall, through production efficiency with 40% less packaging, and improved transportation efficiency by 20%. This new packaging is a 140g packet that will allow 20g to be dispensed daily for 7 days (7dp). The packaging has a chamber that will allow for accurate 10g dosing (either twice daily, or twice at once). Users of the packaging will also be able to close the spout to minimize risk of microbiological contamination. Edesia Nutrition is working with Nutriset to conduct field testing of this new packaging for SQ-LNS, and this mixed-methods study in North Shoa Zone, Amhara Region, Ethiopia, will help inform recommendations for the future use of the package. The study seeks to determine (1) the acceptability of integrating SQ-LNS distribution into the malnutrition program; (2) whether adherence to the 2 different package types differs, and if there are differences in usage; (3) and how the packages perform over time, their perceived safety and functionality, and how they are stored. Educational and communication tools will be developed and pre-tested as part of this study, and will become part of the final deliverable package to Edesia Nutrition, in addition to final recommendations on the product packaging, findings about how the packages are used, and behavior change and nutrition education strategies. The primary outcome of the quantitative evaluation will be adherence, calculated as the number of delivered doses of SQ-LNS divided by the number of expected doses per week (7). Adherence will be measured via weekly self-report via caregiver interview and counts of return of used and unused packages during weekly home visits. The percentage of children who receive a dose during structured observation periods will be calculated. Each adherence outcome will be analyzed separately.
Interventions
DIETARY_SUPPLEMENT7dp SQ-LNS
Small Quantity Lipid-based Nutrient Supplements (SQ-LNS) are currently available in individual daily dose packets of 20g. Healthy children age 6-24 months receive 1 packet per day (1dp), and are typically given a 1- or 2- month supply at a time (30-60 packets). The 7-day package of SQ-LNS has been developed by Nutriset Développement to improve costs and production and transportation efficiency. The new packaging allows 20g to be dispensed daily for 7 days (7dp).
DIETARY_SUPPLEMENT1dp SQ-LNS
Small Quantity Lipid-based Nutrient Supplements (SQ-LNS) are currently available in individual daily dose packets of 20g. Healthy children age 6-24 months receive 1 packet per day (1dp), and are typically given a 1- or 2- month supply at a time (30-60 packets).
Sponsors
University of California, San Francisco
Heidelberg University
Debre Berhan University
Research Institute for Tropical Medicine, Philippines
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
No
Inclusion criteria
(must meet all): * Written informed consent from head of household * Household within the study area * Available for the full 8-week study period * 1 child aged 6-22 months in the household at time of enrollment * Child has MUAC ≥ 12.5cm * Child does not have any clinical complications requiring inpatient treatment or referral to the health post, according to Ethiopian malnutrition treatment guidelines\*\* * Child is not allergic to peanuts, milk, or soy * Household does not have multiple children within the eligible age range
Exclusion criteria
(any excludes): * Head of household declines to sign written informed consent * Household is outside of the study area * Not available for the full 8-week study period * House has either multiple children aged 6-22 months in the household at time of enrollment, or 0 children aged 6-22 months at time of enrollment * Child has MUAC \< 12.5cm * Child has any clinical complications requiring inpatient treatment or referral to the health post, according to Ethiopian malnutrition treatment guidelines * Child is allergic to peanuts, milk, or soy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence | 8 weeks | Adherence will be calculated as the number of delivered doses of SQ-LNS divided by the number of expected doses per week (7). Adherence will be measured via (1) weekly self-report via caregiver interview and (2) weighing (7dp) and counting (1dp) of used and unused sachets during weekly home visits. |
Countries
Ethiopia, Germany, Philippines
Contacts
CONTACTCatherine Oldenburg, ScD
CONTACTHadley Burroughs
PRINCIPAL_INVESTIGATORCatherine Oldenburg, ScD
University of California, San Francisco
Outcome results
None listed