Evaluation of 7-day vs 1-day Packaging of Small Quantity Lipid-based Nutrition Supplementation (SQ-LNS)

Overview

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 supplement 7dp 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 supplement 1dp 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).

Primary outcome measures

• Adherence [Time frame: 8 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Single blind

Primary purpose

Other

Study locations

Ethiopia · 1 center

• Debre Berhan University — Debre Berhan

Germany · 1 center

• Heidelberg University — Heidelberg

Philippines · 1 center

• Research Institute of Tropical Medicine — Manila

Publications

• Seitz CM, Orsini MM. Thirty Years of Implementing the Photovoice Method: Insights From a Review of Reviews. Health Promot Pract. 2022 Mar;23(2):281-288. doi: 10.1177/15248399211053878. PMID 35285331
• Malterud K, Siersma VD, Guassora AD. Sample Size in Qualitative Interview Studies: Guided by Information Power. Qual Health Res. 2016 Nov;26(13):1753-1760. doi: 10.1177/1049732315617444. Epub 2016 Jul 10. PMID 26613970
• Kodish SR, Aburto NJ, Nseluke Hambayi M, Dibari F, Gittelsohn J. Patterns and determinants of small-quantity LNS utilization in rural Malawi and Mozambique: considerations for interventions with specialized nutritious foods. Matern Child Nutr. 2017 Jan;13(1):10.1111/mcn.12234. doi: 10.1111/mcn.12234. Epub 2016 Jan 19. PMID 26787342
• Stewart CP, Wessells KR, Arnold CD, Huybregts L, Ashorn P, Becquey E, Humphrey JH, Dewey KG. Lipid-based nutrient supplements and all-cause mortality in children 6-24 months of age: a meta-analysis of randomized controlled trials. Am J Clin Nutr. 2020 Jan 1;111(1):207-218. doi: 10.1093/ajcn/nqz262. PMID 31697329
• Hess SY, Abbeddou S, Jimenez EY, Some JW, Vosti SA, Ouedraogo ZP, Guissou RM, Ouedraogo JB, Brown KH. Small-quantity lipid-based nutrient supplements, regardless of their zinc content, increase growth and reduce the prevalence of stunting and wasting in young burkinabe children: a cluster-randomized trial. PLoS One. 2015 Mar 27;10(3):e0122242. doi: 10.1371/journal.pone.0122242. eCollection 2015. PMID 25816354
• Dewey KG, Arnold CD, Wessells KR, Prado EL, Abbeddou S, Adu-Afarwuah S, Ali H, Arnold BF, Ashorn P, Ashorn U, Ashraf S, Becquey E, Brown KH, Christian P, Colford JM Jr, Dulience SJ, Fernald LC, Galasso E, Hallamaa L, Hess SY, Humphrey JH, Huybregts L, Iannotti LL, Jannat K, Lartey A, Le Port A, Leroy JL, Luby SP, Maleta K, Matias SL, Mbuya MN, Mridha MK, Nkhoma M, Null C, Paul RR, Okronipa H, Oued PMID 36045000
• Aguayo VM, Baker SK, Dewey KG, Galasso E, Perry A, Sifri Z, Aburmishan D, de Pee S, Guerrero Oteyza SI, Moloney G, Prado EL, Rawat R, Shaker-Berbari L, Shekar M, Stewart CP, Tumilowicz A, Wessells KR. Benefits of small-quantity lipid-based nutrient supplements for child nutrition and survival warrant moving to scale. Nat Food. 2023 Feb;4(2):130-132. doi: 10.1038/s43016-023-00703-2. No abstract ava PMID 37117857
• Abbeddou S, Hess SY, Yakes Jimenez E, Some JW, Vosti SA, Guissou RM, Ouedraogo JB, Brown KH. Comparison of methods to assess adherence to small-quantity lipid-based nutrient supplements (SQ-LNS) and dispersible tablets among young Burkinabe children participating in a community-based intervention trial. Matern Child Nutr. 2015 Dec;11 Suppl 4(Suppl 4):90-104. doi: 10.1111/mcn.12162. PMID 25521188

Identifiers

NCT: NCT07540793 · 25-44863

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗