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

NCT07540793 | Not Yet Recruiting

• 1 other identifier: 25-44863
• Study Type: interventional
• Target: 100
• Locations: 3 countries
• Sites: 3

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 efficienty 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.3 We will also calculate the percentage of children who receive a dose during structured observation periods. Each adherence outcome will be analyzed separately.

Conditions

Prevention; Malnutrition, Child; Nutrition

Keywords

Small Quantity Lipid-based Nutrient Supplement; Child nutrition; Malnutrition prevention

Outcome Measures

Primary Outcomes (1)

• Adherence

  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.

  8 weeks

Study Arms (2)

1dp SQ-LNS

ACTIVE COMPARATOR

Randomization will occur after the baseline assessment. UCSF investigators will generate the randomization sequence. Households will be randomized in a 1:1 fashion to either a 1-month supply of 7DP or 1DP and then crossed over to the other packaging after one month. Households will receive 2 months of SQ-LNS in total. 7DP will be provided as 4 packages per eligible child (28 days' worth of product) and 1DP will be provided as 28 packages per eligible child (28 days' worth of product).

Dietary Supplement: 1dp SQ-LNS

7dp SQ-LNS

EXPERIMENTAL

Randomization will occur after the baseline assessment. UCSF investigators will generate the randomization sequence. Households will be randomized in a 1:1 fashion to either a 1-month supply of 7DP or 1DP and then crossed over to the other packaging after one month. Households will receive 2 months of SQ-LNS in total. 7DP will be provided as 4 packages per eligible child (28 days' worth of product) and 1DP will be provided as 28 packages per eligible child (28 days' worth of product).

Dietary Supplement: 7dp SQ-LNS

Interventions

7dp SQ-LNS DIETARY_SUPPLEMENT

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).

7dp SQ-LNS

1dp SQ-LNS DIETARY_SUPPLEMENT

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).

1dp SQ-LNS

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent from head of household
• Household within the study area
• Available for the full 8-week study period
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Heidelberg University: collaborator
• Debre Berhan University: collaborator
• Research Institute for Tropical Medicine, Philippines: collaborator

Study Sites (3)

Debre Berhan University

Debre Berhan, Ethiopia

Location

Heidelberg University

Heidelberg, Germany

Location

Research Institute of Tropical Medicine

Manila, Philippines

Location

Related Publications (10)

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• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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, Ouedraogo JB, Pickering AJ, Prendergast AJ, Ruel M, Shaikh S, Weber AM, Wolff P, Zongrone A, Stewart CP. Preventive small-quantity lipid-based nutrient supplements reduce severe wasting and severe stunting among young children: an individual participant data meta-analysis of randomized controlled trials. Am J Clin Nutr. 2022 Nov;116(5):1314-1333. doi: 10.1093/ajcn/nqac232. Epub 2023 Feb 10.

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• 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 available.

  PMID: 37117857 BACKGROUND

• 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 BACKGROUND

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  PMID: 6689736 BACKGROUND

• Oldenburg CE, Ouattara M, Bountogo M, Boudo V, Ouedraogo T, Compaore G, Dah C, Zakane A, Coulibaly B, Bagagnan C, Hu H, O'Brien KS, Nyatigo F, Keenan JD, Doan T, Porco TC, Arnold BF, Lebas E, Sie A, Lietman TM. Mass Azithromycin Distribution to Prevent Child Mortality in Burkina Faso: The CHAT Randomized Clinical Trial. JAMA. 2024 Feb 13;331(6):482-490. doi: 10.1001/jama.2023.27393.

  PMID: 38349371 BACKGROUND

MeSH Terms

Conditions

Child Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Catherine Oldenburg, ScD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine Oldenburg, ScD

CONTACT

4154761442; catherine.oldenburg@ucsf.edu

Hadley Burroughs

CONTACT

hadley.burroughs@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 20, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PH (1); ET (1); DE (1)