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7-Day vs 1-Day Packaging for Small Quantity Lipid-Based Nutrient Supplements in Ghana (SQLNS:7D-1D Comparison)

Sponsor: Boston University Charles River Campus • ClinicalTrials.gov ID: NCT07129109

Registry updated: 2026-10-01

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Description

This cluster-randomized crossover trial evaluates whether the packaging format of small-quantity lipid-based nutrient supplements (SQ-LNS) affects caregiver adherence and acceptability when SQ-LNS are delivered through routine growth monitoring services in Northern Ghana. SQ-LNS are a proven intervention for reducing child malnutrition, but packaging format may affect how caregivers store, dispense, and use the product, and it also drives cost and distribution logistics. Up to sixteen health facilities participating in growth monitoring services each deliver both formats: a 1-day sachet (20 g daily) and a 7-day resealable pouch (140 g weekly), with the order of delivery randomized at facility level. Each format is delivered for one month before crossover, and caregivers receive a 28-day supply totaling 560 g in each period regardless of format. The primary outcome is adherence, measured by weighing SQ-LNS returned unconsumed and expressed as the percentage of dispensed product consumed. The trial tests whether adherence with the 7-day pouch is non-inferior to adherence with 1-day sachets, using a margin of 5.0 percentage points. Secondary outcomes include caregiver acceptability and preference, observed dispensing accuracy and package opening, and qualitative assessment of implementation facilitators and barriers. This implementation research study uses a convergent mixed-methods design, integrating quantitative adherence and acceptability data with in-depth interviews and structured observations to inform real-world program implementation. Findings will guide policy and program decisions for integrating SQ-LNS into child health platforms in Ghana and other low-resource settings.

Interventions

small-quantity lipid-based nutrient supplements (SQ-LNS) (Dietary supplement)
Small-quantity lipid-based nutrient supplements are delivered through routine growth monitoring and promotion services in two packaging formats: 1-day 20 g sachets (20DS) and 7-day 140 g resealable pouches (7DRP). Every caregiver receives both formats, one per month, in the order determined by their facility's randomized sequence. In each period the caregiver receives a 28-day supply totaling 560 g.

Eligibility criteria

Inclusion Criteria: * The caregiver is 18 years or older and is the primary caregiver of the child * The child is 6-24 months of age at the time of enrollment * The child is eligible to receive routine growth monitoring and promotion services at the participating clinic * The caregiver provides written informed consent to participate Exclusion Criteria: * The child has severe acute malnutrition (SAM) or medical complications requiring medication or inpatient care * The child has a known allergy to peanuts, milk, or other components of the supplement, or has a medical condition that prevents consumption of complementary foods * The caregiver or child is concurrently enrolled in another nutrition intervention study or clinical trial * The family plans to relocate outside the study area during the two-month follow-up * The caregiver is unwilling to provide informed consent or to follow the study procedures

Conditions

Child Malnutrition

Locations

Ghana Health Service facilities, Kumbungu and Tolon Districts — Kumbungu, Northern Region, Ghana

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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