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.
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
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
Crossover
small-quantity lipid-based nutrient supplements (SQ-LNS)
Dietary supplementSmall-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.
Adherence to SQ-LNS, measured as the percentage of dispensed product consumed
Weight-based adherence, calculated as 100 × (grams of SQ-LNS dispensed - grams of SQ-LNS returned unconsumed) / grams of SQ-LNS dispensed, with returned product weighed net of packaging tare. Participants in both arms receive a 28-day supply totaling 560 g per period (28 × 20 g sachets in the 1-day sachet arm; 4 × 140 g resealable pouches in the 7-day pouch arm). Returned product is weighed at the first contact point reached, following a fixed sequence: the next scheduled growth monitoring clinic visit, then a community outreach growth monitoring event, then a home visit. The 7-day resealable pouch is assessed for non-inferiority to the 1-day sachet using a non-inferiority margin of 5.0 percentage points.
Caregiver acceptability/usability
Caregiver acceptability/usability will be defined as a composite score (Likert-scaled) capturing acceptability, preference, usability, and ease of administration of the SQ-LNS packaging
Caregiver experience with SQ-LNS
Qualitative assessment of caregiver experience with SQ-LNS, including perceptions of packaging, feeding practices, and overall acceptability, collected through semi-structured interviews and analyzed using thematic content analysis.
Dispensing accuracy, measured as the percentage of caregivers dispensing a single day's dose within ±2 g of the 20 g target
At a brief facility-based observation, the caregiver opens the package and dispenses one day's dose into a tared container, which the enumerator weighs. Accuracy is recorded as whether the dispensed dose falls within ±2 g of the 20 g target.
Percentage of caregivers opening the package without a tool or assistance
At the same facility-based observation, the enumerator records whether the caregiver opens the package without using a tool and without assistance.
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