About this trial
This cluster-randomized crossover trial evaluates the impact of two different packaging formats for small-quantity lipid-based nutrient supplements (SQ-LNS) on adherence and acceptability among caregivers of young children in Northern Ghana. SQ-LNS are a proven intervention for reducing child malnutrition, but optimizing packaging formats may improve adherence and scalability.
Sixteen health facilities participating in growth monitoring services will each receive both formats: a 1-day sachet (20g daily) and a 7-day bulk container (140g weekly), with the order of delivery randomized. Each packaging format will be distributed for one month before cross-over. The primary outcomes are adherence (measured through caregiver self-report and sachet counts) and acceptability (assessed via caregiver interviews). Secondary outcomes include caregiver preference, ease of use, and qualitative insights into feeding practices, beliefs, and packaging usability.
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Primary caregiver of a child aged 6-24 months attending growth monitoring and promotion (GMP) services at one of the participating health facilities
Willing and able to provide informed consent
Plans to remain in the area for the duration of the study period
Agrees to participate in surveys and/or interviews related to supplement use
Disqualifiers
Caregiver of a child with a diagnosed severe illness requiring hospitalization
Caregiver under the age of 18
Trial design
Crossover
Treatments tested in this trial
small-quantity lipid-based nutrient supplements (SQ-LNS)
Dietary supplementAll caregivers will receive 2 months of SQ-LNS in this cross-over design. Half of the participants will be randomized to receive the 7-day packaging first, and half will receive the 1-day packaging first.
Treatment groups
Trial outcomes
Primary outcomes
Adherence
Adherence will be defined as the percentage of the 28-day dose of small quantity lipid-based nutrient supplements (SQ-LNS) consumed, measured using a triangulated approach that combines caregiver report with returned-sachet counts and residual-sachet weighing.
Secondary outcomes
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.
Sponsors and contacts
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Boston University Charles River Campus
Lead sponsor
University of Ghana
Collaborator
Edesia Nutrition
Collaborator
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