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Not Yet Recruiting NCT07129109

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

Conditions: Child Malnutrition

Sex: All
Healthy volunteers: Yes
Phase: NA
Enrollment: 505
Sponsor: Boston University Charles River Campus

Location: Sixteen health facilities in the Northern Region of Ghana (exact sites TBD) Tamale

Summary

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

Inclusion Criteria: * 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 Exclusion Criteria: * Caregiver of a child with a diagnosed severe illness requiring hospitalization * Caregiver under the age of 18

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07129109). StuddyBuddy aggregates publicly available trial information.