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

Study acronym: SQLNS:7Dv1D
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 32 days later Dec 2026 → Feb 2027
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Boston University Charles River Campus

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary endpoint(s) modified Show 10 more changesShow less
    • Recruitment opened
    • Primary completion pushed from Dec 2026 to Feb 2027
    • Study completion pushed from Dec 2026 to Jun 2027
    • Start date changed from estimate of Sep 2026 to Sep 28, 2026
    • Eligibility criteria expanded, about 73 words
    • Secondary endpoints: 2 to 4
    • Study description expanded, about 438 words
    • Study site revised
    • Collaborators revised (2)
    • Study title shortened, about 4 words
  2. Notable Primary and study completion dates: Mar 2026 to Dec 2026v2 Show 4 more changesShow less
    • Start date: Jan 2026 to Sep 2026
    • Enrollment target: 500 to 505
    • Study description revised
    • Study site revised
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07129109
Lead Sponsor Boston University Charles River Campus
Collaborators: University of Ghana, Edesia
Conditions
(from sponsor)
Child Malnutrition
Related terms Child Nutrition Disorders
Enrollment 505 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov