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RECRUITING
NCT07129109
NA

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

View on ClinicalTrials.gov

Summary

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.

Official title: Assessing the Performance of 7-Day vs 1-Day Packaging for Small Quantity Lipid-Based Nutrient Supplements in Ghana (SQLNS:7Dv1D Comparison)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

505

Start Date

2026-09-28

Completion Date

2027-06

Last Updated

2026-10-01

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

small-quantity lipid-based nutrient supplements (SQ-LNS)

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.

Locations (1)

Ghana Health Service facilities, Kumbungu and Tolon Districts

Kumbungu, Northern Region, Ghana