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

NCT07129109 | Not Yet Recruiting

• 1 other identifier: SQLNS7
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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. Eight 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.

Conditions

Child Malnutrition

Keywords

Small-quantity lipid-based nutrient supplments (SQ-LNS); Ghana; Infant and young child feeding; Growth monitoring and promotion (GMP)

Outcome Measures

Primary Outcomes (1)

• 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.

  Measured twice per participant: at the end of the first 1-month phase and at the end of the second 1-month phase

Secondary Outcomes (2)

• Caregiver acceptability/usability

  Measured twice per participant: at the end of the first 1-month phase and at the end of the second 1-month phase

• Caregiver experience with SQ-LNS

  At the end of each 1-month crossover period (following each intervention phase)

Study Arms (2)

SQ-LNS 1-day packaging first, followed by 7-day packaging

ACTIVE COMPARATOR

SQ-LNS 1-day packaging first, followed by 7-day packaging

Dietary Supplement: small-quantity lipid-based nutrient supplements (SQ-LNS)

SQ-LNS 7-day packaging first, followed by 1-day packaging

EXPERIMENTAL

SQ-LNS 7-day packaging first, followed by 1-day packaging

Dietary Supplement: small-quantity lipid-based nutrient supplements (SQ-LNS)

Interventions

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

All 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.

SQ-LNS 1-day packaging first, followed by 7-day packaging; SQ-LNS 7-day packaging first, followed by 1-day packaging

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Caregiver of a child with a diagnosed severe illness requiring hospitalization
• Caregiver under the age of 18

Sponsors & Collaborators

• Boston University Charles River Campus: lead
• University of Ghana: collaborator
• Edesia Nutrition: collaborator

Study Sites (1)

Eight health facilities in the Northern Region of Ghana (exact sites TBD)

Tamale, Ghana

Location

MeSH Terms

Conditions

Child Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Central Study Contacts

Lindsey M Locks, ScD

CONTACT

617-353-2710; lmlocks@bu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 19, 2025
• Study Start: January 1, 2026
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GH (1)