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

Boston University Charles River Campus

Status: Begins enrollment this month

Conditions: Child Malnutrition

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07129109

SQLNS7

Details and patient eligibility

About

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.

Full description

Background and Rationale:

Small-quantity lipid-based nutrient supplements (SQ-LNS) have demonstrated effectiveness in reducing child undernutrition, including stunting, wasting, and anemia, particularly among children 6-24 months of age in low- and middle-income countries. Despite strong evidence, uptake and adherence in real-world settings remain suboptimal. Packaging format may influence how caregivers understand, use, and integrate SQ-LNS into daily routines.

This study, titled "Assessing the performance of 7-day vs 1-day packaging for Small Quantity Lipid-based Nutrient Supplements in Ghana," is designed to evaluate how packaging format influences adherence and acceptability when SQ-LNS are distributed through routine growth monitoring services in Northern Ghana.

Study Objectives:

Primary Objective: To compare adherence to SQ-LNS when delivered in 1-day sachets versus 7-day bulk packaging.

Secondary Objectives: To assess caregiver acceptability, preferences, ease of use, and perceptions of both packaging types; and to explore implementation facilitators and barriers to effective delivery and use of SQ-LNS within growth monitoring programs.

Study Design:

This is a cluster-randomized crossover trial embedded within routine child health services at eight health facilities. The trial follows a convergent mixed-methods implementation research design.

Clusters: Health facilities (n=8), each randomized to one of two packaging sequences.

Intervention: Each facility receives one packaging format for one month, then switches to the alternate format for another month.

Participants: Caregivers of children aged 6-24 months attending growth monitoring and promotion (GMP) services during the intervention periods.

Randomization:

Facilities are randomized to one of two sequences:

Sequence A: 1-day sachet → 7-day bulk Sequence B: 7-day bulk → 1-day sachet

Randomization is stratified by facility size or service volume (if available) to ensure balance.

Sample Size:

Based on prior service utilization data and expected recruitment rates, the study aims to enroll approximately 250 caregivers per facility per arm.

Outcomes:

Primary Outcomes:Adherence to SQ-LNS (measured by caregiver self-report, sachet count, and possibly biomarkers or stool colorant testing if available)

Secondary Outcomes:

Caregiver acceptability and preference (structured surveys and Likert scales) Usability and ease of administration Qualitative themes related to packaging, feeding practices, and caregiver experience (in-depth interviews and structured observations)

Data Collection:

Quantitative data will be collected through baseline and endline caregiver surveys, adherence logs, and observational checklists.

Qualitative data will be collected through purposive sampling of caregivers for in-depth interviews, as well as interviews with health workers and program implementers.

Analysis Plan:

Quantitative data will be analyzed using generalized linear mixed models to account for clustering and crossover design. Primary comparisons will assess differences in adherence between packaging formats. Qualitative data will be coded and analyzed thematically using a grounded theory approach.Convergence of quantitative and qualitative data will inform implementation recommendations.

Ethical Considerations:

The study will be submitted for IRB approval from received approval from Boston University and the University of Ghana. Written informed consent will be obtained from all participants. The study poses minimal risk and is embedded in routine health services.

Dissemination:

Findings will be shared with Ghana Health Service, implementing partners, and international stakeholders, and will be submitted for publication in peer-reviewed journals.

Enrollment: 500 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

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

Active Comparator group

Description:

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

Treatment:

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

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

Experimental group

Description:

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

Treatment:

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