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

NCT07129109 | Recruiting

• 1 other identifier: SQLNS7
• Study Type: interventional
• Target: 505
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Child Malnutrition

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Adherence to SQ-LNS, measured as the percentage of dispensed product consumed

  Weight-based adherence, calculated as 100 × (grams of SQ-LNS dispensed - grams of SQ-LNS returned unconsumed) / grams of SQ-LNS dispensed, with returned product weighed net of packaging tare. Participants in both arms receive a 28-day supply totaling 560 g per period (28 × 20 g sachets in the 1-day sachet arm; 4 × 140 g resealable pouches in the 7-day pouch arm). Returned product is weighed at the first contact point reached, following a fixed sequence: the next scheduled growth monitoring clinic visit, then a community outreach growth monitoring event, then a home visit. The 7-day resealable pouch is assessed for non-inferiority to the 1-day sachet using a non-inferiority margin of 5.0 percentage points.

  Measured twice per participant: End of each one-month packaging period (Period 1 and Period 2)

Secondary Outcomes (4)

• 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)

• Dispensing accuracy, measured as the percentage of caregivers dispensing a single day's dose within ±2 g of the 20 g target

  at the end of the first 1-month phase and at the end of the second 1-month phase

• Percentage of caregivers opening the package without a tool or assistance

  at the end of the first 1-month phase and at the end of the second 1-month phase

Study Arms (2)

Arm 1 (1-day sachet first)

ACTIVE COMPARATOR

Caregivers at facilities randomized to this sequence receive SQ-LNS in 1-day 20 g sachets (28 sachets, 560 g) during the first month, then 7-day 140 g resealable pouches (4 pouches, 560 g) during the second month.

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

Arm 2 (7-day pouch first)

EXPERIMENTAL

Caregivers at facilities randomized to this sequence receive SQ-LNS in 7-day 140 g resealable pouches (4 pouches, 560 g) during the first month, then 1-day 20 g sachets (28 sachets, 560 g) during the second month.

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

Interventions

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

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.

Arm 1 (1-day sachet first); Arm 2 (7-day pouch first)

Eligibility Criteria

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

You may qualify if:

• The caregiver is 18 years or older and is the primary caregiver of the child
• The child is 6-24 months of age at the time of enrollment
• The child is eligible to receive routine growth monitoring and promotion services at the participating clinic
• The caregiver provides written informed consent to participate

You may not qualify if:

• The child has severe acute malnutrition (SAM) or medical complications requiring medication or inpatient care
• The child has a known allergy to peanuts, milk, or other components of the supplement, or has a medical condition that prevents consumption of complementary foods
• The caregiver or child is concurrently enrolled in another nutrition intervention study or clinical trial
• The family plans to relocate outside the study area during the two-month follow-up
• The caregiver is unwilling to provide informed consent or to follow the study procedures

Sponsors & Collaborators

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

Study Sites (1)

Ghana Health Service facilities, Kumbungu and Tolon Districts

Kumbungu, Northern Region, Ghana

RECRUITING

MeSH Terms

Conditions

Child Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Lindsey Locks, ScD

  Boston University Charles River Campus

  PRINCIPAL INVESTIGATOR

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: September 28, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

GH (1)