Assessing the Performance of 7-Day vs 1-Day Packaging for Small Quantity Lipid-Based Nutrient Supplements in Ghana (SQLNS:7Dv1D Comparison)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 505
- 试验地点
- 2
- 主要终点
- Adherence
研究概览
简要总结
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.
Sixteen 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Caregiver of a child with a diagnosed severe illness requiring hospitalization
- •Caregiver under the age of 18
研究组 & 干预措施
SQ-LNS 1-day packaging first, followed by 7-day packaging
SQ-LNS 1-day packaging first, followed by 7-day packaging
干预措施: small-quantity lipid-based nutrient supplements (SQ-LNS) (Dietary Supplement)
SQ-LNS 7-day packaging first, followed by 1-day packaging
SQ-LNS 7-day packaging first, followed by 1-day packaging
干预措施: small-quantity lipid-based nutrient supplements (SQ-LNS) (Dietary Supplement)
结局指标
主要结局
Adherence
时间窗: Measured twice per participant: at the end of the first 1-month phase and at the end of the second 1-month phase
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.
次要结局
- 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))