Evaluation of 7-day vs 1-day Packaging of Small Quantity Lipid-based Nutrition Supplementation (SQ-LNS)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Adherence
研究概览
简要总结
Small Quantity Lipid-based Nutrient Supplements (SQ-LNS), are fortified, lipid-based nutritional supplements that were specifically designed for children 6-24 months to prevent malnutrition. Recent research has shown reductions in mortality, severe wasting, severe stunting, iron deficiency anemia, and developmental delays.
SQ-LNS is currently available in individual daily dose packets of 20g. Healthy children age 6-24 months receive 1 packet per day (1dp), and are typically given a 1- or 2- month supply at a time (30-60 packets).
Recently, Nutriset Développement has developed a new packaging design for SQ-LNS that reduces the cost by over 15% overall, through production efficiency with 40% less packaging, and improved transportation efficiency by 20%. This new packaging is a 140g packet that will allow 20g to be dispensed daily for 7 days (7dp). The packaging has a chamber that will allow for accurate 10g dosing (either twice daily, or twice at once). Users of the packaging will also be able to close the spout to minimize risk of microbiological contamination.
Edesia Nutrition is working with Nutriset to conduct field testing of this new packaging for SQ-LNS, and this mixed-methods study in North Shoa Zone, Amhara Region, Ethiopia, will help inform recommendations for the future use of the package. The study seeks to determine (1) the acceptability of integrating SQ-LNS distribution into the malnutrition program; (2) whether adherence to the 2 different package types differs, and if there are differences in usage; (3) and how the packages perform over time, their perceived safety and functionality, and how they are stored.
Educational and communication tools will be developed and pre-tested as part of this study, and will become part of the final deliverable package to Edesia Nutrition, in addition to final recommendations on the product packaging, findings about how the packages are used, and behavior change and nutrition education strategies.
The primary outcome of the quantitative evaluation will be adherence, calculated as the number of delivered doses of SQ-LNS divided by the number of expected doses per week (7).
Adherence will be measured via weekly self-report via caregiver interview and counts of return of used and unused packages during weekly home visits. The percentage of children who receive a dose during structured observation periods will be calculated. Each adherence outcome will be analyzed separately.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(must meet all):
- •Written informed consent from head of household
- •Household within the study area
- •Available for the full 8-week study period
- •1 child aged 6-22 months in the household at time of enrollment
- •Child has MUAC ≥ 12.5cm
- •Child does not have any clinical complications requiring inpatient treatment or referral to the health post, according to Ethiopian malnutrition treatment guidelines**
- •Child is not allergic to peanuts, milk, or soy
- •Household does not have multiple children within the eligible age range
排除标准
- •(any excludes):
- •Head of household declines to sign written informed consent
- •Household is outside of the study area
- •Not available for the full 8-week study period
- •House has either multiple children aged 6-22 months in the household at time of enrollment, or 0 children aged 6-22 months at time of enrollment
- •Child has MUAC < 12.5cm
- •Child has any clinical complications requiring inpatient treatment or referral to the health post, according to Ethiopian malnutrition treatment guidelines
- •Child is allergic to peanuts, milk, or soy
研究组 & 干预措施
1dp SQ-LNS
Randomization will occur after the baseline assessment. UCSF investigators will generate the randomization sequence. Households will be randomized in a 1:1 fashion to either a 1-month supply of 7DP or 1DP and then crossed over to the other packaging after one month.
Households will receive 2 months of SQ-LNS in total. 7DP will be provided as 4 packages per eligible child (28 days' worth of product) and 1DP will be provided as 28 packages per eligible child (28 days' worth of product).
干预措施: 1dp SQ-LNS (Dietary Supplement)
7dp SQ-LNS
Randomization will occur after the baseline assessment. UCSF investigators will generate the randomization sequence. Households will be randomized in a 1:1 fashion to either a 1-month supply of 7DP or 1DP and then crossed over to the other packaging after one month.
Households will receive 2 months of SQ-LNS in total. 7DP will be provided as 4 packages per eligible child (28 days' worth of product) and 1DP will be provided as 28 packages per eligible child (28 days' worth of product).
干预措施: 7dp SQ-LNS (Dietary Supplement)
结局指标
主要结局
Adherence
时间窗: 8 weeks
Adherence will be calculated as the number of delivered doses of SQ-LNS divided by the number of expected doses per week (7). Adherence will be measured via (1) weekly self-report via caregiver interview and (2) weighing (7dp) and counting (1dp) of used and unused sachets during weekly home visits.
次要结局
未报告次要终点