A Randomized Controlled Trial to Assess the Impact of School Meals Including Fish Powder on the Nutritional Status and Diet Quality of Malawian Schoolchildren
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 270
- 试验地点
- 3
- 主要终点
- Zinc concentration in Dried Blood Spots
研究概览
简要总结
Background: This randomized controlled trial (RCT) is a research component of a Food and Agriculture Organization of the United Nations (FAO) project in Malawi. The project aims to initiate pilot programs to integrate fish powders into existing home-grown school feeding program frameworks and meals served in selected schools in Malawi. The objective of the RCT is to assess the impact on dietary diversity and nutrition status (through biomarker analysis) of children receiving school meals in selected pilot schools.
Trial Design: This will be a two-armed single-blinded RCT with a closed cohort design, featuring two parallel groups with a 1:1 allocation ratio. The intervention will include 3-5g of fish powder added to the school meal (per 100g serving) five days per week, while the control group will receive the usual school meal. Children (n=270) of at least 10 years of age will be enrolled in the study. The primary outcome variable is the difference between the two arms in the contribution of school meals to zinc concentration measured in dried blood spots (DBS).
详细描述
This randomized controlled trial (RCT) will be implemented as a research component of the Food and Agriculture Organization of the United Nations (FAO) Flexible Voluntary Contribution fund (FVC) Sub-program entitled "Strengthening Capacity of Small-Scale Aquatic Food Producers for School Food and Nutrition". Starting in 2025, the Sub-program aims to initiate pilot programs to integrate aquatic food products into existing home-grown school feeding program frameworks and meals served in selected schools. The Sub-program has a research component, which will include an RCT in one country (Malawi) to assess the effectiveness of, and monitor the inclusion of, aquatic food products (specifically, fish powder) in school meals in schools participating in the pilot program. The objective of the RCT is to assess the impact on dietary diversity and nutrition status of children receiving meals from schools participating in the pilot program.
This will be done through collection of dried blood spot (DBS) samples pre- and post-intervention, to determine changes in nutritional status using biomarkers for key nutrients which may be attributed to increased fish consumption. The inclusion of fish powder in school meals will be monitored for compliance with the study protocol. Additionally, questionnaires will be administered to assess dietary diversity of schoolchildren to understand changes in nutritional status in the context of the whole diet.
Samples of the fish powders and porridges served in pilot schools will be collected for food composition analysis. Analysis of food composition will be conducted in an accredited laboratory to determine nutrient content of the fish powder, as well as the control (regular school meal) and intervention meal (regular school meal with fish powder added). These data may be used to demonstrate linkages between nutritional composition of fish products / meals and changes in nutritional status of schoolchildren consuming fish powder in school feeding programs.
Supplementary data on the costs and benefits to fish processors supplying fish powder to schools will be collected under the FAO FVC Sub-program.
Implementation of the RCT will be managed by a Trial Manager to be recruited by LUANAR, and supervised by the Principal Investigator and Lead Researcher listed below:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
盲法说明
This RCT is single-blinded, thus students will remain blinded throughout the duration of the RCT, so as not to affect their normal behavior in relation to food consumption or the perception of some students receiving a "superior" meal than others. Unblinding will only be done in cases where it is necessary, for example, if adverse effects are recorded during monitoring and knowledge on which treatment the student receives is relevant.
The research team will not be blinded, but access to personal data will be restricted to only grant access to data necessary for implementation. Compliance supervisors in the study schools will have access to the list of students enrolled in the study in the school where they are located, and the allocation of those students in the treatment and control group. The Trial Manager will have access to the full list of students enrolled in the study across all schools, and their allocation to treatment or control group. Researchers at the Institute of Ma
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The selection of study sites in Malawi will be delimited by two criteria. Firstly, the schools have to be currently implementing a full home-grown feeding modality, where food and ingredients are purchased directly by schools using government, Mary's Meals or WFP funds, given that this modality has been endorsed by the Government of Malawi. All schools that do not implement school meals, are privately funded or implement meals with hybrid or traditional school feeding modalities will be therefore excluded.
- •Secondly, as HGSF programs often require that foods are sourced within a given radius of the school, study sites will be limited to those where fish processing organizations are known to be present. Of these, three districts were selected (Mangochi, Salima and Karonga). As these three districts are lakefront districts, it was recognized that fish may be a more typical part of the diet of people in these districts than in upland districts (Simmance et al. 2022). Thus, one upland district (Dowa), further away from where known fish processing organizations are present, was also selected for testing the intervention.
- •A list of schools will be compiled with data on geographical location, total enrolment, school feeding modality and implementing entity for the four identified districts. For the students to be eligible to participate in the study, they have to be at least 10 years old, considering the minimum age that children can report on their own food consumption . No maximum age is included, as it may be expected that the majority of children enrolled are aged 10-14 years, however, older students who may still be in primary school will not be excluded. Due to the closed cohort design and the duration of the intervention of one term, no loss of students due to termination of the school cycle is expected. Students will be excluded if they have grave intolerances or food allergies or with health conditions that may affect their food consumption. All eligible children in this age group from the selected schools will constitute the sampling frame at the child level. Screening of students for eligibility will be led by the Trial Manager, to be recruited by LUANAR
排除标准
- 未提供
结局指标
主要结局
Zinc concentration in Dried Blood Spots
时间窗: 3-4 month school term (as defined by Malawi school calendar)
Difference between the two arms in the contribution of school meals to zinc concentration (mcg/dL) in DBS collected from selected school children.
Zinc concentration in Dried Blood Spots
时间窗: 3-4 month school term (as defined by Malawi school calendar)
Difference between the two arms in the contribution of school meals to zinc concentration (mcg/dL) in DBS collected from selected school children.
次要结局
- Micronutrient Status of children(3-4 month school term (as defined by Malawi school calendar))
- Diet Scores(3-4 month school term (as defined by Malawi school calendar))
- Micronutrient Status of children(3-4 month school term (as defined by Malawi school calendar))
- Diet Scores(3-4 month school term (as defined by Malawi school calendar))