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Not yet recruiting NCT07085871

Nourishing for Knowledge: Fish Powder in School Meals in Malawi

No phase Interventional Zinc Concentration in DBS

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fish Powder.
Who it may be relevant to
Registry conditions: Zinc Concentration in DBS. Basic parameters: from 10 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Malawi
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Randomized Controlled Trial to Assess the Impact of School Meals Including Fish Powder on the Nutritional Status and Diet Quality of Malawian Schoolchildren

Overview

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).

Detailed description

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:

* Principal Investigator (PI): Professor Alexander Kalimbira (Department of Human Nutrition and Health, LUANAR) * Lead Researcher, FAO: Molly Ahern (Fisheries Officer from the Food and Agriculture Organization (FAO) Fisheries Division's Food Safety, Nutrition and Health team) The study will be done in collaboration with relevant local partners (Malawi Department of Fisheries, Ministry of Education, Ministry of Health, World Food Programme, Malawi Bureau of Standards), and with guidance from identified experts from other institutions, such as University of Bergen (Norway) and Institute of Marine Research (Norway). The CVs of the PI, Lead Researcher and experts from collaborating institutions are included as appendices to the protocol.

Problem Statement / Rationale and Justification Aquatic foods can contribute greatly to nutrition but are often lacking from diets of the most vulnerable. Micronutrient deficiencies are persistent in Sub-Saharan Africa, contributing to serious public health issues (Stevens et al. 2022). Aquatic foods are rich in multiple micronutrients such as vitamins A and B12, iron, and zinc and are one of few natural dietary sources of vitamin D3, iodine, and eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) (two long-chain polyunsaturated fatty acids), which are often lacking in the diets of vulnerable populations. The fatty acids unique to aquatic foods, together with iodine, are necessary for cognitive development, not only during the first 1000 days but also in particular times of adolescence (referred to as "brain spurts") (Thatcher, 1991).Based on FAO Food Balance Sheets, per capita consumption of aquatic foods in Malawi is 10.1kg per annum, less than half the global average (FAO, 2024). Micronutrient deficiencies persist even in countries with relatively high aquatic food consumption, thus pointing to questions relating to quality of the aquatic foods consumed, quality of dietary intake data, or dietary equality, as per capita figures are based on averages and do not consider distribution of foods within the country, community or even within a household. Studies have shown that children's diets in Malawi are sub-optimal, e.g. only nine percent of children aged 6-23 months met minimum acceptable diet (National Statistical Office (NSO) 2021), and very few consume animal source foods such as fish. This is often due to lack of knowledge on the importance of fish for nutrition, or how to incorporate fish into the diets of young children. Several studies have shown that powder made from dried fish can be easily added to existing local recipes, is nutrient-rich (Abbey et al., 2016; Byrd et al., 2021, Bogard et al., 2015), acceptable in diets of young children in many countries (Glover-Amengor et al., 2012), including Malawi (Ahern et al., 2020), and has extended storage life (Ngóng'ola-Manani et al., 2020).

School meal programs offer an entry point for nutrition programs and introducing healthy diets; however they often lack nutritious foods such as fish and other aquatic foods. HGSF programs source ingredients locally but lack foods such as fish, often citing issues such as food safety and cost (Ahern et al. 2021). While there is general recognition that fish and aquatic foods are beneficial for nutrition, the potential benefits of inclusion of aquatic foods in school meal programs (and particularly HGSF programs) have not been studied. HGSF programs offer an entry point for encouraging healthy diets for schoolchildren and community development and contribute to the realization of sustainable development goals (SDGs) 1, 2, 3, 5, 12 and 14. The importance of HGSF for poverty alleviation (SDG1) and zero hunger (SDG 2) have been recognized by the UN Hunger Task Force as well as regional bodies such as African Union Development Agency - New Partnership for African Development (AUDA-NEPAD 2020).

Consumption of animal-source food such as fish with plant-source foods can have an enhancing effect on micronutrient absorption, but questions remain on how small quantities of fish can result in this effect. Consumption of aquatic animal-source foods can improve micronutrient absorption (particularly iron and zinc) from plant-source foods when consumed together (Consalez et al., 2022). Although several publications (Kawarazuka 2010; Kawarazuka and Béné 2011; Byrd et al. 2022; Michaelsen et al. 2009) point to the potential nutritional benefit of small amounts of fish added to meals, there is no empirical evidence. Little is known about the impact on nutritional status made by consumption of low doses of aquatic foods. The minimum quantity of fish that (Consalez et al. 2022) found evidence of for the enhancement of micronutrient absorption from plant-source foods was 40g . This RCT has high ecological relevance due to its real-life setting, as the low dosage of fish powder included in the intervention meal has been designed considering food preferences of schoolchildren, availability and accessibility of fish, and cost considerations for school feeding programs. The RCT will contribute to knowledge by exploring the dose-response relationship for low-dosages of fish (in powdered form) consumed regularly in school meals in selected regions and schools in Malawi .

There is need for evidence of the impact of school meals on nutrition status of schoolchildren, as well as nutrient content of locally produced foods in comparison to imported foods served in schools. The Global Child Nutrition Foundation (GCNF) survey of school meal programs in Malawi defined two key research priorities, including assessing students' nutritional status and class performance and investigating the difference in availability and nutrient content between locally produced foods and imported foods used in school feeding programs (GCNF 2018). Furthermore, there is a lack of knowledge on dietary diversity of schoolchildren, and consumption of aquatic foods in this critical period of growth, particularly through school feeding programmes. This RCT aims to fill these gaps, to build evidence of the nutritional importance of aquatic foods in school meals and contribute to knowledge on diets of schoolchildren in Malawi. The nutrient content of school meals served during the RCT will also be analyzed, contributing to knowledge on nutrient content of locally produced and imported foods used in school feeding programs.

In the past, insufficient funding has resulted in an inability to gather strong evidence of the importance of aquatic foods in school meals in LICs. Pilot programs including aquatic foods in school meals have been implemented by FAO and others in the past through small projects with limited funds, however little is known about the costs and benefits of these programs for consumers and producers. This lack of scientific evidence on costs and benefits to consumers and producers impacts sustainability of these initiatives beyond the termination of project funding. This RCT will complement the FAO FVC Sub-program by contributing to evidence on the costs and benefits of locally produced fish powder used in school feeding pilot programs in Malawi, to provide information which may support decision-making regarding longer-term sustainability of HGSF programs including aquatic food products (see Objectives and Methodology for further information).

Study Objectives The aim of the study is to assess the effects of school meals fortified with locally-produced fish powder on diet quality and nutritional outcomes of schoolchildren in selected Malawian schools, as compared to conventional school meals served in HGSF.

* Objective 1: Measure changes in zinc status of schoolchildren enrolled in a two-armed RCT * Objective 2: Measure changes in micronutrient status of schoolchildren enrolled in a two-armed RCT * Objective 3: Using questionnaires, assess changes in dietary diversity of schoolchildren

Methods / Experimental Design RCT Design The study has been planned as a two-armed single-blinded RCT with a closed cohort design, featuring two parallel groups with a 1:1 allocation ratio for intervention and control groups. The intervention group will receive the normal school meal with 3-5g of fish powder added to it, while the control group will receive the school meal as normal (with no added fish powder).

Null Hypothesis: Fish powder addition to school meals does not change zinc concentration measured in DBS collected from schoolchildren.

Alternative Hypothesis: Fish powder addition to school meals changes zinc concentration measured in DBS collected from schoolchildren.

Intervention and Study Period The intervention will take place during the 2026 school year, likely in the third school term, which runs from May to July. The timing was considered appropriate, as it is a time of year where fish are highly available from Lake Malawi and coincides with one school term. In the case that the intervention cannot take place in this school term, it will be conducted in the following school term, between September and December 2026. The overall FAO FVC Sub-program aims to work with fish processors to process fish powder at times of high fish availability and package and store fish powder so that sufficient quantities are available for the duration of the study.

Schools will receive grant money to purchase fish powder to be added to existing recipes used in schools, and school staff will be trained to prepare recipes. Fish powder was identified in a formative study completed by FAO and LUANAR (2023) as an acceptable product both for schoolchildren who participated in an acceptability trial as well as school health a

Interventions

  • Other Fish Powder
    This RCT aims to test the effectiveness of fish powder (produced from dried fish from Lake Malawi - Lake Malawi sardine) used to fortify school meals. The intervention meal will be the normal school meal, however substituing 3-5g of ingredients (such as soya flour, maize flour or groundnut flour) for 3-5g of fish powder.

Primary outcome measures

  • Zinc concentration in Dried Blood Spots [Time frame: 3-4 month school term (as defined by Malawi school calendar)]
Secondary outcome measures (2)
  • Micronutrient Status of children [Time frame: 3-4 month school term (as defined by Malawi school calendar)]
  • Diet Scores [Time frame: 3-4 month school term (as defined by Malawi school calendar)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

Malawi · 3 centers
  • School to be randomly selected prior to RCT — Mangochi
  • School to be randomly selected prior to RCT — Nkhotakota
  • School to be randomly selected prior to RCT — Salima

Identifiers

NCT: NCT07085871 · FAOFVCGLO188MUL · Project Code: FVC/GLO/188/MUL

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗