Nourishing for Knowledge: Fish Powder in School Meals in Malawi

NCT07085871 | Not Yet Recruiting

• 2 other identifiers: FAOFVCGLO188MULProject Code: FVC/GLO/188/MUL
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 3

Brief Summary

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).

Conditions

Zinc Concentration in DBS

Keywords

Fish; Fish powder; schoolchildren; zinc; DBS

Outcome Measures

Primary Outcomes (1)

• Zinc concentration in Dried Blood Spots

  Difference between the two arms in the contribution of school meals to zinc concentration (mcg/dL) in DBS collected from selected school children.

  3-4 month school term (as defined by Malawi school calendar)

Secondary Outcomes (2)

• 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)

Study Arms (2)

School Meal + Fish Powder

EXPERIMENTAL

The intervention meals will aim to align with the nutrition standards defined by the Government of Malawi, or those developed by FAO and WFP if none are available. Recipes have been developed in line with the Government of Malawi and WFP Home-Grown School Feeding Recipe Book. The total weight of the dried ingredients in the control and treatment meals is equal in the two scenarios proposed below (i.e. there is a direct substitution of ingredients - 5 g of groundnut flour is substituted for 5 g of fish powder in the treatment meals). This was done as school feeding programs are usually on a tight budget, and adding more food may not be feasible. Thus, the total amount of food is not changed, but the number of ingredients increases by one, to include fish powder.

Other: Fish Powder

Normal School Meal

NO INTERVENTION

This arm will receive the school meal as normal, with no additional ingredient.

Interventions

Fish Powder OTHER

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.

School Meal + Fish Powder

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Food and Agriculture Organization of the United Nations (FAO): lead
• Institute of Marine Research: collaborator
• University of Bergen: collaborator
• Lilongwe University of Agriculture and Natural Resources (LUANAR): collaborator

Study Sites (3)

School to be randomly selected prior to RCT

Mangochi, Malawi

Location

School to be randomly selected prior to RCT

Nkhotakota, Malawi

Location

School to be randomly selected prior to RCT

Salima, Malawi

Location

Related Links

• Link to FAO project webpage. The RCT will be conducted as part of this project.

Study Officials

• Alexander Kalimbira, PhD

  Lilongwe University of Agriculture and Natural Resources

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Molly Ahern, MSc

CONTACT

+393208378235; molly.ahern@fao.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: July 25, 2025
• Study Start: April 15, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: July 25, 2025

Record last verified: 2025-07

Locations

MA (3)