Abstract

Abstract Objectives Despite the multitude of evaluations of nutrition intervention trials in low-income settings, documented practice to operate such trials is scarce. We aimed to fill this gap by outlining key steps and resources required to run a small-scale intensive feeding trial such as establishing collaborations, developing an operational infrastructure, and daily orchestration of logistics for food preparation, delivery, and administration. Methods A randomized controlled feeding trial among 223 children in urban slums of Mumbai, India was completed in 2018. We established partnerships to facilitate the acquisition and proper storage of the study intervention, biofortified and conventional pearl millet. Feeding centers (FC) were identified based on a census. Two staff per FC managed daily operations: weighing and dispensing individual portions to participants based on their group allocation, recording of leftovers and adverse events. The study team developed and standardized recipes for all menu items. Development considered staple crop and nutrient density per serving, cost and availability of ingredients, and scalability. Highly accepted recipes were included in a cyclic menu. Hot meals were prepared in partnership with the university canteen, where a kitchen coordinator was responsible for daily quality control, aliquoting, and dispensation to contracted auto-drivers for FC delivery. A certified bakery produced customized shelf stable items in bulk. Items were vacuum packed individually, labeled, and delivered to FC directly. Shelf-life was tested periodically. Results Over 26 tons of crops were procured at a cost of 25,000 USD. The cost of preparing and delivering about 30,000 fresh meals was about 15,000 USD, while the cost of approximately 60,000 shelf stable meals was about 10,000 USD. Over 15 months, we served 91,815 meals at a cost of 0.59 USD/meal in the context of a randomized controlled feeding trial. Conclusions We highlight opportunities and challenges of developing a sustainable food supply system for an intervention trial. We also outline a sustainable model for delivery of nutrient-dense meals in partnership with small-scale producers instead of establishing a centralized kitchen to facilitate advocacy and scale up. Funding Sources HarvestPlus.

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