Using Novel Multimethod Evaluation Approaches to Understand Complex Food System Interventions: Insights from a Supply Chain Intervention Intended to Improve Nutrition.

Background: A "food system" approach to improve diet quality by intervening within areas such as food supply chains is gaining prominence. However, evidence of such interventions' impact, and understanding of appropriate methods to evaluate them, is lacking. Objectives: We present an impact evaluation of an intervention that aimed to increase consumption of nutritious foods by supporting food-producing firms in Kenya. In doing so, we demonstrate how multiple methods, including those from other disciplines, can be used to evaluate a complex food systems intervention. Methods: Four methods focused on food-producing firms and their management, including a survey of intervention participants (n = 83 individuals), a "laboratory-in-the-field" experiment (n = 83 individuals), baseline/endline data on firm performance (n = 71 firms), and semistructured interviews (n = 19 firms). Three methods focused on consumers in neighborhoods targeted by a supported firm: a randomized field experiment tested effects of making a supported product exhaustively available on consumers' purchases and consumption (n = 1295 consumers); 3 discrete choice experiments (n = 1295 consumers) tested factors influencing consumers' willingness to pay for foods with relevant characteristics. Results: Among firms, we saw suggestive evidence of increased networking and business relationships, while laboratory-in-the-field experiments indicated the intervention might foster cooperation among participants. Qualitative interviews suggested that the intervention enabled firms to increase production, improve management, increase revenues, and lower costs. Baseline/endline data confirmed a positive effect only on the launch of new products and hiring workers. In the field experiment, consumption of the supported product increased in areas where it was made available relative to a control group, but this did not increase overall consumption of the food type or dietary diversity. Conclusions: Results showed positive signs of the intervention improving firm-level outcomes but limited impact on consumers' diet quality. The evaluation also demonstrates how diverse methods can be used to evaluate complex interventions.

Food Systems Interventions for Nutrition: Lessons from 6 Program Evaluations in Africa and South Asia.

Although there is growing global momentum behind food systems strategies to improve planetary and human health-including nutrition-there is limited evidence of what types of food systems interventions work. Evaluating these types of interventions is challenging due to their complex and dynamic nature and lack of fit with standard evaluation methods. In this article, we draw on a portfolio of 6 evaluations of food systems interventions in Africa and South Asia that were intended to improve nutrition. We identify key methodological challenges and formulate recommendations to improve the quality of such studies. We highlight 5 challenges: a lack of evidence base to justify the intervention, the dynamic and multifaceted nature of the interventions, addressing attribution, collecting or accessing accurate and timely data, and defining and measuring appropriate outcomes. In addition to more specific guidance, we identify 6 cross-cutting recommendations, including a need to use multiple and diverse methods and flexible designs. We also note that these evaluation challenges present opportunities to develop new methods and highlight several specific needs in this space.

Bifidobacterium longum modifies a nutritional intervention for stunting in Zimbabwean infants.

Child stunting is an indicator of chronic undernutrition and reduced human capital. However, it remains a poorly understood public health problem. Small-quantity lipid-based nutrient supplements (SQ-LNS) have been widely tested to reduce stunting, but have modest effects. The infant intestinal microbiome may contribute to stunting, and is partly shaped by mother and infant histo-blood group antigens (HBGA). We investigated whether mother-infant fucosyltransferase status, which governs HBGA, and the infant gut microbiome modified the impact of SQ-LNS on stunting at age 18 months among Zimbabwean infants in the SHINE Trial ( NCT01824940 ). We found that mother-infant fucosyltransferase discordance and Bifidobacterium longum reduced SQ-LNS efficacy. Infant age-related microbiome shifts in B. longum subspecies dominance from infantis , a proficient human milk oligosaccharide utilizer, to suis or longum , proficient plant-polysaccharide utilizers, were partly influenced by discordance in mother-infant FUT2+/FUT3- phenotype, suggesting that a "younger" microbiome at initiation of SQ-LNS reduces its benefits on stunting.

A systematic review of the impacts of post-harvest handling on provitamin A, iron and zinc retention in seven biofortified crops.

Post-harvest handling can affect micronutrient retention in biofortified crops through to the point of consumption. Here we conduct a systematic review identifying 67 articles examining the retention of micronutrients in conventionally bred biofortified maize, orange sweet potato, cassava, pearl millet, rice, beans and wheat. Provitamin A crops maintain high amounts compared with non-biofortified counterparts. Iron and zinc crops have more variability in micronutrient retention dependent on processing method; for maximum iron and zinc content, whole grain product consumption such as whole wheat flour or only slightly milled brown rice is beneficial. We offer preliminary suggestions for households, regulatory bodies and programme implementers to increase consumer awareness on best practices for preparing crops to maximize micronutrient content, while highlighting gaps in the literature. Our online, interactive Micronutrient Retention Dashboard ( https://www.cpnh.cornell.edu/mn-retention-db ) offers an at-a-glance view of the compiled minimum and maximum retention found, organized by processing method.

Sensory acceptability of biofortified foods and food products: a systematic review.

CONTEXT: It is important to understand the sensory acceptability of biofortified food products among target population groups if biofortification is to be realized as a sustainable strategy for mitigation of micronutrient deficiencies, able to be scaled up and applied through programs. OBJECTIVE: This systemic review aims to summarize and synthesize the sensory acceptability of conventionally bred iron-, zinc-, and provitamin A-biofortified food products. DATA SOURCES: MEDLINE (PubMed), AGRICOLA, AgEcon, CABI Abstracts (Web of Science), and organizational websites (eg, those of HarvestPlus and CGIAR and their partners) were searched for relevant articles. No access to any market research that may have been internally conducted for the commercial biofortified food products was available. DATA EXTRACTION: This review identified articles measuring the sensory acceptability of conventionally bred biofortified food products. Extraction of the hedonic ratings of food products was performed. DATA ANALYSIS: An "Acceptability Index %" was defined based on hedonic scoring to determine an overall rating, and used to categorize biofortified food products as "acceptable" (≥70%) or "not acceptable" (<70%). Additionally, this review narratively synthesized studies using methods other than hedonic scoring for assessing sensory acceptability. CONCLUSIONS: Forty-nine studies assessed the acceptability of 10 biofortified crops among children and adults, in mostly rural, low-income settings across Africa, Latin America, and India; food products made from mineral and provitamin A-biofortified food products were generally acceptable. Compared with studies on provitamin-A biofortified food products, few studies (1 to 2 each) on mineral-enhanced crops such as rice, cowpeas, lentils, and wheat were found, limiting the generalizability of the findings. Similarly, few studies examined stored biofortified food products. Few commercial food products have so far been developed, although new varieties of crops are being continuously tested and released globally. Certain crop varieties were found to be acceptable while others were not, suggesting that particular varieties should be prioritized for scale-up. Determining sensory acceptability of biofortified food products is important for informing programmatic scale-up and implementation across diverse populations and settings.

Global Coverage of Mandatory Large-Scale Food Fortification Programs: A Systematic Review and Meta-Analysis.

Food fortification with micronutrients is widely implemented to reduce micronutrient deficiencies and related outcomes. Although many factors affect the success of fortification programs, high population coverage is needed to have a public health impact. We aimed to provide recent global coverage estimates of salt, wheat flour, vegetable oil, maize flour, rice, and sugar among countries with mandatory fortification legislation. The indicators were the proportion of households consuming the: food, fortifiable food (that is, industrially processed), fortified food (to any extent), and adequately fortified food (according to national or international standards). We estimated the number of individuals reached with fortified foods. We systematically retrieved and reviewed all applicable evidence from: published reports and articles from January 2010 to August 2021, survey lists/databases from key organizations, and reports/literature received from key informants. We analyzed data with R statistical package using random-effects meta-analysis models. An estimated 94.4% of households consumed salt, 78.4% consumed fortified salt (4.2 billion people), and 48.6% consumed adequately fortified salt in 64, 84, and 31 countries, respectively. Additionally, 77.4% of households consumed wheat flour, 61.6% consumed fortifiable wheat flour, and 47.1% consumed fortified wheat flour (66.2 million people) in 15, 8, and 10 countries, respectively, and 87.0% consumed vegetable oil, 86.7% consumed fortifiable oil, and 40.1% consumed fortified oil (123.9 million people) in 10, 7, and 5 countries, respectively. Data on adequately fortified wheat flour and vegetable oil and coverage indicators for maize flour, rice, and sugar were limited. There are major data gaps on fortification coverage for most foods except salt. All countries with mandatory fortification programs should generate and use more coverage data to assess program performance and adjust programs as needed to realize their potential to reduce micronutrient deficiencies (PROSPERO CRD42021269364).

Comparing two simplified questionnaire-based methods with 24-h recalls for estimating fortifiable wheat flour and oil consumption in Mandaluyong City, Philippines.

Information on fortifiable food consumption is essential to design, monitor and evaluate fortification programmes, yet detailed methods like 24-h recalls (24HRs) that provide such data are rarely conducted. Simplified questionnaire-based methods exist but their validity compared with 24HRs has not been shown. We compared two simplified methods (i.e., a household food acquisition and purchase questionnaire [FAPQ] and a 7-day semiquantitative food frequency questionnaire [SQ-FFQ]) against 24HRs for estimating fortifiable food consumption. We assessed the consumption of fortifiable wheat flour and oil using a FAPQ and, for wheat flour only, a 7-day SQ-FFQ and compared the results against 24HRs. The participants included children 12-18 months (n = 123) and their mothers 18-49 years selected for a study assessing child vitamin A intake and status in Mandaluyong City, Philippines. For fortifiable wheat flour, the FAPQ estimated considerably lower mean intakes compared to 24HRs for children and mothers (2.2 vs. 14.1 g/day and 5.1 vs. 42.3 g/day, respectively), while the SQ-FFQ estimated slightly higher mean intakes (15.7 vs. 14.1 g/day and 51.5 vs. 42.3 g/day, respectively). For fortifiable oil, the FAPQ estimated considerably higher mean intakes compared to 24HRs for children and mothers (4.6 vs. 1.8 g/day and 12.5 vs. 6.1 g/day, respectively). The SQ-FFQ, but not the FAPQ, generated useful information on fortifiable food consumption that can inform fortification programme design and monitoring decisions in the absence of more detailed individual-level data. Potential adaptations to improve the FAPQ, such as additional questions on foods prepared away from home and usage patterns, merit further research.

Impact of market-based home fortification with micronutrient powder on childhood anemia in Bangladesh: a modified stepped wedge design.

Background: Anemia poses a significant public health problem, affecting 1.6 billion people and contributing to the loss of 68.4 million disability-adjusted life years. We assessed the impact of a market-based home fortification program with micronutrient powder (MNP) called Pushtikona-5 implemented by Bangladesh Rural Advancement Committee (BRAC) on the prevalence of anemia among children aged 6-59 months in Bangladesh. Methods: We used a modified stepped wedged design and conducted three baseline, two midline, and three endline surveys to evaluate the Pushtikona-5 program implemented through three BRAC program platforms. We interviewed children's caregivers, and collected finger-prick blood samples from children to measure hemoglobin concentration. We also collected data on coverage of Pushtikona-5 and infant and young child feeding (IYCF) practices. We performed bivariate and multivariable analysis and calculated adjusted risk ratios (ARRs) to assess the effect of program outcomes. Results: A total of 16,936 households were surveyed. The prevalence of anemia was 46.6% at baseline, dropping to 32.1% at midline and 31.2% at endline. These represented adjusted relative reductions of 34% at midline (RR 0.66, 95%CI 0.62 to 0.71, value of p <0.001) and 32% at endline (RR 0.68, 95%CI 0.64 to 0.71, value of p <0.001) relative to baseline. Regarding MNP coverage, at baseline, 43.5% of caregivers surveyed had heard about MNP; 24.3% of children had ever consumed food with MNP, and only 1.8% had consumed three or more sachets in the 7 days preceding the survey. These increased to 63.0, 36.9, and 4.6%, respectively, at midline and 90.6, 68.9, and 11.5%, respectively, at endline. Conclusion: These results show evidence of a reduction in the prevalence of anemia and an improvement in coverage. This study provides important evidence of the feasibility and potential for impact of linking market-based MNP distribution with IYCF promotion through community level health workers.

Implementation and maintenance of infant dietary diversity in Zimbabwe: contribution of food and water insecurity.

BACKGROUND: Inadequate food and water resources negatively affect child health and the efficiency of nutrition interventions. METHODS: We used data from the SHINE trial to investigate the associations of food insecurity (FI) and water insecurity (WI) on mothers' implementation and maintenance of minimum infant dietary diversity (MIDD). We conducted factor analysis to identify and score dimensions of FI (poor access, household shocks, low availability & quality), and WI (poor access, poor quality and low reliability). MIDD implementation (n = 636) was adequate if infants aged 12 months (M12) ate ≥ four food groups. MIDD maintenance (n = 624) was categorized into four mutually exclusive groups: A (unmet MIDD at both M12 and M18), B (unmet MIDD at M12 only), C (unmet MIDD at M18 only), and D (met MIDD at both M12 and M18). We used multivariable-adjusted binary logistic and multinomial regressions to determine likelihood of MIDD implementation, and of belonging to MIDD maintenance groups A-C (poor maintenance groups), compared to group D, respectively. RESULTS: Low food availability & quality were negatively associated with implementation (OR = 0.81; 0.69, 0.97), and maintenance (ORB = 1.29; 1.07, 1.56). Poor water quality was positively associated with implementation (OR = 1.25; 1.08, 1.44), but inconsistently associated with maintenance, with higher odds of infants being in group C (OR = 1.39; 1.08, 1.79), and lower odds of being in group B (OR = 0.80; 0.66, 0.96). CONCLUSION: Food security should be prioritized for adequate implementation and maintenance of infant diets during complementary feeding. The inconsistent findings with water quality indicate the need for further research on WI and infant feeding.

Bioaccessibility and bioavailability of biofortified food and food products: Current evidence.

Biofortification increases micronutrient content in staple crops through conventional breeding, agronomic methods, or genetic engineering. Bioaccessibility is a prerequisite for a nutrient to fulfill a biological function, e.g., to be bioavailable. The objective of this systematic review is to examine the bioavailability (and bioaccessibility as a proxy via in vitro and animal models) of the target micronutrients enriched in conventionally biofortified crops that have undergone post-harvest storage and/or processing, which has not been systematically reviewed previously, to our knowledge. We searched for articles indexed in MEDLINE, Agricola, AgEcon, and Center for Agriculture and Biosciences International databases, organizational websites, and hand-searched studies' reference lists to identify 18 studies reporting on bioaccessibility and 58 studies on bioavailability. Conventionally bred biofortified crops overall had higher bioaccessibility and bioavailability than their conventional counterparts, which generally provide more absorbed micronutrient on a fixed ration basis. However, these estimates depended on exact cultivar, processing method, context (crop measured alone or as part of a composite meal), and experimental method used. Measuring bioaccessibility and bioavailability of target micronutrients in biofortified and conventional foods is critical to optimize nutrient availability and absorption, ultimately to improve programs targeting micronutrient deficiency.

Micronutrient deficiencies among preschool-aged children and women of reproductive age worldwide: a pooled analysis of individual-level data from population-representative surveys.

BACKGROUND: Micronutrient deficiencies compromise immune systems, hinder child growth and development, and affect human potential worldwide. Yet, to our knowledge, the only existing estimate of the global prevalence of micronutrient deficiencies is from over 30 years ago and is based only on the prevalence of anaemia. We aimed to estimate the global and regional prevalence of deficiency in at least one of three micronutrients among preschool-aged children (aged 6-59 months) and non-pregnant women of reproductive age (aged 15-49 years). METHODS: In this pooled analysis, we reanalysed individual-level biomarker data for micronutrient status from nationally representative, population-based surveys. We used Bayesian hierarchical logistic regression to estimate the prevalence of deficiency in at least one of three micronutrients for preschool-aged children (iron, zinc, and vitamin A) and for non-pregnant women of reproductive age (iron, zinc, and folate), globally and in seven regions using 24 nationally representative surveys done between 2003 and 2019. FINDINGS: We estimated the global prevalence of deficiency in at least one of three micronutrients to be 56% (95% uncertainty interval [UI] 48-64) among preschool-aged children, and 69% (59-78) among non-pregnant women of reproductive age, equivalent to 372 million (95% UI 319-425) preschool-aged children and 1·2 billion (1·0-1·4) non-pregnant women of reproductive age. Regionally, three-quarters of preschool-aged children with micronutrient deficiencies live in south Asia (99 million, 95% UI 80-118), sub-Saharan Africa (98 million, 83-113), or east Asia and the Pacific (85 million, 61-110). Over half (57%) of non-pregnant women of reproductive age with micronutrient deficiencies live in east Asia and the Pacific (384 million, 279-470) or south Asia (307 million, 255-351). INTERPRETATION: We estimate that over half of preschool-aged children and two-thirds of non-pregnant women of reproductive age worldwide have micronutrient deficiencies. However, estimates are uncertain due to the scarcity of population-based micronutrient deficiency data. FUNDING: US Agency for International Development.

A review of portable quantitative and semi-quantitative devices for measurement of vitamin A in biological samples.

Background: We catalog and summarize evidence of the analytical performance of portable quantitative and semi-quantitative devices for the assessment of vitamin A status and vitamin A deficiency (VAD) in various biological samples-including whole blood, plasma, serum, and milk-in addition to VAD determination by functional indicators such as pupillary response. Methods: We searched the literature for published research articles, patents, and information from manufacturers of mobile devices, particularly those appropriate for low-resource settings. The included devices were required to be portable (lightweight and ideally not needing a power outlet) and to measure vitamin A as well as define VAD. Eligible studies compared a portable device to a reference standard of high-performance liquid chromatography for blood and milk, or a Goldmann-Weekers dark adaptometer for eyes/vision. Where available, identified devices were compared with reference methods across several performance criteria. When possible, we compared the device's performance reported in published studies against the stated performance criteria from the manufacturers' websites. Results: We catalogued 25 portable devices for measuring vitamin A and/or VAD via biological samples. We also identified 18 comparison studies (plus associated reports) assessing nine methods: the iCheck Fluoro, iCheck Carotene, CRAFTi, Tidbit with or without the HYPER filtration system, custom field-friendly immunoassays, and microfluidic assays for blood; the iCheck Fluoro and iCheck Carotene for milk; and the Scotopic Sensitivity Tester-1 for eye function. Conclusions: The iCheck Fluoro and iCheck Carotene are commercially available for use and are acceptable for measuring vitamin A in blood and milk samples, according to the available validation data. Many of the other identified devices, including other portable fluorometers, photometers, immunoassays, microfluidics-based devices, and dark adaptometers, were proofs of concept and not yet commercially available. Furthermore, none of these other devices included manufacturer-described device performance criteria to compare with descriptions from experimental studies. Several gaps remain, including studies comparing the other portable devices against a reference standard, particularly for functional indicators of vitamin A status/deficiency; available manufacturer-reported device performance criteria against which to compare future results of investigations; and more comprehensive reporting of validation metrics including sensitivity, specificity, precision, and Bland-Altman analysis.

Preventive small-quantity lipid-based nutrient supplements reduce severe wasting and severe stunting among young children: an individual participant data meta-analysis of randomized controlled trials.

BACKGROUND: Meta-analyses show that small-quantity lipid-based nutrient supplements (SQ-LNSs) reduce child wasting and stunting. There is little information regarding effects on severe wasting or stunting. OBJECTIVES: We aimed to identify the effect of SQ-LNSs on prevalence of severe wasting (weight-for-length z score < -3) and severe stunting (length-for-age z score < -3). METHODS: We conducted a 2-stage meta-analysis of individual participant data from 14 randomized controlled trials of SQ-LNSs provided to children 6-24 mo of age. We generated study-specific and subgroup estimates of SQ-LNS compared with control and pooled the estimates using fixed-effects models. We used random-effects meta-regression to examine study-level effect modifiers. In sensitivity analyses, we examined whether results differed depending on study arm inclusion criteria and types of comparisons. RESULTS: SQ-LNS provision led to a relative reduction of 31% in severe wasting [prevalence ratio (PR): 0.69; 95% CI: 0.55, 0.86; n = 34,373] and 17% in severe stunting (PR: 0.83; 95% CI: 0.78, 0.90; n = 36,795) at endline. Results were similar in most of the sensitivity analyses but somewhat attenuated when comparisons using passive control arms were excluded (PR: 0.74; 95% CI: 0.57, 0.96; n = 26,327 for severe wasting and PR: 0.88; 95% CI: 0.81, 0.95; n = 28,742 for severe stunting). Study-level characteristics generally did not significantly modify the effects of SQ-LNSs, but results suggested greater effects of SQ-LNSs in sites with greater burdens of wasting or stunting, or with poorer water quality or sanitation. CONCLUSIONS: Including SQ-LNSs in preventive interventions to promote healthy child growth and development is likely to reduce rates of severe wasting and stunting. This meta-analysis was registered at www.crd.york.ac.uk/PROSPERO as CRD42019146592.

Portable Devices for Measurement of Vitamin A Concentrations in Edible Oil: Field Readiness of Available Options.

Vitamin A (VA) deficiency continues to be a major global health issue, despite measures to increase VA intake via consumption of staple foods such as edible oil. Portable quantitative and semiquantitative devices or test kits for internal quality control have the potential to overcome some of the limitations of traditional methods of testing, such as centralized laboratory, expensive equipment, and specially trained staff. This landscape analysis and comprehensive systematic mini-review catalogs and summarizes evidence on the analytical performance of portable quantitative and semiquantitative devices and test kits for the analysis of VA in edible oil. Studies or reports detailing the usability and validation of portable devices and/or test kits, as well as studies comparing device/test kit performance to a reference standard such as high-performance liquid chromatography (HPLC), were included. Identified devices and test kits were compared for performance versus the reference standard, usability, availability, and other characteristics. We identified four portable methods: two devices, the iCheck CHROMA and iCheck Chroma 3 from BioAnalyt; and two test kits, the QuickView from Bagco Enterprises and the Strategic Alliance for the Fortification of Vegetable Oils (SAFO) Test Kit by Badische Anilin and Soda Fabrik (BASF). Included studies reported the following: an internal validation of the portable method, a comparison of the portable method against a reference standard, a comparison of the portable method against another portable method, and several videos and company websites, which detailed device characteristics. iCheck CHROMA and QuickView quantified VA concentrations with high accuracy and precision compared to the reference standard for field-based quantification, were user-friendly, and provided results within 5 min. iCheck Chroma 3 requires more robust validation against a reference standard. We did not find data on internal validation or comparison against a reference standard for the current version of the SAFO test. Compared to QuickView and SAFO, the iCheck devices can transfer results to a hard drive or the Web, have an online order form for purchase, and meet a minimal set of criteria for point-of-need devices. iCheck, QuickView, and SAFO can quantify VA concentrations in the edible oils tested and determine whether a fortified oil meets country standards. Additional research is needed to validate these devices and test kits across additional oil types and document the ability to meet the minimal criteria for point-of-need devices suggested in this mini-review. Validation against a reference standard is required for SAFO. The limited number of portable methods available may be due to market saturation. Future market and use case analyses to inform the market size and utility of the different tests with publicly available data will allow new manufacturers, particularly those in lower-to-middle-income countries, to enter the market.

Evaluating the impact of a countrywide, market-based roll-out of multiple micronutrient supplementation on low birth weight in Bangladesh: protocol for a two-arm, quasi-experimental and mixed-methods evaluation study.

INTRODUCTION: Multiple micronutrient supplementation (MMS) during pregnancy has a greater potential for reducing the risk of low birth weight (LBW) compared with the standard iron-folic acid supplementation. WHO recently included MMS on their Essential Medicines List. The Social Marketing Company (SMC) in Bangladesh is implementing a countrywide, market-based roll-out of MMS to pregnant women. We aimed to evaluate the implementation of the supplementation programme and its impact on reducing LBW. METHODS AND ANALYSIS: A two-arm, quasi-experimental and mixed-methods evaluation design will be used to evaluate the impact of this 36-month roll-out of MMS. In the intervention areas, pregnant women will purchase MMS products from the SMC's pharmacy networks. Pregnant women in comparison areas will not be exposed to this product until the end of the study. We will collect 4500 pregnant women's data on anthropometric, socioeconomic, nutrition-related and relevant programme indicators during recruitment and bimonthly follow-up until the end of their pregnancy. We will measure children's birth weight within 72 hours of birth and evaluate the changes in LBW prevalence. We will observe market-based MMS service delivery-related conditions of the pharmacies and the quality of the provider's service delivery. Concurrently, we will carry out a process evaluation to appraise the programme activities and recommend course correction. Cluster-adjusted multivariable logistic regression or log-binomial regression analysis of quantitative outcome data will be performed. For qualitative data, we will follow a thematic analysis approach. We will consolidate our study findings by triangulating the data derived from different methods. ETHICS AND DISSEMINATION: This study received ethical approval from the institutional review board of icddr,b (PR number 21001). We will recruit eligible participants after obtaining their informed written/verbal consent (and assent where needed) with full disclosure about the study. The results will be disseminated through peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: NCT05108454.

Update on Analytical Methods and Research Gaps in the Use of Household Consumption and Expenditure Survey Data to Inform the Design of Food-Fortification Programs.

The lack of nationally representative, individual-level dietary intake data has led researchers to increasingly turn to household-level data on food acquisitions and/or consumption to inform the design of food-fortification programs in low- and middle-income countries (LMICs). These nationally representative, household-level data come from household consumption and expenditure surveys (HCESs), which are collected regularly in many LMICs and are often made publicly available. Our objectives were to examine the utility of HCES data to inform the design of food-fortification programs and to identify best-practice methods for analyzing HCES data for this purpose. To this end, we summarized information needed to design fortification programs and assessed the extent to which HCES data can provide corresponding indicators. We concluded that HCES data are well suited to guide the selection of appropriate food vehicles, but because individual-level estimates of apparent nutrient intakes rely on assumptions about the intrahousehold distribution of food, more caution is advised when using HCES data to select the target micronutrient content of fortified foods. We also developed a checklist to guide analysts through the use of HCES data and, where possible, identified research-based, best-practice analytical methods for analyzing HCES data, including selecting the number of days of recall data to include in the analysis and converting reported units to standard units. More research is needed on how best to deal with composite foods, foods consumed away from home, and extreme values, as well as the best methods for assessing the adequacy of apparent intakes. Ultimately, we recommend sensitivity analyses around key model parameters, and the continual triangulation of HCES-based results with other national and subnational data on food availability, dietary intake, and nutritional status when designing food-fortification programs.

Decisions to Start, Strengthen, and Sustain Food Fortification Programs: An Application of the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Evidence to Decision (EtD) Framework in Nigeria.

Background: Although the potential impact of food fortification to improve the micronutrient status of populations has been demonstrated beyond a doubt, it is constrained in practice by critical gaps in program design and implementation. These are partly linked to suboptimal decision making. Objectives: We aimed to demonstrate how the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Evidence to Decision (EtD) framework for health system and public health decisions can be applied to formulate recommendations and make decisions in national food fortification programming. Methods: Following a program impact pathway, we reviewed the literature to define the key decision types and identify the corresponding decision makers necessary for designing and implementing effective food fortification programs. We then applied the GRADE EtD framework to the Nigerian fortification program to illustrate how evidence-informed assessments and conclusions can be made. Results: Fortification program decisions were classified into 5 types: 1) program initiation; 2) program design; 3) program delivery; 4) program impact; and 5) program continuation. Policymakers, food processors, and (in cases dependent on or considering external funding) development partners are the main decision makers in a fortification program, whereas technical partners play important roles in translating evidence into contextualized recommendations. The availability and certainty of evidence for fortification programs are often low (e.g., quality and coverage data are not routinely collected and there are challenges evaluating impact in such population-based programs using randomized controlled trials) yet decisions must still be made, underscoring the importance of using available evidence. Furthermore, when making program initiation and continuation decisions, coordination with overlapping micronutrient interventions is needed where they coexist. Conclusions: This framework is a practical tool to strengthen decision-making processes in fortification programs. Using evidence in a systematic and transparent way for decision making can improve fortification program design, delivery, and ultimately health impacts.

Review of the Impact Pathways of Biofortified Foods and Food Products.

Biofortification is the process of increasing the concentrations and/or bioavailability of micronutrients in staple crops and has the potential to mitigate micronutrient deficiencies globally. Efficacy trials have demonstrated benefits of consuming biofortified crops (BFCs); and in this paper, we report on the results of a systematic review of biofortified crops effectiveness in real-world settings. We synthesized the evidence on biofortified crops consumption through four Impact Pathways: (1) purchased directly; (2) in informal settings; (3) in formal settings; or (4) in farmer households, from their own production. Twenty-five studies, covering Impact Pathway 1 (five studies), Impact Pathway 2 (three), Impact Pathway 3 (three), Impact Pathway 4 (21) were included. The review found evidence of an improvement in micronutrient status via Impact Pathway 4 (mainly in terms of vitamin A from orange sweet potato) in controlled interventions that involved the creation of demand, the extension of agriculture and promotion of marketing. In summary, evidence supports that biofortified crops can be part of food systems interventions to reduce micronutrient deficiencies in farmer households; ongoing and future research will help fully inform their potential along the other three Impact Pathways for scaling up.

Making programmes worth their salt: Assessing the context, fidelity and outcomes of implementation of the double fortified salt programme in Uttar Pradesh, India.

Double fortified salt (DFS) has proven efficacy in addressing iron deficiency and anaemia, thus improving maternal and child nutrition outcomes. However, DFS delivery in large-scale settings is less understood, with limited documentation of its fidelity of implementation (FOI). We assessed the FOI of the DFS intervention in Uttar Pradesh, India, to improve the design and implementation of such programmes that aim to reduce the anaemia burden, especially in women of reproductive age (WRA). We conducted in-depth interviews with DFS programme staff (n = 25) and end-user WRAs (23), guided by a programme impact pathway. We transcribed and thematically analysed the interviews and used an adapted analytic framework to document FOI across four domains-objects of intervention, implementation staff, implementation context and target of implementation. DFS utilisation remained low due to a combination of factors including poor product quality, distribution challenges, ineffective promotion and low awareness amongst end-user WRAs. Motivation levels were higher amongst district-level staff compared to frontline staff, who lacked supervisory support and effective incentives to promote DFS. Three typologies of DFS users emerged-'believers', 'thrifters' and 'naysayers'-who indicated differing reasons for DFS purchase and its use or nonuse. The implementation of the DFS programme varied significantly from its theorised programme impact pathway. The adapted analytic framework helped document FOI and assess the programme's readiness for impact assessments and subsequent scale-up. The programme needs product quality improvements, incentivised distribution and stronger promotion to effectively deliver and improve the realisation of its potential as an anaemia prevention strategy.